On November 26, 2018 CBT Pharmaceuticals (CBT) and Zhejiang Bossan Pharmaceutical Co., Ltd (Bossan) reported that they have entered into a clinical collaboration and license agreement to develop their respective assets in combination with each another (Press release, CBT Pharmaceuticals, NOV 26, 2018, View Source [SID1234531604]). The license agreement grants CBT exclusive, worldwide rights outside of Greater China to develop and commercialize ES-072, Bossan’s novel epidermal growth factor receptor (EGFR) inhibitor, in combination with CBT’s proprietary c-Met inhibitor (CBT-101) and anti-PD1 antibody (CBT-501).

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"CBT and Bossan share the desire to pool our respective development compounds on an exclusive, worldwide basis to develop safe and efficacious regimens that may lead to approval for the treatment of a variety of cancers," said Guo-Liang Yu, PhD, CBT Global Chief Executive Officer and Venture Partner, OrbiMed. "As demonstrated by our commitment to evaluate combination therapy with the recent announcement of our APOLLO program, we continue to investigate our assets in combination with other plausible agents with sound mechanistic and scientific rationale, potentially yielding promising results in the clinic."

"Bossan is committed to reinforcing the foundation of lifesaving breakthroughs with new ideas. CBT’s assets have shown promising preclinical and early stage clinical data, and we believe that the synergy of our combined assets may lead to improved outcomes for solid tumor cancer patients," added Bossan Chief Executive Officer, Dr. Hongguang Xia.

CBT and Bossan intend to jointly develop a collaboration product and conduct joint clinical trials of CBT’s c-Met inhibitor (CBT-101), and/or anti-PD1 antibody (CBT-501), in combination with Bossan’s EGFR inhibitor (ES-072). Under the terms of the agreement, CBT will be responsible for conducting clinical trials globally outside of Greater China. Both a Joint Steering Committee and Joint Clinical Development Subcommittee will be formed to oversee and coordinate research, development, manufacturing, regulatory and commercial activities.

About ES-072

ES-072 is a covalent, irreversible, mutant-selective EGFR inhibitor that has nanomolar inhibitory potency against EGFR (L858R, ex19del) and EGFR T790M. Pre-clinical data suggests that ES-072 is able to cross the blood brain barrier. ES-072 is currently in an ongoing Phase 1 clinical trial for non-small cell lung cancer (NSCLC) patients with mutant EGFR in China.

About CBT-101

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’s partner Beijing Pearl Biotechnology Co. Ltd. Visit clinicaltrials.gov for additional information on the ongoing clinical trials: Combination NCT03655613; Single Agent NCT03175224, NCT02896231, and NCT02978261.

About CBT-501

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, NCT03502629, NCT03623581, and NCT03639181