Onward Therapeutics has announced the Phase I clinical trial of OT-A201, a first-in-class bispecific antibody targeting two immune checkpoints is in progress.
The study aims to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumoural activity of OT-A201.
The study is a European multicentre 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 haematological malignancies or advanced/metastatic solid tumours. The second is an expansion stage that will further evaluate the safety and preliminary anti-tumoural activity of OT-A201 as monotherapy or in combination in defined haematological malignancies and solid tumours at the dose(s) selected from the first part.
Onward Therapeutics licensed the exclusive worldwide rights of development, manufacture, and commercialisation of OT-A201 from Biomunex Pharmaceuticals, 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 I study in one of the indications.
“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-litre? 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.
“We are convinced of the potential of this first-in-class bispecific antibody, capable of simultaneously targeting two immune checkpoints, based on our proprietary BiXAb platform, to provide better anti-tumour effects with a favourable therapeutic window and potentially become a true novel immunotherapeutic option for various cancers, both solid and liquid,” added Dr Simon Plyte, Chief Scientific Officer of Biomunex. “This clinical evaluation of our BiXAb format paves the way for the successive development of our first-in-class BiXAb-MAIT engager approach that we will rapidly advance to the clinic.”