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news.Immune Design has entered into partnership with the subsidiaries of Merck to evaluate the safety and efficacy of its oncology investigative agents, G100 and LV305 in combination with Merck's Keytruda (pembrolizumab) to treat patients with non-Hodgkin's lymphoma (NHL) and melanoma, respectively.
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The Phase I trials will evaluate the safety and efficacy of both investigative agents separately combined with an anti-PD-1 therapy Keytruda in these patients.
Merck’s Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
Immune Design president and CEO Dr Carlos Paya said: "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.
"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."
The first clinical trial will evaluate intratumoral administration of G100 with intravenous administration of Keytruda in patients with follicular NHL receiving local radiation.
The trial will also evaluate the response in both injected and non-injected lesions, in addition to an evaluation of the safety of the combination.
The second clinical trial in melanoma is designed to 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 has designed G100 and LV305 investigational agents to work in vivo and activate the immune system through the induction or expansion of anti-tumor CD8 T cells.
G100 is a potent toll-like receptor-4 (TLR4) agonist being developed to generate a robust anti-tumor immune response when administered directly to the tumor micro-environment.
In contrast, LV305 is being developed 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.
Merck Research Laboratories president Dr Roger Perlmutter said: "Our understanding of the immune system’s role and its impact in the treatment of cancer continues to grow.
"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."