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

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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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Spotify CEO Daniel Ek pledges $1Bn of his wealth to back deeptech startups from Europe

At an online event today, Daniel Ek, the founder of Spotify, said he would invest 1 billion euros ($1.2 billion) of his personal fortune in deeptech “moonshot projects”, spread across the next 10 years.

Ek indicated that he was referring to machine learning, biotechnology, materials sciences and energy as the sectors he’d like to invest in.

“I want to do my part; we all know that one of the greatest challenges is access to capital,” Ek said, adding he wanted to achieve a “new European dream”.

“I get really frustrated when I see European entrepreneurs giving up on their amazing visions selling early on to non-European companies, or when some of the most promising tech talent in Europe leaves because they don’t feel valued here,” Ek said. “We need more super companies that raise the bar and can act as an inspiration.”

According to Forbes, Ek is worth $3.6 billion, which would suggest he’s putting aside roughly a third of his own wealth for the investments.

And it would appear his personal cash will be deployed with the help of a close confidant of Ek’s. He retweeted a post by Shakhil Khan, one of the first investors in Spotify, who said “it’s time to come out of retirement then.”

During a fireside chat held by the Slush conference, he said: “We all know that one of the greatest challenges is access to capital. And that is why I’m sharing today that I will devote €1bn of my personal resources to enable the ecosystem of builders.” He said he would do this by “funding so-called moonshots focusing on the deep technology necessary to make a significant positive dent, and work with scientists, entrepreneurs, investors and governments to do so.”

He expressed his desire to level-up Europe against the US I terms of tech unicorns: “Europe needs more super companies, both for the ecosystem to develop and thrive. But I think more importantly if we’re going to have any chance to tackle the infinitely complex problems that our societies are dealing with at the moment, we need different stakeholders, including companies, governments, academic institutions, non-profits and investors of all kinds to work together.”

He also expressed his frustration at seeing “European entrepreneurs, giving up on their amazing visions by selling very early in the process… We need more super companies to raise the bar and can act as an inspiration… There’s lots and lots of really exciting areas where there are tons of scientists and entrepreneurs right now around Europe.”

Ek said he will work with scientists, investors, and governments to deploy his funds. A $1.2 billion fund would see him competing with other large European VCs such as Atomico, Balderton Capital, Accel, Index Ventures and Northzone.

Ek has been previously known for his interest in deeptech. He has invested in €16m in Swedish telemedicine startup Kry. He’s also put €3m into HJN Sverige, an artificial intelligence company in the health tech arena.

#articles, #artificial-intelligence, #balderton-capital, #biotechnology, #business, #daniel-ek, #economy, #energy, #entrepreneurship, #europe, #forbes, #founder, #kry, #machine-learning, #northzone, #private-equity, #spotify, #startup-company, #tc, #telemedicine, #united-states

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Does early-stage health tech need more ‘patient’ capital?

Crista Galli Ventures, a new early-stage health tech fund in Europe, officially launched last week. The firm offers “patient capital” — with only a single LP (the Danish family office IPQ Capital) — and promises to provide portfolio companies with deep healthcare expertise and the extra runway needed to get over regulatory and efficacy hurdles and to the next stage.

The firm has an initial $65 million to deploy and is led by consultant radiologist Dr. Fiona Pathiraja. With offices in London and Copenhagen, it operates as an “evergreen” fund, meaning it doesn’t follow traditional five-year VC fundraising cycles.

In fact, Crista Galli Ventures’ pitch is that traditional venture isn’t well-suited to early-stage health tech where it can take significantly longer to find product-market fit with healthcare practitioners and systems and then become licensed by local regulators.

To dig deeper into this and CGV’s investment remit more generally, I interviewed Pathiraja about what she looks for in health tech founders and startups. We also discussed Crista Galli LABS, which operates alongside the main fund and backs founders from underrepresented backgrounds at the pre-seed stage.

