Clinical Archives - ��

October 19, 2026: �� Receives FDA Feedback Following Pre-IND Meeting Supporting Continued Development of MaaT034 in Solid Tumors

�� — Mon, 19 Oct 2026 15:39:39 +0000

�� Receives FDA Feedback Following Pre-IND Meeting Supporting Continued Development of MaaT034 in Solid Tumors

Positive pre-Investigational New Drug (pre-IND) interaction with the Food Drug Administration (FDA) on Chemistry, Manufacturing and Controls (CMC) and nonclinical topics supports MaaT034’s continued advancement
FDA alignment on the IND-enabling strategy indicates that no additional non-clinical studies are anticipated to be required to support the safety of MaaT034 administration

��

Lyon, France, October 19, 2026 – 6:30pm CET��– �� (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies^TM(MET) dedicated to enhancing survival for patients with cancer through immune modulation, announced productive and constructive feedback from the U.S. FDA following its pre-IND interaction for MaaT034 in potential solid tumor indications including Non-Small Cell Lung Cancer, Melanoma and Renal Cell Carcinoma, focused on CMC and nonclinical development.

Based on the information provided, and pending the receipt and confirmation of the FDA’s final meeting summary, the FDA indicated that ��’s proposed science- and risk-based development approach appears appropriate, subject to review of the complete IND submission. The FDA also indicated that no additional nonclinical studies are required to support the safety of MaaT034 administration. The FDA requested additional information from completed studies for inclusion in the IND submission.

“The positive outcome of our pre-IND interactions with the FDA reinforces the development pathway for MaaT034 and supports its continued advancement toward the clinic. It also represents an important step in ��’s expansion into immuno-oncology, highlighting the broader potential of our first in class co-cultivated microbiome donor-independent platform across cancer care,” said Hervé Affagard, CEO and co-founder of ��.

�� plans to continue its IND-enabling activities and further engage with the FDA through a Type C meeting focused on the proposed clinical development plan and first-in-human study design.

Subject to obtaining the necessary regulatory clearances and the availability of appropriate funding and taking into account the Company’s estimated cash runway to December 2026, �� could initiate a First-in-Human study evaluating MaaT034 in late 2027. To support the clinical development of MaaT034, the Company is exploring financing opportunities from investors and strategic partnerships.

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About ��
�� is a leading, late-stage clinical company focused on developing innovative gut microbiome-driven therapies to modulate the immune system and enhance cancer patient survival. Supported by a talented team committed to making a difference for patients worldwide, the Company was founded in 2014 and is based in Lyon, France.��As a pioneer, �� is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, �� develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. �� has been listed on Euronext Paris (ticker: MAAT) since 2021.

About MaaT034
MaaT034, currently in preclinical development, is a next-generation donor-independent functionally selected, co-cultured microbial ecosystem, designed to improve patient responses to immunotherapy in combination with Immune Checkpoint Inhibitors (ICIs). Developed using ��’s proprietary MET-C co-culturing platform, MaaT034 is optimized for large-scale manufacturing and designed to deliver key microbial functions associated with anti-tumor immune responses.
Preclinical data presented at the AACR and at SITC annual meetings demonstrated that MaaT034 produced key metabolites, recognized as promoting gut barrier restoration and modulating immune responses, such as Short-Chain Fatty Acids (SCFA), secondary bile acids, and tryptophan derivatives. These data support the potential of MaaT034 to promote gut barrier restoration, enhance T-cell activation, and increase anti-tumor activity when combined with anti-PD-1 or anti-PD-L1 therapies.
By restoring microbiome-mediated functions and modulating immune responses, MaaT034 is designed to complement the mechanism of action of immune checkpoint inhibitors and has the potential to improve treatment outcomes in patients with advanced solid tumors.

Forward-looking Statements
All statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company’s control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as “target,” “believe,” “expect,” “aim”, “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could” and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company’s control that could cause the Company’s actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements.

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September 21, 2026: �� Announces Upcoming Pre-IND Meeting with the FDA and Advances MaaT034 Toward Clinical Development in Solid Tumors

�� — Mon, 21 Sep 2026 16:05:22 +0000

�� Announces Upcoming Pre-IND Meeting with the FDA and Advances MaaT034 Toward Clinical Development in Solid Tumors

Pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA), focused on CMC (Chemistry, Manufacturing, and Controls), is scheduled for October 2026, representing the next key regulatory milestone for MaaT034
A First-in-Human study has been designed to determine the optimal dosing and pre-treatment regimen and generate initial clinical proof-of-concept data
Initial clinical development planned in combination with PD-(L)1 inhibitors in solid tumors with high unmet medical needs and limited treatment options, including second-line advanced non-small cell lung cancer (NSCLC), refractory advanced melanoma and other solid tumors
The First-in-Human study could be initiated in late 2027, subject to obtaining the appropriate funding and necessary regulatory clearance

��

Lyon, France, September 21, 2026 – 7:00pm CET��– �� (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies^TM(MET) dedicated to enhancing survival for patients with cancer through immune modulation, today announced the next clinical development steps for MaaT034, the first functionally-selected, co-cultured microbial ecosystem from the Company’s innovative donor-independent MET-C platform, to be evaluated in combination with PD-(L)1 inhibitors in advanced solid tumors.

The MET-C platform combines rational candidate design, artificial intelligence-enabled computational tools for functional feature selection and unique co-culture technology to produce functionally selected microbial ecosystems at an industrial scale. MaaT034 is the first candidate to emerge from this platform and is specifically designed with the objective of optimizing intestinal microbiome functions and to support antitumor immune responses in combination with immune checkpoint inhibitors.

�� has scheduled a Pre-IND CMC-focused meeting with the FDA in October 2026, the next regulatory milestone toward clinical development of MaaT034. The program’s progression toward clinical development is based on a series of preclinical findings presented at the AACR and SITC Annual Meetings¹.

