A new cilia-covered chip could revolutionize portable medical diagnosis
— Read more on ScientificAmerican.com
Im #DealMonitor für den 16. Mai werfen wir einen Blick auf die wichtigsten, spannendsten und interessantesten Investments und Exits des Tages in der DACH-Region. Alle Deals der Vortage gibt es im großen und übersichtlichen #DealMonitor-Archiv.
+++ Der französische Geldgeber Ventech investiert gemeinsam mit Altinvestor High-Tech Gründerfonds (HTGF) in 7Learnings. Das Berliner Startup, das 2019 von Martin Nowak, Eiko van Hettinga und Felix Hoffmann gegründet wurde, bietet Onlinehändlern eine SaaS-Lösung zur Machine Learning-basierten Preissetzung. Der HTGF und mehrere Business Angels investierten 2020 in das junge Unternehmen. Wettbewerber Priceloop, 2020 vom Contorion-Gründer Richard Schwenke und Dat Tran gegründet, wird bereits von Accel, Project A Ventures und den Flixbus-Gründern finanziell unterstützt. Das Berliner Startup positioniert sich als KI-gestützte Software zur Optimierung von Verkaufspreisen. Mehr im Insider-Podcast #EXKLUSIV
+++ 468 Capital investiert nach unseren Informationen eine niedrige siebenstellige Summe in Xeotek. Das Startup aus Frankfurt am Main, 2019 von Benjamin Buick gegründet, ermöglicht Programmier:innen die “einfache Entwicklung, Analyse und den Betrieb von datengetriebenen Big-Data-Anwendungen mit Apache Kafka und ist damit die Datenzentrale für Apache Kafka”. 468 Capital hält nun rund 22 % am jungen Unternehmen. Mehr im Insider-Podcast #EXKLUSIV
+++ Picus Capital investiert nach unseren Informationen eine niedrige siebenstellige Summe in Molab.ai. Das Münchner BioTech-Unternehmen, das von Thilo Bauer und Simon Tatomir gegründet wurde, setzt auf eine Software, die die Entwicklung von Molekülen ermöglicht. “The molab.ai suite benefits a comprehensive range of applications across drug discovery and chemistry”, teilt das Unternehmen mit. Mehr im Insider-Podcast #EXKLUSIV
+++ Zahlreiche Angel-Investor:innen – darunter Christian Reber (Pitch), Felix Ohswald und Gregor Müller (GoStudent), Stephen Weich (Flaschenpost), Fußball-Profi Mario Götze sowie die Business-Influencerinnen Diana zur Löwen und Céline Flores Willers investieren nach unseren Informationen im Rahmen eines Wandeldarlehens rund 1,2 Millionen Euro in Junto. Das Berliner EdTech, das von Marius Hepp, Johannes Schnell-Kretschmer und Feliks Eyser gegründet wurde, setzt auf digitale Live-Trainings für Unternehmen. Zielgruppe sind dabei Führungskräfte. Mehr im Insider-Podcast #EXKLUSIV
+++ Picus Capital und Entrepreneur First investieren nach unseren Informationen eine niedrige siebenstellige Summe in Cinference. Das Unternehmen aus Berlin, das von Cuong To und Christian Wirsching gegründet wurde, nutzt Künstliche Intelligenz, um Proteintherapien zu entwickeln. Mehr im Insider-Podcast #EXKLUSIV
+++ 468 Capital und Lea Partners investieren nach unseren Informationen eine niedrige siebenstellige Summe in F&B Software. Das Unternehmen aus Mannheim, das von Jannik Fritz, zuletzt unter anderem im Investment-Team von Lea Partners gegründet wurde, befindet sich derzeit noch im Stealth-Modus. Mehr im Insider-Podcast #EXKLUSIV
+++ Das amerikanische Unternehmen Las Vegas Sands, ein Resort-Betreiber, investiert gemeinsam mit Bitkraft Ventures 6 Millionen Euro in Bayes Esports. Das Berliner Unternehmen, 2018 gegründet, sieht sich als “weltweit führender Anbieter für Esports-Daten und -Services”. Die Familie Pohlad, Fertitta Capital und der Sony Innovation Fund investierten zuletzt 6 Millionen UD-Dollar in die Bayes Esports-Mutter Bayes, früher als Dojo Madness bekannt. Zum Unternehmen, von Christian Gruber, Mathias Kutzner, Markus Fuhrmann und Jens Hilgers gegründet. gehört auch Shadow Esports.
+++ Ein nicht genanntes Familiy Office, Revent und Altinvestoren wie Earlybird, Wieland Capital, Paua Ventures und High-Tech Gründerfonds (HTGF) investieren in Noscendo. Das Unternehmen aus Duisburg, das 2018 gegründet wurde, entwickelt softwaregestützte Lösungen zur Identifizierung und Bewertung von Krankheitserregern. “With the fresh capital, Noscendo will scale up its operations, invest in the further roll out of its CE-marked IVD software based DISQVER-test, further expand its management team, and speed up the development of its product platform in a strive to release further products this year”, teilt das Unternehmen mit.
+++ Der Wiener Geldgeber Tauros Capital, der auf umsatzbasierte Finanzierunen setzt. investiert 5 Millionen Euro in Neoh – siehe Trending Topics. Das Unternehmen aus Wien, das 2016 von Adel Hafizovic, Manuel Zeller, Patrick Kolomaznik und Alexander Gänsdorfer gegründet wurde, setzt auf kalorienarme Schokoriegel. “Mit ZERO sugar added & 3g NetCarbs ist NEOH der perfekte Snack, wenn du zwischendurch mal Bock auf Süßes hast”, teilt das Food-Startup mit.
+++ Ein nicht genanntes Family Office aus Nordrhein-Westfalen investiert 1 Million Euro in UniApp. Das EdTech aus Frankfurt am Main, das 2020 von Fahed Jaarah gegründet wurde, positioniert sich als “zentralisierte Plattform in Europa, die Studierende, Universitäten und Vermittlungsagenturen zusammenbringt”. Das frische Kapital soll “in den Ausbau der KI-Technologie und in die Sales Expansion” fließen.
Startup-Jobs: Auf der Suche nach einer neuen Herausforderung? In der unserer Jobbörse findet Ihr Stellenanzeigen von Startups und Unternehmen.
BioNTech’s founding story dates back to the late 1990s, when CEO and co-founder Uğur Şahin, his wife and co-founder Özlem Türeci, and the rest of the seven-person founding team began their research.
Focused specifically on an area dubbed “New Technologies,” mRNA stood out as one area with tremendous potential to deliver the team’s ultimate goal: Developing treatments personalized to an individual and their specific ailments, rather than the traditional approach of finding a solution that happens to work generally at the population level.
Şahin, along with Mayfield venture partner Ursheet Parikh, joined us at TechCrunch Disrupt 2021 to discuss the COVID-19 vaccine, his long journey as a founder, what it takes to build a biotech platform company, and what’s coming next from BioNTech and the technologies it’s developing to help prevent other outbreaks and treat today’s deadliest diseases.
“At that time, mRNA was not potent enough,” Şahin recalled. “It was just a weak molecule. But the idea was great, so we invested many years in an academic setting to improve that. And in 2006, we realized ‘Wow, this is now working. Okay, it’s time to initiate a company’.”
Gingko Bioworks, a synthetic biology company now valued at around $15 billion, begins trading on the New York Stock Exchange today.
Gingko’s market debut is one of the largest in biotech history. It’s expected to raise about $1.6 billion for the company. It’s also one of the biggest SPAC deals done to date — Gingko is going public through a merger with Soaring Eagle Acquisition Corp., which was announced in May.
The exterior of the NYSE is decked out in Gingko decor. The imagery is clearly sporting Jurassic Park themes, as MIT Tech Review’s Antonio Regalado pointed out. It’s probably intentional: Jason Kelly, the CEO of Ginkgo Bioworks, has been re-reading Jurassic Park this week, he tells TechCrunch.
The decor also sports a company motto: “Grow everything.”
Ginkgo was founded in 2009, and now bills itself as a synthetic biology platform. That’s essentially premised on the idea that one day, we’ll use cells to “grow everything,” and Gingko’s plan is to be that platform used to do that growing.
Kelly, who often uses language borrowed from computing to describe his company, likens DNA to code. Gingko, he says, aims to “program cells like you can program computers.” Ultimately, those cells can be used to make stuff: like fragrances, flavors, materials, drugs or food products.
The biggest lingering question over Gingko, ever since the SPAC deal was announced, has centered on its massively high valuation. When Moderna, now a household name thanks to its Covid-19 vaccines, went public in 2018, the company was valued at $7.5 billion. Gingko’s valuation is double that number.
“I think that surprises people to be honest,” Kelly says.
Ginkgo’s massive valuation seems even starker when you look at its existing revenues. SEC documents show that the company pulled in $77 million in revenue in 2020, which increased to about $88 million in the first 6 months of 2021 (per an August investor call) The company has also reported losses: including $126.6 million in December 2020 and $119.3 million in 2019.
Gingko is aiming to increase revenue a significant amount in 2021. SEC documents initially noted that the company aimed to draw about $150 million in revenue in 2021, but the August earning call updated that total for the year to over $175 million.
Gingko aims to make money in two ways: first it contracts with manufacturers during the research and development phase (i.e. while the company works out how to manufacture a cell that spits out a certain fragrance, bio-based nylon, or a meatless burger). That process happens in Gingko’s “foundry” a massive factory for bioengineering projects.
This source of money is already starting to flow. Gingko reported $59 million in foundry revenue for 2020, and anticipates $100 million in 2021, per the August investor call.
This revenue, though, isn’t covering the full costs of Gingko’s operations according to the information shared by the company in SEC documents. It is covering an increasing share, though, and as Gingko scales up its platform, costs will come down. Based on fees alone, Kelly projects Gingko will break even by 2024 or 2025.
The second type of revenue comes from royalties, milestone payments, or in some cases equity stakes in the companies that go on to sell products, like fragrances or meatless burgers, made using Gingko’s facilities or know-how. It’s this source of income that will make up the vast majority of the company’s future worth according to its expectations.
Once the product is made and marketed by another company, it requires little to no more work on Gingko’s part – all the company does is collect cash.
The company is often hesitant to incorporate these earnings into projections, because they rely on other companies bringing products to market. That means it’s hard to know for sure when these downstream payments will emerge. “In our models, we are very sensitive that, at the end of the day, they’re not our products. I cannot predict when Roche might bring a drug to market and give me my milestones,” says Kelly.
