Onward Therapeutics announces enrolment of phase 1 trial of bispecific antibody
Betsy Goodfellow | January 24, 2024 | News story | Research and Development | Oncology, Onward Therapeutics, bispecific antibody, clinical trial
Onward Therapeutics has announced that it has begun enrolment for its phase 1 clinical trial of OT-A201, a novel bispecific antibody which intends to target two immune checkpoints. The trial will assess the safety, tolerability, pharmacokinetics, immunogenicity and preliminary anti-tumoural activity of the antibody.
The study will take place in two parts, the first being a dose escalation stage of OT-A201 as a single agent in patients with selected relapsed/refractory haematological malignancies or advanced/metastatic solid tumours. The following part will be an expansion stage, further assessing the safety and preliminary anti-tumoural activity of the antibody as a monotherapy or in combination in defined haematological malignancies and solid tumours in the dose/doses selected in the earlier part.
Onward Therapeutics licensed the rights to the development, manufacturing and commercialisation of the antibody from Biomunex Pharmaceuticals; the two companies will co-develop OT-A201 until the completion of the phase 1 study in one of its indications.
Dr C Grace Yeh, chairman and chief executive officer of Onward Therapeutics, commented: “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.”
Betsy Goodfellow
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