Ottimo Pharma Secures FDA Approval To Begin Trials Of OTP-01, Its First-In-Class Dual-Paratopic PD-1/VEGFR2 Antibody

Ottimo Pharma, an innovative clinical-stage biotechnology company developing one-of-a-kind PD-1/VEGFR2 dual-paratopic antibodies to help extend the lives of people living with cancer, announced that the US Food and Drug Administration has cleared the Investigational New Drug (IND) application for its lead candidate, OTP-01. Following this clearance, the first patient has already been dosed, and enrollment for the clinical study is progressing steadily. Ottimo also confirmed that all manufacturing activities for OTP-01 are taking place exclusively within the United States.

David Epstein, Chair and Chief Executive Officer of Ottimo Pharma, expressed his appreciation for the team’s rapid progress in advancing the candidate into clinical development soon after the company emerged from stealth mode. He said that the company aims to develop OTP-01 as a first-in-class antibody designed to serve as an ideal foundational therapy that can be combined with Antibody Drug Conjugates or chemotherapy. According to him, the intention is to establish a new standard of care for a broad spectrum of solid tumor cancers.

The company’s Phase I/IIA study is a comprehensive, open-label, multicenter clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of OTP-01. The study is currently enrolling patients in the United States and Australia and is expected to expand to approximately 20 clinical centers worldwide as it progresses.

Dr. Mehdi Shahidi, Head of Development and Chief Medical Officer at Ottimo, stated that the goal of the program is to thoroughly assess the potential of this distinctive antibody. He emphasized the importance of generating robust clinical and translational data to guide dose selection, support future combination strategies, and lay the groundwork for broad development across multiple tumor types.