Merck, Immune Design in Immuno-Oncology Pact
Immune Design has entered into clinical collaboration agreements through subsidiaries of Merck & Co. Inc., to evaluate the safety and efficacy of two Immune Design immuno-oncology investigative agents, G100 and LV305, separately combined with Merck’s Keytruda (pembrolizumab), an anti-PD-1therapy, in Phase I trials for treating 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.
Merck’s Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2. By binding to the PD-1 receptor and blocking the interaction with the receptor ligands, Keytruda releases the PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response. The drug is approved in the United States for treating unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Merck is advancing a broad clinical development program for Keytruda with more than 100 clinical trials, across more than 30 tumor types and over 16,000 patients, both as a monotherapy and in combination with other therapies.
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 toll-like receptor-4 (TLR4) agonist designed to generate a 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 I expansion trial.
G100 is a product candidate generated from the company’s Glaas discovery platform, and includes a specific formulation of glucopyranosyl lipid A, a synthetic 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 immune response against the tumor’s preexisting diverse set of antigens. LV305, generated from Immune Design's ZVex platform, is designed to activate the immune system through the in vivo generation of CTLs initially against a specific tumor-associated antigen, NY-ESO-1.
Source: Merck & Co. .