Mondego Bio Announces Selection of a PTPN2 Inhibitor Clinical Candidate and Targets First-in-Human Trials in H1 2026

CANTANHEDE, Portugal, Dec. 22, 2025 /PRNewswire/ — Mondego Bio, a clinical-stage biotechnology company developing next-generation small-molecule immuno-oncology therapies, today 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.

About Mondego Bio

Headquartered in Biocant Park in Cantanhede, Portugal, Mondego Bio is a biotechnology company focused on developing next-generation small-molecule therapies for oncology. The Company was incubated through the AI- and machine-learning–driven discovery platform of Expert Systems, in collaboration with Eilean Therapeutics and Molsoft LLC. Mondego Bio integrates rational design, computational pharmacology, and medicinal chemistry expertise to target intracellular regulators relevant to immune modulation and cancer biology.

For more information, visit www.mondegobio.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of applicable securities laws, including statements regarding the initiation, timing, design, and conduct of planned clinical studies; the potential safety, tolerability, and pharmacologic profile of ZE00-0388; the evaluation of ZE00-0388 in combination with immune checkpoint inhibitors; and Mondego Bio’s development plans and strategic objectives. Forward-looking statements are based on current expectations and assumptions and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied. These risks and uncertainties include, among others, uncertainties inherent in drug discovery and development, clinical trial execution and outcomes, regulatory review processes, and the availability of capital. Mondego Bio undertakes no obligation to update any forward-looking statements except as required by law.

Media Contact

Rita Santos, PhD
Director, External Relations
rsantos@mondegobio.com

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SOURCE Mondego Bio