“Alzheimer’s is open for business:” Controversial FDA approval could pave the way for future drugs

On Monday, a 17-year drought in the world of Alzheimer’s drugs ended with the FDA approval of Biogen’s Aduhlem (aducanumab). The controversy behind the FDA’s decision was considerable, but it doesn’t seem to be spooking drug developers who are now narrowing in on the degenerative brain disease. 

In a nutshell, the approval of Aduhelm came after conflicting results from clinical trials. In November 2020 an independent FDA advisory board did not recommend that the agency endorse the drug, but in June, the agency approved the drug anyway via an Accelerated Approval Program. 

Aduhelm is now the first novel treatment to address one underlying cause of Alzheimer’s – beta-amyloid plaques that accumulate in the brain. 

The drug received support from patient and industry groups (the FDA also noted that the “need for treatment is urgent”, in a statement explaining the agency’s choice). Still, there have been a number of doctors who have expressed concern. One member of the expert committee that voted not to recommend the approval of Aduhelm back in November has resigned since the announcement.

However, the inconsistency of the science and highly public debate around the approval of Aduhelm doesn’t seem to have halted enthusiasm within the pharmaceutical industry. Rather, it may signal a new wave of additional treatments in the next few years, which will piggyback off of the approval of Aduhelm (however controversial that approval may be).

“This is great news for investors and for drug companies that are working towards new drugs,” says Alison Ward, a research scientist at the USC Schaeffer Center for Health Policy and Economics. 

Historically there have been a few factors that have made the development of a drug for Alzheimer’s an uphill battle. 

The first, is a 17-year history of failure to bring a drug through clinical trials. Even Biogen’s clinical trials for Aduhelm were halted in 2019 because it wasn’t clear that they would reach their clinical endpoints (effectively, the target outcomes of the trial). In fact, Aduhlem was approved based on a “surrogate endpoint,” the decline of beta-amyloid, not the primary endpoint, cognitive function. 

Trials for Alzheimer’s drugs have also historically been expensive. A 2018 paper in Alzheimer’s and Dementia: Translational Research and Clinical Interventions (a journal run by the Alzheimer’s Association) estimated that the cost of developing an Alzheimer’s drug was about $5.6 billion. By comparison, the mean investment needed to bring a new drug to market is about $1.3 billion according to analysis of SEC filings for companies that applied for FDA approval between 2009 and 2018 (though the median cost was about $985 million). Older estimates have put the costs of bringing a drug to market at $2.8 billion

For Alzheimer’s specifically, Phase 3 trials are still largely sponsored by industry, but over the past five years, trials sponsored solely by the industry have decreased. Government grants and funding via public-private partnerships have made up an increasing share of available funds.

Martin Tolar, the founder CEO of Alzheon, another company pursuing an oral treatment for Alzheimer’s (currently in a phase 3 clinical trial), says that attracting other forms of funding was a challenge. 

“It was impossible to finance anything,” he says. “It was impossible to get Wall Street interested because everything was failing one after the other after the other.” 

He expects this recent approval of Aduhelm to change that outlook considerably. Already, we are seeing some increased interest in companies already in phase 3 clinical trials: After the FDA announcement, shares of Eli Lilly, also running a phase 3 clinical trial, surged by 10 percent

“I’ve had probably hundreds of discussions, of calls, from bankers, investors, collaborators, pharma, you name it,” Tolar says. “Alzheimer’s is open for business.”

With renewed interest and what appears like a pathway to approval at the FDA, the environment for the next generation of Alzheimer’s drugs seems to be ripening. Right now, there are about 130 phase 3 clinical trials on Alzheimer’s drugs that are either completed, active or recruiting. 

Tolar sees the FDA decision, based on imperfect data, as a “signal of urgency” to approve new treatments that are imminent arrivals. 

As Ward pointed out in a white paper on in-class drug innovation, “follow on” drugs go on to become leaders in the industry, especially if they demonstrate better safety or efficacy than the drug that was first to market.  That, the paper argues, suggests drug approval may “pave the way” for more effective drugs in the future. 

In the case of Alzheimer’s, it might not be one drug that dominates, even as more get approved, she notes. Rather, a cadre of new, approved drugs may go on to compliment one another.

“The way that the medical community is thinking of AD [Alzheimer’s Disease] now is that it’s likely going to be a combination of drugs or a cocktail of drugs that comes together to have true success at delaying progression,” she says.  

“If we’re looking to treat AD with a cocktail of drugs, history suggests it’s individually approved drugs that come together to make those drug cocktails.” 

There are still some potential pitfalls for future drugs to consider. One argument is that with an approved drug available, it may be more difficult to recruit participants in clinical trials, slowing the pace of drug discovery. In that respect, Ward argues that this will ultimately be dwarfed by patients who will now look into a potential diagnosis for Alzheimer’s now that there’s something to treat it with. 

There’s also the fact that Aduhelm’s costs are high (about $56,000 for a year’s supply, the brunt of which will be borne by Medicare), and the data remains questionable. Those factors may push patients towards other drugs, even if they’re in clinical trials. 

Additionally, there is the question of how well Aduhelm actually performs during the critical followup study mandated by the FDA as a condition of the drug’s approval. Whether Aduhelm can truly slow cognitive decline, as well as help address levels of beta-amyloid from the brain, remains questionable based on current data. 

Still, Tolar doesn’t see the results of that study as particularly relevant because the industry will have moved on. Biogen CEO Michel Vounatsos has said it may not share results of this trial for as many as nine years, though he noted the company would try to deliver data sooner. 

 “There will be better drugs by then,” Tolar predicts. 

Tolar’s phase 3 clinical trial just began dosing this week, and is scheduled to end by 2024

Biogen and Esai will likely also have another drug ready for evaluation by then, as two phase 3 clinical trials for another beta-amyloid antibody treatment called lecanemab are scheduled for completion by 2024 and 2027

The signal sent by Monday’s approval may be a pathway for future drugs, rather than an end itself. The data is imperfect, the costs high, and the controversy considerable, but the band-aid has been ripped off. 

#dementia, #drug-development, #drug-discovery, #health, #life-sciences, #tc, #therapeutics

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After contentious debate, FDA approves first Alzheimer’s drug since 2003

On Monday, the US Food and Drug Administration granted approval to a keenly-watched Alzheimer’s drug, aducanumab, developed by the drugmaker Biogen. The decision to approve the drug, which was once abandoned as a failure, has been the subject of debate within the scientific and regulatory community for months.

Aducanumab, which will be marketed as Aduhelm, is the first novel Alzheimer’s treatment to be approved since 2003, the FDA noted in a press release. Aducanumab is also the first novel treatment designed to address one of several proposed underlying causes of Alzheimer’s: the buildup of beta-amyloid plaques in the brain that disrupt the communication of neurons. 

Critically, the drug received a conditional form of FDA approval called the ‘Accelerated Approval Program.’ The accelerated approval pathway is designed to provide early access to drugs for serious conditions if they address markers of disease – even when the FDA has misgivings about the overall results of clinical trials. Because of this, Biogen will still have to conduct a post-approval confirmatory trial of aducanumab. 

If the drug does not work as intended, we can take steps to remove it from the market. But hopefully, we will see further evidence of benefit in the clinical trial and as greater numbers of people receive Aduhelm,” the FDA statement reads. 

TechCrunch has contacted Biogen for comment on the upcoming confirmatory trial, and will update this story with Biogen’s response. 

The use of the accelerated approval pathway is clearly intended to address lingering controversies that have plagued aducanumab in the months leading up to the FDA’s ruling. 

In early-stage trials, there were promising signs that aducanumab might slow cognitive decline, a major Alzheimer’s symptom. In a 2016 trial published in the journal Nature, 125 patients with mild or moderate Alzheimer’s who received monthly infusions of the drug saw levels of plaques decrease, as did symptoms of cognitive decline. 

The decline of the plaques in the brain were “robust and unquestionable” as one Lancet Neurology paper puts it, but the clinical findings were more modest – it wasn’t clear exactly how much people’s cognitive ability benefitted from the treatment. 

These early trials eventually led the FDA to allow the drug to skip phase 2 clinical trials, which are designed to identify dosages of the drug, and proceed directly to phase 3 clinical trials. This move was criticized by some physicians. 

Those phase 3 clinical trials, called ENGAGE and EMERGE, have become the center of tension. Both trials tested monthly intravenous injections of the drug on about 1600 patients with early Alzheimer’s. In 2019, both trials were halted because the drug didn’t appear to be slowing cognitive decline, the primary endpoint of the trials. 

Additional data analyzed in late 2019 from the EMERGE trial suggested that the drug was linked with a 23 percent less cognitive decline, compared to a placebo. There were side effects: namely swelling and inflammation of the brain. This was seen in about 40 percent of Phase 3 trial participants, though most were symptomatic and most of those with symptoms (headache, nausea, visual disturbances) resolved after 4-16 weeks. 

Still, even the new data wasn’t enough to convince an independent FDA advisory committee, who, in November 2020 did not endorse approval of the drug. 

On Monday, The FDA, argued that the drug’s effects on beta-amyloid plaques were strong enough to suggest that benefit outweighed the risk. Critically, the FDA did not comment on the strength of clinical outcomes – in short, the agency is basing this approval on the drug’s ability to address beta-amyloid plaques, not how well each patient cognitive function responds to the drug. The followup study will need to address that outcome directly. 

Still, about 6 million people have Alzheimer’s in the US, and patient organizations have rallied in response to this drug. The Alzheimer’s Association has hailed the drug as a “victory for people living with Alzheimer’s.” 

Ahead of the FDA’s decision on Monday, it was clear that, should aducanumab be approved, it would soon become a “blockbuster drug.” The financial picture around the drug seems to support that idea. 

Trading of Biogen shares were initially halted, but have since jumped 40 percent today, following the announcement. Shares of Eisai Co. Ltd, a Japanese company working with Biogen jumped over 46 percent in the first three hours following the FDA’s approval. 

Certainly, Biogen was banking on this approval as a long-term strategy. In an April 2021, earnings presentation, the company estimated that there were 600 sites ready to launch the treatment post-approval. Biogen has also submitted marketing authorization applications for aducanumab in Brazil, Canada, Switzerland and Australia. On June 7, the company announced that a year’s supply of the drug would cost $56,000

In the wider world of Alzheimer’s drugs, it’s possible other companies may see this approval as proof-of-concept for other drugs targeting beta amyloid plaques. 

