Generate co-founder Molly Gibson and CEO Mike Nally
As the future of machine learning and AI promises to make major breakthroughs in drug development, a suite of startups is looking to scale their own competing robot brain trusts. An ambitious startup out of Flagship Pioneering’s incubator uncloaked last year with its own spin in that arms race — and now it’s primed and ready for a major expansion in the coming years.
Generate Biomedicines has closed a giant $370 million Series B from founding investor Flagship as well as Alaska Permanent Fund, Altitude Life Science Ventures, ARCH Venture Partners, and funds and accounts advised by T. Rowe Price Associates, the company said.
Generate, which debuted in late 2020, is Flagship’s shot at using machine learning advances to change the game in the development of protein therapeutics, with the company promising much faster development times and discovery success rates. It’s a model being tried elsewhere from companies like Exscientia and Insilico, but Generate sets itself apart with its focus on protein sequencing and the goal to produce de novo biologics.
Since launch, Generate has been hard at work crunching data through its system in an attempt to give it the broadest possible platform for discovery. Now, the company is ready to greatly expand its ‘wet lab’ and biology capabilities, CEO Mike Nally told Endpoints News, and that will spell a huge hiring spree for the company as well as new corporate digs in the Somerville, MA area and another site in Andover.
Currently operating with a workforce of around 80, Generate is planning to make the quantum leap to 500 employees over the course of the next two years while also moving into two new facilities in the coming weeks and months. The Andover site will be used to expand the biotech’s range in structural biology, including a big investment in cryogenic electron microscopy (cryo-EM), a cutting-edge technique used to determine the structure of proteins.
The immediate goal is to move past the work of the past two years, primarily proving Generate’s platform could produce higher binding affinity proteins from precursor reference biologics, into the realm of developing protein drugs from scratch using proprietary data learning, Generate’s chief strategy and innovation officer and co-founder Molly Gibson told Endpoints.
‘Since inception, we’ve set out to answer this question whether we can program proteins at the DNA level, and what we’ve done over the past year is take those first insights … really show that at scale and push programs forward,’ Gibson said. ‘We’ve shown that we’ve been able to make significant advances over where we started creating these machine learning algorithms using public data.’
Now, the team said it will be ready to start churning out preclinical candidates by the end of the year with some of those programs expected to hit human trials as early as 2023.
As the clinic moves closer, the Generate team is keeping a close eye on the potential for strategic partnerships given the potential breadth of its platform’s capabilities. Those strategic partnerships, more in the line of substantial R&D team-ups, are a key part of the company’s BD strategy moving forward, Nally said, which the company will have to leverage with its own in-house work.
‘The reality is … we can produce far more than we can consume so we want to make sure we complement our expertise in protein engineering with others’ distinct capability in areas like disease-area biology, manufacturing and clinical development,’ Nally said. ‘Ultimately there’s a huge investment across biotech and pharma in understanding target biology so we think if there’s an appropriate task, this technology may be able to address it in a way that very few other technologies can.’
For years, paper-based processes and individual point solutions dominated the clinical research landscape, and patient participation in clinical trials was largely an in-person engagement. But when the COVID-19 pandemic took a stronghold, traditional clinical trial methods emerged as inadequate, putting clinical trials and the life sciences industry at a crossroads. Practically overnight, the industry had to rapidly shift to decentralized clinical trial methods, while maintaining data quality and regulatory compliance.
Douglas Fambrough, Dicerna CEO (Dicerna via YouTube)
Early this year researchers at Novo Nordisk were beaming as they announced the first drug identified in their RNAi alliance with Dicerna was headed into the clinic. And now they’re coming back for the whole thing.
This morning the Copenhagen-based pharma giant put out word that it is buying Dicerna $DRNA — an RNAi pioneer that has had its up and downs over the years — for $3.3 billion. Novo is paying $38.25 a share — an 80% premium.
