OncoResponse, a clinical-stage biotech company advancing immunotherapies derived from the immune systems of elite cancer responders, has announced a clinical supply agreement with Regeneron for PD-1 inhibitor Libtayo (cemiplimab).
The supply agreement with Regeneron will support the evaluation of Libtayo in combination with OR2805, a fully human monoclonal antibody identified from an elite cancer responder using OncoResponse’s proprietary B-cell discovery platform.
“We believe the ability of OR2805 to potently activate myeloid cells within the tumor microenvironment will not only provide benefit as a monotherapy, but also improve responses to currently available checkpoint inhibitor immunotherapies such as Libtayo,” said Bob Lechleider, chief medical officer of OncoResponse.
“We look forward to evaluating the combination of OR2805 with Libtayo, which has demonstrated efficacy in pivotal trials, serving as the basis for FDA approval in three types of advanced cancers. We believe that this combination treatment approach has the potential to improve the outcomes of patients with cancer.”
OR2805 is being evaluated in an ongoing phase 1 study examining safety, pharmacokinetics and preliminary anti-cancer activity in patients with advanced solid tumors alone and in combination with anti-PD-1 therapy. The trial includes a dose escalation phase, followed by several expansion cohorts. The role of potential biomarkers will be evaluated throughout the study, and more intensively in a separate biology cohort.
OR2805 is a fully human antibody discovered using B cells derived from an elite responder to checkpoint inhibitor (CPI) therapy. This antibody binds to CD163, which is highly expressed on tumor associated macrophages (TAMs) that create an immunosuppressive tumor microenvironment and inhibit anti-tumor T-cell responses.
High frequency of CD163-expressing TAMs generally predicts an unfavorable prognosis in solid tumors. OR2805 is designed to improve anti-tumor T-cell responses, by reversing the immunosuppression of TAMs, as a therapeutic strategy for monotherapy and in combination with CPI.
OncoResponse is a clinical-stage, immuno-oncology biotech company developing cancer immunotherapies using clues from the immune systems of elite cancer responders.
In a broad strategic alliance with MD Anderson Cancer Center, OncoResponse deploys a proprietary B-cell discovery platform to identify and develop novel therapeutics targeting the tumor microenvironment.
Additional pipeline candidates that modulate suppressive macrophage activity are under development.