Onward Therapeutics enters clinical phase with innovative cancer immunotherapy
30 January 2024
Based at the Biopôle in Lausanne, Onward Therapeutics has made a significant leap in the field of biotechnology by initiating the phase 1 clinical trial of OT-A201, its pioneering bispecific antibody.
In February 2021, Onward Therapeutics secured exclusive worldwide rights for the development, manufacture, and commercialization of OT-A201 from Biomunex Pharmaceuticals. This collaboration involves co-developing the bispecific antibody until the completion of the phase 1 study. OT-A201, a first-in-class humanized bispecific antibody, targets two immune checkpoints, holding immense potential for treating advanced hematological malignancies and solid tumors.
OT-A201’s preclinical studies have shown promising results, exhibiting excellent specificity, safety, and notable anti-tumoral activities at various doses. This antibody, based on Biomunex’s BiXAb technology, also features a functional Fc domain that contributes to ADCC activity against tumor cells, displaying properties like good pairing, low aggregation, and high stability.
Advancing innovative projects in the fight against cancer
The newly launched European multicenter study, No. A20101, aims to assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumoral efficacy of OT-A201. This open-label study comprises two parts: a dose escalation stage for patients with specific relapsed/refractory hematological malignancies or advanced/metastatic solid tumors, and an expansion stage to further evaluate the antibody’s safety and efficacy as monotherapy or in combination in defined conditions.
Dosing the first patient has triggered an undisclosed milestone payment to Biomunex, signifying progress in Onward Therapeutics’ journey. Dr. C. Grace Yeh, Chairman and CEO of Onward Therapeutics, expressed enthusiasm about testing OT-A201 in patients, highlighting the company’s efficiency in moving from cell line development to large-scale manufacture and preclinical studies. Yeh’s statement underscores the company’s commitment to its ‘buy-to-build’ business model and marks a crucial milestone in transitioning Onward Therapeutics into a clinical-stage company.