Luis Voloch and Noam Solomon (Immunai)

Stan­ford, Park­er In­sti­tute sci­en­tists team up with two young en­gi­neers in $20M AI play with an im­munol­o­gy fo­cus

Al­most a year ago, a group of sci­en­tists at Stan­ford and the Park­er In­sti­tute for Can­cer Im­munother­a­py pub­lished a pa­per in Na­ture Med­i­cine that chal­lenged a com­mon as­sump­tion about where tu­mor fight­ing cells come from: While re­searchers had thought that the role of check­point block­ade was to rein­vig­o­rate T cells al­ready present in the tu­mor, they sug­gest­ed that the vast ma­jor­i­ty ac­tu­al­ly didn’t come from the tu­mor sites at all.

An­su Sat­pa­thy

The find­ing was made pos­si­ble by sin­gle-cell RNA se­quenc­ing tech­nol­o­gy, which cap­tured tens of thou­sands of cells over time and re­vealed that the army of ac­tive T cells could be found in the blood­stream.

Two re­searchers on the team — Stan­ford pathol­o­gy pro­fes­sor An­su Sat­pa­thy and PI­CI se­nior da­ta sci­en­tist Dan­ny Wells — had been ad­vis­ing an AI start­up with a can­cer fo­cus. But with­in a few months, they jumped on board Im­mu­nai as found­ing sci­en­tists and steered it to­ward a slight­ly dif­fer­ent di­rec­tion, one tied close­ly with the T cell work.

By build­ing an end-to-end plat­form from sam­ple pro­cess­ing to data­base as­sem­bly to da­ta min­ing for bi­o­log­i­cal in­sights, Im­mu­nai’s ul­ti­mate goal is to map out the en­tire im­mune sys­tem, co-founder and CEO Noam Solomon told End­points News.

The com­pa­ny is now emerg­ing from stealth with $20 mil­lion in a seed round led by Vi­o­la Group and TLV Part­ners.

Solomon was a post­doc at MIT when his friend and even­tu­al busi­ness part­ner, Luis Voloch, got him ex­cit­ed about tran­si­tion­ing from tech to biotech — or tech­bio as they would call it. Voloch, who cut his teeth in ma­chine learn­ing at Palan­tir, is now the chief tech­nol­o­gy of­fi­cer of Im­mu­nai.

Dan­ny Wells

They were par­tic­u­lar­ly fas­ci­nat­ed with the com­pu­ta­tion­al con­cept of trans­fer learn­ing, which al­lows one to ap­ply knowl­edge in one area (such as au­toim­mune dis­eases) to an­oth­er (such as can­cer im­munother­a­py).

“That’s why it’s im­por­tant for us to un­der­stand the im­mune sys­tem from the top down,” Voloch said. “It’s on­ly when you look at all these things at once that you can re­al­ly un­der­stand the in­ter­play be­tween these dif­fer­ent cell types and the dif­fer­ent func­tions that these cell types have in dif­fer­ent sce­nar­ios.”

For phar­ma part­ners with check­point drugs and cell ther­a­pies in de­vel­op­ment, Im­mu­nai promis­es to an­swer ques­tions about how com­bos might act to­geth­er on dif­fer­ent cells — with an eye for new bio­mark­ers and tar­gets. When it comes to CAR-T and oth­er TCR ther­a­pies, Voloch said, the team can al­so pro­file the drug be­fore in­fu­sion, track­ing per­for­mance by sub­pop­u­la­tion.

“Our first en­deav­or is to un­der­stand mech­a­nisms of the im­mune sys­tem,” Solomon con­clud­ed.

Un­like some of the oth­er AI shops that have popped up in bio­phar­ma, Im­mu­nai is cer­tain it will not step in­to its own drug dis­cov­ery and de­vel­op­ment. Rather, its 30-strong work­force in Tel Aviv, New York and San Fran­cis­co will de­vote all their at­ten­tion to play­ing as­sist in the bio­phar­ma world. Be­yond the ini­tial ap­pli­ca­tions in can­cer, it al­so sees a fu­ture in every­thing from in­fec­tious dis­ease to Alzheimer’s.

“To each dis­ease there is an im­mune com­po­nent,” Solomon added. “Build­ing this wide data­base, this pan-im­mune data­base, we will be able to de­code this com­po­nent.”

