Ottimo Pharma Announces FDA Clearance of Investigational New Drug (IND) Application for OTP-01, a First-in-Class, Dual-Paratopic, Single-Agent, Anti-PD-1/VEGFR2 Antibody

• First patient dosed and study open in leading oncology centers in US and Australia
• Phase I/IIA 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 and/or VEGF treatment
• IND application data supports the potential of OTP-01 as a differentiated, next-generation antibody with potent PD-1 inhibition and unique VEGFR2 receptor inhibitory properties driving improved immune modulation and vascular normalization
  

LONDON and BOSTON, Jan. 07, 2026 (GLOBE NEWSWIRE) -- Ottimo Pharma (“Ottimo”), an innovative, clinical-stage biotech company developing one-of-a-kind PD-1/VEGFR2 dual-paratopic antibodies to extend the lives of patients living with cancer, today announces the US Food and Drug Administration clearance of the investigational new drug (IND) application for its lead candidate OTP-01. The first patient has been dosed and recruitment is well underway. All manufacturing of OTP-01 is occurring solely in the US.

"I am proud of our Ottimo team for their remarkable speed in bringing OTP-01 into the clinic since coming out of stealth,” said David Epstein, Chair and Chief Executive Officer of Ottimo Pharma. “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.”

The broad Phase I/IIA, open-label, multicenter study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and early anti-tumor activity of OTP-01. The study is enrolling patients in the US and Australia and will expand to approximately 20 centers globally.

“Our 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,” said Dr. Mehdi Shahidi, Head of Development and Chief Medical Officer of Ottimo.

About OTP-01
OTP-01 is a first-in-class, investigational Fc-null, IgG1 monoclonal antibody featuring a unique dual-paratopic design that enables simultaneous engagement of the PD-1 immune checkpoint and the VEGFR-2 angiogenic pathway. As a single agent, OTP-01 maintains conventional IgG architecture, supporting optimal manufacturability and stability. Preclinical data supports the potential of OTP-01 to provide potent PD-1 inhibition combined with uniquely engineered allosteric VEGFR2 receptor inhibition (targeting ligands A/C/D) and modulates multiple immune subsets while optimally promoting tumor vascular normalization. This integrated dual-target engagement is designed to drive tumor microenvironment-biased distribution and enhance intratumoral immune activation. In addition, pre-clinical studies have demonstrated significantly improved anti-tumor efficacy and intratumoral CD8+ T cell infiltration compared to PD-1 inhibition alone. As a one-of-a-kind, next-generation investigative therapy for solid tumors, OTP-01 aims to offer a wider therapeutic window for patients, with the potential to improve outcomes across multiple indications. The antibody is produced with high manufacturing efficiency in the U.S.

About Ottimo Pharma
Ottimo Pharma is a UK-registered clinical-stage private biotechnology company, co-founded by Medicxi and Jonny Finlay, that emerged from stealth in October 2024 to rapidly advance the clinical development of exquisitely designed, unique dual-pathway antibodies to extend the lives of patients living with cancer.

Ottimo is backed by a global syndicate of life science investors, including Medicxi, OrbiMed, Avoro Capital, Samsara BioCapital, RTW Investments, Decheng Capital, Janus Henderson Investors, J.P. Morgan Life Sciences Private Capital, and Invus. For more information, please visit: www.ottimopharma.com.

US Media Contact:
Dana Cooper
dana@dcoopercommunications.com
+1-732-239-6664

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