#Portugal #Mondego Bio #Cantanhede #ZE00-0388 #PTPN2 Inhibitor

Mondego Bio Announces Selection of PTPN2 Inhibitor Clinical Candidate

Mondego Bio, a biotechnology company specialized in developing innovative small-molecule therapies for cancer, has officially selected its lead clinical candidate, ZE00-0388. This highly selective PTPN2 inhibitor aims to transition the company into clinical-stage operations, marking a significant milestone in their journey. The announcement made on December 22, 2025, follows an extensive preclinical evaluation that demonstrated a favorable safety and tolerability profile in relevant animal models.

With the nomination of ZE00-0388, Mondego Bio plans to commence a first-in-human (FIH) Phase 1 clinical trial in the first half of 2026. This trial will characterize the initial safety, tolerability, and pharmacokinetics of the drug, essential for further exploration in oncology settings. The study will feature a dual-track design, including a healthy volunteer cohort to assess safety and pharmacokinetics, as well as oncology patient cohorts to evaluate ZE00-0388's efficacy both as a standalone treatment and in combination with immune checkpoint inhibitors. Key biomarkers will be evaluated in patients with solid tumors to gauge the treatment's effectiveness.

Nikolay Savchuk, CEO of Mondego Bio, emphasized the importance of this step, stating, "The selection of ZE00-0388 marks a pivotal transition for Mondego Bio from discovery into clinical development. 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 a product of artificial intelligence (AI) design, showcasing the innovative methods employed by Mondego Bio. The compound is a selective small-molecule inhibitor of PTPN2 (Protein Tyrosine Phosphatase Non-Receptor Type 2), an intracellular modulator of cytokine and interferon signaling pathways. PTPN2 plays a critical role in regulating the JAK–STAT pathway and is involved in immune regulation within the tumor microenvironment. Preclinical research indicates that modulating PTPN2 activity may enhance interferon signaling and immune cell functionality, making it a promising candidate for further clinical investigation in oncology.

The advancement of ZE00-0388 to clinical development is bolstered by the company’s successful Series A financing, led by prominent investors including Biovance Capital, with additional participation from OrbiMed and Torrey Pines Investment. This financial support is critical as Mondego Bio prepares to navigate the complex landscape of clinical trials and regulatory approvals.

Mondego Bio operates out of Biocant Park in Cantanhede, Portugal, and is dedicated to pioneering next-generation therapies that target vital intracellular regulators crucial to immune modulation and cancer biology. As the biotechnology landscape continues to evolve, Mondego Bio’s innovative approach, integrating rational design with computational pharmacology and medicinal chemistry expertise, positions it at the forefront of cancer treatment advancements.

In conclusion, the announcement of ZE00-0388's selection heralds an exciting new chapter for Mondego Bio and the field of oncology. As the company gears up for its Phase 1 study, the implications of this research could significantly impact therapeutic strategies for cancer treatment in the near future. For more about Mondego Bio and its innovative research initiatives, visit www.mondegobio.com.