TechCrunch: You describe Crista Galli Ventures (CGV) as an early-stage health tech fund that offers patient capital and backs companies in Europe. In particular, you cite deep tech, digital health and personalised healthcare. Can you elaborate a bit more on the fund’s remit and what you look for in founders and startups at such an early stage?

Dr. Fiona Pathiraja: We like founders with bold ideas and international ambitions. We look for mission-driven founders who believe their companies can make a real and positive impact on the lives of people and patients the world over.

We will look for founders who deeply understand the problem they are trying to tackle from all angles — especially the patient’s perspective, but also that of the clinician and relevant regulators — and we want to see that they are building their solutions to solve this. This means they will make an effort to understand the complex and nuanced healthcare landscape and all the stakeholders in it.

In terms of founder characteristics, in my opinion, the best founders will be mission driven, able to tell a compelling story, and motivate others to join them. Grit and resilience are important and several of our portfolio companies were founded around 6-8 years ago and they are doggedly continuing to build.

#biotechnology, #crista-galli-ventures, #entrepreneurship, #europe, #health, #healthcare, #healthtech, #skin-cancer, #startups, #tc, #venture-capital

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Alternative protein companies have raised a whopping $1.5 billion through July of this year

Companies like Perfect Day, Impossible Foods, and a host of other startups that are developing replacements for animal farmed goods used in food, clothes, cosmetics, and chemicals have raised a whopping $1.5 billion through the first half of the year.

That’s according to a new report from The Good Food Institute which is tracking the growth of investments into sustainable foods. The report identified fermentation technologies as a rising third pillar of foundational technologies on which new and established food brands are making products that swap out animal products for other protein sources.

Fermentation technologies, which use microbes like microalgae and mycoprotein, can produce biomass, improve plant proteins and create new functional ingredients, and companies developing and deploying these technologies have raised $435 million in funding through the end of July 2020. It’s an indication of how competitive the market is for food technologies, representing an increase of nearly 60 percent over the $274 million invested in all of 2019, according to GFI.

“Fermentation is powering a new wave of alternative protein products with huge potential for improving flavor, sustainability, and production efficiency. Investors and innovators are recognizing this market potential, leading to a surge of activity in fermentation as an enabling platform for the alternative protein industry as a whole,” said GFI Associate Director of Science and Technology Liz Specht, in a statement. “And this is just the beginning: The opportunity landscape for technology development is completely untapped in this area. Many alternative protein products of the future will harness the plethora of protein production methods now available, with the option of leveraging combinations of proteins derived from plants, animal cell culture, and microbial fermentation.”

Portait of the head of an adult black and white cow, gentle look, pink nose, in front of a blue sky. Image Credit: Getty Images

As the $1.5. billion figure indicates, big-time investors are taking notice. Funds like the Bill Gates -backed Breakthrough Energy Ventures, Temasek, Horizons Ventures, CPP Investment Board, Louis Dreyfus Co., Bunge Ventures, Kellogg, ADM Capital, Danone, Kraft Heinz, Mars, and Tyson Foods’ investment arm have all backed companies in the industry.

In all, fermentation-focused startup companies raised 3.5 times more capital than cultivated meat companies worldwide and almost 60 percent as much as U.S. plant-based meat, egg, and dairy companies, according to the GFI. 

As the industry has grown up, since Quorn became the first company to use fermentation-derived proteins back in 1985, big industrial companies have started to take notice.

While there are at least 44 startups focused on alternative proteins worldwide, according to the GFI report, large publicly traded companies like Novozymes, DuPont, and DSM are also developing product lines for the alternative protein business.

“Given the breadth of applications, we believe that fermentation could solve many current challenges faced by alternative proteins. On the one hand, biomass fermentation can create nutritious, clean protein in a highly efficient and low-cost way. On the other hand, the potential for precision fermentation to produce value-added, highly functional, and nutritious ingredients is very exciting and could revolutionize the plant-based category,” said Rosie Wardle, an investor with the CPT Capital, which specializes in backing startups developing novel protein production technologies. “From an investment perspective, we are very excited about the white space opportunities in this category, and we are actively looking to increase our investments in the space. This new report from GFI is the first comprehensive overview of fermentation for alternative protein applications and should be required reading for everyone who wants to create a more efficient and less harmful global food system.”