Kelly says there’s evidence this model will start to work in the near-term.
Gingko earned a “bolus” milestone payment of 1.5 million shares of The Cronos Group, a cannabis company, for developing a commercially viable, lab grown rare cannabinoid called CBG for commercial use (there are seven more in strains development, says Kelly). These milestone payments (in cash or shares) are earned when a company achieves some predetermined goal using Gingko’s platform.
Gingko has also worked with Aldevron to manufacture an enzyme critical to the production of mRNA vaccines, and plans to collect royalty payments from that relationship — though no foundry fees were collected from this project.
Finally, Gingko has negotiated an equity stake in Motif Foodworks, a spinout company based on its technology. That company has so far raised about $226 million, and will aim to launch a lab-grown beef product developed at Gingko’s foundry, paying Gingko the aforementioned foundry fees already for this contribution.
This rich source of cash will depend a lot on the outside contractor’s ability to manufacture and sell products made using Gingko’s platform. This opens the company up to some risk that’s beyond its control. Maybe, for instance, it turns people don’t want bio-manufactured meat as much as many anticipated – that means some types of downstream payments may not materialize.
Kelly says he’s not particularly worried about this. Even if one particular program fails, he’s planning on having so many programs running that one or two are bound to succeed.
“I’m just sorta like: some will work, some won’t work. Some will take a year, some will take three years. It doesn’t really matter, as long as everybody is working with us,” he says. “Apple doesn’t stress about what apps are going to be the next big app in the app store,” he continues.
One key metric to watch for Gingko going forward will be how many new cell programs they’re managing to close. So far, Gingko has added thirty programs this year, says Kelly. Last year, there were 50 programs.
Remember: some of the projects are Gingko spinouts, like Motif Foodworks, not customers that come to the platform on their own. And historically, the number of companies Gingko has partnered with has been a point of criticism. Per SEC documents, the majority of revenue came from two large partners in 2020 – though Kelly told Business Insider that this was a pandemic-related downturn.
The more programs Gingko has, the more it becomes insulated from the success or failure of any one product. Plus it’s a sign that people are at least using the “app store” for biology.
“The biggest value driver of Gingko is how quickly we add programs,” Kelly says.
Sorcero announced Thursday a $10 million Series A round of funding to continue scaling its medical and technical language intelligence platform.
The latest funding round comes as the company, headquartered in Washington, D.C. and Cambridge, Massachusetts, sees increased demand for its advanced analytics from life sciences and technical companies. Sorcero’s natural language processing platform makes it easier for subject-matter experts to find answers to their questions to aid in better decision making.
CityRock Venture Partners, the growth fund of H/L Ventures, led the round and was joined by new investors Harmonix Fund, Rackhouse, Mighty Capital and Leawood VC, as well as existing investors, Castor Ventures and WorldQuant Ventures. The new investment gives Sorcero a total of $15.7 million in funding since it was founded in 2018.
Prior to starting Sorcero, Dipanwita Das, co-founder and CEO, told TechCrunch she was working in public policy, a place where scientific content is useful, but often a source of confusion and burden. She thought there had to be a more effective way to make better decisions across the healthcare value chain. That’s when she met co-founders Walter Bender and Richard Graves and started the company.
“Everything is in service of subject-matter experts being faster, better and less prone to errors,” Das said. “Advances of deep learning with accuracy add a lot of transparency. We are used by science affairs and regulatory teams whose jobs it is to collect scientific data and effectively communicate it to a variety of stakeholders.”
The total addressable market for language intelligence is big — Das estimated it to be $42 billion just for the life sciences sector. Due to the demand, the co-founders have seen the company grow at 324% year over year since 2020, she added.
Raising a Series A enables the company to serve more customers across the life sciences sector. The company will invest in talent in both engineering and on the commercial side. It will also put some funds into Sorcero’s go-to-market strategy to go after other use cases.
In the next 12 to 18 months, a big focus for the company will be scaling into product market fit in the medical affairs and regulatory space and closing new partnerships.
Oliver Libby, partner at CityRock Venture Partners, said Sorcero’s platform “provides the rails for AI solutions for companies” that have traditionally found issues with AI technologies as they try to integrate data sets that are already in existence in order to run analysis effectively on top of that.
Rather than have to build custom technology and connectors, Sorcero is “revolutionizing it, reducing time and increasing accuracy,” and if AI is to have a future, it needs a universal translator that plugs into everything, he said.
“One of the hallmarks in the response to COVID was how quickly the scientific community had to do revolutionary things,” Libby added. “The time to vaccine was almost a miracle of modern science. One of the first things they did was track medical resources and turn them into a hook for pharmaceutical companies. There couldn’t have been a better use case for Sorcero than COVID.”
New Zealand-based medtech startup HeartLab has raised $2.45 million in seed funding that it says will help the company expand its AI-powered heart scanning and reporting platform to cardiologists in the United States by early next year.
HeartLab provides an end-to-end solution for echocardiograms, the ultrasound tests that doctors use to examine a patient’s heart structure and function. Not only does the software help sort and analyze ultrasound images to help doctors diagnose cardiovascular disease, but it also streamlines the workflow by generating patient reports for doctors that can then be added to a patient’s health record.
Will Hewitt, 21, started HeartLab when he was 18 years old studying applied mathematics and statistics at the University of Auckland and working as a researcher at the Auckland Bioengineering Institute. The idea for the startup came to him as he listened to cardiologist, and now co-founder, Patrick Gladding explain how time-consuming and potentially inaccurate it is for doctors to have to review multiple scans manually everyday.
“You’ve got a really repetitive manual task done by a highly trained professional,” Hewitt told TechCrunch. “To start with, we just decided to train the AI to do one really small part of the doctor’s job, which was to look at these scans and generate a couple of different measurements that normally the doctor would have to do themselves,” said Hewitt.
In order to replicate the tedious process that doctors were doing, HeartLab built its own in-house labeling tool with sonographers that includes step-by-step guides and prompts to collect data on a range of different measurements. Hewitt said this initiative was one of the most valuable efforts of engineering the company has invested in to date because it has lead to cross validation, which is used to test the ability of the machine learning model to predict new data, as well as flag problems like selection bias and overfitting.
Once HeartLab was able to successfully replicate the scanning process, the company worked to expand its services in a way that would relieve doctors of further admin minutiae so they could spend more time actually treating their patients. Usually, doctors use a software tool that analyzes the images, another that visualizes patterns and another that actually writes up the report, says Hewitt. HeartLab’s platform, called Pulse, can now condense those processes into one software.
Cardiologists and sonographers at four different sites in New Zealand are trialing HeartLab’s tech now, which is also awaiting regulatory approval from the U.S.’s Food and Drug Administration. HeartLab anticipates FDA approval of Pulse by the first quarter of 2022, which is when the startup can begin selling the SaaS product.
“To begin with we want to talk to small and medium clinics over in the U.S.,” said Hewitt. “We’ve actually found that our products are most popular at those clinics because it replaces more software than at a larger clinic. At a larger clinic some of these bits of software they’ve already had to purchase, versus a smaller clinic, it’s stuff that they couldn’t access anyway. So when we get to the states, we want to start shipping mostly to those sorts of users while we work out how to best pitch our value proposition to the larger clinics.”
Hewitt says the funds from this round will also help the startup hire 10 more staff members to join the existing 13-member team based in Auckland. Having more tech talent on board will help HeartLab advance its product offering. At the moment, Pulse is at the point where it sees so many scans and takes so many measurements that it can get through the process quicker than a doctor could on their own and actually pick out patterns that a doctor wouldn’t see, according to Hewitt. The next step, which a good chunk of the seed funding is going toward, is how to be diagnostic about disease rather than just being able to indicate it.
“How do we actually provide something that normally doctors would have to order another scan for?” said Hewitt. “One of the key ideas with AI is you can create mappings from low-resolution images like ultrasounds. How can we try to learn a pattern from an ultrasound that’s similar to what you might see from an MRI, for example?”
If HeartLab can figure out how to glean advanced information from an echocardiogram instead of an MRI, it would be able to save hospitals, clinics and patients a lot of money. Each cardiac MRI can cost about $1,000 to $5,000, which is about five times the price of an echocardiogram.
“I’d say the biggest challenge for us is, how can we transform from a company that at the moment can deliver products to a few local clinics successfully to actually building a product that scales and delivers a really good experience to lots of users and different hospitals?” said Hewitt.
Advancements in early diagnostics and imaging tech like HeartLabs’ is causing an increased demand for such tools. As a result, the global AI-enabled medical imaging solutions market is expected to reach $4.7 billion by 2027. By extending its reach to the U.S., where heart disease is the leading cause of death, HeartLab is poised to take a big piece of that pie.
In total, HeartLab has publicly raised about $3.2 million in funding, which includes a pre-seed last October of about $800,000 led by Icehouse Ventures with support from Founders Fund, the San Francisco-based VC firm that led the round announced on Thursday. Icehouse Ventures also contributed to the oversubscribed seed round, along with another New Zealand firm Outset Ventures and private investor and CEO of design platform Figma, Dylan Field.
“The use of AI in medicine is reducing pressures on health systems and ultimately saving lives,” said Founders Fund partner Scott Nolan, who has led investment rounds for three other New Zealand startups, in a statement. “The HeartLab team has built a really compelling AI-powered platform that doctors love to use.”
Less than 3% of genetic material used in global pharmaceutical research is from Africa. The staggering gap is quite surprising because Africans and people of African descent are reported to be more genetically diverse than any other population.
Since launching in 2019, African genomics startup 54gene has been at the forefront of bridging this divide in the global genomics market. Today, the company has secured $25 million in Series B funding to bolster its efforts.
This round comes a year after the company, founded by Dr Abasi Ene-Obong, raised $15 million in Series A and two years after closing a $4.5 million seed round.
In total, 54gene has raised more than $45 million since its inception.
With the world’s analyzed genomes coming mostly from anywhere that isn’t Africa, the continent remains a valuable source of new genetic information for health and drug discovery research.
This is where 54gene’s work is relevant. The company conducts and leverages this research to ensure Africans are recipients of upcoming drug and medical discoveries.
Last year when we covered the company last year, CEO Ene-Obong disclosed that for 54gene to conduct this research, it recruits voluntary participants who donate genetic samples via swab or blood tests.
