OREANDA-NEWS. Immune Design (Nasdaq: IMDZ) today announced it has entered into clinical collaboration agreements through subsidiaries of Merck (NYSE:MRK), known as MSD outside of the United States and Canada, to evaluate the safety and efficacy of two Immune Design immuno-oncology investigative agents, G100 and LV305, separately combined with KEYTRUDA®(pembrolizumab), Merck’s anti-PD-1therapy, in Phase 1 trials in patients with non-Hodgkin’s lymphoma (NHL) and melanoma, respectively. 

The first clinical trial will examine intratumoral administration of G100 with intravenous administration of KEYTRUDA in patients with follicular NHL receiving local radiation. In addition to an evaluation of the safety of the combination, the study will assess the response in both injected and non-injected lesions. The second clinical trial in melanoma will evaluate safety and response to the combination of LV305 and KEYTRUDA in patients who have not yet responded to treatment with KEYTRUDA alone after three months of treatment.

Immune Design’s G100 and LV305 investigational agents are designed to work in vivo and activate the immune system via the induction and/or expansion of anti-tumor CD8 T cells. They are intended to be “off-the-shelf” therapies, in contrast to other T-cell approaches that require individualized ex vivo manipulation. G100 is a potent toll-like receptor-4 (TLR4) agonist designed to generate a robust anti-tumor immune response when administered directly to the tumor micro-environment. LV305, in contrast, is designed to activate the immune system through the in vivo generation of cytotoxic T cells (CTLs), initially against a specific tumor-associated antigen, NY-ESO-1. Immune Design is studying LV305 primarily as part of CMB305, a prime boost approach currently in a Phase 1 expansion trial.

“There is great potential to expand the potential of immunotherapy through combination approaches that will stimulate and enhance the immune system in order to mount the strongest response against cancer,” said Carlos Paya, M.D., Ph.D, President and Chief Executive Officer of Immune Design. “Immune Design has two distinct approaches in oncology, and we look forward to collaborating with Merck to evaluate the potential of combining each of G100 and LV305 with KEYTRUDA in these areas of medical need.”

“Our understanding of the immune system’s role and its impact in the treatment of cancer continues to grow,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “This collaboration with Immune Design adds to a broad clinical program designed to explore the role of KEYTRUDA in innovative immuno-oncology combinations – and underscores our commitment to advance the care of patients with cancer.”

G100 is a product candidate generated from the company's GLAASTM discovery platform, and includes a specific formulation of Glucopyranosyl Lipid A (GLA), a synthetic, toll-like Receptor-4 (TLR-4) agonist. G100 is part of Immune Design's intratumoral immune activation, or ‘Endogenous Antigen’ approach to treating cancer, which leverages the activation of dendritic cells, T cells and other immune cells in the tumor microenvironment to potentially create a robust immune response against the tumor's preexisting diverse set of antigens. Preclinical and clinical data have demonstrated the ability of G100 to activate dendritic cells in tumors and to increase antigen-dependent systemic humoral and cellular Th1 immune responses. In addition to the study planned under this collaboration, a Phase 1 study of G100 in patients with Merkel cell carcinoma (MCC) recently completed enrollment, and Immune Design presented data at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting, the poster for which can be accessed on the company’s website. In the first eight patients in MCC study, G100 has an acceptable safety profile and a fifty percent (50%) objective response rate per protocol.