Evan Feinberg, CEO of Genesis Therapeutics (Boris Feldman)

Genen­tech-part­nered Gen­e­sis Ther­a­peu­tics inks newest AI dis­cov­ery deal with Eli Lil­ly

A Stan­ford biotech rubbed el­bows with Genen­tech in 2020, reach­ing a deal with the big-name biotech just over 18 months ago. And now, the AI out­fit is in its sec­ond part­ner­ship with Big Phar­ma.

Gen­e­sis Ther­a­peu­tics se­cured a deal with big phar­ma Eli Lil­ly, the com­pa­ny an­nounced on Tues­day — to dis­cov­er ther­a­pies “across a range of ther­a­peu­tic ar­eas,” ac­cord­ing to a state­ment put out by the biotech.

Found­ed in 2019 as a spin­out out of Vi­jay Pande’s lab at Stan­ford, Gen­e­sis Ther­a­peu­tics looked to join the in­dus­try-wide push at the time to in­cor­po­rate AI in­to drug R&D. The biotech ini­tial­ly bagged $4.1 mil­lion in seed fund­ing, led by An­dreessen Horowitz. And in the mean­time, it’s got a big name be­hind it as di­rec­tor of the board: for­mer Alex­ion CEO and founder Leonard Bell.

It fur­ther spread its wings af­ter the biotech inked a deal with Genen­tech in 2020 — Roche’s glob­al head of phar­ma part­ner­ing James Sabry said at the time that “AI can help un­lock the next gen­er­a­tion of in­no­v­a­tive ther­a­pies for pa­tients in need of ad­di­tion­al op­tions. We are ex­cit­ed to work with Gen­e­sis’ team to dis­cov­er med­i­cines cur­rent­ly out of reach us­ing con­ven­tion­al meth­ods.” Two months lat­er, it scored $52 mil­lion via a Se­ries A round.

Now on­to the de­tails: the biotech will be us­ing their AI-based drug dis­cov­ery plat­form, which in­cludes ar­ti­fi­cial neur­al net­works and ma­chine learn­ing mod­els to iso­late and pin­point drug can­di­dates for a va­ri­ety of se­vere dis­eases — which so far re­main un­named. Gen­e­sis is able to make “ul­tra-fast and ac­cu­rate pre­dic­tions” of a com­pound’s po­ten­cy, se­lec­tiv­i­ty, tox­i­c­i­ty and more, CEO Evan Fein­berg told End­points News two years ago on the heels of the Genen­tech deal be­ing an­nounced. As far as fi­nan­cials go, Gen­e­sis will get $20 mil­lion up­front for work on three ini­tial tar­gets. Lil­ly will re­tain the op­tion to add two more tar­gets to Gen­e­sis’s plate, and Gen­e­sis is el­i­gi­ble to re­ceive up to $670 mil­lion over­all in com­bined up­front + mile­stone pay­ments, plus po­ten­tial roy­al­ties.

“We are ex­cit­ed to join forces with Lil­ly and their world-class re­search and de­vel­op­ment teams to dis­cov­er nov­el drugs for pa­tients suf­fer­ing with se­vere dis­eases,” Fein­berg said in a state­ment.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Ted White, Verrica Pharmaceuticals CEO

'Hands may be tied': FDA slaps Ver­ri­ca with 3rd CRL due to prob­lems with con­tract man­u­fac­tur­er

The FDA has rejected Verrica Pharmaceuticals’ skin disease treatment for a third time — and once again the contract manufacturer is to blame.

The biotech emphasized that the only deficiency in the complete response letter is related to a general reinspection of the CMO, Sterling Pharmaceuticals, and has nothing to do specifically with its drug-device; the rest of the NDA is good to go.

CEO Ted White said the company is “extremely disappointed,” but will keep working toward approval.

Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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Robert Califf (Michael Brochstein/Sipa USA via AP Images)

House Re­pub­li­cans at­tack Chi­na-on­ly da­ta in FDA sub­mis­sions, seek new in­ves­ti­ga­tion in­to re­search in­spec­tions

Three Republican representatives are calling on the FDA to take a closer look at the applications including only clinical data from China.

The letter to FDA commissioner Rob Califf late last week comes as the agency recently rejected Eli Lilly’s anti-PD-1 antibody, which attempted to bring China-only data but ran into a bruising adcomm that may crush the hopes of any other companies looking to bring cheaper follow-ons based only on Chinese data.

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Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

Delaware court rules against Gilead and Astel­las in years-long patent case

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.