GS-4224

SAN DIEGO--( BUSINESS WIRE )-- OmRx Oncology , or “OmRx,” a new biopharmaceutical venture with investment from Scripps Research, launched with a Phase 2 clinical asset in-licensed from Gilead Sciences, Inc. and a vision for expanding access to immunotherapy in countries where biologic checkpoint inhibitors are often unaffordable and unavailable to patients. The clinical-stage asset, OX-4224, discovered and initially developed by Gilead Sciences, is an investigational oral immune checkpoint inhibitor that targets the PD-1/PD-L1 pathway and will be evaluated by OmRx for the treatment of patients with non-small cell lung cancer (NSCLC). OmRx in-licensed the Phase 2-ready asset and plans to develop it for patients in countries where an oral small molecule would present a more affordable, accessible, and potentially equally effective option to traditional antibody checkpoint inhibitors such as Keytruda® and Opdivo®. OmRx is wholly focused on advancing this clinical-stage program, first as a monotherapy in low and middle-income countries, and eventually, globally for potential all-oral combination therapies. OmRx’s mission to serve patients in low and middle-income countries is shared by Scripps Research, which actively supports a significant number of R&D initiatives addressing global health needs. The company is led by a high-caliber team with expertise in cancer R&D, clinical development, entrepreneurship, and corporate development. The OmRx team includes Dr. William Lee, Ph.D., who serves as Chairman and brings 30 years of experience from his tenure as the former Executive Vice President of Research at Gilead Sciences. “Immune checkpoint inhibitor monoclonal antibodies represent one of the most important treatment advances in cancer in the past two decades, but they are essentially unavailable to cancer patients outside of the major commercial markets. Oral checkpoint inhibitors, meanwhile, could have important advantages over antibodies – they would not require infusions or infusion centers, dosing and patient exposure could be rapidly modulated in the case of immune-related side effects, and they would be significantly cheaper to manufacture,” said Isy Goldwasser, CEO, OmRx. “With the launch of OmRx we can advance a promising oral checkpoint inhibitor that could bring immunotherapy to more people in an affordable way with the goal of reducing the worldwide cancer burden.” OX-4224 will initially be studied as a second-line monotherapy in patients with metastatic NSCLC whose tumors express PD-L1. The Phase 2 randomized, open-label study in India will establish safety and efficacy of OX-4224 in subjects with NSCLC who have not received immune checkpoint inhibitors. “One of the highlights of my career was overseeing the discovery of a small molecule that blocked the PD-1/PD-L1 immune checkpoint and by doing so, could impact cancer therapy globally,” said Dr. William Lee, Chairman, OmRx. “I am extremely grateful to the Scripps team for sharing this vision and investing in OmRx. If OX-4224 demonstrates the safety and efficacy projected, it will make a difference for patients everywhere, and especially in resource-constrained countries like India.” OX-4224 is an investigational product and statements regarding the potential benefits and future development of this investigational product are forward-looking and subject to risks and uncertainties. About OmRx Oncology OmRx Oncology, or “OmRx,” is a biopharmaceutical venture formed around a single clinical-stage asset, OX-4224, an investigational oral checkpoint inhibitor being evaluated for the potential treatment of solid tumors, including non-small cell lung cancer (NSCLC). OmRx’s vision is to expand access to immunotherapies in countries where biologics are the standard of care for many cancers but are inaccessible due to cost and availability. OX-4224 will be studied in India as part of a Phase 2 study to assess its safety and efficacy in patients with advanced NSCLC who have not previously taken checkpoint inhibitors. For more information visit https://omrxonc.com/ .