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.”

Covid-19 roundup: Eu­rope pur­chas­es 80M dos­es of Mod­er­na's vac­cine; CO­V­AXX se­cures $2.8B in emerg­ing mar­ket pre-or­ders

With the announcement of its vaccine efficacy data last week, Moderna is starting to line up customers for its Covid-19 mRNA jabs.

The Massachusetts-based biotech announced Wednesday it has agreed to sell an initial round of 80 million doses to the European Commission, with the option to double the amount to 160 million. Once the member states rubber stamp the approval, the deal will be finalized.

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Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

News brief­ing: FDA re­quests new tri­al for Reata's Friedre­ich's atax­ia pro­gram; J&J's Trem­fya picks up ex­pand­ed la­bel in Eu­rope

Three months after Reata Pharmaceuticals suggested its Friedreich’s ataxia program omaveloxolone could be delayed, the company revealed that is indeed going to be the case.

Reata $RETA shares took a nosedive Wednesday after the biotech revealed that the FDA said supplemental data for its pivotal trial did not strengthen the case for approval. As a result, the drug is likely to need another study before the FDA takes up the case.

Jef­frey Hat­field takes over from Diego Mi­ralles as CEO of Vi­vid­ion; Drag­on­fly scores a new ex­ec with COO Alex Lu­gov­skoy

→ San Diego protein degradation startup Vividion Therapeutics has made a change at the top with Jeffrey Hatfield taking the helm as CEO, replacing Diego Miralles six months after Roche forked over $135 million to collaborate with Vividion on their small molecule degraders. Hatfield is chairman of the board at miRagen Therapeutics and previously held the CEO job at Zafgen and Vitae Pharmaceuticals. He also had a series of leadership roles at Bristol Myers Squibb from 1996-2004, including SVP, immunology and virology divisions.

Chi­na opens the door for biotech in­vestors in Hong Kong to buy Shang­hai stocks, and vice ver­sa

When Shanghai’s STAR board began opening its doors to biotech, it was considered not just a rival to Nasdaq but also the stock exchange in Hong Kong. Those perceptions may take an amicable turn as China expands a mutual access program with the city.

The changes mean investors in mainland China will be able to own Hong Kong biotech chapter stocks, while those in Hong Kong — a much more internationally connected group — would have access to those listed on STAR. In effect, it turns the Shanghai market into a globally accessible exchange overnight while also broadening a key source of revenue for HKEX.

Bax­ter con­tin­ues on-shoring push with $50M In­di­ana ex­pan­sion

It’s been a banner year for the once humdrum business of manufacturing drugs, particularly vaccines. Billions have been spent ramping up facilities for Covid-19 jabs, while individual CDMOs have expanded their facilities, apparently anticipating demand or responding to a government-led push to onshore drug manufacturing.

Now Baxter Biopharma Solutions, the CDMO wing of the many-armed healthcare giant Baxter, is getting in on the game. On Tuesday, they announced plans to spend $50 million to expand their flagship, 600,000 square-foot facility in Bloomington, IN.

Eu­ro­pean Union aims to es­tab­lish patent workaround in case of emer­gen­cies while try­ing to strength­en its own IP

The European Union is looking at ways to bypass patent protections and make it easier to make generic drugs in cases of emergency such as the Covid-19 pandemic, a new document says.

Normally, under WTO regulations, the practice known as “compulsory licensing” is allowed in exceptional circumstances and could be applied as a waiver to bypass patent holders. Wednesday’s document was published as part of the EU’s plan to shore up the intellectual property rights of its member states.