In an editorial that accompanied the 2016 Nature paper on aducanumab, Eric Reiman, executive director of Banner Alzheimer’s Institute, argued that scientific confirmation that beta-amyloid-targeted treatment slows cognitive decline would be a “game changer.” The aducanumab trials have been likened to a test of this idea. Speaking to The Financial Times, Howard Filit, founding executive director of the Alzheimer’s Drug Discovery Foundation, called aducanumab “the first rigorous test of the beta-amyloid hypothesis.”

In that sense, conditional approval may indicate that the FDA is sympathetic to this form of Alzheimer’s treatment. 

There’s at least one more beta-amyloid targeted drug from a major drugmaker (Eli Lilly) clinical trials. We may see some more of them emerge soon, provided that Biogen’s confirmatory study of aducanumab doesn’t prompt the FDA to withdraw approval. 

 

#alzheimers, #drug-discovery, #life-sciences, #pharmaceuticals, #tc

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Artificial raises $21M led by Microsoft’s M12 for a lab automation platform aimed at life sciences R&D

Automation is extending into every aspect of how organizations get work done, and today comes news of a startup that is building tools for one industry in particular: life sciences. Artificial, which has built a software platform for laboratories to assist with, or in some cases fully automate, research and development work, has raised $21.5 million.

It plans to use the funding to continue building out its software and its capabilities, to hire more people, and for business development, according to Artificial’s CEO and co-founder David Fuller. The company already has a number of customers including Thermo Fisher and Beam Therapeutics using its software directly and in partnership for their own customers. Sold as aLab Suite, Artificial’s technology can both orchestrate and manage robotic machines that labs might be using to handle some work; and help assist scientists when they are carrying out the work themselves.

“The basic premise of what we’re trying to do is accelerate the rate of discovery in labs,” Fuller said in an interview. He believes the process of bringing in more AI into labs to improve how they work is long overdue. “We need to have a digital revolution to change the way that labs have been operating for the last 20 years.”

The Series A is being led by Microsoft’s venture fund M12 — a financial and strategic investor — with Playground Global and AME Ventures also participating. Playground Global, the VC firm co-founded by ex-Google exec and Android co-creator Andy Rubin (who is no longer with the firm), has been focusing on robotics and life sciences and it led Artificial’s first and only other round. Artificial is not disclosing its valuation with this round.

Fuller hails from a background in robotics, specifically industrial robots and automation. Before founding Artificial in 2018, he was at Kuka, the German robotics maker, for a number of years, culminating in the role of CTO; prior to that, Fuller spent 20 years at National Instruments, the instrumentation, test equipment and industrial software giant. Meanwhile, Artificial’s co-founder, Nikhita Singh, has insight into how to bring the advances of robotics into environments that are quite analogue in culture. She previously worked on human-robot interaction research at the MIT Media Lab, and before that spent years at Palantir and working on robotics at Berkeley.

As Fuller describes it, he saw an interesting gap (and opportunity) in the market to apply automation, which he had seen help advance work in industrial settings, to the world of life sciences, both to help scientists track what they are doing better, and help them carry out some of the more repetitive work that they have to do day in, day out.

This gap is perhaps more in the spotlight today than ever before, given the fact that we are in the middle of a global health pandemic. This has hindered a lot of labs from being able to operate full in-person teams, and increased the reliance on systems that can crunch numbers and carry out work without as many people present. And, of course, the need for that work (whether it’s related directly to Covid-19 or not) has perhaps never appeared as urgent as it does right now.

There have been a lot of advances in robotics — specifically around hardware like robotic arms — to manage some of the precision needed to carry out some work, but up to now no real efforts made at building platforms to bring all of the work done by that hardware together (or in the words of automation specialists, “orchestrate” that work and data); nor link up the data from those robot-led efforts, with the work that human scientists still carry out. Artificial estimates that some $10 billion is spent annually on lab informatics and automation software, yet data models to unify that work, and platforms to reach across it all, remain absent. That has, in effect, served as a barrier to labs modernising as much as they could.

A lab, as he describes it, is essentially composed of high-end instrumentation for analytics, alongside then robotic systems for liquid handling. “You can really think of a lab, frankly, as a kitchen,” he said, “and the primary operation in that lab is mixing liquids.”

But it is also not unlike a factory, too. As those liquids are mixed, a robotic system typically moves around pipettes, liquids, in and out of plates and mixes. “There’s a key aspect of material flow through the lab, and the material flow part of it is much more like classic robotics,” he said. In other words, there is, as he says, “a combination of bespoke scientific equipment that includes automation, and then classic material flow, which is much more standard robotics,” and is what makes the lab ripe as an applied environment for automation software.

To note: the idea is not to remove humans altogether, but to provide assistance so that they can do their jobs better. He points out that even the automotive industry, which has been automated for 50 years, still has about 6% of all work done by humans. If that is a watermark, it sounds like there is a lot of movement left in labs: Fuller estimates that some 60% of all work in the lab is done by humans. And part of the reason for that is simply because it’s just too complex to replace scientists — who he described as “artists” — altogether (for now at least).

“Our solution augments the human activity and automates the standard activity,” he said. “We view that as a central thesis that differentiates us from classic automation.”

There have been a number of other startups emerging that are applying some of the learnings of artificial intelligence and big data analytics for enterprises to the world of science. They include the likes of Turing, which is applying this to helping automate lab work for CPG companies; and Paige, which is focusing on AI to help better understand cancer and other pathology.

The Microsoft connection is one that could well play out in how Artificial’s platform develops going forward, not just in how data is perhaps handled in the cloud, but also on the ground, specifically with augmented reality.

“We see massive technical synergy,” Fuller said. “When you are in a lab you already have to wear glasses… and we think this has the earmarks of a long-term use case.”

Fuller mentioned that one area it’s looking at would involve equipping scientists and other technicians with Microsoft’s HoloLens to help direct them around the labs, and to make sure people are carrying out work consistently by comparing what is happening in the physical world to a “digital twin” of a lab containing data about supplies, where they are located, and what needs to happen next.

It’s this and all of the other areas that have yet to be brought into our very AI-led enterprise future that interested Microsoft.

“Biology labs today are light- to semi-automated—the same state they were in when I started my academic research and biopharmaceutical career over 20 years ago. Most labs operate more like test kitchens rather than factories,” said Dr. Kouki Harasaki, an investor at M12, in a statement. “Artificial’s aLab Suite is especially exciting to us because it is uniquely positioned to automate the masses: it’s accessible, low code, easy to use, highly configurable, and interoperable with common lab hardware and software. Most importantly, it enables Biopharma and SynBio labs to achieve the crowning glory of workflow automation: flexibility at scale.”

Harasaki is joining Peter Barratt, a founder and general partner at Playground Global, on Artificial’s board with this round.

“It’s become even more clear as we continue to battle the pandemic that we need to take a scalable, reproducible approach to running our labs, rather than the artisanal, error-prone methods we employ today,” Barrett said in a statement. “The aLab Suite that Artificial has pioneered will allow us to accelerate the breakthrough treatments of tomorrow and ensure our best and brightest scientists are working on challenging problems, not manual labor.”

#artificial-intelligence, #augmented-reality, #automation, #biotech, #enterprise, #health, #life-sciences, #rd, #robotics, #science, #startups, #tc

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Biden proposes ARPA-H, a health research agency to ‘end cancer’ modeled after DARPA

In a joint address to Congress last night, President Biden updated the nation on vaccination efforts and outlined his administration’s ambitious goals.

Biden’s first 100 days have been characterized by sweeping legislative packages that could lift millions of Americans out of poverty and slow the clock on the climate crisis, but during his first joint address to Congress, the president highlighted another smaller plan that’s no less ambitious: to “end cancer as we know it.”

“I can think of no more worthy investment,” Biden said Wednesday night. “I know of nothing that is more bipartisan…. It’s within our power to do it.”

The comments weren’t out of the blue. Earlier this month, the White House released a budget request for $6.5 billion to launch a new government agency for breakthrough health research. The proposed health agency would be called ARPA-H and would live within the NIH. The initial focus would be on cancer, diabetes and Alzheimer’s but the agency would also pursue other “transformational innovation” that could remake health research.

The $6.5 billion investment is a piece of the full $51 billion NIH budget. But some critics believe that ARPA-H should sit under the Department of Health and Human Services rather than being nested under NIH. 

ARPA-H would be modeled after the Defense Advanced Research Projects Agency (DARPA), which develops moonshot-like tech for defense applications. DARPA’s goals often sound more like science fiction than science, but the agency contributed to or created a number of now ubiquitous technologies, including a predecessor to GPS and most famously ARPANET, the computer network that grew into the modern internet.

Unlike more conservative, incremental research teams, DARPA aggressively pursues major scientific advances in a way that shares more in common with Silicon Valley than it does with other governmental agencies. Biden believes that using the DARPA model on cutting edge health research would keep the U.S. from lagging behind in biotech.

“China and other countries are closing in fast,” Biden said during the address. “We have to develop and dominate the products and technologies of the future: advanced batteries, biotechnology, computer chips, and clean energy.”

#arpanet, #biden, #biotechnology, #cancer, #congress, #darpa, #diabetes, #government, #health, #joe-biden, #life-sciences, #national-institute-of-health, #national-institutes-of-health, #president, #tc, #united-states, #white-house

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ElevateBio raises $525M to advance its cell and gene therapy technologies

ElevateBio, one of the leading biotech companies focused on gene-based therapies has raised a massive $525 million Series C round of financing, more than doubling the company’s $193 million Series B funding which closed last year. This new funding comes from existing investor Matrix Capital Management, and also adds new investors SoftBank and Fidelity Management & Research Company, and will be used to help the company expand its R&D and manufacturing capabilities, as well as continue to spin out new companies and partnerships based on its research.

Cambridge, Mass-based ElevateBio was founded to bridge the world of academic research and development of cell and gene therapies with that of commercialization and production-scale manufacturing. The startup identified a need for more efficient means of brining to market the ample, promising science that was being done in developing therapeutics that leverage cellular and genetic editing, particularly in treatment of severe and chronic illness. Its business model focuses on both developing and commercializing its own therapies, and also working through long-term partnerships with academic research institutions and other therapeutics biotech companies to bring their own technologies to market.

