OncoResponse has unveiled the outcomes from the Phase I trial of OR502, a humanised anti-leukocyte immunoglobulin like receptor B2 (LILRB2) antibody, for treating advanced solid tumours.
The multicentre, two-part, open-label, first-in-human study assessed OR502’s safety, tolerability, and preliminary anti-tumour activity both as a standalone therapy and in conjunction with cemiplimab, an anti-programmed cell death protein (PD)-1, in patients with advanced solid tumours.
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The Part A dose-escalation phase of the trial was designed to identify the maximum-tolerated dose (MTD) or optimal dose for further evaluation.
Part B, the expansion phase, treated subjects with advanced solid tumours at two separate doses of OR502 to establish the recommended Phase II dose (RP2D) and to evaluate preliminary anti-tumour activity.
According to the findings, OR502 showed a safety profile, without any dose-limiting toxicity (DLT) or adverse events reported even at the maximum dose level.
The treatment exhibited ‘promising’ early efficacy signals as a monotherapy, including two partial responses (PR) and nine cases of stable disease (SD) out of 17 subjects, with a 65% disease control rate.
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By GlobalDataThe company plans to advance OR502 into further trials, evaluating the antibody in two mini-cohorts of patients with cutaneous melanoma and non-small cell lung cancer (NSCLC).
OncoResponse chief scientific officer Kamal Puri said: “OR502 binds to LILRB2 in a unique way to reverse immunosuppression in cancer and offers a potential treatment option to patients who have otherwise struggled with CPI therapy effectiveness.
“OncoResponse has spent years devising strategies to block or reprogramme tumour-associated macrophages to drive anti-tumour activity. We are excited by the vast promise of OR502 with preclinical and initial clinical data showing superiority over other anti-LILRB2 antibodies.”
In September 2022, the company entered into a clinical supply agreement with Regeneron for Libtayo (cemiplimab) a PD-1 inhibitor.
