On May 8, 2025 OmRx Oncology, or "OmRx," a clinical-stage biopharmaceutical venture dedicated to expanding access to cancer immunotherapy worldwide, reported the initiation of a Phase 2 clinical trial of its investigational oral PD-L1 inhibitor, OX-4224, in patients with non-small cell lung cancer (NSCLC) (Press release, OmRx Oncology, MAY 8, 2025, View Source [SID1234652788]).
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OX-4224 is an investigational oral small molecule that targets the PD-1/PD-L1 immune checkpoint pathway and offers a potentially more accessible and cost-effective option compared to existing antibody-based therapies.
The open-label, randomized, Phase 2 study will enroll approximately 50 patients with metastatic NSCLC whose tumors express PD-L1 and who have not previously received immune checkpoint inhibitors, with a focus on India. The trial will assess OX-4224 as a second line monotherapy, evaluating overall response rate in addition to safety and other secondary efficacy endpoints.
"Launching this clinical trial is a key step toward fulfilling OmRx’s mission of addressing global health disparities in cancer treatment," said Isy Goldwasser, CEO, OmRx. "Checkpoint inhibitor antibodies have revolutionized cancer care in high-income countries, but remain largely inaccessible to many patients globally. With OX-4224, we have the opportunity to bring the benefits of immunotherapy to many more people."
OmRx is developing OX-4224 initially for low and middle-income countries (LMICs), where biologics are often inaccessible due to high cost and distribution challenges. OX-4224’s oral formulation removes the need for infusion centers, allows flexible dosing schedules, and offers a more scalable manufacturing model.
"This trial brings us closer to realizing a long-held vision—to offer effective, affordable, and easier-to-administer immunotherapies to the patients who need them most," said Dr. William Lee, Chairman of OmRx and former EVP of Research at Gilead Sciences. "If OX-4224 demonstrates safety and efficacy in the upcoming NSCLC study, it would provide development opportunity to meaningfully change the standard of care for patients in resource-limited settings."
In-licensed from Gilead Sciences, OX-4224 is initially being advanced to improve access to immunotherapy in low-resource settings. Positive results from this trial could also pave the way for broader global development, including in high-income countries, where OmRx aims to explore innovative, all-oral immuno-oncology combination regimens.
OX-4224 is an investigational product and statements regarding its potential benefits are forward-looking and subject to risks and uncertainties.