To this end, ElevateBio is in the business of frequent spin-out company creation, with the new entities each focused on a specific therapeutic. The company has announced three such companies to date, including AlloVir (in partnership with Baylor College of Medicine), HighPassBio (a venture with gene-editing company Fred Hutchinson) and Life Edit Therapeutics (in partnership with AgBiome). There are additional spin-outs in the works, too, according to ElevateBio, but they are not being disclosed publicly yet.

As you might expect, ElevateBio seems to have benefited from the increased appetite for biotech investment stemming from the global pandemic and its impacts. ElevateBio’s AlloVir spin-out is actually working on a T cell therapy candidate for addressing COVID-19, which is potentially effective in eliminating cells infected with SARS-CoV-2 in a patient to slow the spread of the disease and reduce its severity.

#atlas-venture, #biotech, #cambridge, #companies, #disease, #elevatebio, #funding, #health, #life-sciences, #roivant-sciences, #softbank, #tc

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New clinical trial data from Locus Biosciences shows promise in CRISPR-Cas3 technology

Antibiotic resistance is one of the biggest potential threats to global health today. But Locus Biosciences is hoping that their crPhage technology might provide a new solution.

Based in North Carolina’s Research Triangle, the startup recently announced promising phase 1b clinical trial results for their use of CRISPR-Cas3-enhanced bacteriophages as a treatment for urinary tract infections caused by escherichia coli. Led in part by former Patheon executive and current Locus CEO Paul Garofolo, the startup launched in 2015 with the goal of using a less popular application of CRISPR technology to address growing antimicrobial resistance.

CRISPR-Cas3 technology has notably different mechanisms from its more well-known CRISPR-Cas9 counterpart. Where the Cas9 enzyme has the ability to cleanly cut through a piece of DNA like a pair of scissors, Garofolo describes Cas3 more like a Pac-Man, shredding the DNA as it moves along a strand.

“You wouldn’t be able to use it for most of the editing platforms people were after,” he said, noting that meant there wouldn’t be as much competition around Cas3. “So I knew it would be protected for some time, and that we could keep it quiet.”

Garofolo and his team wanted to use CRISPR-Cas3 not to edit harmful bacteria found in the body, but to destroy it. To do this, they took the DNA-shredding mechanism of Cas3 and used it to enhance bacteriophages—viruses that can attack and kill different species of bacteria. Together, co-founder and Chief Scientific Officer Dave Ousterout—who has a Ph.D. in biomedical engineering from Duke—thinks this technology offers an extremely direct and targeted way of killing bacteria.

“We armed the phages with this Cas3 system that attacks E. coli, and that sort of dual mechanism of action is what comes together, essentially, as a really potent way to remove just E. coli,” he said in an interview.

That specificity is something that antibiotics lack. Rather than targeting only harmful bacteria in the body, antibiotics typically wipe out all bacteria they come across. “Every time we take antibiotics, we’re not thinking about all the other parts of us that are impacted by the bacteria that do good things,” said Garofolo. But the precision of Locus Biosciences’ crPhage technology means that only the targeted bacteria would be wiped out, leaving those necessary to the body’s normal function intact.

Beyond offering this more specific approach to treatment of pathogens, or any bacteria-based disease, Garofolo and his team also suspect that their approach will also be extremely safe. Though deadly to bacteria, bacteriophages are typically harmless to humans. The safety of CRISPR in humans is well-established, too.

“That’s our secret sauce,” said Garofolo. “We can build drugs that are more powerful than the antibiotics they’re trying to replace, and they use phage, which is probably one of the world’s safest ways to deliver something into the human body.”

While this new technology could certainly help treat pathogens and infectious diseases, Garofolo hopes that indications in immunology, oncology, and neurology might benefit from it too. “We’re starting to figure out that some bacteria might promote cancer, or inflammation in your gut,” he said. If researchers can identify the bacteria at the root cause of those conditions, Garofolo and Ousterout think the crPhage technology might prove to be an effective treatment.

“If we’re right about that, it’s not just about infections or antimicrobial resistance, but helping people overcome cancer or delay the onset of dementia,” Garofolo said. “It’s changing the way we think about how bacteria really help us live.”


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#biology, #biotech, #biotechnology, #cancer, #cas-3, #crispr, #enzymes, #genetic-engineering, #health, #life-sciences, #locus-biosciences, #north-carolina, #science, #startups

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Immunai raises $60M as it expands from improving immune therapies to discovering new ones, too

Just three years after its founding, biotech startup Immunai has raised $60 million in Series A funding, bringing its total raised to over $80 million. Despite its youth, Immunai has already established the largest database in the world for single cell immunity characteristics, and it has already used its machine learning-powered immunity analysts platform to enhance the performance of existing immunotherapies, but aided by this new funding, it’s now ready to expand into the development of entirely new therapies based on the strength and breadth of its data and ML.

Immunai’s approach to developing new insights around the human immune system uses a ‘multi-omic’ approach – essentially layering analysis of different types of biological data, including a cell’s genome, microbiome, epigenome (a genome’s chemical instruction set) and more. The startup’s unique edge is in combining the largest and richest data set of its type available, formed in partnership with world-leading immunological research organizations, with its own machine learning technology to deliver analytics at unprecedented scale.

“I hope it doesn’t sound corny, but we don’t have the luxury to move more slowly,” explained Immunai co-founder and CEO Noam Solomon in an interview. “Because I think that we are in kind of a perfect storm, where a lot of advances in machine learning and compute computations have led us to the point where we can actually leverage those methods to mine important insights. You have a limit or ceiling to how fast you can go by the number of people that you have – so I think with the vision that we have, and thanks to our very think large network between MIT, and Cambridge to Stanford in the Bay Area, and Tel Aviv, we just moved very quickly to harness people to say, let’s solve this problem together.”

Solomon and his co-founder and CTO Luis Voloch both have extensive computer science and machine learning backgrounds, and they initially connected and identified a need for the application of this kind of technology in immunology. Scientific co-founder and SVP of Strategic Research Danny Wells then helped them refine their approach to focus on improving efficacy of immunotherapies designed to treat cancerous tumors.

Immunai has already demonstrated that its platform can help identify optimal targets for existing therapies, including in a partnership with the Baylor College of Medicine where it assisted with a cell therapy product for use in treating neuroblastoma (a type of cancer that develops from immune cells, often in the adrenal glands). The company is now also moving into new territory with therapies, using its machine learning platform and industry-leading cell database to new therapy discovery – not only identifying and validating targets for existing therapies, but helping to create entirely new ones.

“We’re moving from just observing cells, but actually to going and perturbing them, and seeing what the outcome is,” explained Voloch. This, from the computational side, later allows us to move from correlative assessments to actually causal assessments, which makes our models a lot more powerful. Both on the computational side and on the on the lab side, this is really bleeding edge technologies that I think we will be the first to really put together at any kind of real scale.”

“The next step is to say ‘Okay, now that we understand the human immune profile, can we develop new drugs?’,” said Solomon. “You can think about it like we’ve been building a Google Maps for the immune system of a few years – so we are mapping different roads and paths in the in the immune system. But at some point, we figured out that there are certain roads or bridges that haven’t been built yet. And we will be able to support building new roads and new and new bridges, and hopefully leading from current states of disease or cities of disease, to building cities of health.”

#artificial-intelligence, #biotech, #biotechnology, #cambridge, #cancer-immunotherapy, #funding, #health, #life-sciences, #machine-learning, #machine-learning-technology, #mit, #recent-funding, #science, #stanford, #startups, #tc, #tel-aviv

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Healthvana’s digital COVID-19 vaccination records are about communication, not passports for the immune

As the vaccination campaign to counter COVID-19 gets underway (albeit with a rocky start), a number of companies are attempting to support its rollout in a variety of ways. Healthvana, a health tech startup that began with a specific focus on providing patient information digitally for individuals living with HIV, is helping Los Angeles County roll out mobile vaccination records for COVID-19 using Apple’s Wallet technology. A cursory appraisal of the implementation of this tech might lead one to believe it’s about providing individuals with easy proof of vaccination — but the tech, and Healthvana, are focused on informing individuals to ensure they participate in their own healthcare programs, not providing an immunity pass.

“I generally consider most of healthcare to look and feel like Windows 95,” Healthvana CEO and founder Ramin Bastani said. “We look and feel like Instagram . Why is that important? Because patients can engage in things they understand, it’s easier for them to communicate in the way they’re used to communicating, and that ends up leading them to better health outcomes.”

Bastani points out that they began the company by focusing this approach to patient education and communication on HIV, and demonstrated that using their software led to patients being 7.4 times more likely to show up for their next follow-up appointment versus patients who received follow-up information and appointment notices via traditional methods. The company has built their tooling and their approach around not only producing better health for individuals, but also on reducing costs for healthcare providers by eliminating the need for a lot of the work that goes into clearing up misunderstandings, and essentially hounding patients to follow-up, which can significantly dig into clinician and care staff hours.

“We’re actually also reducing the cost to healthcare providers, because you don’t have 1,000 people calling you asking what are their results, and saying ‘I don’t understand, I can’t log in, I don’t know what it means to be SARS nonreactive,’ or all those things we address through simplicity,” Bastani said. “That’s made a huge difference. Overall, I think the key to all healthcare is going to be to be able to get patients to pay attention, and take action to things around their health.”

That’s the goal of Healthvana’s partnership with LA County on COVID-19 immunization records, too — taking vitally important action to ensure the successful rollout of its vaccination program. All approved COVID-19 vaccines to date require a two-course treatment, including one initial inoculation followed by a booster to be administered sometime later. Keeping LA county residents informed about their COVID-19 inoculation, and when they’re due for a second dose, is the primary purpose of the partnership, and benefits from Healthvana’s experience in improving patient follow-up activities. But the app is also providing users with information about COVID-19 care, and, most usefully, prevention and ways to slow the spread.

While Bastani stresses that Healthvana is, in the end, just “the last mile” for message delivery, and that there are many other layers involved in determining the right steps for proper care and prevention, the way in which they provide actionable info has already proven a big boon to one key measure: contact tracing. In select municipalities, Healthvana will also prompt users who’ve tested positive to anonymously notify close contacts directly from their device, which will provide those individuals with both free testing options and information resources.

