MaaT033 / MaaT Pharma - LARVOL DELTA

Restoration of Gut Microbiota Diversity with Oral Pooled Fecal Microbiotherapy in Acute Myeloid Leukemia Patients after Intensive Chemotherapy: The Phase 1b Cimon Trial (ASH 2022) - P1 | "For IC, 20 patients received cytarabine associated with an anthracycline, 1 patient received azacytidine. Conclusion The CIMON study results show that MaaT033 is safe, well tolerated and effective for gut microbiota restoration in AML patients receiving IC and ATB. A Phase II/III trial is planned to evaluate MaaT033 in preventing allo-HSCT complications."

Clinical • P1 data • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Dermatology • Febrile Neutropenia • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Neutropenia • Oncology • Septic Shock • Transplantation • IL2

Allogenic Hematopoietic Stem Cell Transplant (allo-HSCT) - MaaT033 (Businesswire) - "The Phase 2 PHOEBUS trial is ongoing and is potentially pivotal in Europe. Topline results (1-year overall survival) are expected in Q4 2028."

P2 data • Transplantation

IMMUNOLIFE2: Oral Pooled Fecal Microbiotherapy (MaaT033) Concomitant to Cemiplimab Versus Best Investigator's Choice in Patients With Resistance to Treatment Due to Antibiotics Uptake With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=162 | Recruiting | Sponsor: Gustave Roussy, Cancer Campus, Grand Paris | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Adenocarcinoma • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Pipeline progress continues (Businesswire) - "MaaT033, currently in Phase 2b potentially pivotal trial (PHOEBUS), is ongoing and continued to demonstrate a favorable safety profile, with six DSMB reviews completed in 2025. Topline results for PHOEBUS study are now expected in Q4 2028 (instead of Q4 2027)."

P2b data • Transplantation

MAAT033 FOR GUT MICROBIOTA OPTIMIZATION TO IMPROVE SURVIVAL AFTER ALLOGENEIC HCT: THE PHOEBUS TRIAL (EBMT 2026) - P2 | "Exclusion criteria comprise non-myeloablative and conventional myeloablative conditioning regimen, in vitro T-cell depletion, alloHCT with cord blood cells, use of alemtuzumab, vedolizumab or abatacept for GvHD prophylaxis, and history of chronic digestive disease.Study recruitment is ongoing in France, Germany, Spain, Belgium, The Netherlands and the UK. The PHOEBUS trial explores for the first time the potential of a full microbiota ecosystem therapy to enhance survival in alloHCT recipients. Recruitment is ongoing and preliminary safety assessments are favorable."

Gut Microbiota • Acute Graft versus Host Disease • Chronic Graft versus Host Disease • Gastroenterology • Gastrointestinal Disorder • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease

MAAT033 FOR GUT MICROBIOTA OPTIMIZATION TO IMPROVE SURVIVAL AFTER ALLOGENEIC HCT: THE PHOEBUS TRIAL (EBMT 2026) - P2 | "Exclusion criteria comprise non-myeloablative and conventional myeloablative conditioning regimen, in vitro T-cell depletion, alloHCT with cord blood cells, use of alemtuzumab, vedolizumab or abatacept for GvHD prophylaxis, and history of chronic digestive disease.Study recruitment is ongoing in France, Germany, Spain, Belgium, The Netherlands and the UK. The PHOEBUS trial explores for the first time the potential of a full microbiota ecosystem therapy to enhance survival in alloHCT recipients. Recruitment is ongoing and preliminary safety assessments are favorable."

Gut Microbiota • Acute Graft versus Host Disease • Chronic Graft versus Host Disease • Gastroenterology • Gastrointestinal Disorder • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease

MaaT Pharma to Present Four Abstracts at the 52nd European Bone Marrow Transplantation Annual Meeting and to Highlight Clinigen-Hosted Industry Symposium on acute GvHD Management (Yahoo Finance) - "Oral presentation during Presidential Plenary Session to feature the final results of the ARES pivotal Phase 3 trial evaluating MaaT013 in acute Graft‑versus‑Host Disease (aGvHD) with gastrointestinal involvement...In addition, MaaT Pharma will present three poster communications, featuring: Key results from CHRONOS, a multicenter retrospective cohort study describing real‑world outcomes in third‑line acute gastrointestinal GvHD, and The study designs of two clinical trials (PHOEBUS and THRASSA- pediatric study announced in March 2025) advancing the Company’s therapeutic pipeline."

