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

The post Mondego Bio Announces Selection of a PTPN2 Inhibitor Clinical Candidate and Targets First-in-Human Trials in H1 2026 appeared first on Mondego Bio.

• Mondego Bio is a new Portuguese startup developing breakthrough cancer treatments.
• Mondego Bio was founded by these three investors and represents Biovance Capital Fund I’s inaugural investment.

Lisbon, Portugal – 18 September 2025 – Biovance Capital Partners, a biotech venture capital firm based in Lisbon, Portugal, alongside co-investors OrbiMed, a leading healthcare investment firm, with over $17 billion in assets under management and Torrey Pines Investment, a specialty life-science investment company, announced today the Series A funding of Mondego Bio. Headquartered in Portugal’s main biotech park, Biocant, Mondego Bio is developing best-in-class protein tyrosine phosphatase non-receptor type 2 (PTPN2) inhibitors, providing a potential immuno-oncological therapy with an improved safety and tolerability profile.

As a critical negative regulator of the JAK-STAT pathway, PTPN2 functions to directly regulate signaling through cytokine receptors, including IFNγ receptor. Thus, enhancing IFNγ sensing and signaling through the inhibition of PTPN2 is a potential therapeutic strategy to improve the efficacy of cancer immunotherapy regimens.

“This marks the first investment by Biovance Capital Fund I, which looks to provide crucial capital to develop transformational therapies for unmet medical needs, and attract world-class scientists and investors to Portugal”, said Ricardo Perdigão Henriques, PhD, Managing Partner of Biovance Capital, the investment firm leading the round .“We are excited to join forces with top-tier US healthcare investors to help accelerate safer, more effective treatments—and, ultimately, better outcomes for patients battling cancer,” added João Incio, MD PhD, General Partner of Biovance Capital. “We see this investment as an great excellent opportunity to advance a groundbreaking innovation with the potential to reshape current immunotherapy in oncology”, said André Albergaria, PhD, Principal of Biovance Capital.

“With very compelling science, we are excited to back Mondego Bio’s work on PTPN2 inhibitors in immuno-oncology, marking our first investment in Southern Europe and a successful collaboration with OrbiMed and Biovance Capital” said Nikolay Savchuk, PhD, Managing Partner of Torrey Pines Investment.

“It is great to have Biovance Capital as a local partner in Portugal supporting the development of this company” added Iain Dukes, PhD, Venture Partner at OrbiMed.

The lead programs are based on research initially developed by Eilean Therapeutics, an AI/ML supported oncology platform co-founded by OrbiMed and Torrey Pines.

About Biovance Capital

Biovance Capital is Portugal’s leading life sciences venture capital firm. The company manages Biovance Capital Fund I, a new venture capital fund with a total of € 57 million from the European Investment Fund, the largest Portuguese pharmaceutical company BIAL, the national promotional bank Banco Português de Fomento, the European Commission through the Portugal Tech and Invest EU programs, and private investors from Portugal and abroad. The fund invests in early-stage drug development companies across Europe, with a special focus on Southern Europe. For more information, please visit  www.biovancecapital.com.

About OrbiMed

OrbiMed is a leading healthcare investment firm, with over $17 billion in assets under management. OrbiMed invests globally across the healthcare industry, from start-ups to large multinational corporations, through private equity funds, public equity funds, and royalty/credit funds. OrbiMed seeks to be a capital provider of choice, providing tailored financing solutions and extensive global team resources to help build world-class healthcare companies. OrbiMed’s team of over 100 professionals is based in New York City, London, San Francisco, Shanghai, Hong Kong, Mumbai, Herzliya, and other key global markets. For more information, please visit  www.orbimed.com. 

About Torrey Pines Investment

Torrey Pines Investment, based in San Diego, CA, has focused on early to commercial-stage breakthrough medicines since 2002. Its therapeutic interests include oncology, neurodegenerative and cardiometabolic disorders, infectious diseases, and more. For more information, please visit www.torreypinesinv.com.

Media and Investor Contact:

Ana Agostinho
Office Manager,
Biovance Capital Partners
t: +351 21 982 93 60, e: info@biovancecapital.com

Sanja Tomovska, PhD
Venture Partner,
Torrey Pines Investment
t: +41 795416216, e: stomovska@mondegobio.com

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Mondego Bio today announced preliminary safety and efficacy results for its leading PTPN2 inhibitor, ZE00-0388, presented at the EMBO Workshop Phosphatases: From Basic Research to Translation (July 27–31, 2025, Würzburg, Germany).
The company confirmed on-target modulation of the JAK-STAT pathway and stimulation of IFNγ release in human PBMCs by its lead compounds. ZE00-0388 also demonstrated strong oral bioavailability and significant efficacy when combined with anti–mPD-1 therapy in subcutaneous MC38 colon cancer models in female C57BL/6 mice.
The combination therapy not only halted tumor growth but also induced complete and sustained tumor regression, even after discontinuation of anti–mPD-1 treatment. Across all tested doses, Mondego’s lead compounds showed favorable safety and tolerability profiles.
“These data highlight the potential of ZE00-0388 and our PTPN2 inhibitor program to advance immuno-oncology therapies,” said Sanja Baumann-Tomovska, PhD Mondego Head of BD&L

The post Mondego Bio Presents Promising Preclinical Data on PTPN2 Inhibitor ZE00-0388 at EMBO Workshop appeared first on Mondego Bio.

Chicago, IL – April 30, 2025

Source:  AACR website

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