“Just us doing this in the greater Los Angeles area for less than two months, 12,000+ people have been notified that they’ve been exposed,” Bastani said. “Each of them likely lives with other people and families — this is how you can help slow the spread.”

Contrast that with the relatively slow uptake of the exposure notification tools built into iOS and Android devices via recent software updates provided by Google and Apple working in a rare collaboration. While the technology that underlies it is sound, and focused on user privacy, its usage numbers thus far are far from earthshaking; only 388 people have sent alerts through Virginia’s app-based on the exposure notification framework in three months since its launch, for instance.

Healthvana’s focus on timely and relevant delivery of information, offered to users in ways they’re mostly likely to understand and engage with, is already showing its ability to have an impact on COVID-19 and its community transmission. The startup is already in talks to launch similar programs elsewhere in the country, and that could help improve national vaccination outcomes, and how people handle COVID-19 once they have it, too.

#android, #apple, #biotech, #biotechnology, #covid-19, #google, #health, #healthvana, #hiv, #instagram, #life-sciences, #los-angeles, #startups, #tc, #vaccination, #virginia, #windows-95

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Endeavor BioMedicines raises $62 million to combat pulmonary disease

A new startup has officially emerged for stealth with the raise of its $62 million Series A funding round. Endeavor BioMedicines is led by co-founder and CEO John Hood, who previously led Impact Biomedicines, and its new funding comes from Omega Funds and Longitude Capital, as well as the company’s own management team. Endeavor is also co-founded by Miguel de los Rios, who serves as its Chief Science Officer and who was previously CEO of Rift Biotherapeutics.

Endeavor’s goal is to develop treatments specifically to address pulmonary disease, and the startup is putting its funding towards two Phase 2 clinical trials that will seek to determine whether their therapeutic candidate can reverse or slow the progression of idiopathic pulmonary fibrosis (IPF), a very common type of pulmonary fibrosis that results in long tissue scarring which causes difficulty in breathing for affected patients.

IPF has a significant and worrying fatality rate – the condition comes with “an estimated mean survival of 2-5 years from time of diagnosis,” according to Hood in a press release. Endeavor’s new treatment candidate, called ‘taladegib,’ is an inhibitor that addresses what’s known as the ‘Hedgehog’ pathway for IPF. This pathway, which is primarily responsible for cell differentiation during embryonic development, can also play a role in development of harmful conditions in adults when they malfunction while regulating the regeneration of mature tissues.

Hood’s last company Impact Biomedicines exited in a sale to Celgene Corp worth put to $7 billion, depending on performance milestones set in the terms of the acquisition for passing certain regulatory and sales conditions. That company focused on treatment development specifically for myelofibrosis, a type of blood cancer, using an inhibitor for a specific type of protein kinase.

#biotech, #ceo, #endeavor, #funding, #health, #life-sciences, #science, #tc

0

LabCorp COVID-19 test kit has just been approved for sale over-the-counter

LabCorp has now become the first company to receive approval to sell its COVID-19 test kit over-the-counter without a prescription, according to a statement form the company.

One of the largest diagnostics testing companies in the U.S., LabCorp could be a significant competitor to companies like EverlyWell, which received approvals for its at-home testing kits in May; MyLab Box, which announced a partnership with Walmart earlier this week to sell COVID-19 test kits with the giant retailer; or LetsGetChecked, which has its own at-home test.

LabCorp was actually the first company to receive approval from the FDA for its test kit, and now the company can sell the product through retail channels without a prescription.

“With the first over-the-counter at-home collection kit ever authorized by the FDA for COVID-19, we are empowering people to learn about their health and make confident decisions,” said Dr. Brian Caveney, chief medical officer and president of LabCorp Diagnostics, in a statement. “With this authorization, we can help more people get tested, reduce the spread of the virus and improve the health of our communities.”

It’s pretty inarguable that anything that reduces the friction consumers face in getting tested for SARS-CoV-2, the virus that causes COVID-19, is a good thing. It’s also in line with a broader push to increase healthcare access for consumers in an effort to reduce costs.

When customers purchase the COVID-19 test kit, they register the kit on the company’s website and then follow the instructions given there. Tests results are delivered through a corporate portal and a healthcare provider is available to assist customers who test positive on how to proceed with a course of treatment.

The company said its kit should not be viewed as a substitute for visits to a healthcare professional and is intended for use by adults 18 or older.

It’s important to note that the LabCorp PCR test has not been cleared or approved by the FDA and is being authorized under an emergency use authorization.

#articles, #covid-19, #fda, #food-and-drug-administration, #healthcare, #labcorp, #life-sciences, #medicine, #retailer, #tc, #united-states, #walmart

0

Agricultural biotech startup Boost Biomes adds a strategic investor in Japan’s Universal Materials Incubator

Boost Biomes, the Y Combinator-backed developer of microbiome-based bio-fungicides and bio-pesticides for agricultural applications, has added $2 million in funding and picked up a new strategic investor in Japan’s Universal Materials Incubator.

To date, Boost Biomes has raised over $7 million in financing to support the development of new products like its biofungicide developed from the micro-organisms that live in the soil in a symbiotic relationship with the plants.

The work that Boost does is primarily on understanding the interactions between microbes and plants in the soil. “The goal is to be  the discovery engine and develop new microbial products for use in food and agriculture,” said Boost chief executive and co-founder Jamie Bacher.

The commitment from Japan’s Universal Materials Incubator expands on a $5 million institutional round led by another strategic partner, Yara International, a global crop nutrition company and venture investors like Viking Global Investors and Y Combinator.

Boost hopes to tackle issues in agriculture like spoilage, bacterial contamination and pathogen infrestations, as well as addressing diseases that can affect plant health directly.

Boost is already working with an undisclosed biomanufacturing partner to develop its biofungicide.

UMI’s decision to invest in Boost comes from our evaluation of their team, technology, and the associated market opportunities.  We believe that Boost’s platform generates a unique data set that can be exploited for far superior products with many diverse microbiome applications in food and agriculture,” said Yota Hayama, an investor at UMI, in a statement. “These are critical areas to achieve food security and promote sustainable agriculture. We also expect Boost’s huge potential on other areas where microbiomes are utilized.”

 

#articles, #biotechnology, #food, #japan, #life-sciences, #microbiome, #tc, #viking-global-investors, #y-combinator

0

Resilience raises over $800 million to transform pharmaceutical manufacturing in response to COVID-19

Resilience, a new biopharmaceutical company backed by $800 million in financing from investors including ARCH Venture Partners and 8VC, has emerged from stealth to transform the way that drugs and therapies are manufactured in the U.S.

Founded by ARCH Venture Partners investor Robert Nelsen, National Resilience Inc., which does business as Resilience was born out of Nelsen’s frustrations with the inept American response to the COVID-19 pandemic.

According to a statement the company will invest heavily in developing new manufacturing technologies across cell and gene therapies, viral vectors, vaccines and proteins.

Resilience’s founders identified problems in the therapeutic manufacturing process as one of the key problems that the industry faces in bringing new treatments to market — and that hurdle is exactly what the company was founded to overcome.

“COVID-19 has exposed critical vulnerabilities in medical supply chains, and today’s manufacturing can’t keep up with scientific innovation, medical discovery, and the need to rapidly produce and distribute critically important drugs at scale. We are committed to tackling these huge problems with a whole new business model,” said Nelsen in a statement.

The company brings together some of the leading investment firms in healthcare and biosciences including operating partners from Flagship Pioneering like Rahul Singhvi, who will serve as the company’s chief executive’ former Food and Drug Administration commissioner Scott Gottlieb, a partner at New Enterprise Associates and director on the Resilience board; and Patrick Yang, the former executive vice president and global head of technical operations at Roche/Genentech .

“It is critical that we adopt solutions that will protect the manufacturing supply chain, and provide more certainty around drug development and the ability to scale up the manufacturing of safe, effective but also more complex products that science is making possible,” said Dr. Gottlieb, in a statement. “RESILIENCE will enable these solutions by combining cutting edge technology, an unrivaled pool of talent, and the industry’s first shared service business model. Similar to Amazon Web Services, RESILIENCE will empower drug developers with the tools to more fully align discovery, development, and manufacturing; while offering new opportunities to invest in downstream innovations in formulation and manufacturing earlier, while products are still being conceived and developed.”

Other heavy hitters in the world of medicine and biotechnology who are working with the company include Frances Arnold, the Nobel Prize-winning professor from the California Institute of Technology; George Barrett, the former chief executive of Cardinal Health; Susan Desmond-Hellmann, the former president of product development at Genentech; Kaye Foster, the former vice president of human resources at Johnson and Johnson; and Denice Torres, the former President of Johnson & Johnson Pharmaceutical and Consumer Companies.

#amazon-web-services, #arch-venture-partners, #biotechnology, #companies, #contents, #director, #drug-development, #food-and-drug-administration, #genentech, #healthcare, #johnson, #johnson-johnson, #life-sciences, #manufacturing, #new-enterprise-associates, #partner, #president, #resilience, #roche, #scott-gottlieb, #tc, #web-services

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Nobel laureate Jennifer Doudna shares her perspective on COVID-19 and CRISPR

CRISPR co-discoverer Jennifer Doudna was named a Nobel laureate in Chemistry today, sharing the honour with Emmanuelle Charpentier . We had the opportunity to speak to Doudna recently at our TechCrunch Disrupt 2020 event, and she shared her thoughts on CRISPR, and how it can be used to test and potentially treat COVID-19, as well as what it may do for our ability to address future pandemics and healthcare crises.

“It’s really interesting to think about the ability to program CRISPR to be detecting not only the the current coronavirus, but also other viruses,” she explained in the interview in September. “We were already working on a strategy to co-detect influenza and coronavirus, as you know that it’s really important to be able to do that, but also to pivot very quickly to detect new viruses that are emerging. I don’t think any of us think that, you know, viral pandemics are going away – I think this current pandemic is a call to arms, and we have to make sure that scientifically, we’re ready for the next attack by a new virus.”

Much closer to hand, CRISPR has the potential to greatly expand testing capabilities in the near-term, and to do so in ways that could change the pace, frequency and nature of testing. That could translate to very different frontline care and pandemic management, across both healthcare facilities as well as any shared workspaces.