#articles, #bill-gates, #biotechnology, #breakthrough-energy-ventures, #cellular-agriculture, #chemicals, #cultured-meat, #danone, #dupont, #food, #food-and-drink, #head, #horizons-ventures, #impossible-foods, #mars, #meat, #meat-substitutes, #tc, #technology-development, #temasek, #tyson-foods, #united-states

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Ansa Biotechnologies wants to usher in a new era of DNA manufacturing

Daniel Arlow has spent the last eighteen years studying genomics and synthetic biology. The arc of his career has taken the first-time founder of the new startup Ansa Biotechnologies from MIT to the famous Keasling Lab at the University of California at Berkeley and now to the world of startups.

Now, Arlow is ready to tell the world what he’s been working on at Ansa, which is nothing less than the delivery of the next generation of synthetic DNA manufacturing.

His company is bringing to market a new process for making DNA that Arlow said is faster and more accurate than existing technologies.

“DNA read, write, and edit are the core pillars of synthetic biology,” said Seth Bannon, a founding partner at the frontier investment firm Fifty Years, and an investor in Ansa’s recent $7.9 million investment round. “Currently the ability to write DNA is the main bottleneck in the synthetic biology industry. By enabling faster, longer, and higher quality DNA synthesis with their fully enzymatic process, Ansa will help accelerate the entire synthetic biology industry.”

Arlow likens the state of the industry now to the early days of programming. “If it took three weeks to compile your code or recompile your code to make a simple change you could never make any progress in developing software for the computer,” Arlow said. And that’s the state for programmable biology these days.

“It took a really long time to test your idea after it was designed. It forces you to plan things out much more carefully and to be less spontaneous and less agile,” he said. 

Using Ansa, companies can have DNA made based on their specific requirements at a speed and scale that Arlow said other companies in the market can’t match.

Currently, DNA molecules are made using a thirty year-old chemical method that has limitations on the length of molecules that can be made. By contrast, Ansa’s biologically inspired DNA synthesis method means that the company can make long molecules directly, without the risk of errors that can result from patching pieces of genetic material together.

The company has developed an enzyme that basically adds bases to a DNA molecule. The company basically has a cut and paste function that serves to unblock DNA and then allows another base to be attached.

It’s also important to note that Arlow’s company is doing synthesis as a service rather than selling bioprinters that can enable any researcher to make their own DNA.

“One of the reasons we’re developing our business as a DNA synthesis service… as opposed to making a printer… is because that gives us a much greater ability to vet orders for biosecurity risk before we manufacture them,” Arlow said.

Other companies like DNA Script (from France) and Nuclera (a Cambridge, UK-based company) are going to market with bioprinters that they’re selling directly to research labs, according to Arlow.

All of these businesses are the next iteration of companies like Twist Bioscience, that are manufacturing DNA to power the synthetic biology revolution (something that TechCrunch Disrupt attendees have been hearing a lot about).

Ansa hasn’t shipped any DNA yet, but the company will soon be taking orders to begin competing in a market that Arlow estimates is over $1 billion today and is growing quite rapidly.

“Writing is really the bottleneck,” Arlow said. “The business we’re in is selling to R&D.. the faster we can crank out the DNA the better it is. Part of the reason why we’re still pretty bad at engineering biology is because it takes so long to build a new design. My hope is by building more we’ll get better at designing because we’ll be able to see what works and what doesn’t work.”

