Mondego Bio, a clinical-stage biotechnology company developing next-generation small-molecule immuno-oncology therapies, announced the formal selection of its lead clinical candidate, ZE00-0388, a highly selective inhibitor of PTPN2. Candidate nomination follows completion of an extensive preclinical evaluation package demonstrating a favorable safety and tolerability profile in relevant animal models.

With this milestone, Mondego Bio is transitioning into clinical-stage operations and plans to initiate a first-in-human (FIH) Phase 1 clinical study in the first half of 2026.

The planned clinical program is designed to characterize initial safety, tolerability, and pharmacokinetics, while enabling exploratory translational assessments in oncology. The Phase 1 study is expected to include a dual-track design, consisting of a healthy volunteer cohort intended to assess safety, tolerability, and pharmacokinetics to inform dose selection and exposure characterization, and oncology patient cohorts designed to explore the safety, tolerability, and pharmacologic profile of ZE00-0388 when administered as monotherapy and in combination with immune checkpoint inhibitors, with evaluation of selected biomarkers in patients with solid tumors.

"The selection of ZE00-0388 marks a pivotal transition for Mondego Bio from discovery into clinical development," said Nikolay Savchuk, PhD, Chief Executive Officer of Mondego Bio. "Our preclinical data support a disciplined and measured entry into the clinic. By selectively targeting PTPN2, we aim to investigate its potential role in modulating immune signaling pathways, including in combination with established immuno-oncology approaches."

ZE00-0388 is an AI-designed, highly selective small-molecule inhibitor of PTPN2 (Protein Tyrosine Phosphatase Non-Receptor Type 2), an intracellular regulator of cytokine and interferon signaling. PTPN2 acts as a negative regulator of the JAK–STAT pathway and has been implicated in mechanisms of immune regulation within the tumor microenvironment. Preclinical studies suggest that modulation of PTPN2 activity may influence interferon signaling and immune cell function, supporting further clinical investigation in oncology settings.

Advancement of ZE00-0388 into clinical development is supported by the Company's recent Series A financing, led by Biovance Capital, with participation from OrbiMed and Torrey Pines Investment.