OxOnc Development is a virtual oncology development company formed in 2012 by experienced pharmaceutical and clinical development executives who previously held leadership positions at GSK, Sanofi and Quintiles. The company’s drug development model is based on the expertise and core competencies of the OxOnc Development team to optimally design and execute clinical trials in oncology.
The OxOnc business model is an integration of scientific, clinical, operational and financial resources, and provides a clear value-add proposition to our co-development partner, Pfizer Inc., by providing a P&L-sparing mechanism to fund R&D efforts, externally. The model also allows parallel development in regions outside of the U.S. and EU, or for certain tumor types that are prevalent in a particular ethnic group.
OxOnc is funded by Orbimed Advisors, a leading life sciences venture capital group with $15 billion under management.
In 2013, OxOnc entered into a co-development agreement with Pfizer Inc., to conduct a pivotal, open-label, single arm Phase 2 clinical trial of Pfizer’s crizotinib, marketed under the trademark Xalkori®, for the treatment of patients with advanced non-small cell lung cancer (NSCLC) harboring a ROS1 (c-ros) gene rearrangement (ROS1-positive). On June 3, 2016, OxOnc announced that the study (Study OO-1201) met its primary objective of demonstrating a high overall response rate for crizotinib. A total of 127 ROS1-positive patients from the People’s Republic of China (PRC), Japan, Taiwan and South Korea were enrolled and the study, which represented the largest ROS1-positive NSCLC cohort reported to date. Data confirmed the clinical benefit of crizotinib in this patient population, showing an objective response rate of 69% (95% CI, 61-77) by an independent radiology review. Moreover, the safety profile of crizotinib in patients with ROS1-positive NSCLC was consistent with the known overall crizotinib safety profile. The study is scheduled to be presented as a Poster Discussion at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago on Saturday, June 4, 2016.