“I think from what I’ve seen that very likely before the end of the year, we’re going to see CRISPR diagnostic tests rolling out,” she said. “Whether they’re in laboratory settings – I think that may be the first format that we see – but also something that we’re working on right now at the Innovative Genomics Institute at Berkeley and UCSF and the Gladstone is a strategy for a point-of-care CRISPR tests, where we have a small device that we envision located in different floors of buildings and institutions and dormitories, where you could do very rapid surveillance-type testing of saliva or swab samples.”

Check out the full interview with Doudna above, which also ranges into the most recent advances in CRISPR science, and where it’s heading next for everything from therapeutics, to crop modification.

#biology, #biotech, #biotechnology, #crispr, #emmanuelle-charpentier, #genetic-engineering, #genomics, #health, #innovative-genomics-institute, #jennifer-doudna, #life-sciences, #nobel-prize, #science, #tc

0

Scribe Therapeutics launches a platform for engineering CRISPR-based therapeutics

A new company called Scribe Therapeutics founded by two former members of CRISPR pioneer Jennifer Doudna’s UC Berkely genetics lab (alongside Doudna herself) launched on Tuesday, debuting a platform designed specifically to help develop and engineer new thereapeutics based on CRISPR for addressing specific diseases, with permanent treatments in patients.

Doudna is part of the leadership team behind Scribe, but it’s primarily led by CEO and co-founder Benjamin Oakes, along with VP of Platform Brett T. Staahl. Oakes and Staahl shared time at Doudna’s lab, with Oakes as a student while Staahl was a postdoc. Staahl’s interest was specifically in how gene editing, and CRISPR in particular, could be used to help treat Huntington’s disease – while Oakes, who originally set out to be a practicing medical doctor, realized early on he actually wanted to do more with solving the underlying causes of disease, and changed tack to pursue genome editing.

“I set out on this journey to understand how we could, and how we could best actually solve those underlying problems of disease,” Oakes explained in an interview. That led to him pursuing research in Zinc-Finger Nuclease (ZFN)-based genome editing – a precursor technique to CRISPR that was far less specific and much more work-intensive and time consuming. Doudna’s groundbreaking paper on CRISPR was published in 2012, and Oakes immediately saw the potential, so he joined her lab at Berkeley.

Meanwhile, Staahl was looking at treatment for disorders that specifically lead to neural degeneration – something that had not previously been part of Doudna’s lab’s research prior to him joining.

“He spent several years in the lab, developing strategies for neurons, and really trying to bring that technology to a point where it could be deployed as a real treatment for neurodegenerative disease, with Huntington’s as a model,” Doudna told me. “So Ben and Brett met up, they came from very different backgrounds, they had really different scientific training originally, but they hit it off. And they saw a really exciting opportunity to use the kind of technology development that Ben had been doing, and that he was very keen on continuing, and to focus it on this challenge of neurodegeneration.”

The result is Scribe Therapeutics, which has already raised $20 million in a Series A funding round (plus some small amount of earlier seed financing contributed by the founders) led by Andreessen Horowitz . Scribe has been at work on their solution since 2018, but remained mostly quiet about their progress until Oakes felt confident that what they’re presenting is a real, viable technology that can be used to produce therapeutics now. Representative of that progress, the company is also announcing a new collaboration with large drugmaker Biogen, Inc. to collaborate on CRISPR-based medecines for treating neurological diseases, and specifically Amyotriophic Lateral Sclerosis.

That deal is valued at $15 million in upfront commitments, with as much as $400 million or more in milestone payouts to follow, as well as royalties attached to any shipping therapeutics that result. Oakes says it’s a testament to the maturity of their platform that they were able to secure this partnership. But Scribe will also be pursuing development of its own therapeutics in-house, while partnering where it makes sense – a strategy Oakes says is in service of addressing the greatest number of possible disease treatments the startup can manage. And while it’s already generating revenue, and Oakes says he’s in no rush to secure additional funding, he does believe that ultimately they will seek out additional investment in order to help ensure they can treat as many potential conditions as possible, as quickly and safely as possible.

As for the fundamental science behind Scribe, their advantage lies in the work they’ve done to adapt a molecule called CRISPR-CasX, which is a bit smaller than Cas9 and not derived from pathogen molecules, both of which make it better-suited to therapeutics. Scribe has spent the past year-and-a-half turning CasX into the basis of a platform that works better than any CRISPR protein that exists for delivery via adeno-associated virus (the current state-of-the-art in gene therapy delivery), as well as engineering it for greater specificity.

“We built Scribe specifically to do that, to build an engineering core focused exclusively on making the most advanced the very best therapeutic genome editing molecules that we could,” Oakes said.

#andreessen-horowitz, #biology, #biotech, #biotechnology, #crispr, #disease, #emerging-technologies, #genetic-engineering, #health, #jennifer-doudna, #life-sciences, #model, #science, #tc, #technology-development

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Synthetic biology startups are giving investors an appetite

There’s a growing wave of commercial activity from companies that are creating products using new biological engineering technologies.

Perhaps the most public (and tastiest) example of the promise biomanufacturing holds is Impossible Foods . The meat replacement company whose ground plants (and bioengineered additives) taste like ground beef just raised another $200 million earlier this month, giving the privately held company a $4 billion valuation.

But Impossible is only the most public face for what’s a growing trend in bioengineering — commercialization. Platform companies like Ginkgo Bioworks and Zymergen that have large libraries of metagenomic data that can be applied to products like industrial chemicals, coatings and films, pesticides and new ways to deliver nutrients to consumers.

The new products coming to market

In fact, by 2021 consumer products made with Zymergen’s bioengineered thin films should be appearing at the Consumer Electronics Show (if there is a Consumer Electronics Show). It’s one of several announcements this year from the billion dollar-valued startup.

In August, Zymergen announced that it was working with herbicide and pesticide manufacturer FMC in a partnership that will see the seven-year-old startup be an engine for product development at the nearly 130-year-old chemical company.

#arvind-gupta, #biotechnology, #bolt-threads, #chemicals, #consumer-products, #emerging-technologies, #food, #geltor, #ginkgo-bioworks, #greentech, #healthcare, #impossible-foods, #indiebio, #life-sciences, #lygos, #manufacturing, #mayfield-fund, #memphis-meats, #seth-bannon, #solazyme, #solugen, #startup-company, #startups, #synthetic-biology, #tc, #venture-capital, #zymergen

0

Mission Bio raises $70 million to help scale its tech for improving the development of targeted cancer therapies

California-based startup Mission Bio has raised a new $70 million Series C funding round, led by Novo Growth and including participating from Soleus Capital and existing investors Mayfield, Cota and Agilent. Mission Bio will use the funding to scale its Tapestri Platform, which uses the company’s work in single-cell multi-omics technology to help optimize clinical trials for targeted, precision cancer therapies.

Mission Bio’s single-cell multi-omics platform is unique in the therapeutic industry. What it allows is the ability to zero in on a single cell, observing both genotype (fully genetic) and phenotype (observable traits influenced by genetics and other factors) impact resulting from use of various therapies during clinical trials. Mission’s Tapestri can detect both DNA and protein changes within the same single cell, which is key in determining effectiveness of targeted therapies because it can help rule out the effect of other factors not under control when analyzing in bulk (ie. across groups of cells).

Founded in 2012 as a spin-out of research work conducted at UCSF, Mission Bio has raised a total of $120 million to date. The company’s tech has been used by a number of large pharmaceutical and therapeutic companies, including Agios, LabCorp and Onconova Therapeutics, as well as at cancer research centers including UCSF, Stanford and the Memorial Sloan Kettering Cancer Center.

In addition to helping with the optimization of clinical trials for treatments of blood cancers and tutors, Mission’s tech can be used to validate genome editing – a large potential market that could see a lot of growth over the next few years with the rise of CRISPR-based therapeutic applications.

#articles, #biology, #biotech, #biotechnology, #california, #cancer, #cancer-research, #crispr, #drugs, #health, #labcorp, #life-sciences, #science, #stanford, #stem-cells, #tc, #ucsf

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Mammoth Biosciences lands exclusive license to new CRISPR proteins that could boost gene editing precision

CRISPR pioneer Mammoth Biosciences has secured an exclusive license to a new family of CRISPR proteins, from UC Berkeley, which covers R&D and commercialization across all potential fields. This is a significant addition to Mammoth’s intellectual property holdings, since this new family of CRISPR proteins, known as the Casɸ family, is roughly half the size of Cas9, the protein that effectively launched CRISPR to begin with.

In CRISPR, size actually matters quite a lot – the smaller size of Casɸ could help this new protein family excel in areas including the exact precision of gene editing, as well as easing delivery for use in actual living cells, and combining different target edits in a so-called ‘multiplex’ arrangement.

In July, a peer-reviewed paper published in Science detailed the discovery of Casɸ and outlined its potential advantages for use in CRISPR gene editing. Casɸ was discovered in bacteriophages, which is a type of virus that infects and replicates within bacteria – their literal translation is “bacteria eater.”

Increasing accuracy in CRISPR-based genetic editing has been an ongoing goal in the industry, with various approaches conceived and developed to help mitigate what is known as “off-target” activity, or unintended edits and genetic modifications that can occur when using the original Cas9-based editing approaches.

Mammoth Biosciences was founded by CRISPR co-discoverer Jennifer Doudna, and Douda’s lab at UC Berkeley is the source of the new discovery. This definitely helps strengthen its portfolio, and could lead to significant potential upside to the business through eventual commercialization.

#biology, #biotech, #biotechnology, #crispr, #genetic-engineering, #health, #life-sciences, #mammoth-biosciences, #science, #tc, #uc-berkeley

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Atomwise’s machine learning-based drug discovery service raises $123 million

With a slew of partnerships with large pharmaceutical companies under its belt and the successful spin out of at least one new company, Atomwise has already proved the value of its machine learning platform for discovering and commercializing potential small molecule therapies for a host of conditions.

Now the company has raised $123 million in new funding to accelerate its business.

“Scaling the technology and scaling the team and scaling what we’ve been doing with it,” says chief executive officer Abe Heifets when asked about what comes next for the eight year old business.

Atomwise has already signed contracts worth $5.5 billion with corporate partners that include Eli Lilly & Co., Bayer, Hansoh Pharmaceuticals, and Bridge Biotherapeutics. Smaller, earlier stage companies like StemoniX and SEngine Precision Medicine are also using Atomwise’s tech.