 

#articles, #biology, #biotechnology, #dna, #dna-script, #emerging-technologies, #fifty-years, #genomics, #mit, #seth-bannon, #synthetic-biology, #tc, #twist-bioscience

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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

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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

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Mammoth Biosciences’s CRISPR-based COVID-19 test receives NIH fundings through RADx program

CRISPR tech startup Mammoth Biosciences is among the companies that revealed backing from the National Institutes of Health (NIH) Rapid Accleration of Diagnostics (RADx) program on Friday. Mammoth received a contract to scale up its CRISPR-based SARS-CoV-2 diagnostic test in order to help address the testing shortages across the U.S.

Mammoth’s CRISPR-based approach could potentially offer a significant solution to current testing bottlenecks, because it’s a very different kind of test when compared to existing methods based on PCR technology. The startup has also enlisted the help of pharma giant GSK to develop and produce a new COVID-19 testing solution, which will be a handheld, disposable test that can offer results in as little as 20 minutes, on site.

While that test is still ind development, the RADx funding received through this funding will be used to scale manufacturing of the company’s DETECTR platform for distribution and use in commercial laboratory settings. This will still offer a “multi-fold increase in testing capacity,” the company says, even though it’s a lab-based solution instead of a point-of-care test like the one it’s seeking to create with GSK.

Already, UCSF has received an Emergency Use Authorization (EUA) from the FDA to use the DETECTR reagent set to test for the presence of SARS-CoV-2, and the startup hopes to be able to extend similar testing capacity to other labs across the U.S.

#articles, #biology, #biotech, #biotechnology, #coronavirus, #covid-19, #crispr, #fda, #genetic-engineering, #health, #mammoth-biosciences, #national-institute-of-health, #science, #startup-company, #tc, #tech-startup, #united-states

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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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Emerging from stealth, Octant is bringing the tools of synthetic biology to large scale drug discovery

Octant, a company backed by Andreessen Horowitz just now unveiling itself publicly to the world, is using the tools of synthetic biology to buck the latest trends in drug discovery.

As the pharmaceuticals industry turns its attention to precision medicine — the search for ever more tailored treatments for specific diseases using genetic engineering — Octant is using the same technologies to engage in drug discovery and diagnostics on a mass scale.

The company’s technology genetically engineers DNA to act as an identifier for the most common drug receptors inside the human genome. Basically, it’s creating QR codes that can flag and identify how different protein receptors in cells respond to chemicals. These are the biological sensors which help control everything from immune responses to the senses of sight and smell, the firing of neurons; even the release of hormones and communications between cells in the body are regulated.

“Our discovery platform was designed to map and measure the interconnected relationships between chemicals, multiple drug receptor pathways and diseases, enabling us to engineer multi-targeted drugs in a more rational way, across a wide spectrum of targets,” said Sri Kosuri, Octant’s co-founder and chief executive officer, in a statement.

Octant’s work is based on a technology first developed at the University of California Los Angeles by Kosuri and a team of researchers, which slashed the cost of making genetic sequences to $2 per gene from $50 to $100 per gene.

“Our method gives any lab that wants the power to build its own DNA sequences,” Kosuri said in a 2018 statement. “This is the first time that, without a million dollars, an average lab can make 10,000 genes from scratch.”

Joining Kosuri in launching Octant is Ramsey Homsany, a longtime friend of Kosuri’s, and a former executive at Google and Dropbox . Homsany happened to have a background in molecular biology from school, and when Kosuri would talk about the implications of the technology he developed, the two men knew they needed to for a company.

“We use these new tools to know which bar code is going with which construct or genetic variant or pathway that we’re working with [and] all of that fits into a single well,” said Kosuri. “What you can do on top of that is small molecule screening… we can do that with thousands of different wells at a time. So we can build these maps between chemicals and targets and pathways that are essential to drug development.”

Before coming to UCLA, Kosuri had a long history with companies developing products based on synthetic biology on both the coasts. Through some initial work that he’d done in the early days of the biofuel boom in 2007, Kosuri was connected with Flagship Ventures, and the imminent Harvard-based synthetic biologist George Church . He also served as a scientific advisor to Gen9, a company acquired by the multi-billion dollar synthetic biology powerhouse, Ginkgo Bioworks.

