OmRx Oncology Launches Oral Checkpoint Inhibitor to Expand Global Cancer Immunotherapy Access

SAN DIEGO—OmRx Oncology, a new biopharmaceutical company backed by Scripps Research, has launched with a Phase 2 clinical asset from Gilead Sciences, Inc., aiming to widen access to immunotherapy in regions where biologic checkpoint inhibitors are often too expensive or unavailable.

The asset in question, OX-4224, is a clinical-stage oral immune checkpoint inhibitor targeting the PD-1/PD-L1 pathway. Originally discovered and developed by Gilead Sciences, OX-4224 is an investigational treatment for non-small cell lung cancer (NSCLC). OmRx plans to develop this Phase 2-ready drug to provide a more affordable and accessible alternative to traditional antibody checkpoint inhibitors like Keytruda® and Opdivo®.

OmRx is dedicated to advancing this program, initially as a monotherapy in low and middle-income countries. The company envisions eventually expanding its use globally for potential all-oral combination therapies. Scripps Research, sharing OmRx's mission to aid patients in resource-limited settings, actively supports numerous R&D initiatives focused on global health. OmRx is led by a team with extensive experience in cancer research, clinical development, entrepreneurship, and corporate growth. Among them is Dr. William Lee, Ph.D., Chairman of OmRx, who brings three decades of experience from his previous role as Executive Vice President of Research at Gilead Sciences.

According to CEO Isy Goldwasser, "Immune checkpoint inhibitor monoclonal antibodies have been a significant advancement in cancer treatment over the past twenty years. However, they are largely inaccessible to patients outside major commercial markets. Oral checkpoint inhibitors could offer critical advantages, such as eliminating the need for infusions, allowing rapid dosage adjustments in case of side effects, and reducing manufacturing costs." Goldwasser emphasized that OmRx aims to advance OX-4224 to make immunotherapy more affordable and accessible, thereby helping to reduce the global cancer burden.

OX-4224 will first be evaluated as a second-line monotherapy for patients with metastatic NSCLC whose tumors express PD-L1. A Phase 2 randomized, open-label study in India will assess the safety and efficacy of OX-4224 in NSCLC patients who have not previously received immune checkpoint inhibitors.

Dr. William Lee, Chairman of OmRx, reflected on his career, mentioning the significance of discovering a small molecule capable of blocking the PD-1/PD-L1 immune checkpoint. He expressed gratitude to the Scripps team for their shared vision and investment in OmRx, highlighting the potential impact of OX-4224 if it demonstrates the anticipated safety and efficacy, particularly in resource-constrained nations like India.

OX-4224 remains an investigational product, and any statements regarding its potential benefits and future development are subject to risks and uncertainties.

OmRx Oncology is a biopharmaceutical venture centered on OX-4224, an investigational oral checkpoint inhibitor under evaluation for treating solid tumors, including NSCLC. The company's goal is to expand access to immunotherapies in regions where cost and availability limit the use of biologics. The Phase 2 study in India will focus on the safety and efficacy of OX-4224 for patients with advanced NSCLC who have not previously received checkpoint inhibitors.

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