Paul Chap­lin, Bavar­i­an Nordic

Bris­tol-My­ers Squibb is ready to launch its sec­ond com­bi­na­tion tri­al us­ing Bavar­i­an Nordic’s can­cer vac­cine Prost­vac.

Op­er­at­ing un­der a 2015 deal worth up to about a bil­lion dol­lars, in­ves­ti­ga­tors will com­bine Prost­vac with Yer­voy and Op­di­vo in 10 pa­tients with cas­tra­tion-re­sis­tant prostate can­cer. Then they’ll push en­roll­ment to 55 and divvy up the pa­tients in­to three co­horts, study­ing T cell in­fil­tra­tion in tu­mors with one-on-one com­bos or the triple.

The first tri­al in the part­ner­ship was be­gun last fall, test­ing a com­bi­na­tion of Prost­vac and Yer­voy in ear­ly prostate can­cer.

The the­o­ry here is sim­ple enough. Bris­tol-My­ers check­point drugs are de­signed to take the brakes off an im­mune sys­tem at­tack on can­cer cells while Prost­vac is de­signed to hit the gas. Can­cer vac­cines have proven to be large­ly too mild to gen­er­ate much of a clin­i­cal re­sponse in pa­tients, but re­searchers have the­o­rized that an en­hanced at­tack with check­point drugs could pro­vide a sig­nif­i­cant ben­e­fit.

The step for­ward in the pact is a plus for Bavar­i­an Nordic, which had to scrap plans for an IPO while fend­ing off an open short at­tack by Ker­ris­dale Cap­i­tal, which ridiculed Prost­vac and claimed that the Phase II da­ta it had tout­ed was large­ly an il­lu­sion due to a strik­ing­ly bad place­bo re­sponse.

We’ll know more lat­er this year when Bavar­i­an Nordic re­leas­es top-line da­ta from its Phase III prostate can­cer study.

The move al­so un­der­scores that Bris­tol-My­ers’ com­mit­ment to its check­point pro­gram, led by the CT­LA-4 and PD-1 drugs, re­mains as strong as ever as the com­pa­ny looks to get its groove back fol­low­ing a bit­ter set­back on non-small cell lung can­cer, which saw its ri­vals at Mer­ck leapfrog ahead with Keytru­da.

All the key check­point play­ers, in­clud­ing Genen­tech and Pfiz­er/Mer­ck KGaA, have been bar­rel­ing ahead with hun­dreds of com­bi­na­tion stud­ies, look­ing to grab the lead in var­i­ous niche can­cer mar­kets. That’s a multi­bil­lion-dol­lar op­por­tu­ni­ty no one wants to lose.

“There are now eleven on­go­ing stud­ies of Prost­vac across var­i­ous stages of prostate can­cer. In re­cent years, there has been a grow­ing in­ter­est in the eval­u­a­tion of the im­munother­a­py can­di­date in ear­li­er dis­ease stages, where the can­cer has not yet spread be­yond the prostate. We are ex­cit­ed to learn more about the po­ten­tial of Prost­vac for treat­ing this pop­u­la­tion, and to eval­u­ate the po­ten­tial syn­er­gis­tic ef­fects of com­bin­ing the vac­cine with check­point in­hibitors, as we be­lieve Prost­vac may en­hance the clin­i­cal ac­tiv­i­ty of these drugs,” said Paul Chap­lin, Pres­i­dent & Chief Ex­ec­u­tive Of­fi­cer of Bavar­i­an Nordic.

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.

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.

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.