MedPath

MaaT013

Generic Name
MaaT013
Drug Type
Biotech
Background

MaaT013 is an allogeneic fecal microbiota therapy. It is being investigated for the treatment of Graft-Versus-Host Disease.

MaaT Pharma's MaaT034 Shows Promise in Enhancing Immunotherapy Response for Cancer Treatment

• MaaT Pharma presented promising preclinical data for MaaT034, a next-generation synthetic microbiome therapy designed to improve patient responses to cancer immunotherapies. • Studies in germ-free mice demonstrated that MaaT034 effectively engrafts in the gut, potentiates anti-tumor effects when combined with checkpoint inhibitors, and improves gastrointestinal functions. • As a donor-independent therapy developed using MaaT Pharma's proprietary MET-C platform, MaaT034 represents a significant advancement toward broader applications in oncology treatment.

Microbiome Therapeutics Pipeline Expands with 180+ Novel Therapies in Development Across 140 Companies

• The microbiome therapeutics landscape shows remarkable growth with over 140 companies actively developing 180+ pipeline drugs, spanning various disease areas and therapeutic approaches. • Recent clinical advances include promising results from MaaT Pharma's Phase 3 ARES study for GI-aGvHD and Vedanta Biosciences' Phase 2 CONSORTIUM study of VE303 for recurrent C. difficile infection. • Multiple innovative approaches are being pursued, including live biotherapeutic products, with companies like Microbiotica's MB097 showing potential in enhancing immunotherapy responses in cancer treatment.

MaaT Pharma's MaaT033 Receives Positive DSMB Review in Phase 2b Allo-HSCT Trial

• MaaT Pharma's MaaT033, an oral microbiome therapy, maintains a positive safety profile in the Phase 2b PHOEBUS trial, as confirmed by the second DSMB review. • The DSMB recommended the continuation of the trial without modifications, reinforcing the tolerability of MaaT033 in patients undergoing allogeneic hematopoietic stem cell transplantation (Allo-HSCT). • Patient enrollment in the Phase 2b trial is progressing well across multiple European countries, with 80 patients enrolled by the end of December 2024. • MaaT033 is being investigated as an adjunctive treatment to improve overall survival in Allo-HSCT recipients, addressing a critical need in cancer therapy.

MaaT Pharma Share Price Rises on Positive Clinical Trial Results

MaaT Pharma's share price surged over 19% following the announcement of successful Phase 3 clinical trial results for its MaaT013 treatment in acute graft-versus-host disease, marking a significant advancement in gastrointestinal response rates.

MaaT Pharma SA Advances in Gut Microbiome-Driven Therapies for Cancer Treatment

MaaT Pharma SA, a late-stage clinical company, is making significant progress in the development of gut microbiome-driven therapies aimed at modulating the immune system and improving cancer survival. The company's pipeline includes MaaT013, MaaT033, and MaaT03X, targeting acute graft versus host diseases, acute myeloid leukemia, and solid tumors, respectively.

MaaT013 Shows Promise in Phase 3 Trial for GI-aGvHD

• MaaT Pharma's MaaT013 met its primary endpoint in the Phase 3 ARES trial, demonstrating a 62% gastrointestinal overall response rate (GI-ORR) in patients with GI-aGvHD. • The study showed a 54% estimated 12-month overall survival rate, with responders at day 28 exhibiting a significantly higher survival rate of 67% compared to non-responders. • MaaT Pharma plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in mid-2025 for MaaT013 as a third-line treatment. • The ARES trial represents the first positive pivotal clinical study for a microbiome-based approach in GI-aGvHD, potentially offering a new treatment option for patients.

MaaT Pharma's MaaT013 Shows Promising Data in Acute Graft-versus-Host Disease

• MaaT Pharma presented updated data on MaaT013, showcasing sustained high response rates in patients with acute Graft-versus-Host Disease (aGvHD) from its Early Access Program. • The data revealed a gastrointestinal overall response rate of 51% at Day 28 and an overall response rate of 49% across all organs in the treated patients. • Long-term survival data indicated a 47% overall survival rate at 12 months and 42% at 24 months, demonstrating MaaT013's potential for durable benefit. • Median overall survival among responders to MaaT013 was significantly higher (444 days) compared to non-responders (42 days), suggesting a substantial clinical impact.

