Ramy Farid, Schrödinger CEO

An AI, err ma­chine learn­ing, shop lines up Eli Lil­ly as part­ner ahead of first in-house clin­i­cal tri­al

Life sci­ences soft­ware de­vel­op­er and drug dis­cov­ery out­fit Schrödinger, dur­ing its “plat­form day,” out­lined its pro­grams and path for­ward two months af­ter bring­ing on board long-time biotech an­a­lyst Ge­of­frey Porges, who told End­points News on his first day that the com­pa­ny’s sto­ry had been “over-sim­pli­fied.”

As part of telling its sto­ry on Thurs­day, which in­clud­ed slides of Schrödinger cats, the New York-based com­pa­ny dis­closed an­oth­er part­ner, adding to the dozen or so col­lab­o­ra­tions in the works at Schrödinger.

Eli Lil­ly is the lat­est to sign on the dot­ted line in a small mol­e­cule dis­cov­ery and op­ti­miza­tion deal that will see the In­di­anapo­lis Big Phar­ma dish out up to $425 mil­lion in mile­stones. De­tails of the up­front pay­ment were kept un­der the hood. Roy­al­ties are al­so on the line, and Lil­ly will lead every­thing once the tie-up en­ters the pre­clin­i­cal stage.

The deal comes to light less than two full months af­ter Porges joined as CFO, af­ter a sto­ried time at SVB Se­cu­ri­ties.

Ge­of­frey Porges

On his first day, Porges told End­points that the tim­ing was op­ti­mal to bring a “lot more vis­i­bil­i­ty” to the 32-year-old, 800-em­ploy­ee com­pa­ny.

That was the ap­par­ent mis­sion of Thurs­day’s two-hour hy­brid pre­sen­ta­tion, in which CEO Ramy Farid of­fered up his com­ments on the hype of ar­ti­fi­cial in­tel­li­gence and not­ed half the com­pa­ny’s em­ploy­ees are ded­i­cat­ed to R&D and work­ing to­ward find­ing that “one mag­i­cal mol­e­cule” for its bio­phar­ma part­ners.

“You now al­ways hear [ma­chine learn­ing] be­ing re­ferred to as AI be­cause it just sounds cool­er to call it AI,” Farid said. “It’s just ma­chine learn­ing. In com­pu­ta­tion­al chem­istry, when peo­ple say AI, they mean ma­chine learn­ing.”

The list of com­pa­nies at­tempt­ing to dis­rupt drug dis­cov­ery is ap­proach­ing a full post­sea­son ros­ter at this point: Ex­sci­en­tia, Atom­wise, Re­cur­sion Phar­ma­ceu­ti­cals, in­sitro, XtalPi, Deep Ge­nomics, In­sil­i­co, Cy­toRe­a­son and Benev­o­len­tAI, among oth­ers.

For its own in-house work, Schrödinger will en­ter the clin­ic this quar­ter with a Phase I study of its MALT1 in­hibitor, SGR-1505, in pa­tients with re­lapsed/re­frac­to­ry B-cell lym­phoma. The com­pa­ny al­so said Thurs­day that it ex­pects to ask for an IND for its CDC7 in­hibitor, SGR-2921, in the first half of next year. And a Wee1 in­hibitor de­vel­op­ment can­di­date will be se­lect­ed this quar­ter.

The goal is to syn­the­size and test hun­dreds of mol­e­cules in about 1.5 years to 3 years, com­pared to oth­er mol­e­cule de­sign process­es that Schrödinger claims can take about 4 to 6 years.

That work is part of a laun­dry list of col­lab­o­ra­tors: Nim­bus Ther­a­peu­tics and ShouTi (both of which Schrödinger co-found­ed), Agios, Nim­bus Ther­a­peu­tics, Mor­phic Ther­a­peu­tic, Struc­ture Ther­a­peu­tics, Sanofi, Bright An­gel Ther­a­peu­tics, Pe­tra Phar­ma, Ajax Ther­a­peu­tics, Orex­ia, Take­da, Zai Lab, Bris­tol My­ers Squibb and now Eli Lil­ly.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

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Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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Eu­ro­pean doc­tors di­al up dig­i­tal com­mu­ni­ca­tion with phar­mas, but still lean to­ward in-per­son med meet­ings, study finds

As in-person sales rep access declines in the big five European countries, a corresponding uptick in virtual rep access is happening. It’s not surprising, but it does run counter to pharma companies’ assessment – along with long-held sales rep sway in Europe – that in-person access hadn’t changed.

CMI Media Group and Medscape’s recent study reports that 75% of physicians in the EU5 countries of Spain, Germany, Italy, France and the UK already limit engagements with pharma sales reps, and 25% of those surveyed plan to decrease time with reps.

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Judge al­lows ex­pert tes­ti­mo­ny in GSK tri­al al­leg­ing Zan­tac link to can­cer

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.

No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to clinicaltrials.gov, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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