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.

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.

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.