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.”

J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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FDA hands Mor­phoSys and In­cyte a quick OK on their po­ten­tial block­buster CAR-T al­ter­na­tive

Nearly three years after okaying the CAR-Ts Yescarta and Kymriah, the FDA has approved a new CD19 therapy.

MorphoSys’ Monjuvi, or tafasitamab-cxix, was cleared Friday for use in refractory diffuse large B-cell lymphoma (DBLCL). The approval sets up both MorphoSys and their commercial partner Incyte to compete with Gilead and Novartis in the ultra-competitive indication, where similar trial results and far easier delivery could allow them to cut a fair share of the market.

Rich Heyman (ARCH)

Rich Hey­man joins PMV Phar­ma, a p53 biotech, as it adds $70 mil­lion in Se­ries D

Less than a year after pulling in an impressive $62 million Series C round, PMV Pharma is back at it again.

The Cranbury, NJ-based biotech announced Monday an additional $70 million in Series D financing as it seeks to develop cancer therapies targeting p53 mutations. Additionally, PMV also introduced longtime biotech entrepreneur Rich Heyman as chairman of the board of directors.

“This financing provides PMV Pharma with the resources to expand our pipeline and to potentially advance multiple p53 therapies into the clinic,” said PMV president and CEO David Mack in a statement.

Sanofi un­der for­mal in­ves­ti­ga­tion for De­pakine al­le­ga­tions; Beam li­cens­es CAR-T tech from Ox­ford Bio­med­ica

Sanofi is facing a formal investigation on manslaughter charges, due to accusations that its epilepsy drug Depakine caused birth malfunctions and slow neurological development when taken during pregnancy.

The French pharma was formally charged in February, years after evidence surfaced that the drug, sodium valproate, posed neurodevelopmental risks. Sodium valproate first hit the market in 1967 for the treatment of epilepsy and bipolar disorder, and is currently prescribed in more than 100 countries.

Days af­ter seal­ing Sanofi pact, Kymera beats a path to the Nas­daq with $100M IPO pitch

Back in March, when Kymera Therapeutics closed $102 million in Series C funding led by Biotechnology Value Fund and Redmile Group, CEO Nello Mainolfi noted the protein degradation player was “at the cusp of transitioning” into a fully integrated R&D company. Five months and a major Sanofi pact later, he’s back asking for another little push to get there.

Kymera has penciled in $100 million in its first IPO pitch — although given the public market’s seemingly insatiable appetite for biotechs these days the final figure is anyone’s guess.

CymaBay flash­es pos­i­tive re­sults from the tri­al they have to re­launch

Two weeks after the FDA lifted its clinical hold on their lead drug, CymaBay said it showed positive results in an aborted Phase III trial.

The drug, a small molecule known as seladelpar, had been in development for three different liver conditions before an independent review of a NASH study last year showed that it might actually be damaging patient’s liver cells. The FDA slapped a clinical hold across all three trials, only lifting it last month when an FDA review determined that the drug hadn’t caused liver damage.

Covid-19 roundup: Eli Lil­ly retro­fits RVs for first-of-its-kind an­ti­body tri­al with NIH; Am­gen, Ab­b­Vie, Take­da team on a drug

Eli Lilly and the NIH are about to start a first-of-its-kind trial that researchers and developers have talked about for months as a way of providing temporary immunity to the most at-risk populations.

Lilly announced this morning that it will start a 2,400-person trial with the National Institute for Allergy and Infectious Diseases to test whether its experimental Covid-19 neutralizing antibody can prevent people in nursing homes and assisted living facilities from developing the disease. The idea, known as passive immunity, is that rather than waiting on a vaccine to induce people to develop antibodies, doctors can give them lab-grown antibodies. Ideally, those antibodies will either attack the new SARS-CoV-2 infection, if the patient has recently been exposed, or persist in the blood for several weeks and prevent infection or disease for that period.

So Covid-19 leader BioN­Tech has a can­cer vac­cine in de­vel­op­ment? Yes, and Re­gen­eron just jumped in for the PhII com­bo study

Before the coronavirus global emergency stole the R&D show in biopharma, the leaders in the race to develop new mRNA therapies had a big interest in determining if their tech could be used to create an effective cancer vaccine after all the first-gen tries had failed to impress. So perhaps it’s not surprising that an early cut of the data at frontrunner BioNTech went largely unnoticed.

Unless you were at Regeneron.

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Sev­en plucky di­ag­nos­tics com­pa­nies win a $249M round of con­tracts af­ter sur­viv­ing NI­H's Covid-19 'Shark Tank' com­pe­ti­tion

As US Covid-19 deaths creep past 150,000 and officials stress the importance of contact tracing, the NIH’s Rapid Acceleration of Diagnostics (RADx) program has inked contracts totaling $248.7 million to expand testing capabilities.

The seven contracts, which were chosen “Shark Tank”-style from a pool of 100 proposals, are part of an effort to bump daily testing capacity to 2% of the country’s population by late summer or fall. That would be about 6 million people per day, compared to the current 520,000 to 823,000 tests being administered daily.