Boehringer In­gel­heim adds sec­ond AI part­ner in a month

Three weeks af­ter sign­ing a deal with one AI-fo­cused biotech, Boehringer In­gel­heim is adding an­oth­er.

The Ger­man phar­ma has an­nounced a part­ner­ship with BERG, the da­ta analy­sis and Bayesian AI com­pa­ny found­ed over a decade ago by re­al es­tate bil­lion­aire Carl Berg. Berg will use its com­put­er and wet lab plat­form to in­ves­ti­gate in­flam­ma­to­ry dis­eases, most no­tably at­tempt­ing com­ing up with caus­es, bio­mark­ers, drug tar­gets and drugs for in­flam­ma­to­ry bow­el dis­ease and Crohn’s dis­ease.

Niv­en Narain

“The bi­ol­o­gy be­hind these dis­eases are still not well un­der­stood,” BERG CEO Niv­en Narain told End­points News, not­ing that it can still be dif­fi­cult to dis­tin­guish Crohn’s from IBD. The plat­form will try “to de­mys­ti­fy the bi­o­log­i­cal trig­ger points.”

For Boehringer, the deal comes not long af­ter they inked a deal with In­sil­i­co, the com­pa­ny that pro­voked both en­thu­si­as­tic and deeply skep­ti­cal head­lines last Sep­tem­ber af­ter pub­lish­ing a Na­ture Biotech­nol­o­gy pa­per ex­plain­ing how they de­signed a drug can­di­date mol­e­cule in 21 days. In in­ter­views, Narain is quick to dis­tance BERG from the hype that has sur­round­ed ma­chine learn­ing-fo­cused biotech star­tups, not­ing that Berg em­ploys a wet lab, gen­er­ates their own da­ta, has brought a pair of their own drugs in­to the clin­ic, and us­es a math­e­mat­i­cal ap­proach dis­tinct from ma­chine learn­ing.

“We’re a bi­ol­o­gy com­pa­ny,” Narain said. “We use AI as a tool.”

BERG, though, found­ed in 2006, was among the ear­ly  biotechs to promise that their plat­form can make the drug dis­cov­ery faster, cheap­er, and more ef­fi­cient — the now ubiq­ui­tous and yet un­sub­stan­ti­at­ed claim of the AI biotech world. And they are far from alone in hav­ing a wet lab or gen­er­at­ing their own da­ta.

The com­pa­ny’s ap­proach in­volves tis­sue sam­ples from pa­tients with and with­out dis­ease, sub­ject­ing the cells to dif­fer­ent con­di­tions and wring­ing as much da­ta as pos­si­ble from them: ge­nomics, pro­teomics, metabolomics, lipidomics, and oth­ers. The com­pa­ny then us­es Bayesian AI, a math­e­mat­i­cal method to de­duce causal­i­ty.

With Boehringer, BERG will an­a­lyze tis­sues for a host of ac­tion­able da­ta. That in­cludes bio­mark­ers to di­ag­nose in­flam­ma­to­ry dis­eases ear­ly, to in­di­cate which drugs are most like­ly to work in which pa­tients, and to de­cide what drugs to give to pa­tients who have failed an ear­ly med­ica­tion. Longer term, the hope is to find new drugs.

“This is fur­ther along than just the ba­sic re­search,” Narain said. “There could be ac­tion­able in­sights that come out of this project.”

It’s the third Big Phar­ma part­ner­ship for the com­pa­ny. They have al­so worked with As­traZeneca on Parkin­son’s Dis­ease, help­ing lead to one drug now in lead op­ti­miza­tion, Narain said, and with Sanofi on in­fluen­za and dengue fever vac­cines. They just com­plet­ed a Phase II tri­al on their in­ter­nal pan­cre­at­ic can­cer can­di­date.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Fireside chat between Hal Barron and John Carroll, UKBIO19

It’s time we talked about bio­phar­ma — live in Lon­don next week

Zoom can only go so far. And I think at this stage, we’ve all tested the limits of staying in touch — virtually. So I’m particularly happy now that we’ve revved up the travel machine to point myself to London for the first time in several years.

