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.”

In his­toric Covid-19 ad­comm, vac­cine ex­perts de­bate a sea of ques­tions — but of­fer no clear an­swers

The most widely anticipated and perhaps most widely watched meeting in the FDA’s 113-year history ended late Thursday night with a score of questions and very few answers.

For nearly 9 hours, 18 different outside experts listened to public health agencies and foundations present how the United States’ Covid-19 vaccine program developed through October, and they debated where it should go from there: Were companies testing the right metrics in their massive trials? How long should they track patients before declaring a vaccine safe or effective? Should a vaccine, once authorized, be given to the volunteers in the placebo arm of a trial?

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Pascal Soriot, AstraZeneca CEO (Zach Gibson/Bloomberg via Getty Images)

UP­DAT­ED: FDA gives As­traZeneca the thumbs-up to restart PhI­II Covid-19 vac­cine tri­als, and J&J is prepar­ing to re­sume its study

Several countries had restarted their portions of AstraZeneca’s global Phase III Covid-19 vaccine trial after the study was paused worldwide in early September, but the US notably stayed on the sidelines — until now. Friday afternoon the pharma giant announced the all clear from US regulators. And on top of that, J&J announced Friday evening that it’s preparing to resume its own Phase III vaccine trial.

Ul­tragenyx in­jects $40M to grab Solid's mi­crody­s­trophin trans­gene — while side­step­ping the AAV9 vec­tor that stirred up safe­ty fears

Since before Ilan Ganot started Solid Bio to develop a gene therapy for kids like his son, who has Duchenne muscular dystrophy, Ultragenyx CEO Emil Kakkis has been watching and advising the former investment banker as he navigated the deep waters of drug development.

Just as Solid is getting back up on its feet after a yearlong clinical hold, Kakkis has decided to jump in for a formal alliance.

With a $40 million upfront, Ultragenyx is grabbing 14.45% of Solid’s shares $SLDB and the rights to its microdystrophin construct for use in combination with AAV8 vectors. Solid’s lead program, which utilizes AAV9, remains unaffected. The company also retains rights to other applications of its transgene.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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A top drug pro­gram at Bay­er clears a high bar for CKD — open­ing the door to an FDA pitch

Over the past 4 years, Bayer has been steering a major trial through a pivotal program to see if their drug finerenone could slow down the pace of chronic kidney disease in patients suffering from both CKD as well as Type 2 diabetes.

Today, their team jumped on a virtual meeting hosted by the American Society of Nephrology to offer a solid set of pivotal data to demonstrate that the drug can delay dialysis or a kidney replacement as well as cardio disease, while also adding some worrying signs of hyperkalemia among the patients taking the drug. And they’re hustling it straight to regulators in search of an approval for kidney disease and cardio patients — one of the toughest challenges in the book, as demonstrated by repeated past failures.

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Adam Koppel and Jeffrey Schwartz, Bain

Bain ex­ecs Adam Kop­pel and Jef­frey Schwartz line up $125M for their first blank check deal as Wall Street con­tin­ues to em­brace biotech

Adam Koppel and Jeffrey Schwartz have jumped into the blank check game, raising $125 million for a stock listing in search of a company.

Their SPAC, BCLS Acquisition Corp, raised $125 million this week, with a line on $25 million more as it scouts for a biotech in search of money and a place on Wall Street.

The two principals at Bain Life Sciences have been on a romp since they set up the Bain operation 4 years ago. Their S-1 spells out a track record of 22 deals totaling $650 million for the life sciences group, which led to 9 IPOs.

Covid-19 roundup: An mR­NA play­er gets a boost out of the lat­est round of an­i­mal da­ta; Phase­Bio pulls the plug on treat­ment tri­al

The big tell for CureVac $CVAC is coming up with a looming early-stage readout on their mRNA Covid-19 vaccine in the clinic. But for now they’ll make do with an upbeat assessment on the preclinical animal data they used to get into the clinic.

Researchers for the German biotech say they got the high antibody titers and T cell activation they were looking for, lining up a hamster challenge to demonstrate — in a simple model — that the vaccine could protect the furry creatures. Like the other mRNA vaccines, the drug sends instructions to spur cells to decorate themselves with the distinctive spike on the virus to elicit an immune response.

Chi­nese in­vestors wa­ger $105M on an IPO-bound biotech look­ing to push RNAi as main­stream can­cer ther­a­py

Shortly after Sirnaomics brought in a $47 million Series C for its small interfering RNA pipeline last year, Patrick Lu — the founder, president and CEO — was asked to outline the scientific advances that will be necessary to make better drugs out of RNA tech.

“The next step in the evolution of RNAi as a leading therapeutic will be the ability to safely target organs outside the liver such as lung, brain, etc,” he had offered. “This will revolutionize disease treatments if the industry can demonstrate similar data sets for non-liver targets as we have seen in liver-based diseases.”

Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: FDA anoints Gilead­'s remde­sivir as the Covid-19 treat­ment win­ner, hand­ing down full ap­proval — de­spite some deep skep­ti­cism

Seven months into the Covid-19 pandemic, the race to develop a treatment for the disease that’s proved to be the biggest health crisis in a century has an officially designated winner: Gilead. And they’re picking up the prize — worth billions in peak sales — despite a major study that concluded the drug was no help in reducing the number of people who die from the virus.

The FDA handed down a thumbs-up for remdesivir, the company announced Thursday afternoon, as the drug becomes the first fully approved treatment for Covid-19 in the US. Remdesivir, to be marketed as Veklury, will come with a label for treatment in adults and children older than 12 in Covid-19 cases that require hospitalization.

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