Merck and Dynavax have launched a partnership to investigate the combination of immuno-oncology therapies.
The firms will study the effect of combining Merck's anti-PD-1 therapy Keytruda (pembrolizumab), and its investigational anti-interleukin-10 (anti-IL-10) immunomodulator, MK-1966, with Dynavax’s investigational toll-like receptor 9 (TLR9) agonist, SD-101.
Keytruda, SD-101 and MK-1966 are designed to combat cancer by boosting the immune system's ability to target and destroy tumours.
SD-101 mediates anti-tumour effects by triggering both innate and adaptive immune responses, including the induction of high levels of Type 1 interferon to stimulate the recruitment of T-cells.
Keytruda is a humanized monoclonal antibody, which works by blocking the interaction between programmed death receptor-1 (PD-1) and its ligands, PD-L1 and PD-L2. MK-1966 is an investigational anti-IL-10 immunomodulator designed to neutralise the immune-suppressive environment for tumours.
A Phase 1b/2, multicentre, open-label study will be carried out to evaluate the safety and efficacy of combining SD-101 with Keytruda in patients with advanced melanoma.
Additionally, a Phase 1 study will evaluate the safety and efficacy of combining SD-101 with MK-1966 in patients with solid or hematological malignancies. Both of these studies are expected to begin in the second half of 2015.
Under the terms of the deal, Dynavax will sponsor and fund the SD-101 and Keytruda study, while Merck will sponsor and fund the SD-101 and MK-1966 study. Provisions have been included to extend either collaboration to include a Phase 3 clinical trial.
"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 of oncology early stage development at 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."