OmRx Oncology has initiated a Phase 2 clinical trial of its investigational oral PD-L1 inhibitor, OX-4224, in patients with non-small cell lung cancer (NSCLC). The San Diego-based clinical-stage biopharmaceutical company announced the trial commencement on May 8, 2025, marking a significant step in their mission to expand global access to cancer immunotherapy.
OX-4224 is an oral small molecule that targets the PD-1/PD-L1 immune checkpoint pathway, offering a potentially more accessible and cost-effective alternative to existing antibody-based therapies that dominate the current immunotherapy landscape.
Trial Design and Patient Population
The open-label, randomized Phase 2 study will focus primarily on patients in India, enrolling approximately 50 individuals with metastatic NSCLC whose tumors express PD-L1 and who have not previously received immune checkpoint inhibitors. The trial will assess OX-4224 as a second-line monotherapy, with overall response rate as the primary endpoint, alongside safety and additional secondary efficacy measures.
"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 of 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."
Addressing Global Access Barriers
The development of OX-4224 is initially targeted at low and middle-income countries (LMICs), where biological therapies often remain out of reach due to prohibitive costs and distribution challenges. The oral formulation provides several advantages over traditional antibody-based checkpoint inhibitors:
- Eliminates the need for infusion centers
- Allows for flexible dosing schedules
- Offers a more scalable manufacturing model
- Potentially enhances tumor tissue penetration
- May reduce immune-related adverse events due to shorter half-life and lack of immunogenicity
Dr. William Lee, Chairman of OmRx and former Executive Vice President of Research at Gilead Sciences, emphasized the potential impact: "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. 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."
Current Immunotherapy Landscape for NSCLC
NSCLC represents approximately 85% of all lung cancer cases globally, with a significant portion of patients expressing PD-L1, making them potential candidates for checkpoint inhibitor therapy. While antibody-based PD-1/PD-L1 inhibitors have transformed treatment paradigms in developed nations, their high cost and complex administration requirements have limited their reach in many parts of the world.
The standard antibody checkpoint inhibitors require intravenous administration in specialized facilities, creating logistical and financial barriers for patients in regions with limited healthcare infrastructure. An oral alternative could potentially democratize access to this class of life-extending therapies.
Future Development Potential
OX-4224, which was in-licensed from Gilead Sciences, could see its development expand beyond LMICs if the current trial yields positive results. OmRx has indicated interest in exploring innovative, all-oral immuno-oncology combination regimens that could have applications in high-income countries as well.
"The potential for an oral checkpoint inhibitor extends beyond just replacing antibody therapies in current treatment paradigms," noted a company spokesperson. "It opens possibilities for novel combination approaches and treatment schedules that simply aren't feasible with the current generation of immunotherapies."
About OmRx Oncology
OmRx Oncology is a biopharmaceutical venture built around OX-4224, its investigational oral checkpoint inhibitor being evaluated for solid tumors, including NSCLC. The company's core mission focuses on expanding access to immunotherapies in countries where biologics are the standard of care but remain inaccessible due to cost and availability constraints.
As the Phase 2 trial progresses, the company will be closely monitoring both efficacy and safety signals to determine the potential of OX-4224 to address the significant unmet need for more accessible immunotherapy options worldwide.
