Oncologie Announces First Patient Dosed in Global Phase 2 Trial of Bavituximab Combined with Merck’s KEYTRUDA® for Advanced Gastric and Gastroesophageal Junction Cancer

Recently, VCBeat learned that Oncologie, a global leader in combination cancer immunotherapy, announced that its investigational new drug Bavituximab, in combination with MSD’s (known as Merck in the United States and Canada) anti-PD-1 antibody KEYTRUDA^®Global clinical study of pembrolizumab combination therapy for advanced gastric cancer and gastroesophageal cancer completes enrollment of first patient.

According to reports, Bavituximab is an innovative chimeric monoclonal antibody drug that reverses phosphatidylserine (PS)-mediated immunosuppression by specifically blocking the binding of PS, exposed on the surface of stressed cells in tumors and their stroma, to various immune cell receptors (including TIM and TAM families). Through this mechanism, PS-targeting antibody drugs may help other cancer therapies, including PD-1 inhibitors, attack tumors more effectively and without restriction. A previous retrospective analysis of 90 patients enrolled in a Phase III clinical trial for lung cancer conducted abroad showed that administering Bavituximab prior to PD-1 therapy was expected to significantly improve patient survival rates. As the response rate to PD-1 monotherapy remains relatively limited, combination therapies involving PD-1 inhibitors, particularly with other immunotherapies, have become a key research focus for leading PD-1 developers both in China and internationally.

Pursuant to the previously reached agreement between Dinghang Pharma and Merck & Co., Inc. (MSD), Dinghang Pharma will conduct a single-arm, open-label global Phase 2 clinical study (registered on ClinicalTrials.gov under NCT04099641) to evaluate the efficacy of Bavituximab in combination with KEYTRUDA® for the treatment of patients with advanced gastric cancer and gastroesophageal junction cancer who have experienced failure after at least one prior first-line therapy. The study plans to enroll approximately 80 patients across the United States, the United Kingdom, South Korea, and Taiwan, China. The primary endpoints of the study will assess the antitumor activity, safety, and tolerability of the combination therapy. Secondary endpoints include evaluation of patient plasma drug concentrations and the therapeutic effect on target proteins, along with an exploratory analysis conducted using Dinghang Pharma’s proprietary RNA biomarker platform.

According to data from the "Gastric Cancer Diagnosis and Treatment Guidelines (2018 Edition)" issued by the National Health Commission of China, there are approximately 1.2 million new cases of gastric cancer globally each year, with China accounting for about 40% of these cases. Due to factors such as nonspecific early symptoms and low public awareness of screening, most domestic patients are already at an advanced stage at the time of diagnosis, resulting in an overall five-year survival rate of less than 50%. Dinghang Pharma stated that it hopes to promote the greater role of Bavituximab combination therapy in improving the treatment of gastric cancer and other prevalent refractory cancers through this clinical study on PD-1 combination therapy for gastric cancer conducted in collaboration with Merck & Co.

In June 2019, Dinghang Pharma announced the completion of an $80 million Series B financing round (approximately RMB 560 million). The round was led by DFB Life Science Capital and Nan Fung Life Sciences, with participation from Panacea Venture, Hualing Capital, Korea Investment Partners, and KB Investment. This financing amount ranked among the highest in China’s biopharmaceutical industry for the first half of the year. Currently, Dinghang Pharma is undertaking a Series B2 financing round to accelerate global clinical studies of its existing product pipeline and the development of corresponding novel biomarkers.

Dinghang Pharmaceuticals, founded in 2018, is dedicated to the discovery and development of novel drugs for combination immuno-oncology therapies, with headquarters in Boston, USA, and Shanghai, China. Leveraging the founding team’s academic expertise and extensive commercial experience, the company has built a portfolio of highly differentiated drug candidates with global intellectual property rights. Its product pipeline includes first-in-class agents with novel mechanisms of action, best-in-class drugs designed to improve upon existing therapies, and a companion diagnostic platform for cancer immunotherapy, two of which have entered clinical stages. The company is currently conducting three clinical trials simultaneously.