Owkin CEO Thomas Clozel (L) and CSO Gilles Wainrib

Fol­low­ing tie-up with Sanofi, transat­lantic AI firm se­cures lat­est Big Phar­ma deal in nine-fig­ure Bris­tol My­ers pact

More than six months af­ter se­cur­ing a nine-fig­ure deal with Sanofi for tar­get dis­cov­ery, a French AI re­search group has land­ed its next Big Phar­ma part­ner­ship.

Owkin, un­der the lead­er­ship of CEO Thomas Clozel, an­nounced Wednes­day morn­ing that it’s signed on with Bris­tol My­ers Squibb to op­ti­mize the Big Phar­ma’s clin­i­cal tri­als and im­prove the odds of clin­i­cal suc­cess, ini­tial­ly in car­dio­vas­cu­lar dis­ease. The an­nounce­ment comes af­ter a deal Owkin made with Sanofi last No­vem­ber that build on the pair’s pre­vi­ous dis­cov­ery col­lab­o­ra­tion.

In Wednes­day’s deal, Owkin gets $80 mil­lion in a com­bined up­front and eq­ui­ty pay­ment and po­ten­tial­ly fur­ther pay­ments high­er than $100 mil­lion as clin­i­cal tri­als move in­to lat­er stages. The biotech added in a state­ment that it plans to use the funds to sup­port its da­ta gen­er­a­tion strat­e­gy in mul­ti­ple ther­a­peu­tic ar­eas, pri­mar­i­ly fo­cus­ing on sin­gle-cell omics.

The new col­lab­o­ra­tion dif­fers from the Sanofi deal. In­stead of us­ing its AI plat­form to im­prove tar­get dis­cov­ery ef­forts and seek bet­ter drug com­bi­na­tions, Owkin is pure­ly fo­cused on clin­i­cal tri­al de­sign and op­ti­miza­tion.

Clozel said the com­pa­ny is fo­cus­ing on re­fin­ing the end­points in tri­als, find­ing the right peo­ple and re­duc­ing tri­al “noise.” And as part of its work, there are a few things he wants to keep in mind.

First is find­ing the right sub­groups and defin­ing them with bio­mark­ers. The sec­ond step, ac­cord­ing to the CEO, is to try and in­tro­duce “syn­thet­ic con­trol arms,” which he de­scribed as more ef­fi­cient ways to op­ti­mize a study’s con­trol arm.

“What we do is try to build a more fed­er­at­ed ac­cess to da­ta world­wide, and re­al­ly bring a new way to match pa­tients with mul­ti­ple modal­i­ties, not on­ly in clin­i­cal tri­als, but to im­prove the way you build for the con­trol arms. That’s the sec­ond one,” Clozel said.

The CEO then went on to talk about how im­prov­ing the con­trol arms can help cut costs with­in clin­i­cal tri­als, af­ford­ing the pa­tients in­volved the op­por­tu­ni­ty to take a treat­ment.

Es­sen­tial­ly, fed­er­at­ed learn­ing works by up­load­ing cer­tain pre­dic­tion mod­els to these servers where da­ta are kept — in this case, pa­tient da­ta — and bring­ing the al­go­rithms back to a cen­tral lo­ca­tion, Clozel said. The mod­els are fine-tuned as need­ed, and then Owkin up­loads the new and im­proved pre­dic­tion mod­els back to the servers. This process re­peats over and over, and the da­ta re­main “locked,” stay­ing in one place.

And with this plat­form, it would work to iden­ti­fy bet­ter end­point de­f­i­n­i­tions, op­ti­mize and iden­ti­fy pa­tient sub­groups with dis­tinct bio­mark­ers, and work on es­ti­mat­ing drug can­di­date ef­fi­ca­cy.

“What we’re try­ing to do is re­al­ly bring­ing the plat­form to help with the things that we think can be op­ti­mized,” Clozel told End­points News.

The third thing that Owkin hopes to ac­com­plish is to di­min­ish the ac­tu­al rigid­i­ty of clin­i­cal tri­als, or the “noise,” us­ing a sys­tem called AI-en­abled co­vari­ate ad­just­ments. Clozel said it can al­low for more ef­fi­cient tri­als and im­prove the p-val­ue.

