Tuesday, June 2, 2015

The Merck - Dynavax Phase I/II Immuno-Oncology Candidate Deal: Thanks To Commenter "ASD"!

This is an important validation for the Dynavax SD-101 strategy, and approach. Merck will collaborate (additional financial details withheld) in trials of pembrolizumab with SD-101, as a combination therapy -- assuming safety is established in the first set-to, of these trials.

Indeed, as has been true for decades in the life sciences -- a sure sign of a cresting new wave, in any therapy, is a welter of otherwise siloed competitors, throwing in together -- to test combinations. This is that moment in a wide swath of oncology therapies. So, buckle-up, buttercup -- a lot of news will be coming out of Bristol Myers Squibb, Roche and Kenilworth in the coming two years. Here is a bit of the press release -- to which commenter ASD pointed so kindly, this early morning:

. . . ."The collaboration with Dynavax is rooted in Merck’s commitment to advancing breakthrough science in the field of immuno-oncology in order to address the complex interplay between the immune system and cancer," said Dr. Eric Rubin, vice president and therapeutic area head, oncology early stage development, Merck Research Laboratories. "We are pleased that this latest collaboration not only investigates the potential of KEYTRUDA as a combination therapy, but also includes our new immunomodulator candidate, MK-1966."

"Our interest in working with Merck on these clinical collaborations was propelled by the synergistic activity we have seen when SD-101 is combined with checkpoint inhibitors in preclinical models," said Eddie Gray, chief executive officer of Dynavax. "These collaborations with Merck will facilitate our objective to demonstrate SD-101’s potential to complement multiple therapeutic modalities and thereby provide benefit to patients."

Under the terms of the agreement, Dynavax will sponsor and fund the SD-101 and KEYTRUDA study. Merck will sponsor and fund the SD-101 and MK-1966 study. The agreements include provisions where the parties may agree to extend either collaboration to include a Phase 3 clinical trial. Additional details of the agreements between Dynavax and Merck, through a subsidiary, were not disclosed. . . .

We will keep a close eye on this one. The Dynavax management team has uniformly outstanding pedigrees, here. The day gig has me feeling just a bit exhausted this late afternoon, and so, I will likely fall silent a while now. As ever, though -- new life. . . fertile, fresh and true, will return here, and return soon -- whew.

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