MaaT034 is expected to be developed in combination with PD-(L)1 inhibitors in selected advanced solid tumors, including second-line NSCLC and refractory advanced melanoma, as well as in other solid tumors characterized by significant unmet medical needs and limited treatment options. By modulating the gut microbiome, MaaT034 is designed to help restore anti-tumor immunity and sensitivity to PD-(L)1 inhibitors, with the aim of overcoming acquired resistance and improving outcomes beyond current standard of care benchmarks.

Subject to obtaining the necessary regulatory clearances and the availability of appropriate funding, �� could initiate a First-in-Human study evaluating MaaT034 in late 2027. To support the clinical development of MaaT034, the Company is exploring financing opportunities from investors and strategic partnerships with pharmaceutical companies.

[1] Preclinical data for MaaT034 have been presented at AACR and SITC annual meetings since 2023. Posters are available in the dedicated section of the Company’s website.

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September 18, 2026: �� Provides Update on MaaT013 (Xervyteg®) Potential Development Plan Following CHMP Negative Opinion After Re-examination

�� — Fri, 18 Sep 2026 04:34:32 +0000

�� Provides Update on MaaT013 (Xervyteg®) Potential Development Plan Following CHMP Negative Opinion After Re-examination

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a negative opinion on the Company’s application for a Conditional Marketing Authorization (CMA) for MaaT013 (Xervyteg®), confirming the trend communicated on September 15, 2026, following the Oral Explanation
During the application process, �� proposed conducting a randomized controlled Phase 3 trial versus Best Available Therapy (BAT), named PHOENIX, which would serve the purpose of regulatory submission in the U.S., Europe and other territories
Food and Drug Administration (FDA) Type C feedback supports advancement of the pivotal PHOENIX Phase 3 trial which could enable study initiation leading to a potential first patient enrollment in H1 2027, subject to appropriate funding and regulatory clearance

Lyon, France, September 18, 2026 – 7:30am CET��– �� (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies^TM(MET) dedicated to enhancing survival for patients with cancer through immune modulation, today announced that the CHMP of the EMA has maintained its negative opinion on the CMA application for MaaT013, under the brand name Xervyteg®, for the treatment of acute Graft-versus-Host Disease (aGvHD) in adult patients with gastrointestinal involvement refractory to prior lines of therapy following re-examination. The European Commission is expected to issue its final decision following the CHMP opinion in accordance with the applicable regulatory process¹. The Company also indicates that future developments of MaaT013 (Xervyteg®) will focus on advancing the PHOENIX randomized clinical trial, subject to appropriate financing and regulatory clearance. The Company is actively exploring options to start U.S. focused development plan for MaaT013 (Xervyteg®) with a view to enabling potential global registration.

The CHMP maintained its view in its formal opinion adopted on September 18, 2026 that the available clinical data package based on single arm trial does not allow sufficient characterization of the benefit-risk profile of MaaT013 (Xervyteg®). As part of the re-examination process, �� presented plans for PHOENIX, a global randomized controlled Phase 3 trial intended to generate the additional evidence requested by regulators to further characterize the benefit-risk profile of MaaT013.

�� is advancing the U.S. clinical readiness for PHOENIX, including completion of a feasibility assessment across major clinical trial sites in US and other planned countries. In addition, feedback received following a Type C interaction with the FDA supports advancement of PHOENIX as a registrational Phase 3 trial and provides a framework for finalizing the study protocol and progressing U.S. development activities, including clinical site activation.

Subject to appropriate funding and regulatory clearance, PHOENIX is planned to be conducted across the U.S., Europe and sites in other regions and could also support potential future registration submissions, subject to successful execution and positive results.

PHOENIX is a randomized, controlled, open-label Phase 3 trial evaluating MaaT013 (Xervyteg®) versus pre-specified BAT in patients with corticosteroid- and ruxolitinib-refractory aGvHD. The study is expected to enroll approximately 138 patients randomized 1:1 and will evaluate Day 28 all-organ Overall Response Rate as its primary endpoint, alongside key secondary efficacy and safety endpoints.

In this context, the Company is conducting a strategic review of its assets while taking additional cash preservation measures, to further extend its cash horizon to December 2026 (vs November 2026), based on current operational assumptions.

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About acute Graft-versus-Host Disease
Acute Graft-versus-Host Disease occurs in patients within 100 days of undergoing a stem cell or bone marrow transplant, where the transplanted cells initiate an immune response and attack the transplant recipient’s organs, causing inflammation of the skin, liver and/or gastrointestinal tract and leading to significant morbidity and mortality. GI involvement is associated with severe complications such as profound diarrhea, abdominal pain, intestinal bleeding, and death. These complications are often life-threatening, with increased mortality risk, due to the challenges of managing severe GI inflammation and the associated risks of infection, malnutrition, and organ failure. The standard first-line therapy for treating aGvHD is the use of systemic steroids. If patients do not respond to steroids, they are considered steroid resistant (SR) and other agents can be administered. Currently the only agent approved for treating SR aGvHD after failure of steroid treatment is ruxolitinib, which is currently approved for this indication in USA and has received approval from the European Medicines Agency’s Committee for Human Medicinal Products (CHMP) on March 25, 2022.

