On February 23, 2017 CBT Pharmaceuticals, Inc. (CBT), a life sciences company focused on developing innovative oncology therapeutics, reported preclinical data demonstrating the efficacy of its Programmed Death-1 (PD-1) antibody, CBT-501 (genolimzumab, GB-226), in stimulating various immune cells, generating anti-tumor immunity, and suppressing tumor growth and delaying tumor progression in a preclinical model of colon cancer (Press release, CBT Pharmaceuticals, FEB 23, 2017, View Source [SID1234517818]). The data were presented in a poster at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) – Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Clinical Immuno-Oncology Symposium being held from February 23 – 25, 2017 in Orlando, Florida. The symposium is focused on the latest clinical and translational research in immuno-oncology and the implications for clinical care. Schedule your 30 min Free 1stOncology Demo! "The strong in-vivo preclinical data suggest that CBT-501 may have clinical benefit in a variety of tumor types," said Sanjeev Redkar, Ph.D., Chief Executive Officer and President at CBT Pharmaceuticals. "CBT-501’s novel epitope, with overlapping yet distinct regions compared to incumbent PD-1 inhibitors, may offer a point of differentiation in the clinical setting."
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Presentation Highlights:
CBT-501 efficiently inhibited binding of PD-L1/L2 to PD-1 through competitive action.
CBT-501 enhanced human T-cell activation, as shown by increased release of IL-2 and INF-gamma.
In a humanized preclinical model expressing human PD-1 and implanted with a colon adenocarcinoma (MC38) cell line, CBT-501 significantly inhibited tumor growth in a dose-dependent manner that was comparable or improved over nivolumab.
"These studies support our commitment to advancing the clinical development of genolimzumab (CBT-501) as an immuno-oncology therapy for many types of cancer. Based on these findings, a Phase 1 dose escalation and dose and disease expansion study will be initiated in the first half of 2017," said Gavin Choy, Pharm.D., Chief Operating Officer at CBT Pharmaceuticals.
Genolimzumab Injection (CBT-501)
CBT-501 is a novel humanized IgG4 monoclonal antibody targeting the Programmed Death-1 (PD-1) membrane receptor on T lymphocytes and other cells of the immune system. CBT-501 has a comparable efficacy profile in in vitro and in vivo studies to marketed anti-PD-1 antibodies and has a superior safety profile with very low undesirable antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) activity. The antibody (GB226) has been developed by Genor BioPharma Co. Ltd., a Walvax Company, who owns development and commercialization rights in China. CBT Pharmaceuticals, Inc. retains rest of the world (ROW) rights. An investigational new drug application has been approved by the China Food and Drug Administration (CFDA), and a phase 1 trial will be initiated in China by Genor.