“Some of the most valuable drugs in history work on complex sets of drug targets, which is why Octant’s focus on polypharmacology is so compelling,” said Jason Kelly, the co-founder and CEO of Gingko Bioworks, and a member of the Octant board, in a statement. “Octant is engineering a lot of luck and cost out of the drug discovery equation with its novel platform and unique big data biology insights, which will drive the company’s internal development programs as well as potential partnerships.”

The new technology arrives at a unique moment in the industry where pharmaceutical companies are moving to target treatments for diseases that are tied to specific mutations, rather than look at treatments for more common disease problems, said Homsany.

“People are dropping common disease problems,” he said. “The biggest players are dropping these cases and it seems like that just didn’t make sense to us. So we thought about how would a company take these new technologies and apply them in a way that could solve some of this.”

One reason for the industry’s turn away from the big diseases that affect large swaths of the population is that new therapies are emerging to treat these conditions which don’t rely on drugs. While they wouldn’t get into specifics, Octant co-founders are pursuing treatments for what Kosuri said were conditions “in the metabolic space” and in the “neuropsychiatric space”.

Helping them pursue those targets, since Octant is very much a drug development company, is $20 million in financing from investors led by Andreessen Horowitz .

“Drug discovery remains a process of trial and error. Using its deep expertise in synthetic biology, the Octant team has engineered human cells that provide real-time, precise and complete readouts of the complex interactions and effects that drug molecules have within living cells,” said Jorge Conde, general partner at Andreessen Horowitz, and member of the Octant board of directors. “By querying biology at this unprecedented scale, Octant has the potential to systematically create exhaustive maps of drug targets and corresponding, novel treatments for our most intractable diseases.”

#andreessen-horowitz, #articles, #biology, #biotechnology, #chemicals, #dna, #dna-sequencing, #dropbox, #drug-development, #drug-discovery, #emerging-technologies, #executive, #flagship-ventures, #general-partner, #genetic-engineering, #genetics, #george-church, #ginkgo-bioworks, #google, #harvard, #jason-kelly, #jorge-conde, #pharmaceutical, #synthetic-biology, #tc

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Intel has invested $132M in 11 startups this year, on track for $300M-$500M in total

When it comes to corporate venture capital, semiconductor giant Intel has shaped up to be one of the most prolific and prescient investors in the tech world, with investments in 1,582 companies worldwide, and a tally of some 692 portfolio companies going public or otherwise exiting in the wake of Intel’s backing.

Today, the company announced its latest tranche of deals: $132 million invested in 11 startups. The deals speak to some of the company’s most strategic priorities currently and in the future, covering artificial intelligence, autonomous computing, and chip design.

Many corporate VCs have been clear in drawing a separation between their activities and that of their parents, and the same has held for Intel, but at the same time, the company has made a number of key moves that point to how it uses its VC muscle to expand its strategic relationships and also ultimately expand through M&A. Just earlier this month, it acquired Moovit, an Intel Capital portfolio company, for $900 million (a deal that was knocked down to $840 million when accounting for its previous investment).

Intel Capital identifies and invests in disruptive startups that are working to improve the way we work and live. Each of our recent investments is pushing the boundaries in areas such as AI, data analytics, autonomous systems and semiconductor innovation. Intel Capital is excited to work with these companies as we jointly navigate the current world challenges and as we together drive sustainable, long-term growth,” said Wendell Brooks, Intel senior vice president and president of Intel Capital, in a statement.

The tranche of deals come at a critical time in the worlds of startups and venture investing. Many are worried that the slowdown in the economy, precipitated by the COVID-19 pandemic, will mean a subsequent slowdown in tech finance. Intel says that it plans to invest between $300 million and $500 million in total this year, so this would go some way to refuting that idea, along with some of the other monster deals and big funds that we’ve written out in the last couple of months.

