Phase 1a study in healthy volunteers will assess safety, pharmacokinetics and pathway engagement; Phase 1b study in patients with advanced solid tumors planned to begin in January 2027

在健康志愿者中开展的1a期研究将评估安全性、药代动力学及通路参与情况；计划在2027年1月启动针对晚期实体瘤患者的1b期研究。

CANTANHEDE, Portugal

葡萄牙坎塔涅德

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Nov. 5, 2026

2026年11月5日

/PRNewswire/ -- Mondego Bio today announced the initiation of a first-in-human Phase 1 clinical study of MB‑388, an oral dual PTPN2/PTPN1 inhibitor designed to overcome resistance to cancer immunotherapy by acting in both tumor cells and immune cells.

/美通社/ -- Mondego Bio 今日宣布启动MB-388的首次人体I期临床研究。MB-388是一种口服双重PTPN2/PTPN1抑制剂，旨在通过同时作用于肿瘤细胞和免疫细胞，克服对癌症免疫疗法的耐药性。

The randomized, double-blind, placebo-controlled Phase 1a study will evaluate single and multiple ascending doses of MB‑388 in healthy volunteers. It will assess safety and tolerability, characterize pharmacokinetics (PK) and measure target engagement using blood-based pharmacodynamic (PD) biomarkers..

这项随机、双盲、安慰剂对照的1a期研究将在健康志愿者中评估MB-388的单次和多次递增剂量。该研究将评估安全性和耐受性，表征药代动力学（PK），并利用基于血液的药效学（PD）生物标志物测量靶点结合情况。

MB‑388 was designed to address a central limitation of this inhibitor class: achieving sustained target coverage with an oral molecule while preserving a therapeutic window broad enough for combination with checkpoint inhibitors. In head-to-head preclinical studies against osunprotafib, the leading clinical-stage PTPN2/PTPN1 inhibitor, MB‑388 showed a substantially higher unbound fraction in human plasma, higher oral exposure and longer target coverage.

MB-388 旨在解决该类抑制剂的一个核心局限性：在使用口服分子实现持续靶点覆盖的同时，保留足够宽的治疗窗口，以便与检查点抑制剂联合使用。在与处于临床阶段领先的 PTPN2/PTPN1 抑制剂 osunprotafib 进行的头对头临床前研究中，MB-388 在人血浆中显示出更高的游离分数、更高的口服暴露量以及更长的靶点覆盖时间。

MB‑388 also showed more than 1,000-fold selectivity over unrelated targets and favorable exposure margins in rodent and non-rodent safety studies..

MB-388在啮齿类和非啮齿类动物的安全性研究中，对非相关靶点显示出超过1000倍的选择性，并具有良好的暴露量安全边际。

In preclinical tumor models that respond to or resist PD‑1 blockade, MB‑388 was active both as monotherapy and in combination with anti-PD‑1 treatment. Treatment increased intratumoral CD8-positive T cells and granzyme B, consistent with the intended immune-mediated mechanism.

在对PD-1阻断有反应或耐药的临床前肿瘤模型中，MB-388无论是作为单药治疗还是与抗PD-1治疗联合使用均显示出活性。该治疗增加了肿瘤内CD8阳性T细胞和颗粒酶B的水平，这与预期的免疫介导机制一致。

'Starting the first clinical study of MB‑388 is an important milestone for Mondego,' said Nikolay Savchuk, PhD, Chief Executive Officer of Mondego Bio. 'The Phase 1a 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.'.

“启动MB-388的首项临床研究是Mondego的一个重要里程碑，”Mondego Bio首席执行官Nikolay Savchuk博士表示。“这项1a期研究将明确暴露量、通路参与度和耐受性之间的关系，为我们提供高效推进至计划中的癌症患者研究所需的数据。”

Mondego plans to begin a Phase 1b study in January 2027 in patients with advanced solid tumors who have progressed on or after standard therapy, including patients previously treated with checkpoint inhibitors. The study will first evaluate MB‑388 as monotherapy, then add a combination run-in with PD‑(L)1 blockade once initial monotherapy dose levels have been cleared.

Mondego计划于2027年1月启动一项Ib期研究，针对接受标准治疗后疾病进展（包括既往接受过免疫检查点抑制剂治疗）的晚期实体瘤患者。该研究将首先评估MB-388单药治疗的安全性，在初始单药剂量水平确认安全后，再开展与PD-(L)1抑制剂联合治疗的导入期研究。

The combination program will include both checkpoint-refractory and checkpoint-naive patients..

该联合治疗方案将包括对检查点抑制剂耐药的患者和未接受过检查点抑制剂治疗的患者。

Initial human PK and PD data are expected in December 2026, and a readout from combination dose escalation is planned for December 2027.

预计将于2026年12月获得初步的人体药代动力学（PK）和药效动力学（PD）数据，并计划于2027年12月公布联合给药剂量递增研究的结果。

About Mondego Bio

关于Mondego Bio

Mondego Bio is a Portugal-based biotechnology company developing small-molecule therapies to overcome resistance to cancer immunotherapy. The company was founded with backing from OrbiMed, Torrey Pines Investment and Biovance Capital, with co-investment from the Fundo de Capital e Quase Capital (FC&QC), managed by Banco Português de Fomento (BPF) and supported by the European Union under the InvestEU Fund.

Mondego Bio 是一家总部位于葡萄牙的生物技术公司，致力于开发小分子疗法，以克服对癌症免疫疗法的耐药性。该公司在 OrbiMed、Torrey Pines Investment 和 Biovance Capital 的支持下成立，并获得了由葡萄牙促进银行（BPF）管理的资本与准资本基金（FC&QC）的联合投资，该基金得到欧盟通过 InvestEU 基金提供的支持。

Its lead program, MB‑388, is an oral dual PTPN2/PTPN1 inhibitor designed to act in both tumor and immune cells by restoring interferon-gamma signaling, increasing antigen presentation and enhancing T-cell and natural killer (NK) cell function..

其主导项目 MB-388 是一种口服双重 PTPN2/PTPN1 抑制剂，旨在通过恢复干扰素-γ信号传导、增加抗原呈递以及增强T细胞和自然杀伤（NK）细胞功能，在肿瘤细胞和免疫细胞中发挥作用。

For more information, visit

更多信息，请访问

www.mondegobio.com

www.mondegobio.com

Forward-looking statements

前瞻性陈述

This press release contains forward-looking statements, including statements about the design, timing and results of clinical studies and the therapeutic potential of MB‑388. These statements involve risks and uncertainties, and actual results may differ materially. Mondego Bio undertakes no obligation to update them except as required by law..

本新闻稿包含前瞻性陈述，包括有关MB‑388的临床研究设计、时间安排和结果以及其治疗潜力的陈述。这些陈述涉及风险和不确定性，实际结果可能会有重大差异。除法律要求外，Mondego Bio没有义务更新这些陈述。

Media contact

媒体联系人

Rita Santos, PhD

丽塔·桑托斯，博士

External Outreach Director, Mondego Bio

Mondego Bio 对外联络总监

rsantos@mondegobio.com

rsantos@mondegobio.com

SOURCE Mondego Bio

来源：Mondego Bio