Pharma Focus Europe

OncoResponse Initiates Phase 1/2 Clinical Trial for OR502, an Anti-LILRB2 Antibody, in Patients with Advanced Cancer

Thursday, November 30, 2023

OncoResponse, a clinical-stage biotech company specializing in immunotherapies derived from the immune systems of Elite Cancer Responders, has recently initiated the Phase 1/2 trial for OR502. This groundbreaking humanized anti-leukocyte immunoglobulin-like receptor B2 (LILRB2) antibody is designed to rescue innate and adaptive immune responses from LILRB2-mediated immune suppression. The trial's primary objectives are to evaluate the safety, tolerability, and preliminary anti-tumor activity of OR502, both as a standalone treatment and in combination with anti-PD-1, in individuals with advanced solid tumors.

OncoResponse, emphasized the company's dedication to advancing programs with the potential to improve outcomes for cancer patients. Kamal Puri, PhD, Chief Scientific Officer, highlighted the distinctive binding mechanism of OR502 to LILRB2, which has shown promise in reversing immunosuppression in cancer, as demonstrated in preclinical data surpassing other clinically validated anti-LILRB2 antibodies.

The Phase 1/2 study is an open-label, multicenter trial, encompassing both dose-escalation and expansion phases. OR502, a fully human IgG1 antibody targeting LILRB2, will be administered as a monotherapy and in combination with anti-PD-1. The study aims to determine the maximum-tolerated dose, optimal dose, and preliminary anti-tumor activity. Throughout the trial, biomarkers will be assessed, with a particular focus on a separate biology cohort. Detailed information about the trial is available on, identifier: NCT06090266.

LILRB2, identified as an immunoinhibitory receptor on tumor-associated macrophages within the tumor microenvironment, plays a role in inhibiting checkpoint inhibitor therapy. The mechanism of OR502 involves modulating LILRB2, preventing its engagement with HLA-G on tumor cells, and subsequently halting the suppression of myeloid cells. Elevated expression of LILRB2 has been associated with reduced patient survival across various tumor types. OR502, a humanized monoclonal antibody, specifically targets LILRB2, with the aim of enhancing the activity of tumor-killing T cells and reversing the inhibition of CPI therapy.



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