It still very much works this way. However, instead of depending on third-party health centres like hospitals and sending the samples abroad for analysis, 54gene launched its own genetics sequencing and microarray lab in Lagos last September. The company did this in partnership with U.S.-based biotech company Illumina.
Speaking with TechCrunch, Ene-Obong says in addition to the genotyping capabilities offered, the lab also provides whole-genome sequencing (WGS) and whole-exome sequencing (WES).
Not to bore you with the jargon but here’s why this is important. Genotyping tends to show only 0.02% of an individual’s DNA; however, WGS can show almost 100% of the same person’s DNA.
For WES, although it represents only 1.5% of the human genome, it shows approximately 85% of known disease-related variants.
With these three in place, the company can advance genomics research and expand its ability to help scientists and researchers in Africa.
Unlike fintech and other fast-moving sectors like e-commerce, innovation in healthtech takes some time to take shape finally. 54gene is one of the few startups in the sector and even in Africa to have moved from seed stage to Series B in under two years.
It’s this sort of frightening speed that makes one wonder what the company is doing right. So I ask the CEO whether the company is indeed seeing significant progress in advancing African genomics; he answers in the affirmative.
“Though the arc of conducting early research through drug approval can be long in biotech, we have taken the approach to building the backbone that is needed for short-term successes to long-term gains that provide better healthcare delivery and treatment outcomes from diseases,” he added.
In addition to setting its first lab, the CEO says the company increasing its biobanking capacity by 5x and is counts that as a major success.
During its last raise, 54gene had a biobank capacity for 60,000 samples. If Ene-Obong comments are anything to go by, the two-year-old company currently has a biobank with over 300,000 samples, close to its longer-term aim to manage up to 500,000.
Another one is the recruitment and training of talent to generate and process data needed to produce insights for the company’s drug discovery efforts.
Nigeria has a dearth of experienced clinicians and with the remaining few leaving in droves, it is not hard to see why it is a win for the company. Knowing this, 54gene plans to use part of the new funding to recruit and train more professionals.
Other use of funding will expand its capabilities in sequencing, target identification and validation, and precision medicine clinical trials. Also of great importance is its expansion across the African continent.
To aid this expansion, 54gene will have to carry out partnerships. A recent one occurred between the company and the Tanzania Human Genetics Organization and Ene-Obong says 54gene is in varying stages of conversations with more partners. However, he was tight-lipped on who they might be.
“We are excited about our Africa-first approach which will see us expand to countries within East and West Africa in the coming year,” he added.
54gene made some hires to this end: Michelle Ephraim, Colm O’Dushlaine, Peter Fekkes, Teresia Bost, Jude Uzonwanne — all of who have decades of experience working with companies like Leica Biosystems, Regeneron Genetic Center, Novartis, Celgene, and the Bill and Melinda Gates Foundation.
Pan-African venture capital firm Cathay AfricInvest Innovation Fund led this round. Lead investor from the company’s Series A funding, Adjuvant Capital invested once again with participation from other VCs including KdT Ventures, Plexo Capital, Endeavor Capital, and Ingressive Capital.
AgBiome, developing products from microbial communities, brought in a $116 million Series D round as the company prepares to pad its pipeline with new products.
The company, based in Research Triangle Park, N.C., was co-founded in 2012 by a group including co-CEOs Scott Uknes and Eric Ward, who have known each other for over 30 years. They created the Genesis discovery platform to capture diverse microbes for agricultural applications, like crop protection, and screen the strains for the best assays that would work for insect, disease and nematode control.
“The microbial world is immense,” said Uknes, who explained that there is estimated to be a trillion microbes, but only 1% have been discovered. The microbes already discovered are used by humans for things like pharmaceuticals, food and agriculture. AgBiome built its database in Genesis to house over 100,000 microbes and every genome in every microbe was sequenced into hundreds of strains.
The company randomly selects strains and looks for the best family of strains with a certain activity, like preventing fungus on strawberries, and creates the product.
Its first fungicide product, Howler, was launched last year and works on more than 300 crop-disease combinations. The company saw 10x sales growth in 2020, Uknes told TechCrunch. As part of farmers’ integrated pest program, they often spray fungicide applications 12 times per year in order to yield fruits and vegetables.
Due to its safer formula, Howler can be used as the last spray in the program, and its differentiator is a shorter re-entry period — farmers can spray in the morning and be able to go back out in the field in the afternoon. It also has a shorter pre-harvest time of four hours after application. Other fungicides on the market today require seven days before re-entry and pre-harvest, Uknes explained.
AgBiome aims to add a second fungicide product, Theia, in early 2022, while a third, Esendo was submitted for Environmental Protection Agency registration. Uknes expects to have 11 products, also expanding into insecticides and herbicides, by 2025.
The oversubscribed Series D round was co-led by Blue Horizon and Novalis LifeSciences and included multiple new and existing investors. The latest investment gives AgBiome over $200 million in total funding to date. The company’s last funding round was a $65 million Series C raised in 2018.
While competitors in synthetic biology often sell their companies to someone who can manufacture their products, Uknes said AgBiome decided to manufacture and commercialize the products itself, something he is proud of his team for being able to do.
“We want to feed the world responsibly, and these products have the ability to substitute for synthetic chemicals and provide growers a way to protect their crops, especially as consumers want natural, sustainable tools,” he added.
The company has grown to over 100 employees and will use the new funding to accelerate production of its two new products, building out its manufacturing capacity in North America and expanding its footprint internationally. Uknes anticipates growing its employee headcount to 300 in the next five years.
AgBiome anticipates rolling up some smaller companies that have a product in production to expand its pipeline in addition to its organic growth. As a result, Uknes said he was particular about the kind of investment partners that would work best toward that goal.
Przemek Obloj, managing partner at Blue Horizon, was introduced to the company by existing investors. His firm has an impact fund focused on the future of food and began investing in alternative proteins in 2016 before expanding that to delivery systems in agriculture technology, he said.
Obloj said AgBiome is operating in a $60 billion market where the problems include products that put toxic chemicals into the ground that end up in water systems. While the solution would be to not do that, not doing that would mean produce doesn’t grow as well, he added.
The change in technology in agriculture is enabling Uknes and Ward to do something that wasn’t possible 10 years ago because there was not enough compute or storage power to discover and sequence microbes.
“We don’t want to pollute the Earth, but we have to find a way to feed 9 billion people by 2050,” Obloj said. “With AgBiome, there is an alternative way to protect crops than by polluting the Earth or having health risks.”
There are a growing number of companies interested in CRISPR’s potential to upend medicine. It’s probably safe to say there’s only one company interested in using the gene-editing system to create a living, breathing woolly mammoth. Or, at least, something pretty close to it.
That’s the primary mission of a new company called Colossal. Co-founded by maverick geneticist George Church, and entrepreneur Ben Lamm, the current CEO of Hypergiant, the company aims to bring one of those creatures back to life using CRISPR to edit the genomes of existing Asian elephants. In that sense the creature would be very similar to a woolly mammoth, but would be more like an elephant-mammoth hybrid.
It’s a project that Church’s lab has been invested in for years. But now, Church and Lamm have managed to sell investors on the idea that bringing back a mammoth is more than a science-fiction project.
Today Colossal announced its launch and a $15 million seed round led by Thomas Tull, former CEO of Legendary Entertainment (the company responsible for the likes of Dune, Jurassic World, the Dark Knight). The round includes investments from Breyer Capital, Draper Associates, Animal Capital, At One Ventures, Jazz Ventures, Jeff Wilke, Bold Capital, Global Space Ventures, Climate Capital, Winklevoss Capital, Liquid2 Ventures, Capital Factory, Tony Robbins and First Light Capital.
“These two are a powerhouse team who have the ability to completely shift our understanding of modern genetics while developing innovative technologies that not only help bring back lost species, but advance the entire industry,” Robbins tells TechCrunch. “I am proud to be an investor in their journey.”
Lamm comes to Colossal as the founder of Hypergiant, a Texas-based A.I company. He has also built and sold three other companies: Conversable (acquired by LivePerson), Chaotic Moon Studios (acquired by Accenture) and Team Chaos (acquired by Zynga).
And big, provocative, projects are part of what Church is already famous for.
Church created the first direct genomic sequencing method in the 1980s, and went on to help initiate the Human genome project. Now, he leads synthetic biological efforts at the Wyss Institute, where he has focused on synthesizing entire genes and genomes.
While CRISPR gene editing has only just entered human trials, and typically aims to edit a single disease-causing gene, Church’s projects often think far bigger – often along the lines of speeding along evolution. In 2015, Church and colleagues edited 62 genes in pig embryos (a record at the time), in an effort to create organs for human transplants.
The company spun out of that endeavor, eGenesis, is behind on Church’s initial timeline (he predicted pig organs would be viable transplants by 2019), but the company is performing preclinical experiments on monkeys.
Resurrecting a woolly mammoth has long been in Church’s crosshairs. In 2017, his lab at Harvard University reported that they had managed to add 45 genes to the genome of an Asian elephant in an attempt to recreate the mammoth. Through a sponsored research agreement, this company will fully support the mammoth work at Church’s lab.
The company’s pitch for bringing back the Mammoth, per the press release, is to combat the effects of climate change through ecosystem restoration. Lamm expands on that point:
“Our goal is not to just bring back the Mammoth, that’s a feat in itself,” he says. “It’s for the successful re-wilding of mammoths. If you take that toolkit, you have all the tools are your disposal to prevent extinction or to bring back critically endangered species.”
About 1 million plant and animal species are threatened with extinction. Colossal’s mammoth project, should it succeed, would suggest they have developed the capacity to both repopulate recently dead creatures, and even perform what Lamm calls “genetic rescue” to stop them from disappearing in the first place.
Genetic rescue is the process of increasing genetic diversity in an endangered population – this could be achieved through gene-editing, or in some cases, cloning new individuals to create a wider gene pool (provided the clone and the existing animals have different enough genes). There is already some evidence that this is possible. In February 2021, a black footed ferret named Elizabeth Ann became the first cloned endangered species native to North America. She was cloned from the DNA housed in frozen tissue samples collected in 1988.
Bringing back extinct species might help combat a consequence of climate change, but it doesn’t solve the root problem. As long as the human- based drivers of climate change remain in-tact, there’s not much hope for a newly reborn creature that was killed by climate change the first time; in fact, fluctuating climates were one reason megafauna died off in the first place.
And, there could be serious ecosystem ramifications from re-wilding long-dead species, like spreading novel disease, displacing existing species, and altering the actual landscape (elephants are ecosystem engineers, after all).
