Data demonstrates comparable or improved anti-tumor activity over marketed PD-1 antibody in preclinical model of colon cancer

A Phase 1 study of genolimzumab (CBT-501) in patients with select advanced relapsed/recurrent solid tumors to be initiated in 1H 2017

Santa Clara, CA – February 23, 2017 – CBT Pharmaceuticals, Inc. (CBT), a life sciences company focused on developing innovative oncology therapeutics, presented 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. The data were presented in a poster at the American Society of Clinical Oncology (ASCO) – Society for Immunotherapy of Cancer (SITC) 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.

“The strong in-vivo preclinical data suggest that CBT-501 may have clinical benefit in a variety of tumor types,” said Sanjeev Redkar, PhD, 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.”

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.

About CBT Pharmaceuticals

CBT Pharmaceuticals is a life sciences company developing innovative oncology therapeutics targeting the growth and proliferation of cancer cells. The company is advancing a pipeline of four development-stage assets including CBT-101, an oral c-Met inhibitor targeting the epithelial-mesenchymal transition (EMT) pathway in cancers and CBT-501, a novel humanized monoclonal antibody targeting the Programmed Death-1 (PD-1) membrane receptor of immune cells, as well as two investigational products – a preclinical multi-targeted kinase inhibitor that targets uncontrolled growth signaling pathways and a novel humanized Programmed Death Ligand-1 (PD-L1) antibody that restores the body’s immune system to recognize and kill cancer cells. CBT is headquartered in California and has an Australian subsidiary, CBT Pharmaceuticals (Australia) Pty Ltd to manage all trials conducted in Australia. For additional information, please visit: www.cbtpharma.com

Contact:

Cammy Duong
MacDougall Biomedical Communications
+1 781-591-3443
[email protected]
Contact CBT Pharmaceuticals, Inc.