Clinical-stage biopharmaceutical venture OmRx Oncology (OmRx) has commenced a randomised Phase II clinical trial for its oral programmed death ligand 1(PD-L1) inhibitor, OX-4224, targeting individuals with non-small cell lung cancer (NSCLC).
According to the company, this investigational small molecule will potentially offer a cost-effective and accessible treatment alternative to current antibody-based therapies.
The open-label trial is set to enrol approximately 50 metastatic NSCLC subjects, with a focus on India. These patients will not have been treated with immune checkpoint inhibitors previously. The therapy will be evaluated as a second-line single agent.
In the trial, the overall response rate will be evaluated, alongside safety and other secondary efficacy endpoints.
OX-4224 is being developed by the company primarily for low and middle-income nations, where high expenses and distribution issues limit access to biologic treatments.
The oral formulation of OX-4224 is claimed to eliminate the requirement for infusion centres, provide flexible dosing schedules, and allow for scalable production.
OmRx stated that the therapy’s size and biophysical properties could lead to enhanced penetration into tumour tissue, potentially improving efficacy in specific cancer types.
In addition, the therapy’s lack of immunogenicity and its shorter half-life are claimed to minimise immune-related adverse events commonly associated with antibody checkpoint inhibitors.
In-licensed from Gilead Sciences, the therapy’s advancement is part of OmRx’s strategy to enhance immunotherapy access in regions with limited resources.
The trial‘s positive outcomes could also help to prepare for wider development globally in wealthier nations, where the company intends to investigate potential all-oral immuno-oncology combination regimens.
OmRx Oncology CEO Isy Goldwasser said: “Launching this clinical trial is a key step toward fulfilling OmRx’s mission of addressing global health disparities in cancer treatment.
“Checkpoint inhibitor antibodies have revolutionised 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.”
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