If tackling biodiversity is part of Colossal’s core pitch, why go directly for the mammoth when there are species that might be saved right now? Lamm notes that the company may also try to edit the genomes of Asian elephants to make them more resilient, however, the mammoth project remains the company’s “north star.”
The argument, from Lamm’s perspective, is that the mammoth project is a moonshot. Even if the company shoots for the moon and lands among the stars, they will have to develop proprietary technology for de-extinction that might then be licensed or sold to potential buyers.
“It’s very similar to the Apollo program – which was a literal moonshot. A bunch of technologies were created along the way. Things like GPS, the fundamentals of the internet, and semiconductors. All those were highly monetizable,” he says.
In short, the mammoth project is more like an incubator for developing a host of intellectual property. That might include projects like artificial wombs or other applications of CRISPR, Lamm notes. These products will still face massive scientific hurdles – existing artificial womb projects aren’t even near entering human trials – but those hurdles might be slightly more achievable than living, breathing beings.
Not that Colossal doesn’t have plenty of interim plans while that research is being done. The company is also out to create an especially memorable brand along the way. Lamm says you could think of the brand as “Harvard meets MTV” says Lamm.
Though there’s no company that Lamm says is a direct comparison to Colossal, he mentioned several large space brands and agencies like Blue Origin, SpaceX, and notably NASA in our conversation — “I think that NASA is the best brand the United States ever made,” he notes.
“If you look at SpaceX and Blue Origin and Virgin, my 91 year-old grandmother knew these guys went to space. ULA and other people have been launching rockets and putting satellites up there for decades – nobody cared. These companies did a great job of bringing the public in,” he says.
The big ideas, says Lamm, draw in the public. The intellectual property developed along the way can pacify investors in the meantime. The perspective is inescapably sci-fi, but perhaps it’s supposed to be that way.
And that’s not to say that the company isn’t absolutely dead-set on bringing a mammoth to life. This capital, says Lamm, should be sufficient to help develop a viable mammoth embryo. They’re aiming to have the first set of calves born in the next four to six years.
The CRISPR-based biotech startup Mammoth Biosciences is officially a unicorn, the company says.
The billion dollar valuation comes on the back of a $150 million series D round led by Redmile Group, with participation from Foresite Capital, Senator Investment Group, Sixth Street, Greenspring Associates, Mayfield, Decheng Capital, Plum Alley and NFX. Combined with a late 2020 Series C round of $45 million (which included participation from Amazon), this brings the company’s total financing to $195 million.
Mammoth Biosciences has been a major player in the CRISPR space since its founding in 2017. CRISPR, put simply, is a pair of biological scissors that can cut and replace genes in cells and living organisms, opening up the potential to perhaps permanently cure genetic disease, and perform DNA-based diagnostics.
One of the company’s four founders is one of the original discoverers of CRISPR, Jennifer Doudna, who recently won the 2020 Nobel Prize in Chemistry along with Emmaneulle Charpentier for their 2012 work demonstrating the CRISPR could be used to cut DNA. The company’s other co-founders are Janice Chen (CTO), Lucas Harrington (CSO), and Trevor Martin, (CEO).
There are a handful of other CRISPR-based companies out there, including a number that are already publicly traded. This unicorn milestone stands as a sign that Mammoth’s unique approach to CRISPR could help it distinguish itself in that landscape.
“It’s a milestone,” says Ursheet Parikh, the co-leader of Mayfield’s engineering biology investment practice. “I think the company has a long way to go from here. This round and this valuation are just signifying the promise of this stage of what the future will hold,”
Parikh says he sees Mammoth as a CRISPR “platform.” Mammoth has been discovering new types of CRISPR systems that could be used to solve specific biological problems.
“The best analog is, before you had Intel and Microsoft, if somebody wanted to build a new application, they would have to build a whole new computer function with an operating system,” says Parikh. “You don’t have to build a CRISPR solution from the ground-up. You can work with Mammoth to find the right proteins for specific problems.”
The CRISPR system most people think of when they hear the phrase is a two part mechanism called CRISPR/Cas-9. The actual molecular scissors that cut DNA (and allow for the editing to happen) is typically the Cas-9 protein. However, there’s a whole ecosystem of Cas proteins out there that can also cut DNA, and as Mammoth’s leadership argues, can do so even better in the original depending on the application.
Mammoth is creating a “CRISPR toolbox” or a collection of different Cas proteins. You could think of them as different types of scissors that each have their own specific use cases.
In August 2020, for instance Mammoth discovered a family of proteins called the Casɸ family. This family is an ultra-small version of the typical Cas9 proteins that may make it easier to develop therapies in living people, and could enhance the precision of gene-editing. Mammoth has also characterized a Cas14 system, another family of ultra-small proteins that latch on to different target sequences in the genome (like landing pads that tell Cas proteins approximately where to cut) than the Cas9 proteins do.
“Mammoth was really founded with this idea that there’s this whole universe kind of a CRISPR that goes beyond the legacy systems like Cas9,” says Martin.
The development of a CRISPR toolkit isn’t just interesting science, it’s also a smart business move for Mammoth for another reason: intellectual property ownership.
The original CRISPR/Cas9 system has been the subject of a patent battle between the University of California Berkeley, and MIT’s Broad Institute, where scientists also discovered CRISPR around the same time.
The newer Cas proteins, not part of this patent battle, allow Mammoth to completely sidestep that concern. “The patent disputes that the Broad is involved in concern legacy CRISPR-Cas9 systems. Mammoth’s systems are not Cas9-based, so they are not subject to these disputes,” Martin clarifies.
In essence, Mammoth has been building up a collection of proprietary tools that might later be put to use. Though the possibilities are nearly limitless (genetic medicine or CRISPR-based diagnostics) many of these therapeutic products don’t exist quite yet.
2020 was a big year for CRISPR therapeutics due to an influx of new clinical trials. That suggesting therapeutics are just beginning to work their way through the regulatory requirements – though approvals are still far off.
Companies like CRISPR Therapeutics and Vertex Pharmaceuticals have announced promising results from trials on CRISPR-based beta thalassemia and sickle cell treatments. And this summer, Intellia Therapeutics (another company co-founded by Doudna) and Regeneron took the field a step further, showing that CRISPR-based treatments injected directly into the body were useful in silencing a gene that causes ATTR amyloidosis, a disorder where proteins produced in the liver are misfolded (this can lead to complications, like heart failure over time).
Mammoth’s niche in the expanding world of CRISPR therapeutics, notes Martin, will be a focus on in-vivo applications (or therapies delivered in the human body) which he argues their CRISPR toolbox may enable.
“We don’t have a timeline [for potential products] on the therapeutic side but we’ll definitely be releasing more information over the next few years and we’ve been really excited about the technical results so far,” says Martin.
Diagnostics, however, is already an area where Mammoth could distinguish itself sooner rather than later. There, the company is already working with partners to create viable products.
In January, Mammoth earned funding through the The Defense Advanced Research Projects Agency (DARPA) to develop a point-of-care test that could detect up to 10 pathogens at once, and a larger, lab-based test that could detect up to 1,000. Mammoth has also received funding from the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) program to develop advanced diagnostics using CRISPR, and entered into a partnership with GSK to develop a point-of-care Covid-19 test that could detect viral RNA in about 20 minutes.
Mammoth has continued to straddle both worlds of diagnostics and therapeutics, despite “pressure” to fit into one box or the other, says Parikh. The unicorn valuation, he adds, is an additional sign that the company’s technology can operate in both worlds.
“I think what this milestone, this round, does, is validate their approach to company building, which was really to focus on an area of expertise, rather than just putting themselves in a box, of diagnostics or therapeutics,” he says.
A serial entrepreneur Hiroshi Takatoh recognized the need for convenient and nutritious food for critically ill consumers after losing his late wife to cancer.
Takatoh founded Teatis, a plant-based sugar blocking superfood powder for diabetic consumers, in 2017 in stealth mode and went fully operational in April 2021 by teaming up with a group of doctors and registered nutritionists.
Teatis announced today it has raised $700,000 seed funding to advance its growth in the US market. The seed money brings Teatis’ total funding to over $1million.
The seed round was led by Genesia Ventures, Ryo Ishizuka, former CEO and co-founder of Japanese e-commerce company Mercari and Takuya Noguchi, CEO and founder of Japan’s skincare brand BULK HOMME. Seven other angel investors also participated in the seed funding.
Teatis will use the seed money for production and marketing in the US, where 122 million diabetics and pre-diabetics continue to work for prevention and treatment against diabetes, CEO and co-founder of Teatis Hiroshi Takatoh told TechCrunch. The company is now focusing on the US market where its production is located while its next funding, a Series A, is set for next year, Takatoh added.
“Most of our consumers, about 88%, are diabetics, and our recipe is built to help diabetics manage their blood sugar. A staggering number of Americans suffer from diabetes, and there is significant demand for diabetic-friendly foods that are nutritious, convenient and functional,” Takatoh said.
Teatis develops a supplement for all consumers interested in low-sugar foods, as well as pre-diabetics, Takatoh said. Teatis’ plant-based powders does not contain chemicals or sweeteners but include a special Japanese ingredient such as brown seaweed extract (Arame) that is proven to suppress the absorption of sugar from the intestinal tract and reduce blood sugar levels. The low-sugar powder can be made into teas, lattes or added to smoothies.
The US meal placement market size for diabetes is estimated at $5 billion while the US consumer packaged foods market for diabetes is approximately $300 billion, Takatoh said.
“We combine food science and technology to solve problems for diabetics through food products and telehealth,” Takatoh said.
With its plan on building out a comprehensive one-stop shop for diabetic health, Teatis will launch a Registered Dietitian platform, Teatis RD on Demand, this month, to offer a full-service such as food products, telehealth, and recipes, for those battling diabetes.
Teatis RD on Demand will provide private, 1-on-1 sessions with registered dietitians. It will start at $29 per 30 minutes, which is a reduced cost, versus traditional offline appointments that cost $150 per 30 minutes, and Teledoc, which costs $90 per 30 minutes, according to Takatoh.
“Many existing players in space are old companies that don’t have digital competency and data-driven production methods. Mr. Takatoh is a proven serial entrepreneur with the qualities and boldness to take over the market…I’m excited to see how Teatis’ great ideas and products will help many people who are suffering from diabetes and other chronic diseases in the future,” Genesia Ventures Manager Shunsuke Sagara said.