Now the company will look to capture more of the value of drug discovery for itself, looking to develop and commercialize its discoveries by taking over more of the development process and working with manufacturers at a later stage, according to Heifets.

Atomwise tipped its new strategy last year when it announced a partnership with Velocity Drug Development and a $14.5 million investment to create x-37, a spinoff that’s developing small molecule therapies for endodermal cancers, which include cancers of the liver, pancreas, colon, stomach, and bladder.

“We have something like 750 projects running today around the world,” says Heifets. “These comprise more than 600 unique targets and that’s with a vast range of partnerships.”

The power of Atomwise’s drug discovery platform is its ability to harness machine learning to structure new proteins that have never existed — and ensure that they’re able to reach precise target receptors to accomplish a desired task.

Here, the x-37 spinoff is especially illustrative. One line of research the company is conducting into molecules that can target the PIM3 protein receptor. If a drug can block PIM3, it can kill cancerous endodermal cells, according to Heifets. However, if the molecules bind to another, similar target, PIM1, the therapy can cause heart attacks and kill patients.

“This is a challenge and empirically was considered undruggable,” says Heifets. Atomwise’s company screened 11 billion potential molecules against the targets to come up with 500 potential therapies. They’re now working on refining the therapy to bring something to market.

And x-37 is only one of the companies that Atomwise has created to commercialize various new molecules. There’s also Atropos Therapeutics, Theia Biosciences and vAIrus.

Atomwise is far from the only company to think that the application of machine learning technologies to drug discovery is a winning combination. Menten.ai is a company that’s taken the new technology developments one step further and added quantum computing to the mix to come up with new drugs.

“The market opportunity we’re going after is four times the value of the entire pharma industry today,” said Heifets. “Here’s what that’s about. There’s 20,000 human genes and only 4% have ever been drugs. Another 16% have been evidenced. But the opportunity of drugging the undruggable is way bigger than the entire pharma industry.”

Unlocking that opportunity is going to take lots of capital. That’s why B Capital and Sanabil Investments combined to lead Atomwise’s Series B round. It’s also why companies like DCVC, BV, Tencent, Y Combinator, Dolby Ventures, AME Cloud Ventures and two, undisclosed, insurance companies have invested in the company’s latest round.

 with a goal to commercialize high potential candidates through the drug development process. The company plans to continue to expand its work with corporate partners, which currently include major players in the biopharma space including Eli Lilly and Company, Bayer, Hansoh Pharmaceuticals, and Bridge Biotherapeutics, as well as emerging biotechnology companies like StemoniX and SEngine Precision Medicine. Atomwise has signed approximately $5.5 billion in deal value with corporate partners to date.

To date, Atomwise has worked with 750 academic research collaborations addressing over 600 disease targets, to model and screen over 16 billion new molecules for virtual screening. These molecules have generated 17 pending patent applications and several peer-reviewed publications. There are 285 active drug discovery partnerships with researchers at top universities around the world, and recently announced 15 research collaborations with global universities to explore broad-spectrum therapies for COVID-19, targeting 15 unique and novel mechanisms of action.

“New technologies are enabling better and faster R&D for the life science industry,” said Raj Ganguly, co-Founder and Managing Partner at B Capital Group . “The advancements Atomwise has made with its computational drug discovery platform have effectively cut months or even years off of the R&D lifecycle. More importantly, however, they are solving biology problems previously believed to be unsolvable by researchers and delivering that capability to everyone from academics to big pharma. We’re excited to continue to partner with the Atomwise team on its mission to develop new, more effective therapies.”

For lead investor, B Capital, the Atomwise investment is part of a thesis around lowering the cost of care and improving outcomes.

“Companies like Atomwise that are improving the cost curve are in the same vein of bringing therapies to market faster and cheaper. Which means you can improve access and improve costs and address things like rare diseases,” said Adam Seabrook, a principal at B Capital focused on healthcare.

#ame-cloud-ventures, #articles, #atomwise, #b-capital-group, #bayer, #biotechnology, #chief-executive-officer, #disease, #drug-development, #drug-discovery, #health, #healthcare, #insurance, #life-sciences, #machine-learning, #partner, #quantum-computing, #raj-ganguly, #series-b, #tc, #tencent, #y-combinator

0

Bit Bio’s “enter button for the keyboard to the software of life” nabs the company $41.5 million

Bit Bio, the new startup which pitches itself as the “enter button for the keyboard to the software of life” only needed three weeks to raise its latest $41.5 million round of funding.

Originally known as Elpis Biotechnology and named for the Greek goddess of hope, the Cambridge, England-based company was founded by Mark Kotter in 2016 to commercialize technology that can reduce the cost and increase the production capacity for human cell lines. These cells can be used in targeted gene therapies and as a method to accelerate drug discovery at pharmaceutical companies.

The company’s goal is to be able to reproduce every human cell type.

“We’re just at a very crucial time in biology and medicine and the bottleneck that has become really clear is a scalable source of robust human cells,” said Kotter. “For drug discovery this is important. When you look at failure rates in clinical trials they’re at an all time high… that’s in direct contradiction to the massive advancements in biotechnology in research and the field.”

In the seventeen years since scientists completely mapped the human genome, and eight years since scientists began using the gene editing technology known as CRISPR to edit genetic material, there’s been an explosion of treatments based on individual patient’s genetic material and new drugs developed to more precisely target the mechanisms that pathogens use to spread through organisms.

These treatments and the small molecule drugs being created to stop the spread of pathogens or reduce the effects of disease require significant testing before coming to market — and Bit Bio’s founder thinks his company can both reduce the time to market and offer new treatments for patients.

It’s a thesis that had investors like the famous serial biotech entrepreneur, Richard Klausner, who served as the former director of the National Cancer Institute and founder of revolutionary biotech companies like Lyell Immunopharma, Juno, and Grail, leaping at the chance to invest in Bit Bio’s business, according to Kotter.

Joining Klausner are the famous biotech investment firms Foresite Capital, Blueyard Capital and Arch Venture Partners.

“Bit Bio is based on beautiful science. The company’s technology has the potential to bring the long-awaited precision and reliability of engineering to the application of stem cells,” said Klausner in a statement. “Bit Bio’s approach represents a paradigm shift in biology that will enable a new generation of cell therapies, improving the lives of millions.”

Photo: Andrew Brookes/Getty Images

Kotter’s own path to develop the technology which lies at the heart of Bit Bio’s business began a decade ago in a laboratory in Cambridge University. It was there that he began research building on the revolutionary discoveries of Shinya Yamanaka, which enabled scientists to transform human adult cells into embryonic stem cells.

“What we did is what Yamanaka did. We turned everything upside down. We want to know how each cell is defined… and once we know that we can flip the switch,” said Kotter. “We find out which transcription factors code for a single cell and we turn it on.”

Kotter said the technology is like uploading a new program into the embryonic stem cell.

Although the company is still in its early days, it has managed to attract a few key customers and launch a sister company based on the technology. That company, Meatable, is using the same process to make lab-grown pork.

Meatable is the earliest claimant to a commercially viable, patented process for manufacturing meat cells without the need to kill an animal as a prerequisite for cell differentiation and growth.

Other companies have relied on fetal bovine serum or Chinese hamster ovaries to stimulate cell division and production, but Meatable says it has developed a process where it can sample tissue from an animal, revert that tissue to a pluripotent stem cell, then culture that cell sample into muscle and fat to produce the pork products that palates around the world crave.

“We know which DNA sequence is responsible for moving an early-stage cell to a muscle cell,” says Meatable chief executive Krijn De Nood.

If that sounds similar to Bit Bio, that’s because it’s the same tech — just used to make animal instead of human cells.

Image: PASIEKA/SCIENCE PHOTO LIBRARY/Getty Images

If Meatable is one way to commercialize the cell differentiation technology, Bit Bio’s partnership with the drug development company Charles River Laboratories is another.

“We actually do have a revenue generating business side using human cells for research and drug discovery. We have a partnership with Charles River Laboratories the large preclinical contract research organization,” Kotter said. “That partnership is where we have given early access to our technology to Charles River… They have their own usual business clients who want them to help with their drug discovery. The big bottleneck at the moment is access to human cells.”

Drug trials fail because the treatments developed either are toxic or don’t work in humans. The difference is that most experiments to prove how effective the treatments are rely on animal testing before making the leap to human trials, Kotter said.

The company is also preparing to develop its own cell therapies, according to Kotter. There, the biggest selling point is the increased precision that  Bit Bio can bring to precision medicine, said Kotter. “If you look at these cell therapies at the moment you get mixed bags of cells. There are some that work and some that have dangerous side effects. We think we can be precise [and] safety is the biggest thing at this point.”

The company claims that it can produce cell lines in less than a week with 100 percent purity, versus the mixed bags from other companies cell cultures.

“Our moonshot goal is to develop a platform capable of producing every human cell type. This is possible once we understand the genes governing human cell behaviour, which ultimately form the ‘operating system of life’,” Kotter said in a statement. “This will unlock a new generation of cell and tissue therapies for tackling cancer, neurodegenerative disorders and autoimmune diseases and accelerate the development of effective drugs for a range of conditions. The support of leading deep tech and biotech investors will catalyse this unique convergence of biology and engineering.”

 

#arch-venture-partners, #biology, #biotechnology, #blueyard-capital, #cambridge-university, #cancer, #crispr, #director, #disease, #drug-development, #drug-discovery, #foresite-capital, #founder, #grail, #juno, #life-sciences, #meatable, #operating-system, #stem-cells, #tc, #united-kingdom

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NEA-backed Personal Genome Diagnostics receives FDA clearance for its cancer diagnostic

Personal Genome Diagnostics, the venture-backed developer of a novel diagnostic kit for genomic profiling of different cancers in lab settings, has received clearance from the U.S. Food and Drug Administration for its PGDx elio tissue complete test.

The test’s approval is another step forward for precision therapies that rely on an understanding of the unique genomic profile of an individual patient’s tumor, according to the company.

The test detects single nucleotide variants and the small insertions and deletions known as indels. Single nucleotide variants, indels, and identifying characteristics like the tumor mutation burden can be used by physicians to determine how rapidly a disease like cancer to progress and can provide essential targets for precision therapies to individual tumors.

The information doctors collect from these tests can also be used to help oncologists identify patients for clinical trials.

