Sam Cooper, Phenomic AI

Jim Al­li­son and Pam Shar­ma back a Cana­di­an AI up­start seek­ing to solve the tu­mor stro­ma puz­zle

Jim Al­li­son

A new com­pa­ny out of Toron­to is seek­ing to put AI and ma­chine learn­ing to the test, us­ing the ad­vanced tech­nol­o­gy to iden­ti­fy tar­gets in sol­id can­cers and oth­er chal­leng­ing dis­eases. And it has the back­ing of the in­dus­try’s res­i­dent pow­er cou­ple.

Phe­nom­ic AI of­fi­cial­ly launched Wednes­day with $6 mil­lion in seed fund­ing and an­nounced that Jim Al­li­son and Pam Shar­ma have joined its sci­en­tif­ic ad­vi­so­ry board. The biotech is al­so bring­ing on new CSO Mike Briskin, who has a pro­fes­sion­al his­to­ry with Al­li­son and Shar­ma af­ter work­ing with them and Third Rock Ven­tures to found Jounce Ther­a­peu­tics about a decade ago.

“We’ve been close over the years ever since we start­ed Jounce,” Briskin said. “We start­ed talk­ing about dif­fer­ent ar­eas to move in­to be­yond the T cell … they’ve seen some of the da­ta from some of their col­leagues at MD An­der­son, and they re­al­ly felt like this was some­thing that was worth be­ing in­volved in.”

Pad­ma­nee Shar­ma

Fi­nanc­ing was led by CTI and joined by AV8, Lu­mi­nous and Vi­va BioIn­no­va­tor. Cur­rent in­vestors Garage Cap­i­tal, Hike and Can­tos al­so joined the round.

The com­pa­ny is plan­ning on us­ing its plat­form not on­ly for drug de­vel­op­ment, but to re­search how dif­fer­ent cells act in dis­ease states, main­ly the tu­mor stro­ma. A part of the mi­croen­vi­ron­ment present in sol­id tu­mors, the stro­ma es­sen­tial­ly acts as a bar­ri­er that pre­vents a body’s im­mune sys­tem from at­tack­ing the tu­mor.

Ba­si­cal­ly, the hu­man body builds a wall to pro­tect it­self from the tu­mor, but the tu­mor then hi­jacks the wall and in­stalls its own army to keep the im­mune sys­tem out, CEO Sam Coop­er said.

“That’s re­al­ly what we’re up against, not just a brick wall but a brick wall filled with sol­diers that are fight­ing off every­thing we’re throw­ing at it,” Coop­er said. “What’s ob­vi­ous­ly clear in can­cer though is that you’ve got dif­fer­ent walls in dif­fer­ent pa­tients, there’s no sim­ple way of do­ing this.”

Mike Briskin

While the func­tion of the stro­ma has been known for some time, Briskin said, on­ly re­cent­ly did re­search come about sug­gest­ing that it’s al­so in­volved in some cell-to-cell in­ter­ac­tions and im­mune re­spons­es, such as sig­nal­ing to T cells to stay away from tu­mors. One of Phe­nom­ic’s goals is to de­vel­op drugs that don’t re­quire im­mune sys­tem re­pres­sion in or­der to break the cy­cle of those in­ter­ac­tions.

That’s where the com­pa­ny’s AI plat­form comes in­to play. Through its tech­nol­o­gy, Coop­er said Phe­nom­ic is ca­pa­ble of mod­el­ing how cells and stro­ma com­mu­ni­cate with each oth­er. Then, re­searchers ex­tract “high-di­men­sion­al read­outs” from the mod­els to de­ter­mine what the cells are do­ing and re­late it back to how a tar­get is af­fect­ed.

“This is all too dif­fi­cult to process at scale as a per­son,” Coop­er said. “Where be­fore you had a mash of dif­fer­ent cells and you’ve got no idea of what’s re­al­ly hap­pen­ing, now we can say this in­di­vid­ual cell is sup­press­ing a T cell and pre­vent­ing it from get­ting to the can­cer. And then we can tar­get that with drugs.”

