"– The initiated study will further evaluate the antitumor activity, safety and tolerability of bavituximab plus KEYTRUDA® in a gastric cancer population
– Oncologie’s first global study for bavituximab plans enrollment in the US, UK, Taiwan and South Korea
Boston and Shanghai, October 9th, 2019 – Oncologie, a biopharmaceutical company using an innovative precision medicine platform to develop next-generation oncology therapeutics, announced today the enrollment of the first patient in its global Phase 2 study of bavituximab in combination with Merck’s (known outside of the U.S. as MSD), anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in patients with advanced gastric or gastroesophageal cancer.
Oncologie is collaborating with MSD in this clinical study to evaluate the combination of bavituximab and KEYTRUDA in patients with advanced gastric or gastroesophageal cancer. Bavituximab is a potential first-in-class investigational monoclonal antibody designed to block phosphatidylserine (PS) activation of multiple immune cell receptors, including T-cell immunoglobulin macrophage (TIM) and tumor-associated macrophage (TAM). The rationale to support this study was based on a previously reported retrospective analysis from over 90 patients who were enrolled in a Phase 3 lung cancer study, which demonstrated activity when Bavituximab was given prior to a PD-1 inhibitor.
“Initiating our first sponsored trial is a key milestone for Oncologie as it represents and highlights the progress we’ve made this year,” said Laura E. Benjamin, PhD, President and Chief Executive Officer at Oncologie. “This Phase 2 study is intended to further evaluate the antitumor activity and safety of bavituximab plus pembrolizumab in a gastric cancer population. We look forward to evaluating the potential this combination may provide globally.”
The Phase 2, multicenter, open-label, single-arm global study will assess the safety, tolerability, and efficacy of the investigational agent bavituximab in combination with pembrolizumab, a PD-1 inhibitor, in patients with advanced gastric and gastroesophageal cancer who have progressed on or after at least one prior standard therapy. The study is expected to enroll approximately 80 patients in the United States, United Kingdom, South Korea and Taiwan. The primary endpoint of the study will assess the antitumor activity of the combination, as well as safety and tolerability. In addition, other endpoints include evaluating drug levels, the effect of treatment on target proteins, and an exploratory analysis using Oncologie’s proprietary RNA biomarker signatures.
More information about this clinical study can be found at clinicaltrials.gov under NCT04099641 .
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, as well as by sending an alternate immune activating
signal. 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.
Oncologie is a next generation, oncology therapeutics company. Oncologie leverages its unique biomarker platform to develop targeted therapies that are matched to individual tumors based on the dominant biology of the tumor microenvironment. The current pipeline is focused on mid-stage clinical programs that modify the immune system to enhance efficacy of current standards of care and emerging immunotherapy agents. Headquartered in Boston, Massachusetts and Shanghai, China, Oncologie is working with global partners to acquire and develop innovative drugs for cancer patients around the world. For more information on Oncologie, Inc., please visit WWW.ONCOLOGIE.INTERNATIONAL.".......