Tuesday, March 31, 2015

BMS's Opdivo® Is Still In Front, But This Is Keytruda® Good News

Merck today announced that it will conduct more Phase 1b (i.e., early) studies with another oncology agent in development at Syndax. Financial terms were not disclosed, but this is a nice validation for Arlene Morris, the CEO of Syndax. She continues to embellish her "street cred" here. And Merck can certainly use the help, too. BMS is the one to catch (nivolumab, branded as Opdivo®), in this space -- as I've said for well over 18 months.

From Xconomy Boston, this morning -- a bit (do go read it all):

. . . .Syndax Pharmaceuticals sidestepped an IPO a few months back when it found its cancer drug, entinostat, might have a benefit it didn’t originally anticipate. Now the Waltham, MA-based company is putting that thesis to the test through a deal with Merck.

The two companies announced this morning that they’ll run a Phase 1b/2 clinical trial testing Syndax’s entinostat with Merck’s so-called “checkpoint inhibitor” cancer drug, pembrolizumab (Keytruda), in patients with either advanced non-small cell lung cancer or melanoma. Financial terms weren’t disclosed, but Merck and Syndax will start enrolling patients in the second half of the year. They could also exercise an option to extend the pact to a Phase 3 study if all goes well. . . .

Syndax. . . won a breakthrough therapy designation from the FDA for entinostat in breast cancer — but another opportunity unexpectedly opened up too. A preclinical study published in the Proceedings of the National Academy of Sciences last year showed that entinostat might boost the effectiveness of two types of checkpoint drugs—PD-1 and CTLA-4 blockers, which help the immune system recognize tumors. PD-1 inhibitors (like Merck’s pembrolizumab) and CTLA-4 blockers (such as Bristol-Myers Squibb’s ipilimumab (Yervoy)) are among the first in a new wave of cancer treatments that harness the immune system, rather than just nuke tumors and healthy tissue like chemotherapy. . . .

So -- as ever, we shall see. But a Phase 3 study is a good $100 million to $250 million away from today's spend. Still it is good news. Onward, to tomorrow, one and all. [And just for fun, given yesterday's post -- I am certain that the Governor of Indiana will be true to his word, and let these churches of cannabis worship without interference. Aren't you equally sure of it? Irony. That's for me -- irony!]

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