The list announced today doesn’t include specific investment numbers, but in some cases the startups have also announced the fundings themselves and given more detail on round sizes. These still, however, do not reveal Intel’s specific financial stakes.

Here’s the full list:

• Anodot uses machine learning for to monitor business operations autonomously, covering areas like app performance, customer incidents, and more. The idea is that using the platform to monitor for these incidents means detection and response time can be faster. The full $35 million round was announced back in April.

• Astera Labs is a fabless semiconductor startup focused on connectivity solutions for data-centric systems to remove performance bottlenecks in compute-intensive workloads in areas like AI. It announced its Series B of an undisclosed amount two weeks ago, and prior to this it had raised just over $6 million according to PitchBook.

• Axonne develops next generation high-speed automotive Ethernet network connectivity solutions for connected cars: addressing the issue of merging legacy or proprietary systems with the demands of advanced next-generation applications. Intel invested as part of a $9 million round that actually closed in March.

• Hypersonix uses big-data analytics to determine and predict customer demand for e-commerce, retail and hospitality customers. One of its customers is Amazon — which uses Hypersonix’s platform in its supply chain division. That may come as a surprise, but according to Hypersonix’s CEO the e-commerce giant does not have dedicated analytics teams to serve every division in the company, so sometimes they do buy from third parties. The round was actually announced at the beginning of this month: an $11.5 million deal.

• KFBIO out of China is one of Intel’s biotechnology bets. The company has designed and built a digital pathology scanner, which aims to replace microscopes with its big data, cloud-based, and AI-powered insights. The obvious connection and interest here for Intel is on the processor side, but potentially brings Intel into a sphere where it can flex its muscle around a range of AI and cloud computing applications as well. The deal was closed at the beginning of April and totals around $14.2 million.

• Lilt has built an AI-powered language translation platform, not to compete with the likes of Google Translate for consumers, but to help those with international-facing websites and apps localise their services more efficiently. The company actually announced its round today: a $25 million Series B led by Intel.

• MemVerge focuses on “in-memory” computing, an architecture that makes it easier to deploy heavy, data-centric applications. It closed its round of $24.5 million at the beginning of April, and while it’s always worked with Intel processors, Intel’s investment was not public until today.

• ProPlus Electronics, also out of China, is an electronic design automation (“EDA”) startup that speeds up chip design and fabrication for semiconductor companies manufacturing a variety of chips at scale. It closed its round also at the beginning of April. The exact amount was undisclosed except to note that it was in the “hundreds of millions of Chinese Yuan” (or tens of millions of US dollars).

Retrace is an under-the-radar dental data startup that uses AI to improve “dental decision making,” but according to its site seems also to focus on other healthcare areas. It’s not clear how big the round is or when it closed.

• Spectrum Materials out of China is another stealthy company that supplies gas and other materials to semiconductor makers.

• Xsight Labs based in Israel is building chipset designs to accelerate data-intensive workloads that you typically get with AI and analytical applications. Israel has a huge R&D centre in Israel focused on autonomous driving, one of the applications that’s going to demand a lot in processing power, so this looks like a clearly strategic bet. The company raised $25 million in February, but Intel was not disclosed in that round previously.

#amazon, #artificial-intelligence, #autonomous-systems, #biotechnology, #california, #ceo, #china, #companies, #computing, #corporate-venture-capital, #e-commerce, #ethernet, #gengo, #google, #intel, #intel-capital, #israel, #machine-learning, #moovit, #retrace, #san-francisco-bay-area, #semiconductor, #tc, #tech-finance, #venture-capital

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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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Curative received FDA emergency use authorization for its novel COVID-19 tests

The diagnostics startup Curative has received an emergency use authorization from the Food and Drug Administration for its novel test to determine COVID-19 infection.

The company says that its tests have already been used by the City of Los Angeles since late March and have tested over 53,000 city residents.

Curative’s tests use an oral-fluid sample collected by having the subject cough to produce sputum, which release the virus from deep in the lungs, according to a spokesperson.

