On November 29, 2023 OncoResponse, a clinical-stage biotech company advancing immunotherapies derived from the immune systems of Elite Cancer Responders, reported the dosing of the first participant in the Phase 1/2 trial of OR502, a novel, humanized anti-leukocyte immunoglobulin like receptor B2 (LILRB2) antibody that rescues innate and adaptive immune responses from LILRB2 mediated immune suppression (Press release, OncoResponse, NOV 29, 2023, View Source [SID1234638056]). This Phase 1/2 study is designed to determine the safety, tolerability, and preliminary anti-tumor activity of OR502 administered as a monotherapy and in combination with anti-PD-1 in subjects with advanced solid tumors.
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"Initiating this study in cancer patients reflects our continued commitment to advancing programs that have the greatest potential to improve outcomes for patients undergoing cancer treatment," said Clifford Stocks, Chief Executive Officer of OncoResponse.
"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," said Kamal Puri, PhD, Chief Scientific Officer of OncoResponse. "OncoResponse has spent years devising strategies to block or reprogram tumor associated macrophages to drive anti-tumor activity. We are excited by the vast promise of OR502 in the LILRB2 target space with preclinical data showing superiority to other clinically validated anti-LILRB2 antibodies."
About the Phase 1 Trial
This Phase 1/2 study is an open-label, multicenter, first-in-human dose-escalation and expansion study designed to determine the safety, tolerability, and preliminary anti-tumor activity of OR502, a fully human IgG1 antibody that binds specifically to LILRB2. OR502 will be administered as a monotherapy and in combination with anti-PD-1, cemiplimab, in subjects with advanced solid tumors. The study consists of two parts. Part A is a dose-escalation phase to determine the maximum-tolerated dose (MTD) or optimal dose of OR502 for further evaluation as monotherapy and in combination. Part B is an expansion phase in subjects with advanced solid tumors treated with OR502 at two separate doses, to help determine the recommended Phase 2 dose (RP2D) for further development and determine preliminary anti-tumor activity. The role of potential biomarkers will be evaluated throughout the study, and more intensively in a separate biology cohort. Additional details are available on ClinicalTrials.gov, identifier: NCT06090266.
About OR502
LILRB2 is an immunoinhibitory receptor expressed on tumor-associated macrophages (TAMs) found in the tumor microenvironment (TME). TAMs inhibit the activity of checkpoint inhibitor (CPI) therapy and prevent T cells from killing tumors. Blocking the inhibitory activity of TAMs and promoting the activity of tumor-killing T cells reverses inhibition of CPI therapy, potentially leading to more and deeper responses to CPIs in patients. This is the mechanism of OR502, which modulates LILRB2 by blocking its engagement of HLA-G on tumor cells and prevents the suppression of the myeloid cells. Elevated expression of LILRB2 correlates with reduced patient survival in various tumor types. Our humanized monoclonal antibody, OR502, targets LILRB2 and blocks the inhibitory activity of TAMs and promotes the activity of tumor-killing T cells, reversing inhibition of CPI therapy.