About MaaT013 (Xervyteg®)
��’s Microbiome Ecosystem Therapies (MET) are designed to leverage a full microbiome ecosystem to restore balance and maximize clinical benefits for patients with severe, treatment-induced dysbiosis in acute diseases. MaaT013��is currently under regulatory review by the relevant authorities and has not yet received marketing authorization. ��MaaT013 is a full-ecosystem, off-the-shelf, standardized, pooled-donors, enema Microbiome Ecosystem Therapy^TM for acute, hospital use. It is characterized by a consistently high diversity and richness of microbial species and the presence of Butycore^TM (a group of bacterial species known to produce anti-inflammatory metabolites). MaaT013 aims to restore the symbiotic relationship between the patient’s functional gut microbiome and their immune system to correct the responsiveness and tolerance of immune functions and thus reduce steroid-resistant, gastrointestinal (GI)-aGvHD. MaaT013 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

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September 15, 2026: �� Receives Negative CHMP Trend Vote for MaaT013 (Xervyteg®) Following Re-Examination for its Conditional Marketing Authorization Application in Europe

�� — Tue, 15 Sep 2026 05:04:35 +0000

�� Receives Negative CHMP Trend Vote for MaaT013 (Xervyteg®) Following Re-Examination for its Conditional Marketing Authorization Application in Europe

�� was informed of a negative trend during the Committee for Medicinal Products for Human Use (CHMP)’s Oral Explanation meeting which took place on September 14, 2026
Formal CHMP opinion is expected on September 18, 2026
Based on the feedback received following the Oral Explanation, the remaining concerns relate primarily to the attribution of clinical benefit and safety in the absence of a Randomized Control Trial
The Company will provide further updates following the formal CHMP opinion

��

Lyon, France, September 15, 2026 – 7:30am CET��– �� (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies^TM(MET) dedicated to enhancing survival for patients with cancer through immune modulation, today announced that it has been informed by the CHMP of the European Medicines Agency (EMA) of a “negative trend” opinion following the Oral Explanation, as part of the re-examination procedure of its conditional Marketing Authorization Application (MAA) for MaaT013 (Xervyteg®) for the treatment of aGvHD, following yesterday’s CHMP oral explanation.

“We are deeply disappointed by this outcome. Patients suffering from gastrointestinal-aGvHD continue to face a life-threatening condition with significant unmet medical need and limited treatment options,” said Hervé Affagard, Chief Executive Officer and co-founder of ��. “Together with the hematology community, we remain committed to these patients and will evaluate all available options to make this potentially important treatment accessible to patients worldwide.”

Based on the feedback received post Oral Explanation, the CHMP maintained its view that the available clinical data package, primarily in the absence of a randomized control trial, does not allow sufficient characterization of the benefit/risk of MaaT013 (Xervyteg^®).

The Company will provide additional details following the formal CHMP opinion, which is expected to be communicated on September 18, 2026. The Company will assess the implications of the decision and evaluate all available options and will provide an update to the market as appropriate.

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June 26, 2026: �� Announces Plan to Request Re-Examination Following Negative CHMP Opinion for MaaT013 for the treatment of acute Graft-versus-Host Disease

�� — Fri, 26 Jun 2026 05:15:26 +0000

�� Announces Plan to Request Re-Examination Following Negative CHMP Opinion for MaaT013 for the treatment of acute Graft-versus-Host Disease

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a negative opinion on the conditional Marketing Authorization Application (MAA) for MaaT013 (Xervyteg®), confirming the trend communicated in May 2026 after the Oral Explanation
�� plans to seek re-examination of the opinion and request that a Scientific Advisory Group (SAG) be convened
Second opinion upon re-examination expected during CHMP session in September 2026

��

Lyon, France, June 26, 2026 – 7:30 am CET��– �� (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies^TM(MET) dedicated to enhancing survival for patients with cancer through immune modulation,��today announced that the CHMP of the EMA has adopted a negative opinion on the conditional MAA for MaaT013, under the brand name Xervyteg®, for the treatment of acute Graft-versus-Host Disease (aGvHD) in adult patients with gastrointestinal involvement refractory to prior lines of therapy. This confirms the previously announced negative trend opinion disclosed on May 20, 2026. The Company has reviewed grounds cited by the CHMP and confirms its plan to seek re-examination of the opinion as previously announced.

Under EMA procedures, the re-examination includes the appointment of a new rapporteur and co-rapporteur who will conduct a new and independent evaluation of the dossier. �� will also request a Scientific Advisory Group (SAG) hearing with hematology experts on aGvHD to provide input and insights to the CHMP into, among other things, the clinical reality of managing aGvHD with complex concomitant therapies and patients in high need of solutions due to the severity of the disease and the lack of any other efficient third-line therapy so far.

In its opinion of June 25, 2026, the CHMP maintained the position that, given the use of concomitant therapies to manage aGvHD, the data package, primarily based on the ARES single-arm study, does not allow sufficient attribution of the observed clinical effect and safety to the study treatment alone.

Based on current EMA procedural timelines, a new CHMP opinion is expected within 60 days following validation of the re-examination request, with a second decision anticipated in the CHMP September Session (September 14-17, 2026).

�� remains confident in the clinical profile of MaaT013 (Xervyteg®), to treat a population with very limited treatment options and poor prognosis. This is supported by data from the ARES study, as well as data from the CHRONOS study () and real-world evidence from its Early Access Program, active in 13 countries, with more than 300 patients treated since 2019. The Company also confirms that the re-examination process has no impact on the ongoing Early Access Program, as of today, and that MaaT013 (Xervyteg®) remains available to eligible patients.

��’s strategy also extends beyond MaaT013 (Xervyteg®), supported by the development of MaaT033, an oral microbiome therapy, currently evaluated in a randomized controlled Phase 2 trial for broader prophylactic and outpatient use in hemato-oncology, and by the expansion of its platform into immuno-oncology with the next generation product MaaT034.

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About ��
�� is a leading, late-stage clinical company focused on developing innovative gut microbiome-driven therapies to modulate the immune system and enhance cancer patient survival. Supported by a talented team committed to making a difference for patients worldwide, the Company was founded in 2014 and is based in Lyon, France. As a pioneer, �� is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, �� develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. �� has been listed on Euronext Paris (ticker: MAAT) since 2021.

