Study will evaluate OX-4224 as a second-line monotherapy in patients with PD-L1–positive non-small cell lung cancer, expanding potential access to checkpoint inhibitors in low-resource settings
OmRx Oncology, or “OmRx,” a clinical-stage biopharmaceutical venture dedicated to expanding access to cancer immunotherapy worldwide, today announced 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).
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.
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. For more information visit https://omrxonc.com/.
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Contacts
Media Contact:
Mary Sullivan
OmRx Oncology
mary@omrxonc.com
