Cel­gene rolls along with an­oth­er epi­ge­net­ic pre­clin­i­cal deal fea­tur­ing a Cana­di­an biotech

In an­oth­er de­c­la­ra­tion of its on­go­ing com­mit­ment to deal­mak­ing, Cel­gene is turn­ing to long­time part­ners at Triphase Ac­cel­er­a­tor for its lat­est pre­clin­i­cal as­set.

The area in fo­cus this time? Epi­ge­net­ics.

Specif­i­cal­ly, the drug that Cel­gene has just paid $40 mil­lion for tar­gets the WDR5 pro­tein, which is deemed crit­i­cal for the for­ma­tion and DNA-reg­u­lat­ing ac­tiv­i­ties of MLL1-as­so­ci­at­ed methy­la­tion com­plex­es. They be­lieve it’s a first-in-class can­di­date hold­ing promise in a range of blood can­cers, in­clud­ing acute lym­phoblas­tic leukemia and acute myeloid leukemia.

It’s an op­tion deal — Cel­gene’s fa­vorite type — that gives the Big Biotech the choice to ac­quire the drug af­ter Phase II proof-of-con­cept. That would un­lock $940 mil­lion in po­ten­tial de­vel­op­ment, reg­u­la­to­ry and sales mile­stones for Triphase Ac­cel­er­a­tor.

Since Bris­tol-My­ers Squibb an­nounced its $74 bil­lion buy­out deal for Cel­gene at the be­gin­ning of the year, it’s trig­gered wide­spread fears that one of the most pro­lif­ic BD teams in the in­dus­try will be side­lined. Ranked among the top 10 ven­ture in­vestors for can­cer R&D and top 50 for all ther­a­peu­tic ar­eas, Cel­gene is known among small­er play­ers for pay­ing top dol­lars for re­search it’s ex­cit­ed about. So far it’s shown no sign of flag­ging yet, sign­ing on­to im­muno-on­col­o­gy part­ner­ships with Kyn Ther­a­peu­tics and Ob­sid­i­an Ther­a­peu­tics just days ago.

Ri­ma Al Awar

A spin­out of the On­tario In­sti­tute for Can­cer Re­search, Triphase be­gan its strate­gic re­la­tion­ship with Cel­gene short­ly af­ter its launch in 2010, which en­ti­tled Cel­gene to rights of first re­fusal and first ne­go­ti­a­tion to a hand­ful of prod­ucts in its pipeline.

That re­la­tion­ship was like­ly a key fac­tor for FAC­IT — the On­tario-based or­ga­ni­za­tion which first launched a start­up dubbed Pro­pel­lon to take the WDR5 drug from Ri­ma Al-awar’s drug dis­cov­ery team at OICR in­to com­mer­cial­iza­tion — in its de­ci­sion to trans­fer the as­set to Triphase for fur­ther de­vel­op­ment. The drug is now known as TRPH-395.

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.

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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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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Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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Bet­ter Ther­a­peu­tics cuts 35% of staff while await­ing dig­i­tal ther­a­peu­tic ap­proval

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.

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.

Zhi Hong, Brii Biosciences CEO

Brii Bio­sciences stops man­u­fac­tur­ing Covid-19 an­ti­body com­bo, plans to with­draw EUA re­quest

Brii Biosciences said it will stop manufacturing its Covid-19 antibody combination, sold in China, and is working to withdraw its emergency use authorization request in the US, which it started in October 2021.

The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

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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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