Clinical data • Trial status • Acute Graft versus Host Disease

MaaT Pharma Announces First Patient Randomized in IMMUNOLIFE Phase 2 Study Sponsored by Gustave Roussy, To Explore the Role of the Gut Microbiome To Overcome ICI Resistance in Advanced NSCLC Patients with Antibiotic-Induced Dysbiosis (Businesswire) - "Primary results after 1-year follow-up post-treatment could be expected in late 2030. An interim futility analysis around H1 2027, after the 81st randomized patient."

P2 data • Trial status • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer

A Multicentre, Randomized, Double-Blinded, Phase 2b Study Evaluating the Efficacy and Safety of MaaT033, an Oral, Pooled Microbiome Ecosystem Therapy in Patients Undergoing Allogenic Hematopoietic Cell Transplantation to Improve Overall Survival: The Phoebus Trial (ASH 2023) - P2 | "Exclusion criteria comprise non-myeloablative conditioning regimen, conventional myeloablative conditioning regimen, in-vitro T-cell depletion, alloHCT with cord blood cells, alloHCT from an unrelated donor with ≥ 3/10 HLA-mismatches, use of alemtuzumab, vedolizumab or abatacept for GvHD prophylaxis, history of chronic digestive disease...Exploratory endpoints will describe the impact of MaaT013 on immune recovery, the nutritional status of the patients, and resource utilization...The study is approved in France and Germany; expansion to other countries is planned for 2024. Study start is expected in September 2023."

Clinical • P2b data • Acute Graft versus Host Disease • Chronic Graft versus Host Disease • Gastroenterology • Gastrointestinal Disorder • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Oncology • Transplantation

MaaT Pharma Launches a Capital Increase of Approximately €9 Million (Businesswire) - "Preparation of the commercialization of Xervyteg and related regulatory activities in Europe during the second half of 2026, in collaboration with our commercial partner, contingent upon Xervyteg approval (potential marketing authorization (MA) could be delivered around mid-2026). Advancement of MaaT033 clinical development in Europe, currently being evaluated in an ongoing Phase 2b trial, designed to be pivotal, aimed at improving survival in patients undergoing allogeneic hematopoietic stem cell transplantation."

Financing • Acute Graft versus Host Disease • Transplantation

MaaT Pharma Announces Positive Second Safety Interim Analysis from DSMB for Phase 2b PHOEBUS Trial Evaluating MaaT033 for Patients Receiving Allo-HSCT (Businesswire) - "The DSMB reviewed unblinded safety data on 120 enrolled patients (including 60 patients randomized to receive MaaT033) and monitored patients for 90 days after allo-HSCT as per the trial protocol...Following its review, the DSMB recommended that the study continue as planned, having identified no safety concerns and no excessive mortality related to MaaT033 as of today...All assessments to date have confirmed a favorable safety profile for MaaT033, and recommended continuation of the trial without modifications....Next steps include the routine DSMB review for ongoing safety for MaaT033, conducted every six months, with the next analysis expected for the first quarter of 2026."

DSMB • P2b data • Transplantation

…MaaT033 – Exploratory trials using the MET-N platform (donor derived conducted as Investigator-Sponsored Trials (ISTs) to inform further developments (MaaT Pharma Press Release) - "This investigator-sponsored, randomized, multicenter Phase 2 trial will evaluate MaaT033 in patients with advanced non-small cell lung cancer (NSCLC), with MaaT Pharma supplying the investigational product. The trial is expected by the sponsor to start in H2 2025."

Trial status • Non Small Cell Lung Cancer

Allogenic Hematopoietic Stem Cell Transplant (allo-HSCT) - MaaT033 (Businesswire) - "The last patient enrollment in the trial is anticipated for mid-2026 while the 1-year OS results are expected in H2 2027."