Whatever events we have lined up, we’ve always built in plenty of opportunities for all of us to get together and talk. For London, live, I plan to be right out front, meeting with and chatting with the small crowd of biopharma people we are hosting on October 12 at Silicon Valley Bank’s London headquarters. And there’s a lengthy mixer at the end I’m most looking forward to, with several networking openings between sessions.

Tim Miller, Forge Biologics CEO

CNS-fo­cused gene ther­a­py biotech forges man­u­fac­tur­ing deal for hear­ing loss drug

A growing gene therapy company is teaming up with one of the largest gene therapy manufacturers to get its drug into patients in clinical trials.

Myrtelle announced on Monday that it inked a deal with Forge Biologics to make Myr-201, a gene therapy indicated for monogenic hearing loss. The target patient population, Myrtelle said, is people with a type of hearing loss called DFNB8, or autosomal recessive deafness 8.

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Pfizer and BioNTech's original Marvel comic book links evolving Covid vaccine science to Avengers' evolving villain-fighting tools.(Source: Pfizer LinkedIn post)

Pfiz­er, BioN­Tech part­ner with Mar­vel for Avengers and Covid-fight­ing com­ic book

Pfizer and BioNTech are collaborating with Marvel to celebrate “everyday” people getting Covid-19 vaccines in a custom comic book.

In the “Everyday Heroes” digital comic book, an evolving Ultron, one of the Avengers’ leading villains, is defeated by Captain America, Ironman and others. The plotline and history of Ultron is explained by a grandfather who is waiting with his family at a clinic for Covid-19 vaccinations.

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Take­da to pull key hy­poparathy­roidism drug from the mar­ket af­ter years of man­u­fac­tur­ing woes

Takeda on Tuesday morning made an announcement that almost 3,000 people with the rare disease known as hypoparathyroidism were fearing.

Due to unresolved supply issues and manufacturing woes, Takeda said it will cut its losses and discontinue its hypoparathyroidism drug, known as Natpara (parathyroid hormone), halting all manufacturing of the drug by the end of 2024, but the entire inventory will be available until depleted or expired, a company spokesperson said via email.

Eli Lil­ly and Te­va pre­pare for court bat­tle over mi­graine med ri­val­ry

It looks like Eli Lilly and Teva Pharmaceuticals are going to trial.

A federal appeals court on Monday refused to invalidate three of Teva’s patents for its migraine treatment Ajovy, while also declining to issue a summary judgment in favor of either company, which would effectively end the case without a full trial.

Teva filed suit against Lilly back in 2018, alleging that the company infringed upon nine patents with its rival migraine drug Emgality. The rival drugs were both approved in September 2018 for the preventative treatment of migraine, and are designed to block calcitonin gene-related peptide (CGRP), a protein associated with the onset of migraine pain.

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Rep. Vern Buchanan (R-FL) (Bill Clark/CQ Roll Call via AP Images)

Af­ter cov­er­age re­stric­tions for Alzheimer's drugs, bi­par­ti­san House bill would force CMS to re­view drugs in­di­vid­u­al­ly

When Biogen’s controversial Alzheimer’s drug Aduhelm was hit with a national decision from CMS that restricted coverage to only randomized trials, practically guaranteeing a commercial flop in the near term, questions surfaced over why CMS also included all amyloid-targeted monoclonal antibodies for Alzheimer’s disease.

With Eisai and Biogen’s second Alzheimer’s drug, lecanemab, now showing it can slow the rate of cognitive decline versus placebo, lining up for a likely full approval next spring, the question now turns to whether that data, which is being presented at the Clinical Trials on Alzheimer’s Congress in San Francisco in late November, will be enough for CMS when it asks, “Does the anti-amyloid mAb meaningfully improve health outcomes (i.e., slow the decline of cognition and function) for patients in broad community practice?”

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FDA+ roundup: Ad­comm date set for Cy­to­ki­net­ics heart drug; New gener­ic drug guid­ance to re­duce fa­cil­i­ty de­lays

The FDA on Wednesday set Dec. 13 as the day that its Cardiovascular and Renal Drugs Advisory Committee will review Cytokinetics’ potential heart drug, meaning regulators aren’t likely to meet the Nov. 30 PDUFA date that was previously set.

The drug, known as omecamtiv mecarbil, read out its first Phase III in November 2020, hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as the key to breaking into the market, failing to significantly differ in reducing cardiovascular death from placebo.

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