CBT Pharmaceuticals Receives First Australian Ethics Approval to Initiate APOLLO-1 Phase 1/2 Clinical Trial for Hepatocellular and Renal Cell Carcinoma
Pleasanton, CA, and Hangzhou, Zhejiang, China, 8 August 2018
CBT Pharmaceuticals (CBT), a U.S. and China-based innovative biopharmaceutical company committed to becoming a leader in the discovery and development of oncology combination therapies, today announced the receipt of ethics approval from the Bellberry Human Research Ethics Committee (HREC) in Australia for its planned APOLLO-1 clinical trial. HREC is an independent ethics review board compliant with strict national Health and Medical Research Council (NHMRC) guidelines for clinical trials.
“Ethics approval is an essential element of the process to initiate a clinical trial in Australia as we prepare to launch our first combination study with our proprietary c-Met inhibitor and anti PD-1 immunotherapies,” stated Sanjeev Redkar, PhD, President and Chief Executive Officer. “We are thrilled to partner with the world-leading oncologists and hepatologists in Australia who are highly experienced clinical trial investigators and share our commitment to the development of new combination approaches to treat cancer patients.”
APOLLO-1 is a Phase 1/2 open label, multi-center dose escalation and expansion study of combination immunotherapy in locally advanced or metastatic disease: CBT-101 (c-Met inhibitor) with CBT-501 (anti-PD-1) in hepatocellular carcinoma (HCC), or CBT-101 and nivolumab in renal cell carcinoma (RCC). CBT-101 is CBT’s c-Met inhibitor targeting the epithelial to mesenchymal transition (EMT) pathway, and CBT-501 is CBT’s IgG4 humanized monoclonal antibody against the Programmable Death-1 (PD-1) membrane receptor on immune cells. Nivolumab (OPDIVO®; Bristol-Myers Squibb Company) is approved for advanced kidney cancer. CBT-101 will be administered concomitantly with the PD-1 cancer immunotherapy.
“Our c-Met inhibitor may improve responses to cancer immunotherapy in settings beyond c-MET-dependent tumors by eliminating resistance in the tumor microenvironment, reactivating T-cells to kill the tumor, and sustaining that T-cell response. We look forward to initiating the trial in the next few weeks,” added Tillman Pearce, MD, Chief Medical Officer.
About CBT-501 (genolimzumab Injection)
CBT-501 is a novel IgG4 humanized monoclonal antibody against the Programmable Death-1 (PD-1) membrane receptor on immune cells. It has a comparable efficacy profile in in vitro and in vivo studies to the marketed anti-PD-1 antibodies, nivolumab and pembrolizumab, and has a favorable profile with very low antibody-dependent cell-mediated cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC) activity. In China, CBT-501 is referred to as GB226 where it is being developed by CBT partner Genor Biopharma Co., Ltd. Visit clinicaltrials.gov for additional information on the ongoing clinical trials: NCT03053466, NCT03374007, and NCT03502629.
CBT-101 Oral Capsule
CBT-101 is a novel, small molecule drug that targets the epithelial to mesenchymal transition (EMT) pathway that is dysregulated in several tumors. It is a specific inhibitor of the c-Met receptor. CBT-101 has demonstrated tumor inhibitory effect in a variety of human primary c-Met amplified gastric, hepatic, pancreatic and lung cancer xenograft animal models with c-Met fusions, mutations or amplifications. In China, CBT-101 is referred to as PLB1001 where it is being developed by CBT partner Beijing Pearl Biotechnology Co. Ltd. Visit clinicaltrials.gov for additional information on the ongoing clinical trials: NCT03175224, NCT02896231, and NCT02978261.
About CBT Pharmaceuticals, Inc.
CBT Pharmaceuticals, Inc. is an innovative biopharmaceutical company committed to becoming a global leader in the discovery and development of oncology combination therapies that harness the immune system and target specific molecular pathways to tame cancer. The company’s existing pipeline consists of five development-stage assets including three novel, humanized monoclonal antibodies that restore the body’s immune system to recognize and kill cancer cells, and two targeted therapies against uncontrolled growth signaling pathways. For more information, please contact us and follow us on Twitter @CBTpharma.