Onward Therapeutics Begins Phase 1 Trial of OT-A201 Bispecific Antibody

Onward Therapeutics, a biotech firm dedicated to pioneering cancer immunotherapies, has initiated a phase 1 clinical trial for OT-A201. This innovative bispecific antibody is designed to target two immune checkpoints simultaneously, offering a novel approach to cancer treatment. The trial's primary objective is to assess the drug's safety, tolerability, and its impact on tumor activity, along with pharmacokinetics and immunogenicity.

The trial is structured in two phases, with the initial stage focusing on determining the optimal dosage for OT-A201 when used as a standalone treatment for patients with specific types of relapsed or refractory blood cancers and advanced solid tumors. The subsequent stage will delve into the drug's safety and efficacy in both monotherapy and combination settings for a more defined group of cancers at the dosages established earlier.

OT-A201's development, manufacturing, and commercial rights were exclusively secured by Onward Therapeutics from Biomunex Pharmaceuticals in 2021. The collaboration between the two companies will continue throughout the phase 1 trial. The commencement of patient dosing has led to a milestone payment to Biomunex, the amount of which remains undisclosed.

Dr. C. Grace Yeh, the Chairman and CEO of Onward Therapeutics, highlighted the swift progression from cell line development to clinical trials, attributing this to the expertise of the team. The trial signifies a pivotal step for the company as it transitions into a clinical-stage entity and underscores its 'buy-to-build' strategy aimed at fostering innovation.

Dr. Alain Herrera, the Chief Medical Officer, emphasized the persisting need for innovative cancer treatments despite advancements in immunotherapy. He expressed optimism about OT-A201's potential to tackle tumor resistance and enhance anti-tumor effects, citing promising results from in vitro and in vivo studies that suggest a favorable therapeutic profile.

OT-A201 stands out as a first-of-its-kind humanized bispecific antibody with a unique structure derived from Biomunex's BiXAb technology. It targets two immune checkpoints and has shown remarkable specificity and safety in preclinical trials. The antibody's functional Fc domain is expected to enhance its effectiveness against tumor cells through antibody-dependent cellular cytotoxicity (ADCC).

Onward Therapeutics, a clinical-stage enterprise, is on a mission to discover and develop groundbreaking cancer therapies. Guided by a seasoned team with a wealth of experience in translational science and drug development, the company is also involved in the advancement of an allogeneic natural killer cell therapy and an onco-metabolism program. Headquartered in Switzerland, with a presence in France and Taiwan, Onward Therapeutics continues to drive forward in its quest to revolutionize cancer treatment.