About acute Graft-versus-Host Disease
Acute Graft-versus-Host Disease occurs in patients within 100 days of undergoing a stem cell or bone marrow transplant, where the transplanted cells initiate an immune response and attack the transplant recipient’s organs, causing inflammation of the skin, liver and/or gastrointestinal tract and leading to significant morbidity and mortality. GI involvement is associated with severe complications such as profound diarrhea, abdominal pain, intestinal bleeding, and death. These complications are often life-threatening, with increased mortality risk, due to the challenges of managing severe GI inflammation and the associated risks of infection, malnutrition, and organ failure. The standard first-line therapy for treating aGvHD is the use of systemic steroids. If patients do not respond to steroids, they are considered steroid resistant (SR) and other agents can be administered. Currently, ruxolitinib is the standard second-line treatment for steroid-refractory acute graft-versus-host disease. More recently, remestemcel L (rknd) was approved in December 2024 in the United States, specifically for use in the pediatric population as a second-line treatment.

About MaaT013 (Xervyteg®)
��’s Microbiome Ecosystem Therapies (MET) are designed to leverage a full microbiome ecosystem to restore balance and maximize clinical benefits for patients with severe, treatment-induced dysbiosis in acute diseases. MaaT013 (Xervyteg®) is a full-ecosystem, off-the-shelf, standardized, pooled-donors, enema Microbiome Ecosystem TherapyTM for acute, hospital use. It is characterized by a consistently high diversity and richness of microbial species and the presence of ButycoreTM (a group of bacterial species known to produce anti-inflammatory metabolites). Xervyteg® (MaaT013) aims to restore the symbiotic relationship between the patient’s functional gut microbiome and their immune system to correct the responsiveness and tolerance of immune functions and thus reduce the symptoms of steroid-resistant, gastrointestinal (GI)-aGvHD. Xervyteg® (MaaT013) has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

The post June 26, 2026: �� Announces Plan to Request Re-Examination Following Negative CHMP Opinion for MaaT013 for the treatment of acute Graft-versus-Host Disease appeared first on ��.

May 20, 2026: �� Provides an Update on the Application for Marketing Authorization of MaaT013 (Xervyteg®) in the treatment of acute Graft-versus-Host Disease

�� — Wed, 20 May 2026 18:42:29 +0000

�� Announces Provides an Update on the Application for Marketing Authorization of MaaT013 (Xervyteg®) in the treatment of acute Graft-versus-Host Disease

During the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) Oral Explanation, the Company received a “negative trend” opinion for the upcoming June CHMP vote
Subject to the formal CHMP vote expected in the June Meeting, the Company plans to request a re-examination procedure for the application

��

Lyon, France, May 20, 2026 – 8:45pm CET��– �� (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies^TM(MET) dedicated to enhancing survival for patients with cancer through immune modulation, today it has been informed by the CHMP of the EMA of a “negative trend” opinion on its conditional Marketing Authorization Application (MAA) for MaaT013 (Xervyteg®) for the treatment of acute Graft-versus-Host Disease (aGvHD), following its recent CHMP oral explanation.

The CHMP formal vote is expected at the upcoming June Meeting, and subject to the formal vote, the Company intends to request a re-examination of the application, a standard procedure enabling a new independent scientific assessment by a different set of reviewers. The EMA’s procedure provides that the CHMP shall re-examine its opinion within 60 calendar days following receipt of the Company’s official request for re-examination.

“We continue to strongly believe in the potential for registration of MaaT013 (Xervyteg®). We remain committed to working closely with the EMA to progress this application, encouraged by the therapy’s potential to address the significant unmet medical need in patients with aGvHD and by the continued support from the hematology community,” said Hervé Affagard, CEO and co-founder of ��.��“Our application remains under review, and we are fully committed to engaging constructively in the re-examination process.”

For context, the CHMP feedback shared during the Oral Explanation reflects challenges, in the Company’s view, expected for first-in-class therapies based on a novel therapeutic approach, particularly those based on a single-arm pivotal trial. The application for MaaT013 (Xervyteg®) is assessed under the Conditional Marketing Authorization (CMA) pathway, which is designed to facilitate earlier access to medicines addressing unmet medical needs while confirmatory data is generated post-approval.

The Company is taking cash management measures to extend its financial visibility into November 2026 (vs August 2026), covering the upcoming regulatory milestones including the re-examination process, while continuing to advance its pipeline.

MaaT013 (Xervyteg®) is supported by clinical data from the pivotal ARES study, and real-world data with the ongoing Early Access Program active in 13 countries and with 300+ patients globally treated to date since 2019. Data supporting MaaT013 (Xervyteg®) has previously been presented at major international congresses and in peer-reviewed publications. The Company remains committed to advancing MaaT013 (Xervyteg®) through the European regulatory process, expanding patient access and progressing its broader pipeline in microbiome-based in oncology.

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About Xervyteg® (MaaT013)
��’s Microbiome Ecosystem Therapies (MET) are designed to leverage a full microbiome ecosystem to restore balance and maximize clinical benefits for patients with severe, treatment-induced dysbiosis in acute diseases. MaaT013��is currently under regulatory review by the relevant authorities and has not yet received marketing authorization. ��MaaT013 is a full-ecosystem, off-the-shelf, standardized, pooled-donors, enema Microbiome Ecosystem Therapy^TM for acute, hospital use. It is characterized by a consistently high diversity and richness of microbial species and the presence of Butycore^TM (a group of bacterial species known to produce anti-inflammatory metabolites). MaaT013 aims to restore the symbiotic relationship between the patient’s functional gut microbiome and their immune system to correct the responsiveness and tolerance of immune functions and thus reduce steroid-resistant, gastrointestinal (GI)-aGvHD. MaaT013 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

The post May 20, 2026: �� Provides an Update on the Application for Marketing Authorization of MaaT013 (Xervyteg®) in the treatment of acute Graft-versus-Host Disease appeared first on ��.