Enrollment status • P2b data • Transplantation

MAAT033 TO ENSURE OPTIMAL GUT MICROBIOTA TO IMPROVE SURVIVAL IN PATIENTS? RECEIVING ALLOGENEIC HCT: PHOEBUS TRIAL (EHA 2025) - "Exclusion criteria comprise non-myeloablative and conventional myeloablative conditioning regimen in vitro T-cell depletion alloHCT with cord blood cells use of alemtuzumab vedolizumab or abatacept for GvHD prophylaxis and history of chronic digestive disease.Study recruitment is currently ongoing in France Germany Spain Belgium The Netherlands and the UK. The PHOEBUS trial explores for the first time the potential of a full microbiota ecosystem therapy to enhance survival in alloHCT recipients. Recruitment is ongoing and preliminary safety assessments are favorable."

Clinical • Gut Microbiota • Acute Graft versus Host Disease • Chronic Graft versus Host Disease • Gastroenterology • Gastrointestinal Disorder • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Oncology

IASO: Safety and Gut Microbiota Analysis of an Oral Microbiotherapy in Patients With Amyotrophic Lateral Sclerosis (clinicaltrials.gov) - P1 | N=15 | Completed | Sponsor: MaaT Pharma | Active, not recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ Jul 2024

Trial completion • Trial completion date • Amyotrophic Lateral Sclerosis • CNS Disorders

IMMUNOLIFE2: Oral Pooled Fecal Microbiotherapy (MaaT033) Concomitant to Cemiplimab Versus Best Investigator's Choice in Patients With Resistance to Treatment Due to Antibiotics Uptake With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=162 | Not yet recruiting | Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

MaaT Pharma To Present Updated Data for MaaT013 in Early Access Program at the European Hematology Association (EHA) Annual Congress (Businesswire) - "Oral presentation will highlight updated data in Early Access Program (EAP) for 173 patients with acute Graft-vs-Host Disease (aGvHD) treated with MaaT013. Poster presentation selected for ongoing Phase 2b trial of MaaT033 in patients receiving allogeneic hematopoietic stem cell transplantation (allo-HSCT)"

Clinical data • Clinical protocol • Acute Graft versus Host Disease

MaaT Pharma Announces Promising Final Data Readout for Phase 1b Evaluating MaaT033 in Amyotrophic Lateral Sclerosis (ALS) (Businesswire) - P1 | N=15 | NCT05889572 | Sponsor: MaaT Pharma | "An external Scientific Advisory Committee took place at the end of March 2025 to review the full data. Below are the key takeaways from the Committee’s review: MaaT033 demonstrated a favorable safety and tolerability profile, supported by biomarker and microbiome analyses. A rapid and sustained engraftment of bacterial species from MaaT033 was observed, mostly occurring within the first month and maintained during the 1-month follow-up period. A slower rate of disease progression (based on ALSFRS-R slopes) was noted to be interpreted with caution given the short follow up, limited sample size and single-arm Phase 1b design."

P1 data • Amyotrophic Lateral Sclerosis

The Capital Increase will enable the Company to pursue its developments plan and confirm its potential for being a key player in hemato-oncology. (Businesswire) - "...the Company is targeting to submit its Market Authorization Application for MaaT013 in aGvHD with the European agency in June 2025, with a potential approval expected in H2 2026; the Company is also preparing for a commercial launch in Europe, based on compelling Phase 3 data released in January 2026...in the US, the Company is preparing for the launch of a dedicated US Phase 3 trial in aGvHD...in view of a late 2026 commercial launch, if approved...the Company will continue the ongoing allo-HSCT Phase 2b study 'PHOEBUS' (1yr-OS read out expected in late 2027)."

EMA approval • EMA filing • Launch Europe • Launch US • P2b data • Acute Graft versus Host Disease • Transplantation

MaaT Pharma Announces Positive Safety Interim Analysis from DSMB for Phase 2b Trial Evaluating MaaT033 for Patients Receiving Allo-HSCT (Businesswire) - P2b | N=387 | PHOEBUS (NCT05762211) | Sponsor: MaaT Pharma | "MAAT...announced the positive outcome of a key DSMB safety interim analysis for the Phase 2b trial PHOEBUS, the world’s largest randomized controlled trial evaluating microbiome therapy in oncology to date....As a result of their unblinded analysis, the DSMB recommended the trial to proceed as planned, showing no excessive mortality related to MaaT033 as of today. This additional positive outcome further reinforces MaaT033’s safety profile and supports MaaT033’s integration in the allo-HSCT setting without significant risks of severe adverse events....The next DSMB unblinded interim analysis with mortality monitoring is scheduled for Q3 2025 at the 120-patient mark. The routine DSMB review for ongoing safety, conducted every six months, is also expected for Q3 2025."