MaaT Pharma Announces First U.S. Patient Treated with MaaT013 for aGvHD Under Expanded Access Program

• MaaT Pharma has treated its first U.S. patient with MaaT013 for acute Graft-versus-Host Disease (aGvHD) under an FDA-approved compassionate access program. • The patient, having undergone multiple prior therapies, received MaaT013 at City of Hope Hospital, a leading cancer institution in Los Angeles. • This single-patient expanded access program allows for investigational drug use when standard therapeutic options are limited or unavailable. • MaaT Pharma is advancing a Phase 3 trial in Europe with topline results expected in January 2025 and plans a U.S. Phase 3 trial for aGvHD.

Graves' Disease and Graft-versus-Host Disease: Pipeline Therapeutics Update

• Several companies are actively developing novel therapies for Graves' Disease, targeting mechanisms like IGF-1R and FcRn. • Clinical trials are underway for Batoclimab (Phase III), VRDN-001 (Phase III), and Linsitinib (Phase II/III) to address Graves' Disease. • The Graft-versus-Host Disease pipeline includes over 65 drugs in development, with companies like MaaT Pharma and Syndax Pharmaceutical leading the way. • Therapies like MaaT013 and axatilimab are in advanced stages of clinical trials, offering potential new treatments for Graft-versus-Host Disease.

MaaT Pharma's MaaT013 Shows Promising Long-Term Efficacy in Refractory GI-aGvHD

• MaaT Pharma's MaaT013 demonstrates a 51% gastrointestinal overall response rate (GI-ORR) at day 28 in steroid-refractory or dependent gastrointestinal acute Graft-versus-Host Disease (GI-aGvHD) patients. • Long-term follow-up data reveals a 42% overall survival rate at 24 months, with significantly higher survival in patients responding to MaaT013 compared to non-responders. • In a subset of patients who previously received ruxolitinib, GI-ORR improved to 59% at day 28, suggesting enhanced efficacy in this specific population. • Topline results from the pivotal Phase 3 ARES trial evaluating MaaT013 in GI-aGvHD patients are expected in January 2025.

MaaT Pharma Completes Enrollment in Phase 3 Trial of MaaT013 for Acute Graft-versus-Host Disease

• MaaT Pharma has completed recruitment for its Phase 3 ARES trial evaluating MaaT013 in patients with steroid and ruxolitinib-refractory acute Graft-versus-Host Disease. • The ARES trial is a multicenter, European, open-label, single-arm study assessing the safety and efficacy of MaaT013, with topline results expected in January 2025. • MaaT013, a Microbiome Ecosystem Therapy, aims to modulate the immune system by optimizing gut microbiota balance and has shown high efficacy and low toxicity in earlier reviews. • MaaT Pharma anticipates commencing the registration process for MaaT013 in Europe in 2025, potentially marking the first approved microbiome-driven immunomodulator in oncology.

MaaT Pharma Announces Global Offering to Fund Microbiome Ecosystem Therapies Development

MaaT Pharma, a clinical-stage biotech company, has launched a global offering of approximately 18 million euros to fund the development of its Microbiome Ecosystem Therapies. The offering includes a reserved offering to specific investors and a public offering to retail investors, with the aim of supporting the company's Phase 3 trial for MaaT013 and expanding its pipeline development.

MaaT Pharma Advances Microbiome Therapeutics in Oncology

MaaT Pharma, a leading microbiome therapeutics company, is making significant strides in oncology with its innovative treatments. The company's lead product, MaaT013, is currently in phase 3 trials for gastrointestinal acute graft-versus-host Disease (GI-aGvHD), showing promising results. Additionally, MaaT Pharma is exploring the potential of its second candidate, MaaT033, in enhancing overall survival for HSCT and cellular therapy recipients, marking a pivotal moment in microbiome-based cancer treatment.
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