April 1st, 2026: �� Announces Publication of Retrospective Data in Third-Line Acute GvHD from the CHRONOS Study in Bone Marrow Transplantation Journal

�� — Wed, 01 Apr 2026 05:24:14 +0000

�� Announces Publication of Retrospective Data in Third-Line Acute GvHD from the CHRONOS Study in Bone Marrow Transplantation Journal

CHRONOS is one of the largest real-world��studies��including refractory GI-aGvHD patients��(n=59) treated with third-line best available treatments other than microbiome-based��therapy
Results from CHRONOS have been presented at the upcoming EBMT 2026 Annual Congress and included 29% 12-month overall survival (OS) and 37% Day-28 GI-overall response rate (GI-ORR), supporting the urgent need for new therapeutic options
CHRONOS results have been included in the MaaT013 (Xervyteg^®) Marketing Authorization Application filed with the European Medicines Agency (EMA) to contextualize the third-line setting for patients suffering from GI-aGvHD and being resistant to prior lines of treatment
MaaT013 (Xervyteg^®) Marketing Authorization application is currently under regulatory review by the EMA, with feedback anticipated mid-2026, based on EMA’s standard timelines

��

Lyon, France, April 1^st, 2026 – 7:30am CET – �� (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies^TM(MET) dedicated to enhancing survival for patients with cancer through immune modulation, today announced the publication of CHRONOS, a large multicenter retrospective cohort study evaluating real-world‑ outcomes of third-line systemic therapies (excluding microbiotherapy) in 59 patients with steroid- and ruxolitinib-refractory aGvHD with gastrointestinal involvement in the peer‑reviewed journal Bone Marrow Transplantation, the official journal of the European Society for Blood and Marrow Transplantation (EBMT). The article is available here: . The CHRONOS data have also been presented during a poster session by Johannes Clausen, MD, hematologist at Ordensklinikum Linz Elisabethinen, Hematology Department, Linz, Austria and primary author of the publication at the 2026 EBMT Annual Congress.

CHRONOS is a multicenter real‑world study offering, to the Company’s best knowledge, one of the largest and most current real‑world recent benchmarks of third‑line systemic treatments (excluding microbiotherapy) in patients with steroid‑ and ruxolitinib‑refractory aGvHD. The study reports limited durability of response and limited survival benefit with currently available off-label therapeutic options in this high-risk patient population. �� sponsored the CHRONOS study to contextualize the final results of the pivotal ARES trial evaluating MaaT013 (Xervyteg^®), announced in December 2025 and support its Marketing Authorization Application. This multi-center retrospective study provides real-world evidence on patients with steroid- and ruxolitinib-refractory or -intolerant aGvHD for context on how MaaT013 (Xervyteg^®) could potentially support evolving treatment standards in the third-line setting.

“CHRONOS provides a contemporary reference point for third-line GI-aGvHD, underscoring both the gravity of this condition and the persistent lack of standardized, effective therapies. The study highlights the stark limitations of current options and sets a meaningful new benchmark for this challenging clinical setting”, said Johannes Clausen, MD, hematologist at Ordensklinikum Linz Elisabethinen, Hematology Department, Linz, Austria.

The CHRONOS study retrospectively evaluated 59 adult patients, treated across 16 European transplant centers in Austria, Belgium, France and Spain, in whom treatment with corticosteroids (first-line) and ruxolitinib (second-line) failed.

Most patients presented with a severe form of aGvHD (46% of grade III and 48% of grade IV) and were steroid-resistant (97%) and resistant to ruxolitinib (95%). Twelve different third-line therapies were used, the most frequent being anti-TNF‑α (n=20), extracorporeal photopheresis (n=17) and vedolizumab (n=10).

Key findings from CHRONOS study include:

GI-overall response rate (ORR) at Day 28 was 37% with 22% GI-complete response (n=13), 10% GI-very good partial response (n=6), and 5% GI-partial response (n=3), and all-organ ORR at Day 28 was 36%
Response rates declined by Day 56 with a GI-ORR of 22% and all-organ ORR of 20%, suggesting rapid loss of response
12‑month overall survival: 29%
Median overall survival: 86 days

These findings highlight the poor prognosis of patients progressing beyond ruxolitinib, emphasizing the need for novel treatments and the absence of treatment standardization, the heterogeneity and limited benefits of current third-line interventions.

Until then, the only multicenter benchmark for patients with steroid-refractory aGvHD following ruxolitinib failure or intolerance included a retrospective analysis conducted across nine U.S. centers between 2016 and 2019, reporting modest outcomes in this high-risk population, with an overall response rate of 36% and a 12-month survival of 15% (Abedin et al. (2021)[1]. CHRONOS (Clausen J. et al., Bone Marrow Transplantation 2026), a more recent multicenter retrospective study reflecting contemporary standards of care, demonstrated incremental improvement in OS, with an overall response rate of 37% and a 12-month survival of 29%. This progression in OS but not in ORR highlights the evolution of clinical practice in this setting and establishes a critical contemporaneous benchmark for regulatory evaluation of the most innovative therapeutic approaches such as MaaT013 (Xervyteg^®), assessed in the ARES registration study.

For contextual information, the results from the single-arm pivotal ARES trial were presented at the ASH 2025 Annual Congress and at the EBMT 2026 Annual Congress, and included for reference:

GI-ORR at Day 28 occurred in 41/66 patients (62%) and mostly consisted of complete response (CR) (38%, 25/66 patients), and very good partial response (VGPR) (20%, 13/66 patients), substantially higher than the 37% GI-ORR reported in CHRONOS
All-organ ORR at Day 28 occurred in 42/66 patients (64%) patients and was similarly driven by high rates of CR (36%, 24/66 patients) and VGPR (18%, 12/66 patients)
Response maintained at Day 56 with a GI-ORR of 47% and an all-organ ORR of 45%
12 months overall survival: 54% vs 29% reported in CHRONOS
Median overall survival not reached, indicating that a majority of patients remained alive beyond the longest follow‑up period, while CHRONOS reported 86 days

Full dataset available .