The new diagnostics test cover 35 different tumor types.

“There has not, until this point, been one standardized test for all kinds of cancer that any lab across the country can perform,” said Dr. Pranil Chandra, Chief Medical Officer of Genomic and Clinical Pathology Services, PathGroup, an early collaborator for PGDx elio tissue complete, in a statement. “With this clearance, labs across the country will for the first time have an option for a regulated, standardized test that examines a broad view of cancer pathways and genomic signatures across advanced cancers.”

To date, Personal Genome Diagnostics has raised over $99 million, according to Crunchbase. The company’s investors include New Enterprise Associates, Bristol Myers Squibb, Inova Strategic Investments, Co-win Healthcare Fund, Helsinn Investment Fund, Windham Venture Partners, Maryland Venture Fund

“We are proud to have led the first institutional round for PGDx,” said Dr. Justin Klein, in a statement when the company raised a $75 million round back in 2018. “Rapid advances in immuno-oncology, targeted agents, and combination cancer therapies are heightening the importance of tumor genome testing that enables treatments to be targeted to those patients most likely to benefit.”

 

#biology, #biotechnology, #cancer, #disease, #life-sciences, #new-enterprise-associates, #tc, #tumor

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As more studies roll in, little evidence that hydroxychloroquine works

Hospital Corpsman 3rd Class Kimberly Wyss, from Ventura, Calif., dons surgical gloves aboard the hospital ship USNS <em>Mercy </em>(T-AH 19).

Enlarge / Hospital Corpsman 3rd Class Kimberly Wyss, from Ventura, Calif., dons surgical gloves aboard the hospital ship USNS Mercy (T-AH 19). (credit: flickr)

A study observing COVID-19 patients has found no evidence that the malaria drug hydroxychloroquine, touted as a possible treatment for COVID-19, made a difference to the chance that patients would need a ventilator. The results also suggested that patients treated with hydroxychloroquine had a higher rate of death than those who weren’t treated with the drug.

The study was not a randomized clinical trial, which means that the evidence it offers is tentative and should be interpreted with caution. It was also published on preprint server medRxiv, which means it has not yet been peer-reviewed.

But interpreting the evidence with caution does not mean disregarding it completely. This study is one of a growing number telling us that we don’t yet know enough about hydroxychloroquine, adding more weight to the argument that we need to wait for better-quality evidence from randomized controlled trials before we start widespread use of a drug with significant side effects.

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#coronavirus, #covid-19, #covid19, #health, #life-sciences, #medicine, #pandemic, #science

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The value of lives saved by social distancing outweighs the costs

Economic activity vs. social distancing is a careful balancing act.

Enlarge / Economic activity vs. social distancing is a careful balancing act. (credit: Mata Hitij)

As Ars reported recently, evidence from the 1918 flu pandemic suggests that cities with more aggressive lockdown responses had stronger economic recoveries.

There’s more than one way to think about the economics of lockdowns, and a paper due to be published in the Journal of Benefit-Cost Analysis has an entirely different approach. It accepts that lockdowns will hurt the economy compared to business-as-usual but calculates whether that cost is outweighed by the lives that will be saved by social-distancing measures.

The answer is yes—by $5.2 trillion. That’s an estimate that changes based on a range of different assumptions, but it represents what the authors consider the most realistic scenario.

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#biology, #covid-19, #health, #life-sciences, #science, #uncategorized

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LabCorp’s at-home COVID-19 test kit is the first to be authorized by the FDA

LabCorp’s at-home COVID-19 test, which is called ‘Pixel,’ has received the first Emergency Use Authorization (EUA) for such a test missed by the U.S. Food and Drug Administration (FDA). The test is an at-home collection kit, which provides sample collection materials including a nasal swab to the user, who then uses the included shipping package to return the sample to a lab for testing.

Until now, the FDA has not authorized any at-home testing or sample collection kits for use, and in fact clarified its guidelines to specifically note that their use was not authorized under its guidelines when a number of startup companies debuted similar products for at-home collection and round-trip testing with labs already certified to run molecular RT-PCR tests to detect the presence of COVID-19.

The FDA notes that only LabCorp’s COVID-19 RT-PCR test has received this authorization, and that it still requires any such test to have an EUA before they can being offering services, whether or not the test is administered at home with the help of guidance from an authorized medical professional via telemedicine. Some labs facilitating at home serology tests using an exception in the FDA guidelines, but these are not viewed by the agency as tests that can confirm a case of COVID-19.

Opening up at-home testing (even via just sample collection, vs. full at-home test administration) is a big step in terms of a change in the way the agency has operated thus far. The FDA has recently updated its guidelines to note that it is working with at-home test providers to determine the best way to make those available to the public, since it “sees the public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection.”

LabCorp is a U.S. medical diagnostics company with over 40 years of experience, including at-home testing via its Pixel line for colorectal cancer, diabetes, and cardiac lipid conditions. It seems like the FDA is favoring long-standing industry experience in terms of who it’s willing to open up authorizations for with at-home collection, which is likely due to the potential for increased error when you add unsupervised self-collection, packing and logistics into the mix.

Testing for COVID-19 in the U.S. currently relies on drive-through sites, as well as in-clinic and hospital testing. These tests have a high bar for access in terms of risk profile and symptom presentation, and their administration also exposes the healthcare professionals running them to risk of contracting the infection themselves. At-home testing could increase overall testing rates, while decreasing risk to frontline healthcare workers, providing a better picture of the true extent and depth of the COVID-19 pandemic.

#articles, #biotech, #coronavirus, #covid-19, #diabetes, #food-and-drug-administration, #health, #infection, #labcorp, #life-sciences, #science, #tc, #telemedicine, #united-states

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Mammoth Biosciences receives first peer-reviewed validation of CRISPR-based COVID-19 test

SF-based CRISPR diagnostics startup Mammoth Biosciences has published the first peer-reviewed study that shows validation of using its testing method to detect the presence of COVID-19 in patients. The study, published in Nature, shows performance on par with existing PCR-based molecular tests, the one ones currently authorized for use by the FDA to test for the novel coronavirus.

Mammoth’s DETECTR platform is designed to have advantages over traditional testing methods in a few different ways, including in its reconfigurability to address new viruses, since it uses CRISPR to target specific genetic sequences, and activate a “cleavage” that effectively acts as a signal for the diagnostic equipment to pick up. Basically, in the same way CRISPR allows scientists to target a specific string of DNA for removal or alteration, with scalpel-like precision, Mammoth’s diagnostic allows for programmable, targeted matching with a reference string, leading to confirmation that viral RNA is present in the patient.

The test that Mammoth is developing showed validated use in under two weeks, the researchers claim, since their platform is designed from the ground up for rapid reconfigurability to address new viral threats. The test can deliver results in under 45 minutes, and the results delivery is via what’s called a ‘lateral flow strip,’ which is essentially the same kind of read-out you see with at-home pregnancy tests, making them relatively easy to interpret. DETECTR also doesn’t require a lab setting to delver results, and instead can be conducted with portable heat blocks, combined with commonly available standard reagents.

In the study, which included samples from 36 patients with confirmed COVID-19 infections, and 42 patients who had other types of viral respiratory infections, the tests showed 95% positive diagnostic accuracy, and 100% negative efficacy. Samples used were taken from respiratory swabs.

This doesn’t mean this test can roll out to actual sites for use, but it’s a good validation of Mammoth’s model and test design, and could eventually lead to actual deployment of its test in a clinical setting, providing other, larger-scale studies back up the data.

#biology, #biotech, #biotechnology, #coronavirus, #covid-19, #crispr, #emerging-technologies, #fda, #health, #life-sciences, #mammoth-biosciences, #science, #startups, #tc, #virus

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Extreme closeup of mouse-brain slice wins top Life Science Microscopy prize

Detail from the winning entry in the first Olympus Global Image of the Year Life Science Light Microscopy Award. It shows immunostaining of a mouse-brain slice with two fluorophores.

Enlarge / Detail from the winning entry in the first Olympus Global Image of the Year Life Science Light Microscopy Award. It shows immunostaining of a mouse-brain slice with two fluorophores. (credit: Ainara Pintor/Olympus)

For several years now, we’ve regularly featured the winners of Nikon’s annual Small World microscopy contest. Now, Olympus has entered the artful imaging arena with its first Global Image of the Year Award. Like the Small World contest, the intent is to highlight artful scientific imaging in hopes of inspiring the world to appreciate the inherent beauty of microscopy imaging. Olympus announced the winners (one global winner, plus three regional winners), along with several runners-up, last month. They do not disappoint.

As Ars’ John Timmer noted in his 2018 Small World coverage: “Microscopy is a sibling of photography in many ways beyond the involvement of high-end lenses. While it might not matter for scientific purposes, a compelling microscope image depends on things like composition, lighting, exposure, and more. And these days, both fields rely heavily on post-processing.” All those elements are abundant in the new crop of Olympus winners.

Spain’s Ainara Pintor snagged the top honor from over 400 submissions with her gorgeous image of an immunostained mouse-brain slice, titled Neurogarden. The image focuses on the hippocampus area of a single slice, but there are more than 70 million neurons in the mouse brain as a whole, according to Pintor. Howard Vindin of Australia won the regional prize for Asia-Pacific by capturing an autofluorescence image of a mouse embryo. US entrant Tagide de Carvalho won the regional award for the Americas with his colorful image of a tardigrade. The regional winner for Europe, the Middle East, and Africa was the UK’s Alan Prescott, for his image capturing the frozen section of a mouse’s head.

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#gaming-culture, #life-science-imaging, #life-sciences, #microphotography, #microscopy, #olympus, #science

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Cell and gene therapy startup ElevateBio raises $170 million

While economic conditions and the ongoing global coronavirus pandemic may not make for the best atmosphere for raising funding, some companies are still announcing round closures with significant money committed. Cambridge-based ElevateBio, for instance, revealed a $170 million Series B funding on Monday, with participation from new investors The Invus Group, Surveyor Capital, EDBI, and Vertex Ventures, along with existing investors F2 Ventures, MPM Capital, EcoR1 Capital, Redmile Group and Samsara BioCapital.

ElevateBio, which was officially launched to the public less than a year ago, specializes in development of new types of cellular and genetic therapies, and operates by the creation of new companies under its portfolio each dedicated to the development and manufacturing of a specific type of therapeutic approach. This funding brings the total raised by ElevateBio to over $300 million, on top of a $150 million Series A round that the company announced last year, led by Swiss investment bank UBS’ Oncology Impact Fund.

