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.

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

A Mer­ck part­ner is sucked in­to the fi­nan­cial quag­mire as key lender calls in a note

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.

David Loew (Ipsen)

Ipsen snags an ap­proved can­cer drug in $247M M&A deal as an­oth­er bat­tered biotech sells cheap

You can add Paris-based Ipsen to the list of discount buyers patrolling the penny stock pack for a cheap M&A deal.

The French biotech, which has had plenty of its own problems to grapple with, has swooped in to buy Epizyme $EPZM for $247 million in cash and a CVR with milestones attached to it. Epizyme shareholders, who had to suffer through a painfully soft launch of their EZH2a inhibitor cancer drug Tazverik, will get $1.45 per share along with a $1 CVR tied to achieving $250 million in sales from the drug over four consecutive quarters as well as an OK for second-line follicular lymphoma by Jan. 1, 2028.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,400+ biopharma pros reading Endpoints daily — and it's free.

Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,400+ biopharma pros reading Endpoints daily — and it's free.

Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,400+ biopharma pros reading Endpoints daily — and it's free.

Members of the G7 from left to right: Prime Minister of Italy Mario Draghi, European Commission President Ursula von der Leyen, President Joe Biden, German Chancellor Olaf Scholz, British Prime Minister Boris Johnson, Canadian Prime Minister Justin Trudeau, Prime Minister of Japan Fumio Kishida, French President Emmanuel Macron and European Council President Charles Michel (AP Photo/Susan Walsh)

Biden and G7 na­tions of­fer funds for vac­cine and med­ical prod­uct man­u­fac­tur­ing project in Sene­gal

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Chris Anzalone, Arrowhead CEO

Take­da, Ar­row­head spot­light da­ta from small tri­al show­ing RNAi works in a rare liv­er con­di­tion

Almost two years after Takeda wagered $300 million cash to partner with Arrowhead on an RNAi therapy for a rare disease, the companies are spelling out Phase II data that they believe put them one step closer to their big dreams.

In a small, open label study involving only 16 patients who had liver disease associated with alpha-1 antitrypsin deficiency (AATD), Arrowhead’s candidate — fazirsiran, previously ARO-AAT — spurred substantial reductions in accumulated mutant AAT protein in the liver, a hallmark of the condition. Investigators also tracked improvements in symptoms, with seven out of 12 who received the high, 200 mg dose seeing regression of liver fibrosis.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,400+ biopharma pros reading Endpoints daily — and it's free.