The study aims to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumoral activity of OT-A201. The study is a European multicenter and open-label study that will be conducted in two parts. The first part is a dose escalation stage of OT-A201 as single agent in patients with selected relapsed/refractory hematological malignancies or advanced/metastatic solid tumors. The second part is an expansion stage that will further evaluate the safety and preliminary anti-tumoral activity of OT-A201 as monotherapy or in combination in defined hematological malignancies and solid tumors at the dose(s) selected from the first part.

Onward Therapeutics licensed the exclusive worldwide rights of development, manufacture, and commercialization of OT-A201 from Biomunex Pharmaceuticals (Biomunex), a biopharmaceutical company discovering and developing bi- and multi-specific antibodies, in February 2021. Onward Therapeutics and Biomunex will co-develop this bispecific antibody until the completion of the phase 1 study in one of the indications. Dosing of the first patient has triggered an undisclosed amount of milestone payment to Biomunex.

"With the drug development expertise and successful track records of the Onward Therapeutics team, we have moved forward from the cell line development, scale up, 1,000-liter manufacture, preclinical pharmacology and toxicology studies, as well as clinical development and regulatory application of OT-A201 rapidly and efficiently. We are enthusiastic to test OT-A201 for the first time in patients. The study marks an important milestone of Onward Therapeutics in transitioning into a clinical stage company. It also represents a step forward in advancing innovative projects based on our 'buy-to-build' business model", said Dr. C. Grace Yeh, Chairman and CEO.

"Despite the recent advances in cancer immunotherapy, there is still a significant unmet need for new treatment options to improve clinical outcome. OT-A201 offers an effective strategy to overcome tumor resistance and to provide better anti-tumor effects. This bispecific antibody has shown excellent in vitro and in vivo activity and safety, opening up the possibility of a favorable therapeutic window. We are looking forward to providing clinically meaningful information from this study to bring a differentiated approach in difficult-to-treat cancer patients", said Dr. Alain Herrera, Chief Medical Officer.