SEATTLE, WA, USA I November 2, 2021 I OncoResponse, a clinical-stage biotech company advancing immunotherapies derived from the immune systems of elite cancer responders, today announced initiation of a Phase 1/2 study of OR2805 in patients with advanced cancer. OR2805 is a fully human monoclonal antibody identified from an elite cancer responder using OncoResponse’s proprietary B-cell discovery platform.

The study will evaluate the safety, pharmacokinetics and preliminary anti-cancer activity of OR2805 in patients with advanced solid tumors alone and in combination with anti-PD-1 therapy. The trial will include 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. identifier: NCT05094804

“The initiation of our Phase 1 clinical trial of OR2805 represents a significant milestone for OncoResponse. OR2805 has the potential to reverse the inhibitory effect of tumor associated macrophages, or TAMs, and unlock a potent anti-tumor response,” said Bob Lechleider, MD, Chief Medical Officer of OncoResponse. “Preclinical studies have demonstrated the ability of OR2805 to effectively counter the inhibitory activity of M2 macrophages, and we now intend to determine how that will translate to clinical activity.  OncoResponse is dedicated to bringing novel and effective therapies that modulate the tumor microenvironment into the clinic to help patients who desperately need additional treatment options.” 

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 recently highlighted platform and preclinical data on OR2805 in an oral presentation “Using the Human Immune System to Identify Antibodies that Modulate the Tumor Microenvironment” at the Macrophage-Directed Therapies Summit. The presentation, by Kamal D. Puri, PhD, Chief Scientific Officer, can be accessed from the Publications page of the OncoResponse website.

About OncoResponse
OncoResponse, Inc. 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. The company’s lead candidate, OR2805, has entered clinical studies. Additional pipeline candidates that modulate suppressive macrophage activity are under development.  OncoResponse is a privately held company backed by investment from MD Anderson Cancer Center, Rivervest Venture Partners, Qatar Investment Authority, Redmile Group, Magnetar Group, Yonjin Venture, Bering Capital, ARCH Venture Partners, Helsinn Investment Fund, Canaan Partners, GreatPoint Ventures, InterVest (Korea), Takeda Ventures, Buchang Pharma (China), Alexandria Real Estate Equities and William Marsh Rice University.  For more information please visit and follow us on LinkedIn and Twitter.

SOURCE: OncoResponse