The Price of Re­lief: Ex­plor­ing So­lu­tions to the Ris­ing Costs of On­col­o­gy Drugs

In 2020, The National Cancer Institute estimated about 1.8 million new cases of cancer diagnosed in the United States, while the costs associated with treatment therapies continued to escalate. Given the current legislative climate on drug pricing, it’s never been more important to look at the evolution of drug pricing globally and control concerns of sustainable and affordable treatments in oncology.

Lat­est news on Pfiz­er's $3B+ JAK1 win; Pacts over M&A at #JPM22; 2021 by the num­bers; Bio­gen's Aduhelm reck­on­ing; The sto­ry of sotro­vimab; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

For those of you who attended #JPM22 in any shape or form, we hope you had a fruitful time. Regardless of how you spent the past hectic week, may your weekend be just what you need it to be.

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A $3B+ peak sales win? Pfiz­er thinks so, as FDA of­fers a tardy green light to its JAK1 drug abroc­i­tinib

Back in the fall of 2020, newly crowned Pfizer chief Albert Bourla confidently put their JAK1 inhibitor abrocitinib at the top of the list of blockbuster drugs in the late-stage pipeline with a $3 billion-plus peak sales estimate.

Since then it’s been subjected to serious criticism for the safety warnings associated with the class, held back by a cautious FDA and questioned when researchers rolled out a top-line boast that their heavyweight contender had beaten the champ in the field of atopic dermatitis — Dupixent — in a head-to-head study.

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Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

Rob Califf ad­vances as Biden's FDA nom­i­nee, with a close com­mit­tee vote

Rob Califf’s second confirmation process as FDA commissioner is already much more difficult than his near unanimous confirmation under the Obama administration.

The Senate Health Committee on Thursday voted 13-8 in favor of advancing Califf’s nomination to a full Senate vote. Several Democrats voted against Califf, including Sen. Bernie Sanders and Sen. Maggie Hassan. Several other Democrats who aren’t on the committee, like West Virginia’s Joe Manchin and Ed Markey of Massachusetts, also said Thursday that they would not vote for Califf. Markey, Hassan and Manchin all previously expressed reservations about the prospect of Janet Woodcock as an FDA commissioner nominee too.

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Michel Vounatsos, Biogen CEO (World Economic Forum/Ciaran McCrickard)

Bio­gen vows to fight CM­S' draft cov­er­age de­ci­sion for Aduhelm be­fore April fi­nal­iza­tion

Biogen executives made clear in an investor call Thursday they are not preparing to run a new CMS-approved clinical trial for their controversial Alzheimer’s drug anytime soon.

As requested in a draft national coverage decision from CMS earlier this week, Biogen and other anti-amyloid drugs will need to show “a meaningful improvement in health outcomes” for Alzheimer’s patients in a randomized, placebo-controlled trial to get paid for their drugs, rather than just the reduction in amyloid plaques that won Aduhelm its accelerated approval in June.

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CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

Susan Galbraith, AstraZeneca EVP, Oncology R&D

Can­cer pow­er­house As­traZeneca rolls the dice on a $75M cash bet on a buzzy up­start in the on­col­o­gy field

After establishing itself in the front ranks of cancer drug developers and marketers, AstraZeneca is putting its scientific shoulder — and a significant amount of cash — behind the wheel of a brash new upstart in the biotech world.

The pharma giant trumpeted news this morning that it is handing over $75 million upfront to ally itself with Scorpion Therapeutics, one of those biotechs that was newly birthed by some top scientific, venture and executive talent and bequeathed with a fortune by way of a bankroll to advance an only hazily explained drug platform. And they are still very much in the discovery and preclinical phase.

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‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.

A patient in Alaska receiving an antibody infusion to prevent Covid hospitalizations in September. All but one of these treatments has been rendered useless by Omicron (Rick Bowmer/AP Images)

How a tiny Swiss lab and two old blood sam­ples cre­at­ed one of the on­ly ef­fec­tive drugs against Omi­cron (and why we have so lit­tle of it)

Exactly a decade before a novel coronavirus broke out in Wuhan, Davide Corti — a newly-minted immunologist with frameless glasses and a quick laugh — walked into a cramped lab on the top floor of an office building two hours outside Zurich. He had only enough money for two technicians and the ceiling was so low in parts that short stature was a job requirement, but Corti believed it’d be enough to test an idea he thought could change medicine.

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