Mondego Bio Advances AI-Designed PTPN2 Inhibitor ZE00-0388 to Phase 1 Clinical Trials
核心洞察
Mondego Bio (搜索) has selected ZE00-0388 (搜索), a highly selective PTPN2 (搜索) inhibitor, as its lead clinical candidate following extensive preclinical evaluation demonstrating favorable safety and tolerability profiles.
The company plans to initiate first-in-human Phase 1 trials in the first half of 2026, featuring a dual-track design with healthy volunteers and oncology patients.
ZE00-0388 (搜索) is an AI-designed small-molecule that targets PTPN2 (搜索), an intracellular regulator of cytokine and interferon signaling pathways within the tumor microenvironment.
Mondego Bio (搜索), a clinical-stage biotechnology company based in Cantanhede, Portugal, has announced the formal selection of ZE00-0388 (搜索), a highly selective inhibitor of PTPN2 (搜索), as its lead clinical candidate. The milestone marks the company's transition from discovery to clinical-stage operations, with plans to initiate first-in-human Phase 1 trials in the first half of 2026.
The candidate nomination follows completion of an extensive preclinical evaluation package that demonstrated a favorable safety and tolerability profile in relevant animal models. ZE00-0388 (搜索) represents a novel approach to immuno-oncology through selective targeting of PTPN2 (搜索) (Protein Tyrosine Phosphatase Non-Receptor Type 2), an intracellular regulator of cytokine and interferon signaling.
AI-Designed Therapeutic Approach
ZE00-0388 (搜索) is an AI-designed, highly selective small-molecule inhibitor that targets PTPN2 (搜索), which acts as a negative regulator of the JAK-STAT pathway (搜索). The protein 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.
"The selection of ZE00-0388 (搜索) marks a pivotal transition for Mondego Bio (搜索) 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 (搜索), we aim to investigate its potential role in modulating immune signaling pathways, including in combination with established immuno-oncology approaches."
Comprehensive Phase 1 Clinical Design
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 two distinct cohorts.
The first track will include a healthy volunteer cohort intended to assess safety, tolerability, and pharmacokinetics to inform dose selection and exposure characterization. The second track will comprise oncology patient cohorts designed to explore the safety, tolerability, and pharmacologic profile of ZE00-0388 (搜索) when administered as monotherapy and in combination with immune checkpoint inhibitors, with evaluation of selected biomarkers in patients with solid tumors (搜索).
Company Background and Funding
Mondego Bio (搜索) is headquartered in Biocant Park in Cantanhede, Portugal, and focuses 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 (搜索), in collaboration with Eilean Therapeutics and Molsoft LLC (搜索). Mondego Bio integrates rational design, computational pharmacology, and medicinal chemistry expertise to target intracellular regulators relevant to immune modulation and cancer (搜索) biology.
The advancement of ZE00-0388 (搜索) into clinical development is supported by the company's recent Series A financing, led by Biovance Capital (搜索), with participation from OrbiMed (搜索) and Torrey Pines Investment (搜索).