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.”

What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; and more

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

Merck Research Laboratories CMO Roy Baynes

Mer­ck­'s Keytru­da un­corks full da­ta on lat­est ad­ju­vant win — this time in melanoma — adding bricks to ear­ly can­cer wall

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Mer­ck flesh­es out Keytru­da win in first-line cer­vi­cal can­cer, adding more fire­pow­er to its ear­ly can­cer push

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.

EQRx chairman Alexis Borisy and CEO Melanie Nallichieri

EQRx, CStone un­furl full lung can­cer da­ta for PD-L1 drug in what the part­ners are call­ing a first

As a self-stylized drug pricing disruptor, EQRx has high hopes for its lead PD-(L)1 to offer proof of concept for the entire business model. After touting a win back in May, the biotech is back with full data in lung cancer that could back up an approval.

Patients dosed with EQRx and CStone Pharmaceuticals’ sugemalimab posted median progression-free survival of 9 months compared with 5.8 months for patients given placebo (p=0.0026), according to full data from the Phase III GEMSTONE-301 study in Stage III non-small cell lung cancer set to be presented at this weekend’s #ESMO21.

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As­traZeneca touts Imfinzi im­munother­a­py com­bos for lung can­cer in push to dri­ve PD-L1 drug up­take

Facing the big dogs in the PD-(L)1 space, AstraZeneca has taken its own contender Imfinzi into blockbuster territory in its four years on the market but sees even bigger things for the drug. Combinations could be the key, and early results from a mid-stage test are adding some fuel to that strategy.

Imfinzi combined with one of two investigational immunotherapies — a CD73 antibody dubbed oleclumab or an Innate’s anti-NGK2a named monalizumab — topped Imfinzi alone in terms of overall response and progression-free survival in patients with stage III non-small cell lung cancer whose tumors had not worsened during concurrent chemoradiation, according to interim data from the Phase II COAST trial set to be presented at #ESMO21.