Date: 2016-09-20
Type of information: Initiation of the trial
phase: 2a
Announcement: initiation of the trial
Company: Merck&Co (USA - NJ) BiolineRx (Israel)
Product: BL-8040 in combination with Keytruda® (pembrolizumab)
Action
mechanism: peptide/monoclonal antibody/immune checkpoint inhibitor. . BL-8040 is a short peptide that functions as a high-affinity antagonist for CXCR4, a chemokine receptor that is directly involved in tumor progression, angiogenesis (growth of new blood vessels in the tumor), metastasis (spread of the disease to other organs or organ parts) and cell survival. CXCR4 is over-expressed in more than 70% of human cancers and its expression often correlates with disease severity. BL-8040 has been shown to induce the mobilization of healthy hematopoietic stem cells from the bone marrow into the peripheral blood. BL-8040 also mobilizes cancer cells from the bone marrow and other sites and may therefore expose these cells to chemo- and bio-based anti-cancer therapy and induce apoptosis (cell death). Pre-clinical studies show that BL-8040 is efficient, both alone and in combination with the anti-cancer drug rituximab, in reducing bone marrow metastasis of lymphoma cells and stimulating lymphoma cell death. BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously developed under the name BKT-140. 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. In January 2016, BioLineRx entered into a collaboration with MSD, known as Merck in the US and Canada, to support a Phase 2 study investigating BioLineRx's BL-8040 in combination with Keytruda® in patients with metastatic pancreatic cancer.
Disease: pancreatic cancer
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: The Phase 2a study, named the COMBAT study, is an open-label, multicenter, single-arm trial designed to evaluate the safety and efficacy of the combination of BL-8040 and Keytruda® (pembrolizumab), MSD's anti-PD-1 therapy, in up to 30 subjects with metastatic pancreatic adenocarcinoma. The study is designed to evaluate the clinical response, safety and tolerability of the combination of these therapies as well as multiple pharmacodynamic parameters, including the ability to improve infiltration of T cells into the tumor and their reactivity. It is expected to take place in the US, Israel and additional territories. (NCT02907099)
Latest
news: * On September 20, 2016, BioLineRx announced the initiation of a Phase 2a trial investigating BL-8040 in combination with Keytruda® (pembrolizumab), MSD's anti-PD-1 therapy, in patients with metastatic pancreatic cancer. The Phase 2a study, named the COMBAT study, is designed to evaluate the clinical response, safety and tolerability of the combination of these therapies as well as multiple pharmacodynamic parameters, including the ability to improve infiltration of T cells into the tumor and their reactivity. The study will be conducted in the US, Israel and additional territories. * On June 28, 2016, BioLineRx announced the filing of regulatory submissions required to commence a Phase 2a trial for BL-8040 in combination with Keytruda® (pembrolizumab) for the treatment of patients with pancreatic cancer. The study is expected to commence shortly after receipt of regulatory approval, anticipated in the third quarter of 2016.