Emulate Inc., a biotech company focused on developing “organ-on-a-chip” technology, closed an $82 million Series E round on Tuesday. This latest round is intended to formulate a massive investment in a “roadmap” for developing model organ systems created to fit drugmakers’ needs and bring the idea of an organ-on-a-chip into use in the lab.
An organ-on-a-chip is pretty much exactly what it sounds like: it’s a recreation of a human organ (or system of human organs) scaled down into a tiny piece of hardware about the size of a AA battery. That hardware, the so-called “chip,” contains chambers where human cells (like brain cells, the kidney, lung, brain intestine, etc), can be grown. Then the chip can be manipulated to simulate breathing, blood flow through an organ or other mechanical forces that might happen in a human body.
Ultimately, the chip is supposed to mimic the conditions within a human body, and allow drugmakers to better predict what might happen when a new candidate is introduced. It’s a new model for experiments that could prove critical in the pre-clinical study process. Right now that area of research is dominated by traditional cell- or animal-based models – though Emulate, and other similar companies are hoping to change that paradigm.
Emulate was founded in 2013 and has, so far, raised about $255 million in funding. This most recent Series E round, led by Northpond Ventures and Perceptive Advisors, is part of Emulate’s plan to invest more heavily in R&D, and create specific organ-on-a-chip applications that they’ve honed in on through conversations with drug companies. So far, Emulate counts 21 major drug companies, including Roche, Genentech, Johnson & Johnson and Gilead Sciences as customers.
“We researched what pharma is spending their R&D dollars on – particular types of molecules, biologics and so-forth – then we created a roadmap, a series of applications aligned to where big pharma is spending their money” Jim Corbett, the CEO of Emulate tells TechCrunch.
In January, Emulate announced several new products and services that are part of this roadmap. They include the Emulate brain chip, designed to aid with research into central nervous system disorders (like Alzheimer’s), an immune cell recruitment application that will investigate how the immune system interacts across the lungs, liver, and intestine (using lung-chips, liver-chips, and intestine chips), and a microbiome model integrated into the liver chip.
Corbett says the company will look to roll out 14 applications over the next two years, seven of which will roll out next year.
Organs on chips have been around for about a decade. The NIH has launched them into space to study the effects of spaceflight, and has been developing tissue chip testing and validation programs since 2010.
A 2020 review paper in Bioengineering notes the organ-on-a-chip industry was recently valued around $21 million, but could grow to about $220 million by 2025.
A lot of that growth will depend on the potential for an organ-on-a-chip to disrupt the preclinical side of the drug testing process. And that itself depends a lot on how the FDA views data collected on that platform.
The specific organ-on-a-chip technology itself doesn’t need to be FDA approved (it’s not a therapeutic or device), but drug companies will almost certainly seek assurance that the agency is receptive to experiments using organs-on-chips.
From Corbett’s perspective, he says the FDA has proved “very receptive” to data collected on these platforms.
There is evidence the company has worked closely with the FDA in the past. In 2020, for instance, Emulate entered into a Cooperative Research and Development Agreement (CRADA), with the FDA. A CRADA agreement allows a non-federal collaborator to provide funding and equipment for a research project conducted at an FDA laboratory. The FDA provides no funding, but does allow for the collaborator to license intellectual property developed during such projects.
Through this program, Emulate’s lung chips were used in COVID-19 research. The brain chip, liver, and intestine chips were also used for individual research projects.
FDA collaboration aside there’s also been regulatory movement that could favor companies pursuing organ chips. For instance, the FDA Modernization Act of 2021, introduced in Congress in April, which would allow the FDA to use “alternative testing methods to animal testing” to evaluate safety and efficacy of drugs. The bill specifically includes organs on chips in its definition of a non-clinical test or study.
“If the Modernization Act goes through, it’s clearly spelled out,” says Corbett.
Still, the field of organ-on-a-chip research is relatively new. Whether or not it will eventually help more drug candidates materialize is still theory. Though, with a new round of funding and a changing regulatory environment, we could have solid answers sooner rather than later.
Climate change is affecting farming all over the world, and solutions are seldom simple. But if you could plant crops that resisted the heat, cold, or drought instead of moving a thousand miles away, wouldn’t you? Avalo helps plants like these become a reality using AI-powered genome analysis that can reduce the time and money it takes to breed hardier plants for this hot century.
Founded by two friends who thought they’d take a shot at a startup before committing to a life of academia, Avalo has a very direct value proposition, but it takes a bit of science to understand it.
Big seed and agriculture companies put a lot of work into creating better versions of major crops. By making corn or rice ever so slightly more resistant to heat, insects, drought or flooding, they can make huge improvements to yields and profits for farmers, or alternatively make a plant viable to grow somewhere it couldn’t before.
“There are big decreases to yields in equatorial areas — and it’s not that corn kernels are getting smaller,” said co-founder and CEO Brendan Collins. “Farmers move upland because salt water intrusion is disrupting fields, but they run into early spring frosts that kill their seedlings. Or they need rust resistant wheat to survive fungal outbreaks in humid, wet summers. We need to create new varieties if we want to adapt to this new environmental reality.”
To make those improvements in a systematic way, researchers emphasize existing traits in the plant; this isn’t about splicing in a new gene but bringing out qualities that are already there. This used to be done by the simple method of growing several plants, comparing them, and planting the seeds of the one that best exemplifies the trait — like Mendel in Genetics 101.
Nowadays, however, we have sequenced the genome of these plants and can be a little more direct. By finding out which genes are active in the plants with a desired trait, better expression of those genes can be targeted for future generations. The problem is that doing this still takes a long time — as in a decade.
The difficult part of the modern process stems (so to speak) from the issue that traits, like survival in the face of a drought, aren’t just single genes. They may be any number of genes interacting in a complex way. Just as there’s no single gene for becoming and Olympic gymnast, there isn’t one for becoming drought-resistant rice. So when the companies do what are called genome-wide association studies, they end up with hundreds of candidates for genes that contribute to the trait, and then must laboriously test various combinations of these in living plants, which even at industrial rates and scales takes years to do.
“The ability to just find genes and then do something with them is actually pretty limited as these traits become more complicated,” said Mariano Alvarez, co-founder and CSO of Avalo. “Trying to increase the efficiency of an enzyme is easy, you just go in with CRISPR and edit it — but increasing yield in corn, there are thousands, maybe millions of genes contributing to that. If you’re a big strategic [e.g. Monsanto] trying to make drought tolerant rice, you’re looking at 15 years, 200 million dollars… it’s a long play.”
This is where Avalo steps in. The company has built a model for simulating the effects of changes to a plant’s genome, which they claim can reduce that 15-year lead time to 2 or 3, and the cost by a similar ratio.
“The idea was to create a much more realistic model for the genome that’s more evolutionarily aware,” said Collins. That is, a system that models the genome and genes on it that includes more context from biology and evolution. With a better model, you get far fewer false positives on genes associated with a trait, because it rules out far more as noise, unrelated genes, minor contributors, and so on.
He gave the example of a cold-tolerant rice strain that one company was working on. A genome-wide association study found 566 “genes of interest,” and to investigate each costs somewhere in the neighborhood of $40K due to the time, staff, and materials required. That means investigating this one trait might run up a $20M tab over several years, which naturally limits both the parties who can even attempt such an operation, and the crops that they will invest the time and money in. If you expect a return on investment, you can’t spend that kind of cash improving a niche crop for an outlier market.
“We’re here to democratize that process,” said Collins. In that same body of data relating to cold-tolerant rice, “We found 32 genes of interest, and based on our simulations and retrospective studies, we know that all of those are truly causal. And we were able to grow 10 knockouts to validate them, 3 in a 3-month period.”
To unpack the jargon a little there, from the start Avalo’s system ruled out more than 90 percent of the genes that would have had to be individually investigated. They had high confidence that these 32 genes were not just related, but causal — having a real effect on the trait. And this was borne out with brief “knockout” studies, where a particular gene is blocked and the effect of that studied. Avalo calls its method “gene discovery via informationless perturbations,” or GDIP.
Part of it is the inherent facility of machine learning algorithms when it comes to pulling signal out of noise, but Collins noted that they needed to come at the problem with a fresh approach, letting the model learn the structures and relationships on its own. And it was also important to them that the model be explainable — that is, that its results don’t just appear out of a black box but have some kind of justification.
This latter issue is a tough one, but they achieved it by systematically swapping out genes of interest in repeated simulations with what amount to dummy versions, which don’t disrupt the trait but do help the model learn what each gene is contributing.
“Using our tech, we can come up with a minimal predictive breeding set for traits of interest. You can design the perfect genotype in silico [i.e. in simulation] and then do intensive breeding and watch for that genotype,” said Collins. And the cost is low enough that it can be done by smaller outfits or with less popular crops, or for traits that are outside possibilities — since climate change is so unpredictable, who can say whether heat- or cold-tolerant wheat would be better 20 years from now?
“By reducing the capital cost of undertaking this exercise, we sort of unlock this space where it’s economically viable to work on a climate-tolerant trait,” said Alvarez.
Avalo is partnering with several universities to accelerate the creation of other resilient and sustainable plants that might never have seen the light of day otherwise. These research groups have tons of data but not a lot of resources, making them excellent candidates to demonstrate the company’s capabilities.
The university partnerships will also establish that the system works for “fairly undomesticated” plants that need some work before they can be used at scale. For instance it might be better to super-size a wild grain that’s naturally resistant to drought instead of trying to add drought resistance to a naturally large grain species, but no one was willing to spend $20M to find out.
On the commercial side, they plan to offer the data handling service first, one of many startups offering big cost and time savings to slower, more established companies in spaces like agriculture and pharmaceuticals. With luck Avalo will be able to help bring a few of these plants into agriculture and become a seed provider as well.
The company just emerged from the IndieBio accelerator a few weeks ago and has already secured $3M in seed funding to continue their work at greater scale. The round was co-led by Better Ventures and Giant Ventures, with At One Ventures, Climate Capital, David Rowan and of course IndieBio parent SOSV participating.
“Brendan convinced me that starting a startup would be way more fun and interesting than applying for faculty jobs,” said Alvarez. “And he was totally right.”
The U.S. Food and Drug Administration (FDA) has granted full approval to Pfizer-BioNTech’s COVID-19 vaccine, making it the first vaccine to achieve that status. The mRNA-based vaccine has been available since late last year through an Emergency Use Authorization (EUA), and will continue to be offered under that designation for those aged 12 to 15 until that separate approval process goes through, but the U.S. drug regulator now recognizes the Pfizer vaccine as fully approved and certified for adults 16 and up.
