Date: 2017-01-17
Type of information: Clinical research agreement
Compound: Prophage™ (HSPPC-96) and pembrolizumab (Keytruda®)
Company: Agenus (USA - MA) Merck&Co (USA - NY) National Cancer Institute (USA)
Therapeutic area: Cancer - Oncology
Type agreement: clinical research
Action mechanism: monoclonal antibody/immune checkpoint inhibitor/immunotherapy product. Keytruda® (pembrolizumab - MK-3475) is an investigational, highly selective monoclonal anti-PD-1 antibody designed to restore the natural ability of the immune system to recognize and target cancer cells by selectively achieving dual ligand blockade (PD-L1 and PD-L2) of the PD-1 protein. By blocking PD-1, MK-3475 enables activation of the immune system’s T-cells that target cancer by essentially releasing a brake on the immune system. Pembrolizumab is being evaluated across more than 30 types of cancers, as monotherapy and in combination.Keytruda® is the first approved drug that blocks the PD-1 cellular pathway. Prophage is an autologous cancer vaccine candidate derived from proteins extracted from the patient's tumor. The vaccine candidate consists of heat shock protein peptide complexes that include the chaperone gp-96 (HSPPC-96) naturally bound to tumor protein fragments. Administration of HSPPC-96 bearing the precise antigenic fingerprint of the patient's particular cancer represents an effective immune education strategy that enhances recognition of a tumor as 'non-self' leading to a potent anti-tumor immune response.
Disease: newly diagnosed glioblastoma
Details: * On January 17, 2017, Agenus announced a clinical trial collaboration with the National Cancer Institute (NCI). The double-blind, randomized controlled Phase 2 trial will evaluate the effect of Agenus' personalized autologous vaccine candidate, Prophage™ (HSPPC-96), in conjunction with Merck&co's pembrolizumab on the overall survival rate of patients with newly diagnosed glioblastoma (ndGBM). The trial will be conducted by the Brain Tumor Trials Collaborative (BTTC), a consortium of top academic centers led by Dr. Mark Gilbert, Chief of the Neuro-Oncology Branch at the NCI Center for Cancer Research. The trial aims to assess the efficacy of PD-1 targeted checkpoint blockade in combination with a heat-shock protein based vaccine candidate in an indication in which this vaccine has shown improved progression-free survival, as presented at ASCO 2015. It is a two-arm trial with one arm receiving pembrolizumab as a monotherapy and a second arm receiving both Prophage and pembrolizumab in combination. Forty-five patients will be randomly assigned to each arm.
Under this collaboration, Agenus will supply Prophage™, Merck&Co will provide pembrolizumab (Keytruda®) and NCI and BTTC member sites will recruit patients and conduct the trial.
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