DSMB • P2b data • Transplantation

Gut microbiota restoration with oral pooled fecal microbiotherapy after intensive chemotherapy: the phase Ib CIMON trial. (PubMed, Blood Adv) - P1 | "The purpose of this dose-ranging phase I study (CIMON) was to evaluate the first-in-man use of MaaT033, a pooled, allogeneic, lyophilized, and standardized fecal microbiotherapeutic product, formulated as a delayed-release capsule for oral administration...Moreover, inflammatory markers (C-reactive protein, interleukin-6) decrease with treatment, while short-chain fatty acids increase over time. A randomized, placebo-controlled phase IIb trial, in recipients of alloHCT patients in ongoing."

Journal • P1 data • Transplantation • CRP • IL6

MaaT Pharma Announces Positive Second DSMB Review of Ongoing Phase 2b Clinical Trial Evaluating MaaT033 for Patients Receiving Allo-HSCT (Businesswire) - "MaaT Pharma...announced that the DSMB completed its second safety assessment of the Phase 2b trial PHOEBUS, the largest randomized controlled trial assessing microbiome therapy in oncology to date, and recommended continuation of the trial without modification. The routine DSMB, which convenes every six months, is composed of 5 independent experts, reviewed safety data on 59 patients (cutoff date as of October 31st, 2024) and concluded that MaaT033 is well tolerated and has an acceptable safety profile....Upcoming milestones include the routine DSMB review for ongoing safety, conducted every six months, as well as a DSMB assessing mortality imbalance between arms, respectively at 60 patients (expected in Q1 2025) and at 120 patients (expected in Q3 2025), after 90 days of follow-up post Allo-HSCT."

DSMB • Transplantation

Oral Pooled Fecal Microbiotherapy to Prevent Allogeneic Hematopoietic Cell Transplantation Complications (PHOEBUS Trial) (clinicaltrials.gov) - P2 | N=387 | Recruiting | Sponsor: MaaT Pharma | Phase classification: P2b ➔ P2

Phase classification • Hematological Malignancies • Transplantation

MaaT Pharma Announces Positive Phase 1b Results, Meeting Primary Endpoint in the Evaluation of MaaT033 in Amyotrophic Lateral Sclerosis (ALS) (Businesswire) - P1 | N=15 | IASO (NCT05889572) | Sponsor: MaaT Pharma | "MaaT Pharma...announced that the exploratory single-arm, open-label Phase 1b clinical trial named IASO (NCT05889572) evaluating MaaT033 in ALS has met its primary endpoint assessing the safety and tolerability of MaaT033 with multiple doses. The independent Data Safety and Monitoring Board (DSMB) concluded that MaaT033 showed good safety and tolerability in ALS patients when dosed for two months. Preliminary microbiome analysis confirms the successful engraftment of MaaT033, the Company’s oral capsule, outlining further the safety and tolerability outcome...Additional study endpoints are expected to be analysed in the coming months. Based on the current evidence from the Phase 1b IASO study, the DSMB supports proceeding to Phase 2. MaaT Pharma plans to determine the next steps based on a comprehensive analysis of the study’s overall data, expected in early 2025."

DSMB • P1 data • Amyotrophic Lateral Sclerosis • CNS Disorders

Baseline and safety data from IASO, a pioneering open-label phase 1b pilot trial assessing the safety, tolerability and gut microbiota Analysis of an Oral microbiotherapy in amyotrophic lateral sclerosis (ALS-MND 2024) - P1 | "A total of 18 patients meeting the Revised El Escorial criteria for possible, probable, laboratory-supported probable or definite ALS were screened for eligibility, of whom 15 qualified to initiate the bowel preparation (Baseline) and 14 initiated MaaT033 treatment in 2 ALS expert centers in France. The main baseline demographic and disease characteristics are: 64% male, 36% female, median age (min; max) of 59 (34; 74) years old, 93% limb onset. An initial Data Safety Monitoring Board found that MaaT033 was generally well tolerated with a good safety profile based on the clinical data from the first 8 patients who received at least one dose of MaaT033."

Clinical • Gut Microbiota • P1 data • Amyotrophic Lateral Sclerosis • CNS Disorders • Inflammation