Part of receiving the approval means that Pfizer and BioNTech can now officially market their vaccine in the U.S., and the FDA revealed it’ll be offered under the trade dress ‘Comirnarty,’ which doesn’t strike me as particularly catchy but at least it’s less of a mouthful than ‘the Pfizer-BioNTech COVID-19 vaccine.’ FDA approval also means that the vaccine has met all of the administration’s standards for safety and efficacy, including preclinical and clinical trial data, as well as information about tits manufacture, and data gathered from its use during the EUA period.
There’s hope that this new full authorization will encourage fence-sitters who have offered up ‘I’ll wait until it’s fully approved’ as an excuse for not yet having gotten the vaccine despite its availability. At the very least, it’s going to be a lot harder for those hesitating to justify their unreasonable and irresponsible stance in the face of the ongoing pandemic.
Comirnarty got flagged for ‘Priority Review’ by the FDA, which essentially means that the administration devoted its full attention to the process in order to expedite it. No word yet on a timeline for Moderna’s approval, but it’s also in the priority review queue.
We’ll be talking to BioNTech CEO and co-founder Uğur Şahin at TC Disrupt 2021 this year, so be sure to check out that virtual event coming up September 21-23.
Solving the twin challenges of human and planetary health is the greatest task of our generation, and it also presents the greatest entrepreneurial opportunity in history, which is why we’ve partnered with Mayfield to bring you an engineering biology track to Disrupt 2021 this September 21-23. Haven’t secured your spot yet? Grab your ticket now for $99 (or even less if you’re a student, founder or nonprofit/government employee)!
Mayfield has over 50 years of experience under its VC belt, and it got there by investing in people first, with a focus on enterprise, consumer and engineering biology companies. They have served as early investors to iconic biotech and health IT entrepreneurs throughout their 50+ year history — from Amgen and Genentech to Mammoth Biosciences — whose mission is to create a better world for this and future generations.
This track will feature insights from the founders of multibillion-dollar companies Twist Bioscience, Gingko Bioworks and Adaptive Bio; NotCo (a rising planetary health star and Indie Bio company) and Mammoth Biosciences (a breakout CRISPR platform company co-founded by Nobel Prize winner Jennifer Doudna); plus Mostafa Ronaghi, the premier SPAC manager and former CTO of Illumina and more innovators working to solve the twin challenges of human and planetary health.
Do you science? Then you won’t want to miss any of the sessions below. Check the Disrupt 2021 agenda for days and times according to your time zone.
Bioplatforms for Saving the Planet: Mayfield’s Arvind Gupta joins two iconic entrepreneurs, Twist CEO Emily Leproust and Ginko Bioworks CEO Jason Kelly, to discuss their founder journeys — from inception through IPO and beyond — and how they are changing our world for the better.
Saving Lives with Precision Biology: Mayfield’s Ursheet Parikh joins Mostafa Ronaghi (former CTO, Illumina), Chad Robins (co-founder & CEO, Adaptive Biotechnologies), Yan Zhang (CEO, Mission Bio) and Diego Rey (co-founder & CSO, Endpoint Health) to talk about how these leaders are leveraging biology breakthroughs to save lives.
Taking Care of the Next Generation: Mayfield’s Kamini Ramani joins these three exceptional leaders — Sandra Oh Lin (KiwiCo), Maneesh Jain (Mirvie) and Stu Landesberg (Grove Collaborative) — to talk about creating a better world now and for future generations, building movements and communities and the milestones in getting to escape velocity.
The New Human and Planetary Health Pioneers: Mayfield’s Arvind Gupta joins leaders of two breakout companies — Trevor Martin (Mammoth Biosciences) and Matias Muchnick (NotCo) — in a discussion about the founder journey and tips for scaling your business.
Rewiring the Brain to Improve the Quality of Life: Mayfield’s Ursheet Parikh joins neuroscientists, physicians and entrepreneurs — Nanea Reeves (TRIPP), Konstantinos Alataris (Nēsos) and Paul Dagum (Mindstrong Health) — in a discussion about building brain-based businesses that improve the quality of life.
TechCrunch Disrupt 2021 takes place September 21-23. If you science — heck, even if you don’t — be sure to catch the sessions in this special engineering biotech track to learn from visionary leaders determined to build a better world. Buy your Disrupt 2021 pass and join this fascinating conversation for less than $99.
Swing Therapeutics, a digital therapeutics startup, has received an FDA breakthrough device designation for their 12 week smartphone-assisted fibromyalgia management program. This is the company’s first breakthrough designation, and precedes a deluge of clinical trials scheduled for this year.
Swing Therapeutics was founded in 2019 and has raised a total of $9 million in seed funding led by JAZZ Venture partners. The company is focused on managing chronic pain, and specifically fibromyalgia.
This FDA breakthrough designation was awarded to the company’s smartphone adaptation of an acceptance and commitment therapy (ACT) program originally designed and tested at the University of Manitoba. Swing Therapeutics has exclusively licensed the program, and adapted it to form their own phone-based version.
“We basically used [The University of Manitoba program] as a basis for our program and then really built on top of it, and adapted it to a sort of experience that would work great for a modern day smartphone interface,” says Mike Rosenbluth, the founder and CEO of Swing Therapeutics.
This FDA designation will allow Swing Therapeutics expedited review at the FDA as the company conducts a series of clinical trials on the product.
At the moment, there is no cure for fibromyalgia, but the FDA has approved three drugs that can help manage symptoms. Those include: Lyrica, which is usually prescribed to treat nerve damage, but is also used to treat fibromyalgia; Cymbalta, which was originally developed to treat depression, anxiety and diabetic neuropathy; and Savella, an SSRI that’s similar to treatments for depression.
Outside of the drug world, there’s some evidence ACT can help patients who live with chronic pain (including fibromyalgia).
One meta-review of 25 studies on ACT and chronic pain, for instance, found that ACT therapy had small effects on pain intensity. But the therapeutic process of teaching patients to accept their pain (but not ignore it) was linked with moderate and long-term improvements in depression, anxiety and quality of life.
“What ACT does is it tries to help people accept those symptoms and things that are uncontrollable. It helps people think about their values – what is really important to them,” says Rosenbluth. “And then they try to make behavior-based changes aligned with those values.”
In that vein, Swing Therapeutics’ platform is designed to be prescribed by a doctor as a treatment management tool. Once prescribed, the patient would enter a 41 session acceptance and commitment therapy program that’s run entirely on their phone, and broken into “daily doses.” A “daily dose” might include a prompt for a mindfulness session or a short writing prompt.
The University of Manitoba program that Swing’s smartphone program is based on does have a randomized controlled trial to its name. It was initially validated in a study on 67 participants who either received treatment as usual or their regular treatment plus ACT delivered via an 8-week online course.
Completing the course was linked with improvements in depression symptoms and improvements in patients’ scores on the Fibromyalgia Impact Questionnaire (FIQ-R), which measures the effects of fibromyalgia on sleep, pain perception fatigue, or psychological distress. The course appeared to help patients improve their “pain acceptance” and through that mechanism the experience of fibromyalgia.
Importantly, the Swing Therapeutics program does differ slightly from the University of Manitoba program – namely, it’s designed for almost daily use, over 12 weeks on a smartphone, as opposed to 8 weeks on a computer. Even these small changes warrant their own independent clinical trials to ensure this approach also helps fibromyalgia patients benefit from this specific ACT therapy program.
Swing Therapeutics has several of these clinical trials at different stages.
This spring, Swing completed enrollment of a 67-person pilot study on their adapted treatment for fibromyalgia (patients were assigned to an active control or the ACT digital therapy). This study is ongoing. Last week, Swing also launched a large-scale study called REACT-FM. This study, currently recruiting, aims to enroll about 100 to 150 patients who will use the ACT product for two weeks.
Finally, the company is also in the development phase for a Phase 3 randomized controlled trial. After completion of that study, the company plans to submit to the FDA for full approval of the platform. That study, says Rosenbluth, is planned to launch at the end of the year.
The FDA breakthrough therapy designation has already helped shape these studies. As the trials continue, this designation means the device will continue to enjoy expedited review, which could smooth the platform’s journey through clinical trials.
“We found it really useful to be able to have that channel dialogue with the FDA, so that we can make sure that we’re aligned in clinical study design and our approaches are in line with things that the FDA expects,” Rosenbluth says.
GSK Next, the innovation arm of GlaxoSmithKlein, is launching a new mentorship and business development program. Called the Re/Wire Health Studio, the program will eventually select six startups who will win access to nine weeks of mentoring, business development expertise, and cash grants.
The Re/Wire Health Studio is designed for growth and early-stage startups focused on “everyday health.” That means products that aid in detecting long-term health problems, incentivize proactive care, or help someone manage a condition, for example. Under the umbrella of “everyday health” the studio will work with startups applying everyday health principals to three areas of focus: oral health, mental resilience, or women’s health.
Companies from all over the world can apply, but they must be prepared to launch in the U.S. with a minimum viable product, or be ready to perform in-market development. Applications close September 20, 2021, and the full cohort will be announced in October.
The Re/Wire Health studio is a joint project between the GSK and R/GA Ventures – which will act as the Studio’s operational partner and help select the cohort.
TechCrunch spoke with Nick Tate, the Vice President of Global Digital Innovation at GSK Consumer Healthcare and head of GSK Next, to talk about what he looks for in a startup, what selected companies will gain from participation, and the types of projects he’s excited to hear more about.
This interview has been condensed and lightly edited for clarity.
TechCrunch: Just to start off, I’d love to have you expand on what you’re looking for in applicants to the GSK Re/Wire Health Studio. What are two or three things are you looking for?
Tate: GSK consumer healthcare is extremely ambitious when it comes to our consumers, the science we are trying to drive and the solutions we are trying to create. One of the big things we look out for is people who really have got an ambition to make a significant positive dent on the world, and have surrounded themselves with people to create that energy.
Drive and excitement is one aspect of it. Then there’s technical capability. We’re looking for companies that are prepared to launch in the US with at least a minimum viable product in service or in-market.
The reason for that is [Re/Wire Health Studio] is about taking a service or a platform and saying: How can we genuinely help? How can we deliver value so these propositions can really live in the world and make an impact on everyday health?
TechCrunch: What are the hard and soft skills you want to see in a leadership team?