Wednes­day’s deal fol­lows three years of col­lab­o­ra­tion be­tween Owkin and Bris­tol My­ers, ac­cord­ing to Clozel, in­clud­ing a num­ber of projects to iden­ti­fy bio­mark­ers and im­prove clin­i­cal tri­al out­comes us­ing re­al-world da­ta.

Venkat Sethu­ra­man

Bris­tol My­ers SVP of glob­al bio­met­rics and da­ta sci­ences Venkat Sethu­ra­man said in a state­ment that “We look for­ward to col­lab­o­rat­ing with Owkin to ex­tend our ap­pli­ca­tions of AI and ma­chine learn­ing to en­hance our dis­cov­ery and de­vel­op­ment pro­grams with high-qual­i­ty, di­verse da­ta from clin­i­cal and re­al world sources.”

In its ear­li­er pact with Sanofi, the Big Phar­ma gave Owkin $90 mil­lion just for ex­clu­siv­i­ty for the first three years of the deal, plus $180 mil­lion in an eq­ui­ty in­vest­ment and more on the line in mile­stone pay­ments. That deal was fo­cused on four on­col­o­gy tar­gets: NSCLC, triple neg­a­tive breast can­cer, mesothe­lioma and mul­ti­ple myelo­ma, Owkin told End­points at the time.

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In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

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But then things happen that remind you why you do it in the first place. Perhaps a Supreme Court rules to overturn the constitutional right to abortion and a group of women biotech leaders makes it clear they strongly dissent; perhaps new data on gender diversity in the industry come out that look all too similar to the old ones, suggesting women are still dramatically underrepresented at the top; perhaps protests and conflicts around the world put in stark terms the struggles that many women still face in earning the most basic recognition.

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Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

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Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

However, the eminent physician-scientist is more than just a drug developer mastermind. She’s also a practicing physician, mother to two young women, an avid backpacker and intersecting all those interests — a champion of young women and people of color in STEM and life sciences.

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Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

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Vikram Sheel Kumar, Clear Creek Bio CEO

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Paxlovid has become a big moneymaker for Pfizer this year, projecting $22 billion in sales on the year. But the Big Pharma has begun its search for a next-generation Covid antiviral and potential combination therapies as supply of Paxlovid greatly eclipses actual use of the antiviral.

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After releasing better-than-anticipated data on two mid-stage studies Wednesday morning, Prometheus Biosciences’ CEO said the company would “take some time to assess” its next financing options.

It only needed about seven hours. Wednesday afternoon after the market closed, the biotech announced it would seek $250 million through an equity offering as the company looks to edge out anti-TL1A competitor Pfizer and its new partner Roivant.

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Piper Trelstad, head of CMC, Bill & Melinda Gates Medical Research Institute

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More and more women are driving innovation and taking leadership roles in biotech – as evidenced today in the release of Endpoints News’ list of the top 20 women in the R&D world – but those gains are beginning to extend across pharma sectors.

In pharma manufacturing in the US today, around 46% of all roles are occupied by women, according to the US Bureau of Labor Statistics for 2021. And according to a Bloomberg report, women’s roles across manufacturing roles had a massive boost after the start of the pandemic.

Phar­ma rep­u­ta­tion re­tains 'halo' even as pan­dem­ic me­dia cov­er­age re­cedes — sur­vey

The Covid-19 halo effect on the pharma industry is continuing, according to a new global study from Ipsos. The annual survey for the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) finds considerable goodwill from consumers across measures of trust, cooperation with governments, and advancing research and drug development.

“Despite the pandemic in many countries no longer being the top of mind concern generally – although it does remain the top concern as a health issue – the industry’s reputation has remained positive,” said Ipsos research director Thomas Fife-Schaw.

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FDA commissioner Robert Califf (Jose Luis Magana/AP Images)

FDA pulls On­copep­tides' Pepax­to in­di­ca­tion, open­ing the door for dan­gling ac­cel­er­at­ed ap­proval en­force­ment

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In recent months, US regulators have honed in on reforming the accelerated approval pathway and preventing drugmakers from continuing to sell their medicines in the event of a confirmatory study flop. The moves come after commissioner Rob Califf has called for companies to do more to produce post-marketing evidence quickly earlier this year.

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