“Acute GvHD remains a devastating disease with a profound unmet medical need. There is a clear necessity for evidence-based, standardized strategies in the third-line setting. By providing an updated and credible benchmark, CHRONOS offers critical context to interpret the results of the pivotal ARES trial and the potential clinical benefit observed with MaaT013 (Xervyteg^®) in this vulnerable patient population”, stated Prof. Florent Malard, MD, PhD, Professor of Hematology at Saint-Antoine Hospital and Sorbonne University, and lead investigator of the ARES trial.

Building on these historical benchmarks, the ARES trial demonstrates the potential for MaaT013 (Xervyteg^®) contingent to EMA’s approval, to offer improvement in patient outcomes and contribute to the evolving treatment landscape in this high-risk population.

[1] Abedin S, Rashid N, Schroeder M, Romee R, Nauffal M, Alhaj Moustafa M, Kharfan-Dabaja MA, Palmer J, Hogan W, Hefazi M, Larson S, Holtan S, DeFilipp Z, Jayani R, Dholaria B, Pidala J, Khimani F, Grunwald MR, Butler C, Hamadani M. Ruxolitinib resistance or intolerance in steroid-refractory acute graft-versus-host disease – a real-world outcomes analysis. Br J Haematol. 2021 Nov;195(3):429-432. doi: 10.1111/bjh.17700. Epub 2021 Jul 12. PMID: 34254289; PMCID: PMC9293486.

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About the CHRONOS Study
CHRONOS is a multicenter, retrospective, non‑interventional cohort study based on real‑world data collected from medical charts by participating European transplant centers. The study included adult patients (≥18 years) who underwent allogeneic hematopoietic stem cell transplantation (allo‑HSCT) and received third‑line systemic therapy for acute graft‑versus‑host disease (aGvHD) with gastrointestinal involvement between May 30, 2019 and September 30, 2024. Eligible patients presented with MAGIC Grade II–IV GI‑aGvHD at treatment initiation and were resistant or dependent on high‑dose corticosteroids and resistant or intolerant to ruxolitinib used as first‑ and second‑line therapies. Any third‑line systemic treatment was permitted, with the exception of fecal microbiotherapy.

The post April 1st, 2026: �� Announces Publication of Retrospective Data in Third-Line Acute GvHD from the CHRONOS Study in Bone Marrow Transplantation Journal appeared first on ��.

March 23, 2026: �� Presents the ARES Phase 3 Pivotal Trial Final Data During the Presidential Plenary Session at the 52nd Annual Meeting of the European Society for Bone and Marrow Transplantation

�� — Mon, 23 Mar 2026 13:56:37 +0000

�� Presents the ARES Phase 3 Pivotal Trial Final Data During the Presidential Plenary Session at the 52nd Annual Meeting of the European Society for Bone and Marrow Transplantation

��

Lyon, France, March 23^rd, 2026 – 6:00pm CET – �� (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies^TM(MET) dedicated to enhancing survival for patients with cancer through immune modulation, today announced that Florent Malard, MD, PhD, hematology professor at Saint‑Antoine Hospital and Sorbonne University, presented the final results from the Phase 3 ARES single‑arm pivotal trial evaluating MaaT013 in acute Graft‑versus‑Host Disease (aGvHD). The presentation took place during the Presidential Plenary Session at the 2026 Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT) in Madrid, Spain. MaaT013 is currently under review by the European Medicines Agency (EMA) following the submission of a Marketing Authorization Application in June 2025, with a decision expected mid-2026, as previously disclosed.

Professor Malard emphasized that “gastrointestinal acute GvHD remains a profoundly devastating condition, associated with dismal outcomes. The response rates observed in the ARES trial—62% GI-ORR at Day 28, sustained at 47% at Day 56 and 44% at Month 3—together with a 54% one-year overall survival, strongly suggest that this therapeutic approach may provide a clinically meaningful benefit for these patients.”

The final efficacy results from the ARES study, previously disclosed in December 2025, are summarized below.

The ARES trial is a single-arm, open-label trial evaluating MaaT013 as third-line treatment in 66 adult patients with severe GI-aGvHD refractory to corticosteroids and ruxolitinib across 50 sites in six European countries:

Patient profile:

91% (n=60) presented with Grade III–IV aGvHD with GI involvement
86% (n=57) were steroid-resistant and 14% (n=9) steroid-dependent; all were refractory to ruxolitinib
Male: 53%, Female: 47%

Final Efficacy Outcomes:

GI-ORR at Day 28 occurred in 41/66 patients (62%) and prevalently consisted of complete response (CR) (38%, 25/66 patients), and very good partial response (VGPR) (20%, 13/66 patients).
All-organ ORR at Day 28 occurred in 42/66 patients (64%) and was similarly driven by high rates of CR (36%, 24/66 patients) and VGPR (18%, 12/66 patients).
GI-ORR at Day 56 was maintained at 47% (31/ 66 patients) and prevalently consisted of CR (35%, 23/66 patients).
All-organ ORR at Day 56 was 45% (30/66 patients) and prevalently consisted of CR (35%, 23/66 patients).
GI-ORR and all-organ ORR at 3 months were both 44% (29/ 66 patients), with a prevalence of CR (36%, 24/66 patients).
A durable response was observed, with an estimated cumulative incidence of loss of response at 12 months of 20% (95% CI: 9 to 33) for GI. For all-organs, the estimated cumulative incidence of loss of response at 6 months was 26% (95% CI: 14 to 40).��
Overall survival (OS) at 12 months was 54%.
Median overall survival was not reached, indicating that more than half of the patients were still alive at the end of the study. This suggests a durable survival benefit and reinforces the strong efficacy signal observed in the pivotal ARES study. The median OS of Day 28 responders was not reached, while it was only 54 days for Day 28 non-responders.
The OS was significantly higher in patients who had a GI response at Day 28 than those who did not respond: 68% vs 28% respectively (p <0.0001) at 1 year, suggesting a strong association between early GI response and improved survival in refractory GI-aGvHD.
A Data and Safety Monitoring Board (DSMB) provided ongoing safety oversight throughout the study. The final DSMB review conducted in March 2025 reported that “the study results show an acceptable safety profile and a favorable benefit /risk ratio”.

