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.

One Response

  1. Does anybody know what the following news really means in practical terms? I ask because my wife has stage IV lung cancer, and we’re hoping for approval sometime soon. I THINK it means, since Opdivo is already approved for use, and it can legally be used off label, this NCCN guideline thing means it’s no longer experimental and it will be covered by Medicare and many insurance companies. But the guidelines are behind a paywall, and I can’t verify.

    begin quote…………

    In a report published Monday, Morgan Stanley analyst David Risinger and his team reiterated an Overweight rating on Bristol-Myers Squibb Co (NYSE: BMY) after the National Comprehensive Cancer Network (NCCN) updated its guidelines for the treatment of Non-Small Cell Lung Cancer (NSCLC) to include Opdivo in second-line non-squamous and squamous NSCLC.

    According to the analysts, this is significant news because the company “has not yet filed with the FDA for non-squamous approval.” Even further, the NCCN said it “does not recommend testing for PD-L1, because many patients with metastatic NSCLC benefit from [Opdivo].”

    ………….end quote

    Source –

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