Onward Therapeutics transitions to the clinical stage

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. The two companies agreed to co-develop this bispecific antibody until the completion of the phase 1 study in one of the indications. OT-A201 is a first-in-class humanized bispecific antibody targeting two immune checkpoints. With the potential synergistic anti-cancer effects, it is being evaluated as a new treatment for advanced haematological malignancies and solid tumors.

In preclinical studies, OT-A201 has demonstrated excellent specificity, and safety and displayed significant anti-tumoral activities at different doses with the potential for a wider therapeutic window as compared to its parental antibodies. Based on the proprietary structure generated from the BiXAb technology of Biomunex, OT-A201 possesses a functional Fc domain in contributing to ADCC activity against tumor cells. It has demonstrated good pairing, low aggregation, high stability, and good manufacturability.

The launched study No. A20101 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 a 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. 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 of Onward Therapeutics.

(Press release/RAN)