Here’s how the letter digitally signed by the FDA’s chief science officer, Denise Hinton, describes the Rucative test:

To use your product, SARS-CoV-2 nucleic acid is first extracted, isolated and purified from oropharyngeal (throat) swab, nasopharyngeal swab, nasal swab, and oral fluid specimens. The purified nucleic acid is then reverse transcribed into cDNA followed by PCR amplification and detection using an authorized real-time (RT) PCR instrument. The Curative-Korva SARS-Cov-2 Assay uses all commercially sourced materials or other authorized materials and authorized ancillary reagents commonly used in clinical laboratories as described in the authorized procedures submitted as part of the EUA request. 

Curative, which was first covered by DotLA, is processing the tests in conjunction with Korva Labs, a testing facility associated with UCLA.

These tests hope to get around the supply chain shortages that constrain the number of tests the US can conduct. Currently, the US is still experiencing a shortage of test kits because the supply chain for critical components used in test kits has been disrupted by the global COVID-19 pandemic, the company said.

Curative is working to build alternatives to many of the sample collection and extraction kit components and what it calls more scalable RNA extraction methods that don’t rely on the use of magnetic silica beads.

The company was initially founded in January 2020 to focus on a novel test for sepsis, but pivoted to focus on COVID-19 testing as the disease swept across the globe.

“Our goal is to assemble an orthogonal supply chain to supply coronavirus test kits. Doing so will help us avoid buying materials that would constrain public health and CDC laboratories from ramping up production,” the company said on its website. “We are also working to partner with other operations looking to spin up testing facilities to help them source necessary reagents.”

Curative says that its test is better for two reasons. Its sampling method reduces the risk of exposure for healthcare workers and requires less Personal Protective Equipment and its use of an alternative supply chain means it can scale tests rapidly.

The company can already process roughly 5,000 tests per day and is manufacturing 20,000 test kits over the same period. Test results can be delivered in around 31 hours.

“Broad access to testing is critical to our nation’s response to COVID-19 and with this authorization, we can continue scaling and distributing our test nationwide,” said Fred Turner, the chief executive and founder of Curative Inc. “Our work with the Cities of Los Angeles and Long Beach has helped thousands of people access testing at drive-through facilities and we are fully equipped to expand that access to help thousands more across the country. At the same time, we are continuing to work with the FDA to validate our test for at-home collection, which would expand access even more.”

With the new authorization, the company is going to begin working with additional distributors around the country.

The Curative tests are already used by Los Angeles, Long Beach and through testing organized by LA County and the LA County Fire and Sherrif’s Department. The tests aren’t being sold directly to consumers and must be ordered by a physician, the company said.

Backed by the venture firm DCVC, Curative has already been the subject of some controversy when its investor sent a letter to limited partners indicating they’d be able to get access to the Curative tests upon request.

The firm wrote:

“… please let us know as soon as possible if you are experiencing COVID-19 symptoms and are unable to get tested. Through a unique relationship with one of our portfolio companies, we will expedite delivery of a test kit (simple, fast, safe saliva/cheek swab) that should provide results within 1-3 days via return by mail.”

In a subsequent blog post, the partners at DCVC explained their outreach.

With changes in regulations enabling telemedicine across state lines, we wanted to make sure everyone DCVC knows was aware of Carbon’s excellent care and full suite of testing. And yes, that includes people who work at our Limited Partners, who are making difficult decisions for themselves and their families in difficult times like the rest of us.

With Carbon moving at the pace they do with their fast, friendly electronic on-boarding, and with Curative’s testing capability likely ramping to 10,000+ tests a day in the next ten days, the combined health care firepower can indeed “expedite” care for everybody.

Was our language a little boastful? Yes, no excuses. And we’re sorry if folks got the wrong idea. No one is “jumping in line.” We will always strive to point out to our friends and community where they can get quick access to quality care as well as access to other cutting-edge technology in our portfolio.