The biotech company has ramped up quickly, nearing completion of a 140,000 square foot facilitating in Massachusetts to focus on R&D. It also launched a company called AlloVir that’s working on T-cell immunotherapy for combating viruses that specifically arise stem cell transplantations, and is already in the later stages of clinical trials. Finally, it launched another company called HighPassBio, which is also aimed at helping treat stem cell-related diseases using T-cell therapies, in this case specifically around the potential relapse of leukaemia following a transplant.

As you might expect, ElevateBio is also turning the attention of some of its efforts towards research focused on mitigating the impact of COVID-19; specifically, its AlloVir subsidiary has expanding an existing research agreement in place with the Baylor College of Medicine to work on developing a type of T-cell therapy that can help protect patients with conditions that compromise their immune systems and put them at increased risk for COVID-19.

#biology, #biotech, #biotechnology, #cambridge, #coronavirus, #covid-19, #drugs, #edbi, #health, #invus-group, #life-sciences, #manufacturing, #massachusetts, #pharma, #recent-funding, #science, #startups, #stem-cell, #tc, #vertex-ventures

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Even uncontacted tribes in Brazil may face coronavirus risk

Members of an uncontacted tribe in Acre, northwestern Brazil, 2009.

Enlarge / Members of an uncontacted tribe in Acre, northwestern Brazil, 2009.

Ethnos360, an “aviation missionary” organization based in Arizona, has recently announced the use of a new helicopter to provide supplies and transport to its operations in remote western Brazil.

The organization, which aims to reach “the last tribe regardless of where that tribe might be,” has previously operated in western Brazil with a bush plane. This has restricted its activities because of the permit requirements and expense of building and maintaining an airstrip. The helicopter, the organization writes, will “open the door to reach ten additional people groups living in extreme isolation.” While questionable at any time, the current pandemic creates a context in which the decision to contact these groups is especially insensitive.

Leave us alone

This region of western Brazil is home to the highest number of uncontacted tribes in the world, according to nonprofit Survival International, which campaigns for the land rights of indigenous people as well as the right for uncontacted groups to remain so. Survival International points to uncontacted people’s hostile behaviors, like pointing arrows at aircraft and leaving crossed spears in the forest, as evidence that these groups do not want to interact with outsiders.

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#coronavirus, #life-sciences, #medicine, #pandemic, #science

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Despite Trump’s claims, Google isn’t building the coronavirus screening site — and it’s not ready

In a press conference at the White House, President Trump today announced that 1,700 Google engineers were working on a coronavirus screening site. That site was supposedly the first step in a new screening process that would lead people from figuring out if their symptoms warranted more testing to the location of new “drive through” testing stations. But Trump was wrong. This screening site isn’t being developed by Google . Instead, it’s being built by Verily, Alphabet’s life science division — and it’s not ready to launch yet either.

While both share the same parent company in Alphabet, these are two very different companies. In addition, as Verily noted in a statement it provided almost three hours after Trump made the announcement, this site isn’t quite ready yet.

“Verily is developing a tool to help triage individuals for COVID-19 testing. We are in the early stages of development, and planning to roll testing out in the Bay Area, with the hope of expanding more broadly over time,” the company said in its statement. “We appreciate the support of government officials and industry partners and thank the Google engineers who have volunteered to be part of this effort.”

Dr. Debbie Birx, White House Coronavirus Response Coordinator speaks as US President Donald Trump (R) and other members of the White House Coronavirus Task Forcee listen at a press conference on COVID-19, known as the coronavirus, in the Rose Garden of the White House in Washington, DC, March 13, 2020. – Trump is declaring coronavirus a national emergency. (Photo by SAUL LOEB / AFP) (Photo by SAUL LOEB/AFP via Getty Images)

Verily specifically mentions that the site is in its “early stages.” Debbie Birx, the White House Coronavirus Response Coordinator, as well as Trump, made no mention of the fact that this site wasn’t ready yet or that it would only roll out in the Bay Area at first.

Instead, anybody watching the press conference surely came away with the impression that the site was essentially ready, especially given its pivotal role in the overall screening process.

“I want to thank Google. Google is helping to develop a website,” Trump said. “It’s gonna be very quickly done — unlike websites of the past — to determine whether a test is warranted and to facilitate testing at a nearby convenient location. We have many, many locations behind us, by the way. We cover this country and large parts of the world, by the way. We’re not gonna be talking about the world right now, but we cover very, very strongly our country. Stores in virtually every location. Google has 1,700 engineers working on this right now. They have made tremendous progress.”

Similarly, when Birx presented the new screening approach, she specifically noted that the process will start with the screening website. Given some of Trump’s earlier comments in the press conference, a number of pundits believed that the site would be ready by Sunday night.

Here is Verily’s statement about its plans for its site, according to a spokesperson: “What I can share at this time is that our aspiration is for the triage tool to be used much more broadly. Initially, we’re linking it with several sites in the Bay Area to test and iterate, and collaborating closely with organizations like Quest Diagnostics and LabCorp who are also working on additional approaches to making testing more accessible and expedient in other areas.”

In a different statement to The Verge, Verily said the tool was originally meant for healthcare workers and that the presidential announcement changed its course to becoming a public site. Whatever the original intent of the project, it seems quite clear that Verily was taken somewhat aback by the announcement.

Now, it’s not uncommon for anybody outside of the tech world to use Alphabet and Google interchangeably. Still, Verily is not Google and the Bay Area is not the whole country. Those are important facts.

#alphabet, #articles, #california, #coronavirus, #covid-19, #google, #life-sciences, #president, #tc, #trump, #verily, #white-house

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As national COVID-19 cases top 1,000, insurers waive treatment fees and US preps stimulus

The number of COVID-19 cases in the U.S. crossed 1,000 on Tuesday as President Donald Trump met with the nation’s largest insurers and members of his cabinet to discuss how to pay for treatment and lessen the financial blow of the disease’s spread.

With the nation’s healthcare apparatus beginning to get a better understanding of the proliferation of the virus that causes COVID-19 within its borders, efforts have shifted fully from containing the disease’s spread to stopping the contagion from getting worse.

“What we would like the country to realize is that as a nation we can’t be doing the kinds of things we would be doing a few months ago,” said Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, during the daily briefing from the President’s Coronavirus Task Force. “It doesn’t matter if you’re in a state that has no cases or one case, you have to start taking seriously what you can do now, if and when the infections will come, and they will come.”

The government and private testing facilities Quest and LabCorp are quickly distributing new test kits, with the expectation that 5 million will be made available by the end of the week. The availability of testing means that more cases will be diagnosed and efforts will be made to limit the spread in the new clusters as they’re identified.

However, that rollout might be hampered by a potential shortage of a critical component of the tests — the “RNA extraction” kits, first reported by Politico earlier on Tuesday.

“RNA extraction is the first step in being able to perform” a COVID-19 test, Michael Mina, associate medical director of molecular diagnostics at Brigham and Women’s Hospital in Boston told Politico. “If we cannot perform this step, the [coronavirus] test cannot be performed.”

More roadblocks to testing could limit the identification of clusters of the virus that causes COVID-19 and stop governments from taking the kinds of dramatic action that medical professionals think could be necessary to mitigate the spread of the virus.

“When you have community spread you’re going to ratchet up the kinds of mitigations that you have,” said Fauci. “Everyone should be saying all hands on deck. This is what we need to be doing.”

In New York state that’s meant establishing a containment zone around New Rochelle, a city that has been the focal point for the disease’s spread in the region.

That mitigation strategy looks like an extreme version of the steps that Dr. Scott Gottlieb, the former Food and Drug Administration chief recommended over the weekend.

Meanwhile, more companies made calls for remote work for their employees and took steps to shield their workers from financial hardship caused by the disease — either through illness or because of the mitigation strategies imposed by the companies themselves. Their commitments come as President Trump and his economic advisors move forward with a stimulus package to boost the economy and provide a safety net for companies that are paying for workers’ time off.

Earlier in the day in a briefing at the White House, Vice President Mike Pence outlined the steps that insurance companies would be taking to ensure that patients receive the treatment they need.

 

“All the insurance companies here — either today or before today — have agreed to waive all copays on coronavirus testing and extend coverage for coronavirus treatment in all of their benefit plans,” Vice President Pence said. Last week the government said that Medicare and Medicaid beneficiaries would have their testing and treatment covered.

“They’ve also agreed to cover telemedicine so that anyone, particularly among the vulnerable senior population, would not feel it necessary to go to a hospital or go to their doctor,” said Pence. “They’ll know that telemedicine is covered.”

And for tech companies like Instacart, Postmates, Alphabet, Microsoft, Amazon, Salesforce, and Facebook, which have all committed to paying for hourly workers sickened by the virus or who have lost work due to office closures, the Federal government may provide some financial assistance (not that the tech companies need it).

Following up on the commitment made yesterday,  Director of the United States National Economic Council Larry Kudlow said at Tuesday’s briefing that the administration is putting together a proposal for a payroll tax cut and tax deferrals for small and medium-sized businesses who are impacted by the spread of COVID-19. 

Technology companies and the billionaires that own them are also chipping in to help local communities and finance initiatives looking for new diagnostics to identify the disease and treatments for the sick.

Earlier today, Amazon announced a $5 million initiative to help local businesses affected by the outbreak of COVID-19 in Seattle, while the Gates Foundation committed $50 million to a $125 million effort to develop treatments.

Still, executives at startups operating clinics in geographies affected by the virus that causes COVID-19 are saying that the infrastructure is not yet in place to adequately and effectively diagnose and treat the disease.

“Testing isn’t being done widely,” said one executive at a startup that runs a network of clinics and urgent care centers. “The supplies in the country are just very limited right now.” 

#alphabet, #amazon, #biology, #boston, #chief, #coronavirus, #director, #donald-trump, #executive, #facebook, #federal-government, #food-and-drug-administration, #gates-foundation, #head, #instacart, #insurance, #labcorp, #life-sciences, #medicare, #microsoft, #mike-pence, #postmates, #president, #salesforce, #scott-gottlieb, #seattle, #tc, #technology, #telemedicine, #united-states, #vice-president, #white-house

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