Phe­nom­ic isn’t dis­clos­ing its ini­tial two tar­gets just yet, but Coop­er said the com­pa­ny’s drug can­di­dates will be fo­cused around can­cer as­so­ci­at­ed fi­brob­lasts, or CAFs. Can­cers that show the least re­sponse to im­mune ther­a­pies typ­i­cal­ly have high­er stro­mal con­tent, and Phe­nom­ic is hop­ing that at­tack­ing the CAFs may prove piv­otal for new­er drug can­di­dates.

If all goes well, Phe­nom­ic won’t be pro­duc­ing typ­i­cal check­point in­hibitor drugs. In fact, Coop­er said that due to the re­al­i­ty of can­cer, they may sign on ex­ist­ing in­hibitors to use in com­bi­na­tion with an an­ti-stro­mal com­pound.

Ul­ti­mate­ly, the com­pa­ny was in­spired by Al­li­son’s work. Should their even­tu­al drugs con­vert im­mune ther­a­py-re­sis­tant tu­mors in­to those that can be treat­ed, if even a lit­tle bit, Phe­nom­ic will con­sid­er that a suc­cess.

“The rev­o­lu­tion in this field at the start was Jim Al­li­son’s il­lus­tra­tion of us­ing a check­point in­hibitor in metasta­t­ic melanoma, re­sult­ing in what in turn were long-term re­spons­es,” Briskin said. “You can see that now in some of these pa­tients, and our goal is to ex­tend those ben­e­fits to a greater num­ber of pa­tients.”

Charles Baum, Mirati CEO

UP­DAT­ED: Mi­rati plots a march to the FDA for its KRAS G12C drug, breath­ing down Am­gen’s neck with bet­ter da­ta

Mirati Therapeutics $MRTX took another closely-watched step toward a now clearly defined goal to file for an approval for its KRAS G12C cancer drug adagrasib (MRTX849), scoring a higher response rate than the last readout from the class-leading rival at Amgen but still leaving open a raft of important questions about its future.

Following a snapshot of the first handful of responses, where the drug scored a tumor response in 3 of 5 patients with non-small cell lung cancer, the response rate has now slid to 45% among a pooled group of 51 early-stage and Phase II patients, 43% — 6 of 14 — when looking solely at the Phase I/Ib. Those 14 patients had a median treatment duration of 8.2 months, with half still on therapy and 5 of 6 responders still in response.

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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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Michel Vounatsos, Biogen CEO (via YouTube)

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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Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

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All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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CRISPR Ther­a­peu­tics gets a snap­shot of off-the-shelf CAR-T suc­cess in B-cell ma­lig­nan­cies — marred by the death of a pa­tient

Just days after scientific founder Emmanuelle Charpentier shared the Nobel prize for her work on CRISPR/Cas9, CRISPR Therapeutics $CRSP is showing off a snapshot of success in their early-stage study for an off-the-shelf CAR-T approach to CD19+ B cell malignancies — a snapshot marred by the death of a patient who had been given a high dose of the treatment.

Using their gene editing tech, researchers for CRISPR engineered cells from healthy donors into an attack vehicle aimed at cancer, something that has been achieved with great success using patients’ own cells — the autologous approach. But autologous CAR-T is hampered by the more complex vein-to-vein requirement that delays treatment, and now CRISPR Therapeutics along with other players like Allogene are determined to replace the pioneers with CAR-T 2.0.

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Biond­Vax stock im­plodes af­ter a big PhI­II gam­ble for its uni­ver­sal flu vac­cine fails

After flying high on Wall Street for the last few months of a pandemic, BiondVax’s stock and dreams of getting approval for its universal flu vaccine hit the windshield.

The Jerusalem-based biotech announced on Friday that its only clinical candidate, M-001, failed both primary and secondary endpoints in a Phase III study. There was no statistically significant difference in reduction of flu illness and severity between the vaccine and placebo groups, according to the company. The vaccine did prove safe, if ineffective, BiondVax said.

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.