Phase 1 Trial Launched for Biomunex's Innovative Cancer Antibody

In a significant development for the field of immunotherapy, a French biopharmaceutical firm, Biomunex Pharmaceuticals, has reported the commencement of a Phase 1 clinical trial in 2023. This trial is a collaborative effort with Onward Therapeutics SA, a global biotech company specializing in cancer treatments. The trial's focus is on a novel bispecific antibody, OT-A201, which targets two immune checkpoints and is derived from Biomunex's proprietary BiXAb® platform.

The study aims to assess the safety, tolerability, pharmacokinetics, immunogenicity, and initial anti-tumor effects of the antibody, which has shown promising results in preclinical studies. These studies have highlighted the antibody's favorable characteristics, including good pairing, low aggregation, high stability, and excellent manufacturability, along with its specificity and safety.

The Phase 1 trial is structured as a European multicenter, open-label study, divided into two phases. The first phase involves dose escalation to evaluate the safety and tolerability of the BiXAb candidate in patients with advanced solid tumors or hematological malignancies. This stage will determine the maximum tolerated dose and the recommended Phase 2 doses. The second phase is an expansion stage that will further assess the safety and preliminary anti-tumor activity of the candidate, both as a monotherapy and in combination with other treatments.

Dr. Pierre-Emmanuel Gerard, Biomunex's founder and CEO, expressed enthusiasm for the clinical trial, emphasizing the potential impact of their antibodies on cancer patients, particularly those with significant unmet medical needs. The trial is a testament to the scientific and technological relevance of Biomunex's BiXAb platform, which is designed to rapidly and efficiently identify, generate, and develop novel bispecific antibodies.

Dr. Simon Plyte, Biomunex's Chief Scientific Officer, also commented on the potential of the "first-in-class" bispecific antibody, highlighting its ability to target two immune checkpoints simultaneously. He believes that the antibody could provide enhanced anti-tumor effects with a favorable therapeutic window, potentially offering a novel immunotherapeutic option for various cancers.

Biomunex Pharmaceuticals, based in Paris and Cambridge, MA, is led by an experienced international team and is dedicated to discovering and developing breakthrough immunotherapeutic approaches. The company's BiXAb platform is a robust, next-generation technology for creating bi- and multi-specific antibodies, validated through licensing agreements and collaborations with the pharmaceutical and biotech industry.

The company is also pioneering an immuno-oncology approach that utilizes bispecific antibodies from its BiXAb platform to target, engage, and redirect MAIT cells, a subset of T cells found throughout the body, particularly in mucosal and barrier tissues, to eliminate cancer cells. This approach holds promise for the treatment of solid tumors and represents a significant advancement in cancer therapy.