Tate: I think we’re looking for people who have that rare mix of ambition, and reality. You can look at their proposition and believe they’re excited about it – but as we all know [running a startup] is very hard stuff. The ability to be data driven in how they look at propositions is important.
And it’s absolutely important that the consumer experience is at the heart of what they do. Putting ‘care’ into everyday healthcare is incredibly important to the sorts of propositions we think are going to make a tangible difference today and into the future.
TechCrunch: What are two or three things that you hope companies will gain from participating?
Tate: I’d want them to have a genuine understanding of route to scale and what that means. At GSK I think we’re in a really unique position to offer a real perspective on what it takes to have a proposition that can travel.
I’d also want them to leave with a better understanding of themselves, their business, their business model, and what it takes to succeed in the market.
The last 18 months have taught us amazing things do happen when partnerships really work. I’m excited about bringing this understanding of what it takes to really make something global through GSK.
TechCrunch: What elements do GSK and R/GA Ventures each bring to the Re/Wire Health Studio?
Tate: From a GSK perspective, we think about what it takes to get into the market in a very changing and dynamic environment of everyday health. We think about manufacturing, regulatory processes, designing for the right kind of outcomes, and of course the science – that’s what we’re known for.
These are things a business needs to think about down the line, but they don’t have the bandwidth to consider right now. These are very specific skills that the GSK does day in and day out with our existing brands that we think are incredibly important for startups to consider.
From an R/GA perspective, we talk about this notion of creative capital. They’re bringing this team of award winning strategists, technologists, designers, and consultants because we know that a business is just more than a brand, a product is just more than one interaction.
TechCrunch: I like to hear you expand a bit on why Re/Wire Health Studio is interested in propositions related to oral care, mental resilience and women’s health. Why did you highlight those three focus areas?
Tate: Beyond the expertise we believe we can bring to the table today, we see all of these areas as extremely exciting unmet needs with the ability to create a genuine impact on people’s everyday health.
They address multiple issues for consumers across the world (both today and tomorrow) and will fundamentally be emboldened by better data, insights, and human-centric solutions.
TechCrunch: When was the last time you were really blown away by a pitch or proposition? What really made it stick in your head?
I think, without naming and particular names, it’s when people have really taken a proposition and turned it on its head. Or, the nature of their endeavor is just so ambitious.
We’ve all been in those meetings where you meet people and you’re like ‘my goodness, what you are trying to achieve is absolutely incredible.’ I take a lot away from people from purpose, ambition, drive and the audacity to try something.
What I find so incredibly exciting about everyday health is that there’s nothing more important than it, and it’s one thing we tend to sleepwalk through. When it’s all said and done, you don’t sit on your deathbed wishing you had slightly different luggage or a nicer watch, you wish you had probably taken better care of your health.
So when I meet startups who have an ambition to solve those sorts of problems for people all around the world, the hairs at the back of my neck go up. I get incredibly excited about working with those types of people.
If you injure your elbow, surgery can help. If you lose a leg, prostheses are available. But problems within the brain are more difficult to treat, and for stroke victims rehabilitation is largely left to the body’s own repair mechanisms. BrainQ aims to change that with a device that stimulates the damaged part of the brain and promotes self-repair, showing enough improvement in studies to warrant a Breakthrough Device certification from the FDA — and the company has just raised $40M to take it to market.
It should be said at the outset that doubting the efficacy of some brainwave-emitting miracle device is natural. And in fact when I spoke with BrainQ’s founder Yotam Drechsler, he reminded me of the last time we’d talked — back in 2017, at which time I “expressed strong skepticism.”
No hard feelings — the tech was largely notional then, he admitted — but since that time the team has continued its work, raised some money, and what was a promising if not well supported thesis then has turned into one backed by firsthand data and clinical outcomes. The resulting system could be the biggest improvement to stroke therapy in decades or more.
Strokes can result in various obvious impairments, such as grip strength or coordination, but of course the injury is not to the hand or leg itself, it is to the networks in the brain that govern those parts. But medical science has no method for directly rebuilding those networks — the brain must do so on its own, in its own time.
To aid this, regular physical therapy and brain health checkups, sometimes for years on end, are used to in essence make sure the brain is still working on it and that the parts of the body don’t themselves fall into disrepair.
The most interesting improvements to this process in recent years have added tech into the loop to provide immediate feedback, such as that one’s balance is skewed to one side, and providing stimuli that aim to counteract that. But ultimately it’s still targeted physical therapy.
Drechsler and BrainQ see the problem a little differently. It’s not simply an injury but a disturbance to the brain’s carefully cultivated homeostasis, one which it has no means to counteract. He compared a stroke not to an analogous injury but to a baby born prematurely and whose body is not up to the task of heating itself. What do you do in such a case? You don’t attempt to “fix” the body so it can operate at lower temperatures, or supercharge the heat output — you just put the kid in an incubator, and everything proceeds as it should.
BrainQ’s device does something similar, making the brain operate better by changing its local environment.
“We map the channels of healthy brains and non-healthy brains and compare them. Once we find these, we use a low-intensity magnetic field therapy to resonate in the brain and facilitate its endogenous recovery mechanisms,” explained Drechsler.
It’s been shown in other contexts that this type of stimulation can produce improved neuroplasticity — the capability of the central nervous system to reprogram itself. By narrowly targeting stroke-affected areas, BrainQ’s device promotes neuroplasticity in them, leading to expedited recovery.
But it’s not simply a matter of saying “the stroke affected the ventral half of the right occipital lobe, aim the magnets there.” The brain is a complicated system, and strokes affect networks, not just a given cubic centimeter. BrainQ has deployed machine learning and a large collection of data to better understand how to target those networks.
Without diving too deeply into how the brain operates, let it suffice to say that certain networks operate locally at very specific spectral signatures or frequencies as detected by EEG readings. The left hand and left foot may occupy the same region of the motor cortex, but the hand might operate at 22 Hz, while the foot operates at 24 Hz, for example.
“The question is, how do you find these signatures?” asked Drechsler. As it’s somewhat difficult to explain, I asked him to put it in his own words after we spoke:
The novelty of BrainQ’s investigational treatment lies in the data-driven method we have deployed in order to inform the ELF-EMF frequency parameters. In choosing these parameters, our aim is to select frequencies that characterize motor-related neural networks in the CNS, and are related to the disability a person experiences following a stroke or other neurological trauma. To achieve this, we have analyzed a large-scale amount of healthy and non-healthy individuals’ brainwaves (electrophysiology data). Our technology uses explanatory machine learning algorithms to observe the natural spectral characteristics and derive unique therapeutic insights. These are used by BrainQ’s technology to target the recovery of impaired networks.
The device they’ve created to administer the treatment is unusual. Because it’s a whole-brain magnetic field generator, it has a rather bulky cylindrical headpiece , but the rest of it fits into a sort of back brace and hip pack. That’s because, unlike the more common magnetic brain imaging tech, MRI, the fields and currents involved are extremely small.
“We use very, very low intensity, about the same level as normal brain activity,” said Drechsler. “It’s not about creating an action potential or a jump in activity, it’s about creating the right conditions for the recovery mechanisms.”
The results of this stimulation were borne out in a small (25 patients) but decisive study due to be reviewed and published soon (preprint abstract here). Patients given the BrainQ treatment in addition to normal therapy saw hugely improved recovery evaluations, which look at metrics like improvements to balance and strength. 92 percent saw major improvements over just therapy and 80 percent achieved what could be called recovery (though this term is inexact).
Generally speaking the therapy would last for about an hour at a time, during which the patient would do various physical exercises while wearing the device, and they would need to be repeated five days a week for two months or so. The headset feeds the patient’s own patterns into BrainQ’s cloud-based service, which does the crunching and matching necessary to produce a tailored treatment pattern. It’s all run via tablet app, which can be operated by a caregiver (such as an outpatient nurse) or by using a built-in telemedicine platform.
Drechsler said that this approach was poorly received early on, and not just by this reporter.
“In 2017, we started to set the ground for a cloud-connected therapeutic device that can treat the patient wherever she or he is,” he said. “Back then no one was willing to even talk about treating patients outside the controlled environment of the hospital. Then in 2020 COVID came and everything changed.”
He noted that during the pandemic, many of those recovering from a stroke who would normally visit the hospital for regular care were (and some remain) unable to do so. A home-based therapy with low risk and potentially great outcomes would be of enormous benefit for thousands and thousands of people currently recovering from a stroke. And importantly, he notes, it doesn’t shift resources away from existing treatment plans, just improves their outcomes. (“We don’t move anybody’s cheese.”)
Here is where you would normally read something along the lines of “but it maybe five years before the FDA approves it for insurance and use.” But BrainQ recently received Breakthrough Device certification, an expedited approval process that, since just the beginning of this year, also confers qualification for coverage under Medicare. This means that conceivably, BrainQ could be shipping devices very soon — though still a year or two out.
Its next step, very prudently, is a larger scale study, towards which the company intends to devote a large portion of its recent fundraise, $40M led by Hanaco Ventures, with Dexcel Pharma and Peregrine Ventures participating.”
“The reason why we raised all this money is we are on the verge of a unique study with 12 sites,” Drechsler said. While he could not yet name the hospitals or research organizations they partnered with, he said they were basically the cream of the stroke rehabilitation crop and “really we couldn’t aspire for better than getting all these top sites in the same study. There’s this excitement that maybe something new is coming — in stroke recovery there has been almost no progress in the last two or three decades, and physical therapy has been the standard for two hundred years.”
Without making any promises, he suggested that this line of inquiry could move medicine towards not just mitigating but reversing some disabilities, a feat the value of which can hardly be enumerated.
“I was looking over my pitch decks from 2016,” Drechsler mused. “Early on as a CEO, you have big dreams. We heard a lot of skepticism early on in the process, but I was proud to see that many of those dreams have materialized.”
The Department of Health and Human Services (HHS) Office of the Inspector General will review the FDA’s accelerated approval pathway, the office announced Wednesday. This sweeping review comes just two months after the controversial approval of Biogen’s Alzheimer’s drug Aduhelm.
The review will focus on the FDA’s accelerated approval pathway — a route that allows drugs for serious diseases without existing treatments to be approved if they hit certain interim benchmarks (called surrogate endpoints). These drugs are thought to provide clinical benefit, but that benefit hasn’t actually been demonstrated before the drug is approved. Once the drug is approved, a phase four study would need to demonstrate clinical efficacy.
This is the pathway that allowed for the highly controversial approval of Aduhelm, the first Alzheimer’s drug to be approved since 2003. It’s this approval that set the HHS-OIG review process in motion, per the Inspector General’s Wednesday announcement.