Accurate testing remains the most important feature of any effort to contain the COVID-19 outbreak and a number of startup companies are working on novel diagnostics.

As Harvard University epidemiologist, William Hanage told Business Insider, “Figuring out what’s actually going on in the community is the key part of dealing with this pandemic.”

#amplifiers, #biology, #biotechnology, #dcvc, #disease, #food-and-drug-administration, #fred-turner, #infection, #long-beach, #los-angeles, #physician, #rt, #spokesperson, #supply-chain, #tc, #ucla, #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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Aspen Neuroscience raises $70 million for its experimental Parkinson Disease treatment

Since 2012, Dr. Jeanne Loring, the founder of the eponymous Loring Lab at Scripps Research, has been thinking about how to use pluripotent stem cells as a potential treatment for Parkinson Disease.

Now, eight years later, Aspen Neuroscience, the company she founded to bring her research to market has raised $70 million in funding and is set to begin clinical trials.

Roughly 60,000 Americans are diagnosed with Parkinson disease, which destroys parts of the brain responsible for motor function. The disease causes a debilitating loss of movement as a result of the degradation of a specific type of neuron in the brain responsible for the production of dopamine — a chemical that facilitates the brain’s control of mood and movement.

Aspen’s experimental treatment takes skin cells from patients who already have Parkinson’s disease and converts those cells into pluripotent stem cells using the technique that won Shinya Yamanaka and John Gurdon the Nobel Prize for medicine back in 2012.

It was Yamanaka’s discovery that in some ways served as a trigger for the work that Loring and Aspen’s chief executive officer Dr. Howard Federoff would be bringing to market eight years later.

Other cell replacement therapies for Parkinson’s had run into difficulties because patient’s bodies would reject the introduction of foreign neurons — in much the same way that organ transplants are sometimes unsuccessful because a host rejects the foreign tissue.

Aspen’s technology uses the host’s own tissue to develop the stem cells that will become the basis for treatment. A patient who carries a diagnosis of Parkinsons would be consented to give a biopsy and the tissue collected is then placed in a cell culture. The cells are then converted into pluripotent stem cells through the introduction of an inert viral RNA that recodes the cell structure.

Those pluripotent stem cells are then converted into neurons that are then transplanted into a patient to replace the ones that Parkinson’s disease has destroyed.

Federoff and Loring have known each other for years, and when the former vice chancellor for health affairs at the University of California, Irvine heard what Loring and her team was working on he stepped down to join her company as chief executive.

Federoff previously founded MedGenesis Therapeutix, another privately held company working on a treatment for Parkinsons. “Much of what we do for Parkinsons and the extant gene therapy is stabilizing the disease,” says Federoff. “Cells of fibroblasts help to dial the clock back.”

The key is the use of autologous cells — those collected from the same individual that will receive the transplant, says Federoff.

Aspen’s novel approach was compelling enough to win the support of longtime healthcare investors including OrbiMed, ARCH Venture Partners, Frazier Healthcare Partners, Domain Associates, Section 32, and former Y Combinator President, Sam Altman.

Following the new round, Aspen is significantly expanding its board of directors to include Faheem Hasnain, the founder of Gossamer Bio who’s taking the chairman role at Aspen; Tom Daniel a venture partner at ARCH Ventures, and Peter Thompson, a partner at OrbiMed.

Aspen’s first product is currently undergoing investigational new drug (IND)-enabling studies for the treatment of sporadic forms of Parkinson disease, the company said. Its second product uses gene correction and neuron therapy to try to treat genetic forms of Parkinson disease. 

According to the company, the financing will support the completion of all remaining investigational studies and FDA submission of the studies relating to the company’s lead product. In addition, the financing will support data collection from a Phase 1 clinical trial and the expansion into Phase 2 randomized studies.

#arch-venture-partners, #biology, #biotechnology, #founder, #parkinsons-disease, #sam-altman, #stem-cells, #tc, #university-of-california, #y-combinator

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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.

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