OmRx Oncology Launches Phase 2 Trial of Oral Checkpoint Inhibitor OX-4224 for NSCLC
• OmRx Oncology launched with the goal of increasing access to cancer immunotherapy in low and middle-income countries. • OX-4224, an oral PD-1/PD-L1 inhibitor in-licensed from Gilead Sciences, will be evaluated in a Phase 2 trial for NSCLC. • The Phase 2 study will be conducted in India, focusing on patients with NSCLC who have not received prior checkpoint inhibitors. • OmRx aims to develop OX-4224 as a more affordable and accessible alternative to antibody checkpoint inhibitors.
OmRx Oncology, a new biopharmaceutical company, has launched with a Phase 2-ready asset, OX-4224, in-licensed from Gilead Sciences. The company aims to expand access to immunotherapy in countries where biologic checkpoint inhibitors are often unaffordable. The lead asset, OX-4224, is an investigational oral immune checkpoint inhibitor targeting the PD-1/PD-L1 pathway.
OmRx plans to evaluate OX-4224 for the treatment of patients with non-small cell lung cancer (NSCLC). The Phase 2 randomized, open-label study will be conducted in India to assess the safety and efficacy of OX-4224 as a second-line monotherapy in patients with metastatic NSCLC whose tumors express PD-L1 and who have not received prior immune checkpoint inhibitors.
According to Isy Goldwasser, CEO of OmRx, oral checkpoint inhibitors could offer advantages over antibodies, including eliminating the need for infusions, enabling rapid modulation of dosing in case of immune-related side effects, and reducing manufacturing costs. This approach could potentially bring immunotherapy to more people in an affordable way, reducing the worldwide cancer burden.
The company is led by a team with expertise in cancer R&D, clinical development, and corporate development, including Dr. William Lee, former Executive Vice President of Research at Gilead Sciences, who serves as Chairman. Dr. Lee highlighted the potential impact of OX-4224 in resource-constrained countries like India, provided it demonstrates projected safety and efficacy.
OX-4224 is an investigational oral small molecule that blocks the PD-1/PD-L1 immune checkpoint. 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.

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