Oncologie and MSD Announce Clinical Collaboration to Evaluate Bavituximab in Combination with KEYTRUDA® for Advanced Gastric or Gastroesophageal Junction Cancer

On August 13, 2019, VCBeat (WeChat ID: vcbeat) learned from foreign media that biotechnology company Oncologie announced a clinical trial collaboration agreement with MSD to evaluate the efficacy and safety of a combination therapy consisting of its investigational anti-phosphatidylserine (PS) antibody Bavituximab and MSD’s anti-PD-1 therapy Keytruda for the treatment of advanced gastric cancer or gastroesophageal junction cancer.

Pursuant to the terms of the agreement, Dinghang Pharma will conduct a single-arm, open-label Phase II clinical trial to evaluate the efficacy and safety of this oncology combination therapy in patients with advanced gastric cancer and gastroesophageal junction (GEJ) cancer who have experienced failure of at least one prior line of therapy. The clinical study is scheduled to enroll approximately 80 eligible patients in the United States, the United Kingdom, South Korea, and Taiwan, China, in the second half of 2019.

Bavituximab is a chimeric monoclonal antibody targeting phosphatidylserine (PS). PS is a phospholipid exposed on the surface of stressed cells within tumors and their stroma. Bavituximab blocks the binding of PS to various immune cell receptors, including TIM and TAM families, thereby reversing PS-mediated immunosuppression. Studies have demonstrated that antibodies targeting PS can modulate the function of immune cells in the tumor microenvironment, eliciting diverse immune activation and antitumor immune responses.

This mechanism also enables other anticancer therapies to attack tumors more effectively and without restriction. Importantly, Bavituximab has demonstrated a manageable safety profile and tolerability in clinical trials completed to date.

Keytruda is a PD-1 monoclonal antibody developed and manufactured by Merck Sharp & Dohme (MSD) in the United States. This PD-1 inhibitor blocks the binding of the PD-1 receptor on the surface of T cells to its ligands, thereby activating T cells and enabling them to attack tumors. Keytruda was approved by the U.S. FDA in 2014 for the treatment of advanced, unresectable, and drug-resistant melanoma, and its indications for other cancers have been expanding year by year.

“Gastric cancer represents a significant unmet medical need in many regions worldwide, and we are committed to understanding the clinical benefits of Bavituximab and KEYTRUDA in this hard-to-treat cancer,” said Dr. Laura Benjamin, Founder and CEO of Dinghang Pharma.

Dinghang Pharma, founded in 2018 and headquartered in Boston, USA, is a global leader in innovative drugs focused on cancer immunotherapy. The company is dedicated to discovering and developing novel agents for combination cancer immunotherapies. Leveraging the founding team’s academic expertise and extensive commercial experience, Dinghang Pharma has built a portfolio of new drug candidates with global intellectual property rights and high differentiation.

Dinghang Pharma’s product candidates include first-in-class drugs with novel mechanisms of action, best-in-class drugs that offer improvements over existing therapies, and a companion diagnostics platform for cancer immunotherapy. The company currently has three clinical-stage products, primarily covering multiple solid tumor indications such as liver cancer, gastric cancer, lung cancer, and melanoma.

Merck & Co., Inc., founded in 1891 and headquartered in Whitehouse Station, New Jersey, USA, is one of the world’s largest pharmaceutical companies and a globally recognized leader in healthcare. The company primarily focuses on innovative pharmaceuticals, life sciences, and advanced functional materials technologies.

MSD has always been driven by technology to create value for patients and customers. MSD’s business is primarily divided into four divisions: the Merck Serono division, the Consumer Healthcare division, the MilliporeSigma division, and the Performance Materials division.

(Compiled by Cheng Tao)