Mark DePristo (L) and Peyton Greenside (BigHat)

On the hunt for a bet­ter an­ti­body, BigHat Bio­sciences de­buts with $19M Se­ries A to scale its 'wet lab' AI plat­form

Next-gen an­ti­bod­ies have be­come some­what of a Holy Grail in the drug de­vel­op­ment world, but the process of ac­tu­al­ly cre­at­ing those an­ti­bod­ies has proven to be dif­fi­cult and time con­sum­ing. A brand-new Cal­i­for­nia out­fit is look­ing to solve that time crunch by bring­ing AI and ma­chine learn­ing in­to the lab.

BigHat Bio­sciences de­buted Wednes­day with a $19 mil­lion Se­ries A round to help scale up its “wet lab” AI and ma­chine learn­ing plat­form to speed de­vel­op­ment of next-gen an­ti­bod­ies.

The San Car­los, CA team led by and Broad in­sti­tute vet­er­an Mark De­Pris­to and chief sci­en­tist Pey­ton Green­side, a Stan­ford grad with Broad blood­lines, are aim­ing to bring AI and ma­chine learn­ing in­to the ex­per­i­men­tal process in an at­tempt to dra­mat­i­cal­ly in­crease the speed of an­ti­body dis­cov­ery.

“The re­al goal of our ex­per­i­men­tal plat­form is to en­able us to go from a pre­dic­tion to an in sil­i­co de­sign through to a syn­the­sized, pu­ri­fied and char­ac­ter­ized an­ti­body in a mat­ter of days,” Green­side told End­points News. “What that means is there’s this core work cell that al­lows us to go from DNA to pro­tein very quick­ly and have a very rapid char­ac­ter­i­za­tion of that pro­tein.”

What that looks like in prac­tice is turn­ing out hun­dreds of an­ti­bod­ies in very short or­der — an out­put that could play well in terms of fu­ture out­li­cens­ing deals with bio­phar­ma play­ers. But in the short term, BigHat, which takes its rather nerdy moniker from the “hat” func­tion in sta­tis­tics de­not­ing an es­ti­mat­ed val­ue, will work on de­vel­op­ing and scal­ing its plat­form to give it even more pre­dic­tive and com­pu­ta­tion­al pow­er to pro­duce more an­ti­bod­ies, De­Pris­to said.

The biotech will al­so look to turn drug­mak­er, shep­herd­ing ther­a­peu­tic pro­grams through the clin­ic in the far fu­ture, De­Pris­to said. In terms of what that could look like, De­Pris­to said BigHat was look­ing more at de­sign chal­lenges for an­ti­bod­ies rather than spe­cif­ic ther­a­peu­tic ar­eas, but he did specif­i­cal­ly call out au­toim­mune dis­eases, on­col­o­gy and an­ti-in­fec­tives.

“Be­cause our plat­form can op­ti­mize for pret­ty much any mea­sur­able prop­er­ty of a mol­e­cule — so not just affin­i­ty — we can op­ti­mize for bi­o­log­i­cal func­tion,” De­Pris­to said. “We’re look­ing for pro­grams where the bi­o­log­i­cal ef­fect is not just max­i­mized by high affin­i­ty. The goal is not to per­ma­nent­ly stick the cell to a mol­e­cule but to re­al­ly ac­ti­vate the cell and get its bi­o­log­i­cal func­tion mov­ing.”

With $19 mil­lion in hand from the Se­ries A round led by VC firm An­dreessen Horowitz and joined by 8VC, AME Cloud Ven­tures and In­no­va­tion En­deav­ors, BigHat will look to grow its team of nine em­ploy­ees, adding team mem­bers in the bi­ol­o­gy and com­pu­ta­tion­al spaces. The ex­pand­ed team will add pow­er to BigHat’s plat­form “10 to 100x,” De­Pris­to said.

The com­pa­ny comes with a star-stud­ded sci­en­tif­ic ad­vi­so­ry team, in­clud­ing No­bel lau­re­ate Bri­an Ko­bil­ka, AI and deep learn­ing ex­perts in Jake Gard­ner and An­drew Gor­don Wil­son, and a slew of ex­perts in life sci­ences, en­tre­pre­neur­ship and drug dis­cov­ery. That ad­vi­so­ry team was specif­i­cal­ly con­struct­ed to help BigHat not on­ly scale its plat­form but pre­pare for the tough trans­la­tion­al work that would be re­quired to take its an­ti­bod­ies in­to the clin­ic, De­Pris­to said.

Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

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Paul Sekhri

The next big biotech su­per­star? Paul Sekhri has some thoughts on that

It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though.

“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic.

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UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Pascal Soriot, AstraZeneca CEO (AP Images)

Pas­cal So­ri­ot cash­es in As­traZeneca’s chips on Mod­er­na for $1.2B cash in­jec­tion

While still working to prove its own Covid-19 vaccine, AstraZeneca has reportedly capitalized on the success of another.

The company has sold off its 7.7% stake in Moderna and turned it into $1.2 billion in cash, according to the Times, beefing up the reserves just as Pascal Soriot is wrapping up his $39 billion acquisition of Alexion and its rare disease pipeline.

AstraZeneca’s stock sale follows a similar move by Merck in December. But like its pharma brethren, the British giant is keeping its R&D collaborations with Moderna.

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Af­ter bail­ing on Covid-19 vac­cines, Mer­ck will team up with J&J to pro­duce its shot as part of un­usu­al Big Phar­ma pact

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

Ab­b­Vie tees up a biotech buy­out af­ter siz­ing up their Parkin­son's drug spun out of Ke­van Shokat's lab

AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease.

The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression.

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Fi­bro­Gen shares skid low­er as a sur­prise ad­comm rais­es risks on roxa OK

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.

In­tro­duc­ing End­pointsF­DA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.

Or­biMed, bio­phar­ma's biggest in­vestor, clos­es $3.5B in three new pri­vate funds

One of the world’s leading biopharma investors has pulled in its next rounds of cash, with the funds planned to go to dozens of companies around the world.

OrbiMed raised $3.5 billion across three private investment funds, it announced Monday, as it continues building on its long track record in healthcare and biopharma. All in all, the firm expects to invest in at least 60 companies across the US, Asia and Europe.

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