Bris­tol My­ers inks pro­tein de­grad­er deal via Cel­gene team's link to seed-stage biotech

Bris­tol My­ers Squibb is adding to its pro­tein de­grad­er line­up, which al­ready in­cludes the likes of A-Al­pha Bio and Evotec, by link­ing arms with a lit­tle-known biotech that’s been com­mu­ni­cat­ing with the sci­en­tists at Cel­gene for the past few years.

The Big Phar­ma is in­vest­ing in Syn­theX and lay­ing out a $550 mil­lion vi­sion for the Bay Area seed-stage biotech that was just “a sketch on a nap­kin” in Toron­to in 2016, co-founder and CEO Maria Solov­ey­chik told End­points News in a pre­view of the Tues­day morn­ing pact.

Maria Solov­ey­chik

Bris­tol My­ers is tap­ping in­to Syn­theX’s so-called ToRNe­DO plat­form, a whirl­wind of a name which dis­cov­ers mol­e­c­u­lar glues to serve as the bridge to new small mol­e­cule de­graders. It’s a mul­ti-tar­get deal with the to­tal po­ten­tial of $550 mil­lion be­ing the on­ly fig­ure of­fered up by Syn­theX and its Big Phar­ma col­lab­o­ra­tor. Solov­ey­chik char­ac­ter­ized the deal as “the first one that we can dis­close,” sug­gest­ing oth­er bio­phar­mas might have al­ready got­ten in the front door.

Through the Cel­gene gold­en tick­et com­pe­ti­tion, Syn­theX has known sci­en­tists at the now-ac­quired BMS com­pa­ny since at least 2018, build­ing up that re­la­tion­ship over the years to cul­mi­nate in to­day’s pact. The up­start CEO not­ed Syn­theX was talk­ing to “a cou­ple of oth­er Phar­mas” as well.

The small team, not spun out from any­where, is fo­cused on mak­ing the ear­ly-stage drug dis­cov­ery process “a bit more func­tion­al, re­duce the amount of sec­ondary screens we have to do and counter-se­lec­tions af­ter­wards,” Solov­ey­chik said. In­stead of re­ly­ing on proxy read­outs, the biotech is “putting in func­tion­al se­lec­tion as a re­quire­ment for com­pounds to come out of the screens,” she ex­plained.

Syn­theX us­es ge­net­ic en­gi­neer­ing to cre­ate the cells that give the read­outs, and the first plat­form they built does pro­tein-pro­tein in­ter­ac­tions. The plat­form of BMS fo­cus de­tects the degra­da­tion of a pro­tein us­ing spe­cif­ic E3 lig­as­es, she said, not­ing it was de­vel­oped in 2019.

Pri­or to the BMS back­ing, the biotech had been fund­ed by seed in­vestors and “a cou­ple of small­er cash in­fu­sions,” the CEO said. Bankrollers in­clude SOSV ac­cel­er­a­tor, Mor­gan No­ble Health­care Part­ners, 8VC, and Oriza Ven­tures, among oth­ers.

The com­pa­ny is about to start rais­ing a Se­ries A, which would like­ly fu­el an en­try in­to the clin­ic for its in­ter­nal pipeline, ac­cord­ing to the CEO, who not­ed sci­ence will de­ter­mine which as­set goes in­to hu­man stud­ies first.

Six ear­ly-stage pro­grams are list­ed on Syn­theX’s pipeline, in­clud­ing a KRAS as­set, the hot­ly-watched gene be­hind Am­gen’s Lumakras and its biotech com­peti­tor Mi­rati Ther­a­peu­tics.

Syn­theX wants to avoid “the sin­gle-mu­ta­tion ap­proach that’s been seen as re­al­ly promis­ing, but at the same time there’s a lot of re­sis­tance com­ing up in the clin­ic,” the CEO ex­plained, “so we’re try­ing to think through or­thog­o­nal ap­proach­es that won’t be as sus­cep­ti­ble to these types of re­sis­tance mech­a­nisms by go­ing af­ter syn­thet­ic lethals.”

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; and more

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Am­gen, years be­hind ri­vals, says PhI obe­si­ty drug shows dura­bil­i­ty signs

While NBC ran “The Biggest Loser” for 17 seasons, deemed toxic by critics for the reality show’s punishing exercise and diet upheavals, researchers in pharmaceutical labs have been attempting to create prescription drugs that induce weight loss — and one pharma betting it can require less frequent dosing is out with a new crop of data.

Amgen was relatively late to the game compared to its approved competitor Novo Nordisk and green light-approaching rival Eli Lilly. But early data suggested Amgen’s AMG 133 led to a 14.5% weight reduction in the first few months of dosing, buoying shares earlier this fall, and now the California pharma is out with its first batch of durability data showing that figure fell slightly to 11.2% about 150 days after the last dose. Amgen presented at the 20th World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease on Saturday afternoon.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Chris Kim, Liminatus Pharma CEO

A fledg­ling biotech goes SPAC route to bankroll can­cer vac­cine, CAR-T and CD47

A relatively unknown clinical-stage biotech — backed by a Korean lighting company and focused on a cancer vaccine out of a Thomas Jefferson University lab — is headed to Nasdaq via the blank check route.

Liminatus Pharma will get about $316 million in proceeds from the SPAC combination to fund its ongoing Phase IIa study of a cancer vaccine, bring a CAR-T therapy into the clinic and prep a CD47 immune checkpoint inhibitor for human trials, the company said this week.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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US month­ly costs for biosim­i­lars 'sub­stan­tial­ly high­er' than Ger­many or Switzer­land, JA­MA re­search finds

As the global biologics market is expected to hit nearly the half-trillion-dollar mark this year, new JAMA research points to the importance of timely biosimilar entry, particularly as fewer biosimilars are entering the US than in Europe, and as monthly treatment costs for biosimilars were “substantially higher” in the US compared with Germany and Switzerland.

Among the three countries, biosimilar market share at launch was highest in Germany, but increased at the fastest rate in the US, the authors from the University of Zurich’s Institute of Law wrote in JAMA Network Open today.

Kirk Myers is shown in a still image from a new film series showcasing the efforts of HIV advocates funded by Gilead.

Gilead spot­lights HIV projects and the com­mu­ni­ty lead­ers dri­ving them in new mi­ni-doc­u­men­tary films

Gilead is going behind the scenes of some of the HIV initiatives it funds through grants in a new film series narrated by the people helming the projects.

The first four films and leaders come from across the US — Arianna Lint in Florida and Puerto Rico, Cleve Jones in San Francisco, June Gipson in Mississippi and Kirk Myers in Texas. Their HIV-focused efforts range from addressing unmet needs of the transgender community to delivering social services and high-quality health care in underserved communities.

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EMA pulls an opi­oid from the 1950s used to treat dry cough

The European Medicines Agency said Friday that it’s pulling from all European markets pholcodine-containing medicines, which are an opioid used in adults and children for the treatment of dry cough and in combo with other drugs as a treatment for cold and flu.

The decision to pull the medicines comes as the EMA points to the results from the recent ALPHO study, which show that use of pholcodine during the 12 months preceding anesthesia is linked to a risk of an anaphylactic reaction related to the neuromuscular blocking agents (NMBAs) used (with an adjusted OR of 4.2, and a 95% confidence interval of 2.5 to 6.9).