On January 17, 2017 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a pipeline of immune checkpoint antibodies and cancer vaccines, reported a clinical trial collaboration with the National Cancer Institute (NCI) (Press release, Agenus, JAN 17, 2017, View Source [SID1234517428]). 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’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. Schedule your 30 min Free 1stOncology Demo! 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 (Free ASCO Whitepaper) 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.
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Under this collaboration, Agenus will supply Prophage, Merck will provide pembrolizumab (Keytruda) and NCI and BTTC member sites will recruit patients and conduct the trial.
About Prophage
Prophage is an individualized autologous 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.
In a Phase 2 study of Prophage monotherapy, patients with ndGBM exhibited an improved progression-free and overall survival as compared to historical control with standard of care.
About KEYTRUDA (pembrolizumab)
KEYTRUDA is a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma; for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (TPS ≥50%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations and upon disease progression on or after platinum-containing chemotherapy in patients with NSCLC whose tumors express PD- L1 (TPS ≥1); and for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. KEYTRUDA is administered as an intravenous infusion every three weeks for the approved indications.
For Safety and Prescribing Information for KEYTRUDA (pembrolizumab), please see View Source