Protocols

Moderna kicks off mRNA cancer vaccine study; Biotech stocks were checked this month — but that’s a good thing

Moderna has kicked off its Phase I study for a personalized cancer vaccine, with the first dose in patients announced today. The messenger RNA-based vaccine, named mRNA-4157, accounts for 20 patient-specific mutations and is to be tested both on its own (for resected solid tumors) and in combination with Merck’s Keytruda (for unresectable solid tumors). “Having now successfully designed, manufactured and dosed a completely customized personalized cancer vaccine, we look forward to progressing the Phase I clinical study and gathering important human data on mRNA-4157 in the months ahead,” said CMO Tal Zaks in a statement. The biotech unicorn plans to enroll up to 90 patients in the trial, dubbed KEYNOTE-603. In a young field that combines two of the hottest concepts, where Eli Lilly is now also a player, the results will likely have important implications.

→ The Medicines Company $MDCO has brought Pfizer vet Geno Germano onto its board. Germano most recently was president of Intrexon but left after a short stint. Chairman Fredric Eshelman, meanwhile, is being bumped up to executive chairman.

→ Disappointing quarterly earnings reported by mega-cap biotechs (think Gilead and Celgene) have translated to a stock market correction, CNBC observes, but for some analysts this presents a perfect opportunity to buy. While Tuesday the IBB slid below its 200-day intraday moving average for the first time since May, Washington Crossing Advisor’s Chad Morganlander argued it actually “creates a window of opportunity,” as the health care industry as a whole has promising prospects, and “the regulatory issues, as well as government concerns, are going to be a passing issue.” Others looked to biotech’s plunge two years ago for comparison and said this year, biotech stocks will do just fine.

→ In a quest to expand the list of indications for its flagship drug Jakafi (ruxolitinib), Incyte $INCY announced today that it has treated the first essential thrombocythemia patient in a clinical trial. The goal is to compare ruxolitinib against anagrelide as a treatment for those with the rare, chronic blood cancer who are also intolerant of or resistant to hydroxyurea. 120 patients are expected to enroll in the pivotal RESET study, which adopts the proportion of patients achieving platelet and white blood cell control over 1 year of follow-up as its primary endpoint. With IDO1 drug epacadostat also in the pipeline, Incyte will stay busy.



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