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news.Merck and Dynavax Technologies have entered into two clinical trial collaboration agreements to investigate the potential synergistic effect of combining immunotherapies from their respective pipelines.
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The companies will conduct clinical trials to evaluate the combination of Dynavax’s investigational toll-like receptor 9 (TLR9) agonist SD-101, with Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) and its investigational anti-interleukin-10 (anti-IL-10) immunomodulator MK-1966.
SD-101, Keytruda and MK-1966 are immunotherapies designed to improve the body’s own defenses to combat cancer.
Dynavax’s SD-101 is designed to mediate anti-tumor effects by triggering both innate and adaptive immune responses, including the induction of high levels of Type 1 interferon to stimulate recruitment of T-cells.
Keytruda works by blocking the interaction between programmed death receptor-1 (PD-1) and its ligands, PD-L1 and PD-L2, while MK-1966 is designed to neutralize the immune-suppressive environment for tumors.
A multicenter, open-label Phase Ib/II trial will be initiated in the second half of this year as part of the collaboration and it will evaluate the safety and efficacy of combining SD-101 with Keytruda in patients with advanced melanoma.
Second study under the deal will be a Phase I trial designed to assess the safety and efficacy of combining SD-101 with MK-1966 in patients with solid or hematological malignancies. It is scheduled to be started in the second half of 2015.
Merck Research Laboratories oncology early stage development therapeutic area head and vice-president Dr Eric Rubin said: "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.
"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."
The deal will see Dynavax sponsor and fund the SD-101 and Keytruda study, while Merck will sponsor and fund the SD-101 and MK-1966 study.
Dynavax CAEO Eddie Gray said: "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.
"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."