Oncologie, Merck to Evaluate Bavituximab in Combination with KEYTRUDA for Gastroesophageal Cancer

Oncologie has entered into a clinical collaboration agreement with Merck to evaluate the combination of Oncologie's investigational drug Bavituximab, an antibody that blocks the activity of phosphatidylserine (PS), and Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with advanced gastric or gastroesophageal cancer.

Under the terms of the agreement, Oncologie will conduct a Phase 2 single arm open-label study to determine the efficacy and safety of Bavituximab in combination with KEYTRUDA in patients who have advanced gastric and gastroesophageal cancer, after they have failed at least one line of treatment. The study is expected to enroll approximately 80 patients in the U.S., United Kingdom, Korea and Taiwan, China. The study is anticipated to start enrollment in the second half of 2019.

"Gastric cancer is an area of significant unmet medical need in many parts of the world and we are committed to understanding the clinical benefit of Bavituximab and KEYTRUDA in this difficult-to-treat cancer," said Laura Benjamin, Ph.D., Founder and CEO of Oncologie. "This collaboration reflects a shared commitment to the goal of improving the lives of cancer patients in meaningful ways."

Bavituximab is an investigational chimeric monoclonal antibody that targets the activity of phosphatidylserine (PS). Bavituximab is believed to reverse PS-mediated immunosuppression by blocking the engagement of PS with its receptors. PS-targeting antibodies have been shown to shift the functions of immune cells in tumors, resulting in multiple signs of immune activation and anti-tumor immune responses. This mechanism may play an important role in allowing other cancer therapies to more effectively attack tumors by reversing the immunosuppression that limits the impact of those treatments. Importantly, Bavituximab has also demonstrated a manageable safety and tolerability profile in previous clinical trials conducted to date, which may allow it to be combined effectively with other agents.

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