The ARES trial results have been submitted to a peer-review leading medical journal for potential publication and will also be presented during an oral presentation by Professor Malard on March 27, 2026, during the annual congress of the French Society of Hematology in Paris. ��

In addition to the oral presentation, �� presents three poster communications, during the EBMT Congress:

PHOEBUS

Title: MaaT033 for Gut Microbiota Optimization To Improve Survival after Allogeneic HCT: the Phoebus Trial
Abstract number: A093
Session: Transplant and Cellular Therapies – Clinical
Session Date/Time: Monday, March 23, 2026 – 18:00 – 19:00 CET
Location: VELAZQUEZ
Presenter: Malard, MD, PhD, hematology professor at Saint-Antoine Hospital and Sorbonne University and PHOEBUS Trial lead investigator

CHRONOS

Title: Key results from CHRONOS, a multicenter retrospective cohort study describing real-world outcomes in third-line acute gastrointestinal GvHD
Abstract number: B005
Session: Graft-versus-Host Disease – Clinical
Session Date/Time: Tuesday, March 24, 2026 – 18:00 – 19:00
Location: VELAZQUEZ
Presenter: Johannes Clausen, MD, hematologist at Ordensklinikum Linz Elisabethinen, Hematology Department, Linz, Austria

THRASSA

Title: THRASSA, a Multicenter Open-label Study Evaluating the Safety, Tolerability and Efficacy of MaaT013 in Ruxolitinib-Refractory or Intolerant Paediatric/Adolescent Participants with Gastrointestinal Acute Graft-versus-Host Disease
Abstract number: P222
Session: Paediatrics – Clinical
Session Date/Time: Sunday, March 22, 08:30 – 18:00 CET
Location: e-Poster area
Presenter: Marion Bruelle, Clinical Scientist at ��

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About MaaT033
MaaT033, a standardized, donor-derived, high-richness, high-diversity oral Microbiome Ecosystem Therapy^TM containing anti-inflammatory Butycore^TM species, is currently being developed as an adjunctive therapy seeking to improve overall survival in patients receiving HSCT and other cellular therapies. Its aim is to seek to optimize microbiota function and to address a larger patient population in a chronic setting. MaaT033 has been granted Orphan Drug Designation by the European Medicines Agency (EMA).

The post March 23, 2026: �� Presents the ARES Phase 3 Pivotal Trial Final Data During the Presidential Plenary Session at the 52nd Annual Meeting of the European Society for Bone and Marrow Transplantation appeared first on ��.

March 9, 2026: �� to Present Four Abstracts at the 52nd European Bone Marrow Transplantation Annual Meeting and to Highlight Clinigen-Hosted Industry Symposium on acute GvHD Management

�� — Mon, 09 Mar 2026 17:00:48 +0000

�� to Present Four Abstracts at the
52nd European Bone Marrow Transplantation Annual Meeting and to Highlight Clinigen-Hosted Industry Symposium on acute GvHD Management

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
Poster presentations for:
- CHRONOS, a multicenter retrospective cohort study describing real-world outcomes in third-line acute gastrointestinal GvHD not treated with microbiotherapy
- PHOEBUS, a Phase 2b trial, potentially pivotal, evaluating MaaT033 seeking to improve survival after allogeneic hematopoietic transplantation (HCT),
- THRASSA, a multicenter, open‑label paediatric/adolescent study evaluating MaaT013 in patients with ruxolitinib‑refractory or ruxolitinib‑intolerant gastrointestinal aGvHD
Clinigen, ��’s strategic commercial partner for MaaT013’s Early Access Program and commercialization in Europe��pending European Medicines Agency (EMA) approval, will host an Industry Symposium on advancing care for steroid-refractory gastrointestinal aGvHD

��

Lyon, France, March 9, 2026 – 6:00pm CET – �� (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies^TM(MET) dedicated to enhancing survival for patients with cancer through immune modulation,��today announced that clinical data and updates from key programs within its hemato‑oncology pipeline will be presented at the 2026 EBMT Annual Meeting, taking place March 22–25, 2026 in Madrid, Spain.

An oral presentation, scheduled during the Presidential Plenary Session, will detail the final results, including overall survival data, from the Company’s lead asset MaaT013, which is currently under review by the European Medicines Agency (EMA) following the submission of a Marketing Authorization Application in June 2025.

In addition, �� 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.

With this broad clinical data presentation at the 2026 EBMT Annual Meeting, �� reaffirms its position in hemato‑oncology across the full care continuum of HCT and its commitment to improving outcomes for patients undergoing allogeneic transplantation.

During this year’s Congress, Clinigen, ��’s strategic commercial partner for MaaT013’s Early Access Program and commercialization in Europe pending EMA approval, will host a dedicated symposium on . MaaT013 is currently under regulatory review and not yet approved.

The symposium will be chaired by Florent Malard, MD, PhD, hematology professor at Saint-Antoine Hospital and Sorbonne University and Fabio Ciceri, MD, PhD, Associate Professor of Hematology, University Vita-Salute San Raffaele. It will also feature renowned hematology experts such as Zinaida Peric, MD, hematologist University of Rijeka (Croatia); Chair, GvHD Subcommittee, Transplant Complications Working Party, EBMT, Ernst Holler, Professor at University Medical Center Regensburg (Germany) and Jaime Sanz, MD, hematologist and coordinator of the Bone Marrow Transplant Unit at the University Hospital La Fe in Valencia (Spain). The details of the Symposium are below:

Title:
Date: Sunday, March 22, 2026
Time: 12:30 – 14:00 CET
Room: N101–102

Professor Malard will also speak at a workshop session dedicated to the Current state of microbiota transplantation in allogeneic HCT, independently from any activities related to the Company, on Monday, March 23, 2026, from 11:00am – 11:20am CET in Velazquez location (W02 Workshop | GVHD beyond immunosuppression – Regulation, repair, and innovation).

