Mondego Bio has initiated a first-in-human Phase Ia clinical trial of MB‑388, an oral dual protein tyrosine phosphatase non-receptor type (PTPN2/PTPN1) inhibitor, which is designed to act in both tumour cells and immune cells to overcome resistance to cancer immunotherapy.
The placebo-controlled, randomised, double-blind trial is assessing MB‑388’s single and multiple ascending doses in healthy volunteers.
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It aims to evaluate the therapy’s tolerability and safety, characterise its pharmacokinetics, and measure target engagement using blood-based pharmacodynamic biomarkers.
The company anticipates initial human pharmacokinetic and pharmacodynamic results in December 2026.
Mondego Bio subsequently plans to start a Phase Ib trial in January 2027 for patients with advanced solid tumours who progressed during or after standard treatment, including checkpoint inhibitors.
After monotherapy dose levels are cleared, the trial will incorporate a combination run-in with programmed cell death ligand 1 (PD-(L)1) blockade covering both checkpoint-naive and checkpoint-refractory patients.
Readout from combination dose escalation is scheduled for December 2027.
Mondego Bio CEO Nikolay Savchuk said: “Starting the first clinical study of MB‑388 is an important milestone for Mondego. The Phase Ia study will define the relationship between exposure, pathway engagement and tolerability, giving us the data to move efficiently into our planned study in patients with cancer.”
In preclinical tumour models that responded or resisted PD-1 blockade, MB‑388 showed activity as a single agent and in combination with anti-PD-1 therapy, increasing intratumoral cluster of differentiation 8 (CD8)-positive T cells and granzyme B.
When tested against osunprotafib, a clinical-stage PTPN2/PTPN1 inhibitor, MB‑388 demonstrated higher oral exposure, longer target coverage, and a substantially higher unbound fraction in human plasma.
Based in Portugal, Mondego Bio focuses on developing small-molecule therapies that restore interferon-gamma signalling, increase antigen presentation, and enhance natural killer and T-cell function.
The company was founded with support from Biovance Capital, OrbiMed, and Torrey Pines Investment, with co-investment from the Fundo de Capital e Quase Capital, which is managed by Banco Português de Fomento and supported by the InvestEU Fund.
