Ottimo Pharma Receives FDA Clearance for First-in-Class Dual PD-1/VEGFR2 Antibody OTP-01
核心洞察
Ottimo Pharma (搜索) has received FDA clearance for its investigational new drug application for OTP-01 (搜索), a first-in-class dual-paratopic antibody targeting both PD-1 (搜索) and VEGFR2 (搜索) pathways.
The Phase I/IIA multicenter study has begun dosing patients in the US and Australia, with plans to expand to approximately 20 centers globally.
Preclinical studies demonstrate that OTP-01 (搜索) provides significantly improved anti-tumor efficacy and enhanced CD8+ T cell infiltration compared to PD-1 (搜索) inhibition alone.
Ottimo Pharma (搜索) announced that the US Food and Drug Administration has cleared the investigational new drug (IND) application for OTP-01 (搜索), a first-in-class dual-paratopic antibody designed to simultaneously target the PD-1 (搜索) immune checkpoint and VEGFR2 (搜索) angiogenic pathway. The first patient has been dosed and recruitment is underway at leading oncology centers in the US and Australia.
Novel Dual-Target Approach
OTP-01 (搜索) represents a unique therapeutic approach as an Fc-null, IgG1 monoclonal antibody featuring dual-paratopic design that enables simultaneous engagement of both PD-1 (搜索) and VEGFR-2 (搜索) pathways. The antibody maintains conventional IgG architecture while supporting optimal manufacturability and stability, with all manufacturing occurring in the United States.
"We are developing this unique, first-in-class antibody to be the ideal backbone therapy to combine with Antibody Drug Conjugates or chemotherapy, with the aim of creating a new standard of care across a wide range of solid tumors (搜索)," said David Epstein, Chair and Chief Executive Officer of Ottimo Pharma (搜索).
Clinical Trial Design and Objectives
The broad Phase I/IIA, open-label, multicenter study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and early anti-tumor activity of OTP-01 (搜索). The adaptive study aims to assess and optimize the dose of OTP-01 and provide safety, tolerability, and early efficacy data initially in patients known to benefit from PD-1 (搜索) and/or VEGF treatment.
The study is currently enrolling patients in the US and Australia and will expand to approximately 20 centers globally. Dr. Mehdi Shahidi, Head of Development and Chief Medical Officer of Ottimo, stated that the aim is to "fully assess the potential of this distinctive antibody by generating comprehensive clinical and translational data to inform both dose selection and combination strategies, and to set the stage for broad development across multiple tumor types."
Preclinical Evidence and Mechanism
Preclinical data supports OTP-01 (搜索)'s potential to provide potent PD-1 (搜索) inhibition combined with uniquely engineered allosteric VEGFR2 (搜索) receptor inhibition, specifically targeting ligands A/C/D. The integrated dual-target engagement is designed to drive tumor microenvironment-biased distribution and enhance intratumoral immune activation while promoting tumor vascular normalization.
Pre-clinical studies have demonstrated significantly improved anti-tumor efficacy and intratumoral CD8+ T cell infiltration compared to PD-1 (搜索) inhibition alone. The antibody modulates multiple immune subsets while optimally promoting tumor vascular normalization, offering the potential for a wider therapeutic window across multiple indications.
Company Background and Funding
Ottimo Pharma (搜索) is a UK-registered clinical-stage private biotechnology company that emerged from stealth in October 2024. The company is co-founded by Medicxi (搜索) and Jonny Finlay and is backed by a global syndicate of life science investors, including Medicxi, OrbiMed (搜索), Avoro Capital, Samsara BioCapital, RTW Investments, Decheng Capital, Janus Henderson Investors, J.P. Morgan Life Sciences Private Capital, and Invus.
Epstein noted the team's "remarkable speed in bringing OTP-01 (搜索) into the clinic since coming out of stealth," highlighting the rapid progression from company launch to first patient dosing within months of emerging from stealth mode.