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Gilead is going all in — hook, line and sinker — on its oncology alliance with Arcus. And they are going for broke.
The big biotech unveiled a deal that now delivers $725 million in opt-in payments covering the clinical development programs for Arcus, ranging from their closely watched anti-TIGIT programs for domvanalimab and AB308 to etrumadenant (the A2a/A2b adenosine receptor antagonist) and quemliclustat, the small molecule CD73 inhibitor. Gilead will also cover half of the development costs, handing Terry Rosen’s biotech a deal that gives them a clear cash runway to achieving all its goals in oncology.
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Protein degradation is one of the hot drug classes of the future, but competitors are piling in with the likes of C4, Arvinas, Frontier Medicines and Vividion jostling for position. A new startup wants to apply the lessons learned from degradation outside the cell, and it now has the greenlight from RA Capital to steam ahead.
Avilar Therapeutics launched Thursday with $60 million from founding investor RA to chase a novel protein degradation drug class the startup is calling ATACs— short for ‘ASGPR Targeting Chimeras’ — that looks to trash unwanted proteins circulating outside the human cell.
Catherine Stehman-Breen and Vic Myer, Chroma CEO and CSO
A handful of the world’s most prominent gene editing-focused academics have been working for over a year on a new company built around a new approach for modifying DNA to treat disease. Known as Chroma Medicine, it launched on Wednesday with $125 million in early funding from Atlas, Newpath, Cormorant and several other VCs.
Chroma will focus on a markedly different way of modifying the genome than most of the gene editing biotechs that have arisen since CRISPR was pioneered nearly a decade ago. Instead of trying to erase or rewrite portions of a patient’s actual DNA — those As, Ts, Cs and Gs — Chroma will try to change the way that DNA is expressed in the cell.
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A few weeks after Jennifer Doudna introduced CRISPR/Cas9 genome editing to the world, one of her old students decided to take the central part of the biology-altering invention and kill it.
CRISPR/Cas9, as the name implies, is a two-part system: a string of letters called a guide RNA, that says where to cut the DNA. And an enzyme, Cas9, that does the cutting. Often compared to molecular scissors, it was the first system that allowed researchers to cut DNA with ease and precision, promising potential cures for genetic diseases such as sickle cell and cystic fibrosis.
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Merck is making room for yet another use on its Keytruda label — this time, as the first adjuvant immunotherapy for certain renal cell carcinoma patients after they’ve had kidney surgery.
The FDA has approved Keytruda in the adjuvant setting three weeks before its goal date, marking the latest in a streak of label expansions and giving the PD-1 superstar a leg up on its checkpoint inhibitor rivals.
Mene Pangalos (AstraZeneca via YouTube)
New follow-up data suggest that AstraZeneca’s long-acting antibody can protect high-risk populations from contracting Covid-19 for as long as six months, beefing up the case for it as a form of ‘passive immunization’ or ‘passive vaccination.’
At a six-month cutoff for the Phase III PROVENT trial, investigators tracked an 83% reduction in risk of symptomatic Covid-19 after one dose of the antibody among 4,991 volunteers. The company did not spell out case counts on either arm, noting only that there were no severe disease or Covid-related deaths in the AZD7442 arm and two additional cases of severe Covid-19 in the placebo arm (for a total of five severe cases and two related deaths).
John Reed (Jeff Rumans for Endpoints News)
For most of the up-and-coming AI players in the biotech space, we’ve seen a slew of deals to utilize AI and machine learning in drug discovery and manufacturing. Companies such as Insilico and Generate — just to name two — have been bagging partnerships and deals left and right.
Sanofi, though, has now lined up a new deal with one of the lower profile ops in Europe, going with a big investment with an eye to improving its odds in clinical development — and the biotech industry’s newest AI deal touts a new ingredient: federated learning.
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https://endpts.com/flagships-machine-learning-startup-generate-bags-370m-in-latest-round-with-plans-for-a-big-hiring-spree/