“The FDA’s approval of Aduhelm raised concerns due to alleged scientific disputes within the FDA, the advisory committee’s vote against approval, allegations of an inappropriately close relationship between the FDA and the industry, and the FDA’s use of the accelerated approval pathway,” the announcement reads.
“In response to these concerns, we will assess how the FDA implements the accelerated approval pathway.”
While the FDA has defended its decision to approve Aduhlem via this pathway, there has been significant backlash about the drug’s efficacy and how it got approved in the first place.
Aduhelm, also known as aducanumab, had demonstrated it could reduce amyloid plaques in the brain (sticky compounds that disrupt communications between brain cells). However, there have been lingering questions about how much patients actually benefited from the drug. It was unclear whether lowering levels of amyloid plaques would actually slow rates of Alzheimer’s most pernicious symptom: cognitive decline.
In March 2019, two phase three trials of the drug were shut down after independent monitoring committees found that the drug wasn’t improving patients rates of cognitive decline. Another analysis conducted by Biogen in October, however, yielded different results. One phase three clinical trial of the drug did not show any improvements in cognitive decline, but the other trial did show some modest effects in patients who got the highest doses.
In November 2020 an independent FDA committee declined to endorse the drug for approval. Yet, by June 2021, the drug was approved anyway.
Within the pharmaceutical industry, the approval of Aduhelm initially sparked optimism that the FDA might open its doors to more biomarker-based approvals. However, that optimism wasn’t shared by the wider scientific community.
Three members of the independent committee that had advised against the drug’s approval resigned in protest. Based on the inconsistent data, major hospital systems like Mt. Sinai and the Cleveland Clinic have indicated they won’t prescribe the drug.
Part of the controversy around Aduhelm’s approval has centered around allegations of an especially close working relationship between the FDA and Biogen leading up to the drug’s approval. As STAT first reported, Biogen launched an internal effort called Project Onyx to try to convince regulators to approve the drug, and some FDA officials eventually played active roles in the drug’s approval, including joint presentations before external experts.
In a July 9 letter, Janet Woodcock, acting FDA Commissioner, called for HHS-OIG to conduct an external review that would investigate this working relationship.
“We believe an independent assessment is the best manner in which to determine whether any interactions that occurred between the manufacturer and the agency’s review staff were inconsistent with FDA’s policies and procedures,” she wrote on Twitter.
While the HHS-OIG investigation was spurred by the Aduhelm controversy, this review will not focus on reviewing the scientific evidence behind Aduhlem (or any other drug, for that matter). Rather it will peek under the hood of the entire accelerated approval pathway to assess how, and when, the FDA chooses to allow drugmakers to go down that road.
HHS-OIG will review interactions between the FDA and outside parties, policies and procedures, and interrogate the FDA’s compliance with those procedures. The review will cover the Aduhelm review process but will also interrogate how the pathway was used to approve other drugs as well.
In a statement on Twitter Woodcock also said that the FDA will “fully cooperate” with the HHS-OIG review.
“Should the HHS OIG identify any actionable items and provide the agency with any recommendations, the FDA would review those expeditiously to determine the best course of action,” she said.
Should actions be required, they could have significant ramifications for drugs in the future, as this pathway is already an attractive option for other companies pursuing Alzheimer’s drugs.
Eli Lilly, for instance, is also working on an Alzheimer’s drug called donanemab, has released exploratory findings from a Phase II trial showing that the drug lowered levels of amyloid and other biomarkers and was associated with patient improvements. However, the bulk of the results rest on the drug’s efficacy against biomarkers of Alzheimer’s, rather than individual patient outcomes.
In a Q2 earnings call this week, Eli Lilly’s senior vice president and chief scientific medical officer, Daniel M. Skovronsky, noted that the FDA’s approval of Aduhelm “reflects a shift in policy and sets a new path for Alzheimer’s drug approval in the U.S,” and Eli Lilly still intends to file for FDA approval for donanemab using the FDA accelerated approval pathway by the end of the year.
But, that’s the same pathway that will now be under investigation by HHS-OIG.
Still, we might not see results anytime soon, so it is unclear how this news will impact future Alzheimer’s drugmakers seeking to capitalize on a perceived “shift in policy.” The report is scheduled to be released in 2023.
Rani Therapeutics, a San Jose-based company developing a pill to replace medical injections, went public on Friday.
According to S-1 filings, shares were estimated to price between $14 and $16 last week. On Friday, shares debuted slightly lower, around $11. Rani raised about $73 million in its debut.
Rani’s debut comes amidst a flurry of IPO activity in therapeutics. In 2020, 71 biotech companies went public. Already in 2021, 59 companies have IPO’ed and even more are on the way. On July 30 alone, eight different biotech companies are expected to begin trading, including Rani Therapeutics.
Rani Therapeutics, is, as Imran puts it “laser focused” on itself, rather than the IPO activity around it. The decision to go public was partially bolstered by the results of a phase I study– early evidence that the RaniPill, the company’s flagship product could be brought into the clinic.
“We are already in humans, and clearly on a strong path to make oral biologics [a] reality. This is a hot and unique market for life science direction and we’re excited to be driving innovation in this area,” Imran tells TechCrunch.
Rani Therapeutics flagship product is RaniPill, essentially, a capsule designed to deliver medicines that would usually be delivered via injections. TechCrunch covered the pill in more detail here, but it works according to a few basic steps.
The pill is covered by a coating resistant to stomach acid. Once the pill enters the small intestine, the coating dissolves, allowing for a small balloon to inflate. Once that small balloon inflates, medication is delivered by a microneedle (which dissolves after the drug is administered). Then, the rest of the balloon is “excreted through normal digestive processes,” per the company’s S-1 filing.
This whole process occurs in a pill that, on the outside, looks like a gel capsule.
There is evidence for some conditions suggesting patients prefer oral drugs to injections: for example, studies on cancer patients have illuminated patient preference for oral therapies rather than regular injections. That’s not the case for every condition. Some patients show preference long-acting medicines delivered via injection rather than having to take lots of pills (this is the case in for some HIV patients).
However, it’s fair to say that needles aren’t exactly pleasant. A 2019 review and meta analysis of 35 studies found that between 20 and 30 percent of young adults are afraid of needles, a fear which can lead some people to avoid medical treatments or vaccines.
Rani Therapeutics has been developing capsules for drugs that have already been approved by the FDA, but are often administered via regular injections. They include:
The product furthest along in the research cycle is the pill developed to administer octreotide (called RT-101), which was tested in a phase I clinical trial on 62 participants. The trial results, partially reported in the S-1 filing, showed 65 percent bioavailability of the octreotide drug, compared to an injection. That suggests that the pills can get the drugs into the body efficiently, though these results are early.
Next year, the company plans to initiate two additional Phase I studies on PTH for osteoporosis, and human growth hormone. Studies on the rest of the drugs in the pipeline are scheduled for 2023.
Ultimately, the company’s goal is to validate the RaniPill independently of specific drugs. The company is pursuing an Investigational Device Exemption (IDE), which would allow the company to test RaniPill in a clinical study without a drug involved. This study aims to establish how safe the product is for repeated dosing, and is slated to begin next year.
“I think we want to continue to generate data with drugs, because we will be making drugs. But nonetheless, it’s important to establish what the platform’s safety and tolerability is,” said Imran. So that’s quite important as well.”
The company’s leadership does have a track record of successful exits in the biotech space.
Rani Therapeutics was founded in 2012 by Mir Imran, a founder who has already overseen several exits and acquisitions of medical device companies. In 1985, Imran developed an implantable cardiac defibrillator as part of his first company, Intec Systems, which was later acquired by Eli Lilly. Since, he has started 20 different medical device companies, of which 15 have either IPOed or been acquired.
However, for now, Rani Therapeutics financials report significant losses. Net losses for 2019 and 2020 totaled $26.6 million and $16.7 million, respectively. As of March 2021, the company was running a deficit of $119.6 million.
In total, the company has raised about $211.5 million in funding since inception, without counting cash generated from today’s IPO. RaniTherapeutics has plans to use the $73 million raised during the IPO to fund the IDE study and pursue additional clinical trials.
Swiss alternative protein company Planted has raised its second round of the year, a CHF 19M (about $21M at present) “pre-B” fundraise that will help it continue its growth and debut new products. A U.S. launch is in the cards eventually but for now Planted’s exclusively European customers will be able to give its new veggie schnitzel a shot.
Planted appeared in 2019 as a spinoff from Swiss research university ETH Zurich, where the founders developed the original technique of extruding plant proteins and water into fibrous structures similar to real meat’s. Since then the company has diversified its protein sources, adding oat and sunflower to the mix, and developed pulled pork and kebab alternative products as well.
Over time the process has improved as well. “We added fermentation/biotech technologies to enhance taste and texture,” wrote CEO and co-founder Christoph Jenny in an email to TechCrunch. “Meaning 1) we can create structures without form limitation and 2) can add a broader taste profile.”
The latest advance is schnitzel, which is of course a breaded and fried piece of pounded-thin meat style popular around the world, but especially in the company’s core markets of Germany, Austria, and Switzerland. Jenny noted that Planted’s schnitzel is produced as one piece, not pressed together from smaller bits. “The taste and texture benefit from fermentation approach, that makes the flavor profile mouth watering and the texture super juicy,” he said, though of course we will have to test it to be sure. Expect schnitzel to debut in Q3.
It’s the first of several planned “whole” or “prime” cuts, larger pieces that can be prepared like any other piece of meat — the team says their products require no special preparation or additives and can be dropped in as 1:1 replacements in most recipes. Right now the big cuts are leaving the lab and entering consumer testing for taste tuning and eventually scaling.
The funding round came from “Vorwerk Ventures, Gullspång Re:food, Movendo Capital, Good Seed Ventures, Joyance, ACE & Company (SFG strategy) and Be8 Ventures,” and was described as a follow-on to March’s CHF 17M series A. No doubt the exploding demand for alternative proteins and growing competition in the space has spurred Planted’s investors to opt for more aggressive growth and development strategies.
The company plans to enter several new markets over Q3 and Q4, but the U.S. is still a question mark due to COVID-19 restrictions on travel. Jenny said they are preparing so that they can make that move whenever it becomes possible, but for now Planted is focused on the European market.
(Update: This article originally misstated the new round as also being CHF 17M – entirely my mistake. This has been corrected.)