Noam Solomon and Luis Voloch (Immunai)

Wad­ing deep­er in­to tar­get dis­cov­ery and val­i­da­tion, Im­mu­nai bags $60M to beef up both AI al­go­rithms and lab bench­es

Noam Solomon and Luis Voloch set out, when they launched Im­mu­nai in 2018, to map out the im­mune sys­tem cell by cell.

The two en­gi­neers — who had met at MIT and like to il­lus­trate their com­pa­ny’s stature by point­ing out the num­ber of em­ploy­ees who had been trained at Palan­tir, Google or Face­book — saw the po­ten­tial in col­lat­ing all the in­for­ma­tion churned out by a sin­gle cell-se­quenc­ing mul­ti-omics plat­form. You can tell drug­mak­ers what ex­act­ly is in their cell ther­a­py prod­ucts, pro­file for aca­d­e­mics the im­mune re­sponse to their ex­per­i­men­tal treat­ments, or even sug­gest new bio­mark­ers that seem to be rel­e­vant in a dis­ease.

“Every sam­ple that we se­quence is more than a ter­abyte of in­for­ma­tion,” Solomon, the CEO, told End­points News. “So if we are talk­ing about the data­base on the or­der of thou­sands and even tens of thou­sands of sam­ples, we’re talk­ing about mas­sive data­bas­es, and run­ning com­pu­ta­tions on such a large data­base re­quires dif­fer­en­ti­at­ed ca­pa­bil­i­ties.”

But as Im­mu­nai signed more deals, they re­al­ized that some­thing else was miss­ing. Part­ners of­ten didn’t have a “da­ta-dri­ven” way to val­i­date the tar­gets, Solomon said, and they be­lieve they could help by of­fer­ing one more step be­yond min­ing in­sights from their big data­base.

So hav­ing raised $20 mil­lion in seed fund­ing last May, the duo have bagged a $60 mil­lion Se­ries A to move in­to what they call func­tion­al ge­nomics.

“It moves us from the cor­rel­a­tive analy­sis — which can still be very pow­er­ful — in­to things that are like causal val­i­da­tion,” CTO Voloch said. “We’re build­ing our whole in­fra­struc­ture to be able to do this at a scale and so­phis­ti­ca­tion that no one has right now.”

The set­up will be com­plete with a wet lab equipped to con­duct both in vi­vo and in vit­ro test­ing. Af­ter its al­go­rithms iden­ti­fy a ge­net­ic sig­na­ture po­ten­tial­ly tied to tu­mor re­sponse, for ex­am­ple, sci­en­tists at the com­pa­ny could then de­sign ex­per­i­ments to tease out the tar­get’s val­ue.

That’s the promise, at least, for the col­lab­o­ra­tors at Bay­lor Col­lege of Med­i­cine and the phar­ma cus­tomers who gained ac­cess to the AI plat­form through a deal with 10x Ge­nomics.

Im­mu­nai has so far ac­crued sam­ples “in the thou­sands” with a 70-strong team spread across 15 coun­tries, and there are plans to dou­ble or even triple the group as they push to se­quence more.

But Voloch em­pha­sized that it’s the abil­i­ty to look at in­di­vid­ual cells — some­times lon­gi­tu­di­nal­ly, track­ing T cell clon­al ex­pan­sion over the course of treat­ment — that mat­ters most.

“We have a data­base of cells so peo­ple can query for cells of spe­cif­ic fea­tures,” he said. “And that’s how we’ve been think­ing about it and so all of our ma­chine learn­ing and AI is large­ly at that cell unit.”

Schus­ter­man Fam­i­ly In­vest­ments, Duquesne Fam­i­ly Of­fice, Catalio Cap­i­tal Man­age­ment and Dex­cel Phar­ma led the round, while ex­ist­ing in­vestors Vi­o­la Ven­tures and TLV Part­ners par­tic­i­pat­ed.

Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serves, 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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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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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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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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