MaaT Pharma Secures €37.5 Million EIB Loan to Advance Hemato-Oncology Programs
MaaT Pharma, a pioneering clinical-stage biotechnology company focused on Microbiome Ecosystem Therapies™ (MET) to enhance survival for cancer patients through immune modulation, today announced it has secured a €37.5 million loan from the European Investment Bank (EIB). This significant financing marks a pivotal step in accelerating MaaT Pharma's late-stage clinical programs in hemato-oncology.
The EIB's funding aligns with its strategic commitment to supporting innovative biotech companies, particularly those with cutting-edge expertise in therapeutic areas like hemato-oncology. This structured debt financing is a crucial component of MaaT Pharma's multi-source funding strategy, reflecting confidence in the company's scientific approach and pipeline.
Key Programs to Benefit from the Loan:
The €37.5 million loan will be disbursed in four tranches (€3.5M, €6.0M, €8.0M, and €20.0M) and will primarily fuel the advancement of MaaT Pharma's lead hemato-oncology clinical assets:
Xervyteg® (MaaT013): This is MaaT Pharma's lead investigational asset, designed to treat acute Graft-versus-Host Disease (aGvHD), a severe and often life-threatening complication following allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Regulatory Status: Xervyteg® is currently under regulatory review by the European Medicines Agency (EMA) for potential marketing authorization. MaaT Pharma submitted its Marketing Authorization Application (MAA) to the EMA in June 2025, following positive topline results from its pivotal Phase 3 ARES study (NCT04769895). The ARES study demonstrated a significant gastrointestinal overall response rate of 62% at Day 28 and an estimated 1-year overall survival of 54%. A potential marketing authorization could be granted around mid-2026.
Commercialization: MaaT Pharma recently partnered with Clinigen for the commercialization of Xervyteg® in Europe, anticipating a potential 2026 launch if approved.
Early Access Program (EAP): The company continues to provide Xervyteg® through its EAP in Europe and the US, addressing increasing physician demand for patients with aGvHD and other indications. If approved, Xervyteg® is poised to become the first microbiota therapeutic approved by the EMA and the first approved therapy globally in third-line gastrointestinal aGvHD.
MaaT033: This is another significant oral-form drug candidate in MaaT Pharma's pipeline.
Clinical Evaluation: MaaT033 is currently undergoing Phase 2b clinical evaluation in the PHOEBUS trial (NCT05762211). This international, multi-center, randomized, double-blind, placebo-controlled study is investigating MaaT033's efficacy in improving overall survival at 12 months for patients with blood cancer undergoing allo-HSCT. It is currently the largest randomized controlled trial evaluating a microbiome therapy in oncology, aiming to enroll 387 patients across up to 56 sites.
Safety Profile: Positive safety interim analyses from the PHOEBUS trial, including a review after 30 patients were treated for 90 days, have shown no early safety concerns or excess mortality, allowing the trial to continue as planned. A next unblinded interim analysis is scheduled for Q3 2025 at the 120-patient mark.
Prior Results: Positive results from a Phase 1b trial in hemato-oncology (CIMON clinical results) indicated good microbiome engraftment, persistence, and a satisfactory safety profile for MaaT033.
MaaT Pharma's Innovative Approach:
MaaT Pharma's core focus is on Microbiome Ecosystem Therapies (MET). These therapies aim to restore a healthy gut microbiota balance, which in turn modulates the immune system to improve patient outcomes in cancer. The company leverages proprietary pooling and co-cultivation technologies to develop high-diversity, standardized drug candidates.
This substantial EIB loan not only provides critical financial resources but also strongly reinforces confidence in MaaT Pharma's innovative approach and the significant potential of microbiome-based therapies to address critical unmet medical needs in hemato-oncology.
I'm Aisha shehu
Talksocialtalka News