EBMT abstracts are now available at . Details of the �� presentations are as follow:

Oral presentation:

Title:
Abstract number: GS2-8
Session: GS2 Presidential Symposium
Session Date/Time: Monday, March 23, 2026 – 17:33 – 17:42 CET
Location: VELAZQUEZ
Presenter: Prof. Florent Malard, MD, PhD, hematology professor at Saint-Antoine Hospital and Sorbonne University and ARES Trial lead investigator

Poster Presentations:

PHOEBUS

Title:
Abstract number: A093
Session: Transplant and Cellular Therapies – Clinical
Session Date/Time: Monday, March 23, 2026 – 18:00 – 19:00 CET
Location: VELAZQUEZ
Presenter:�� Prof. Florent Malard, MD, PhD, hematology professor at Saint-Antoine Hospital and Sorbonne University and PHOEBUS Trial lead investigator

CHRONOS

Title:
Abstract number: B005
Session: Graft-versus-Host Disease – Clinical
Session Date/Time: Tuesday, March 24, 2026 – 18:00 – 19:00
Location: VELAZQUEZ
Presenter: Johannes Clausen, MD, hematologist at Ordensklinikum Linz Elisabethinen, Hematology Department, Linz, Austria

THRASSA

Title:
Abstract number: P222
Session: Paediatrics – Clinical
Session Date/Time: Sunday, March 22, 08:30 – 18:00 CET
Location: e-Poster area
Presenter: Marion Bruelle, Clinical Scientist at ��

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About Clinigen
Clinigen is a global pharmaceutical services company trusted by over 1,000 pharma and biotech partners. With more than 35 years of experience, we accelerate access to critical medicines at every stage of the product lifecycle. As pathfinders, our team of over 1,100 specialists expertly navigate the complexities of clinical trial supply, early access programs, regulatory services, and long-term commercialisation through both licensed and unlicensed pathways. Operating across five continents, we deliver innovative solutions to over 130 countries each year. Whatever the challenge, we find a way. Explore our services at��

About MaaT013
��’s Microbiome Ecosystem Therapies (MET) are designed to leverage a full microbiome ecosystem to restore balance and maximize clinical benefits for patients with severe, treatment-induced dysbiosis in acute diseases. MaaT013��is currently under regulatory review by the relevant authorities and has not yet received marketing authorization. ��MaaT013 is a full-ecosystem, off-the-shelf, standardized, pooled-donors, enema Microbiome Ecosystem Therapy^TM for acute, hospital use. It is characterized by a consistently high diversity and richness of microbial species and the presence of Butycore^TM (a group of bacterial species known to produce anti-inflammatory metabolites). MaaT013 aims to restore the symbiotic relationship between the patient’s functional gut microbiome and their immune system to correct the responsiveness and tolerance of immune functions and thus reduce steroid-resistant, gastrointestinal (GI)-aGvHD. MaaT013 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

The post March 9, 2026: �� to Present Four Abstracts at the 52nd European Bone Marrow Transplantation Annual Meeting and to Highlight Clinigen-Hosted Industry Symposium on acute GvHD Management appeared first on ��.

January 20, 2026: �� 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

�� — Tue, 20 Jan 2026 17:34:25 +0000

�� 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

IMMUNOLIFE, a Phase 2 randomized exploratory study, will evaluate the potential of MaaT033 in combination with Cemiplimab versus Best Investigator Choice (i.e.: second line) in enhancing disease control rate in patients with Non-Small Cell Lung Cancer (NSCLC) who have received antibiotics
The IMMUNOLIFE trial is sponsored by Gustave Roussy, a world-renowned center in cancer treatment and conducted within the IMMUNOLIFE consortium, which brings together leading experts in immuno-oncology including Lisa Derosa, MD, PhD
This exploratory trial assesses the rationale for combining a full-ecosystem microbiotherapy with immune checkpoint inhibitors (ICIs) in patients presenting antibiotic-induced dysbiosis and improve clinical outcomes
This collaboration will generate additional data to advance MaaT034 program in immuno-oncology and the Company’s microbiome-informed AI platform

Lyon, France, January 20, 2026 – 6:30pm CET – �� (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies^TM(MET) dedicated to enhancing survival for patients with cancer through immune modulation, announced that the first patient has been randomized in the IMMUNOLIFE Phase 2 clinical trial, a randomized multicenter study evaluating the potential of an oral pooled fecal microbiotherapy (MaaT033) in combination with Regeneron’s Cemiplimab (CB) in enhancing disease control rate versus best investigator’s choice (BIC) in patients with advanced non-small cell lung cancer (NSCLC) who have developed resistance to PD-1/PD-L1 blockade following antibiotic (ATB) exposure and who present ATB-induced gut dysbiosis.

The IMMUNOLIFE trial is evaluating MaaT033 in combination with CB vs BIC in 162 patients with advanced NSCLC who are refractory to immune checkpoint inhibitors (ICIs) and have received antibiotics. Patients are randomized (1:1) to receive either MaaT033 orally for one week prior to each cycle of CB (administered every 3 weeks for 6 months), followed by CB alone, or BIC. The primary objective is to assess whether the combination is associated with an improved disease control rate at 12 weeks compared to BIC. The study includes 14 centres in France, with patient enrolment of approximately 2 years and total CB treatment duration of 2 years. Primary results after 1-year follow-up post-treatment could be expected in late 2030. An interim futility analysis around H1 2027, after the 81^st randomized patient.

“Gut dysbiosis is increasingly recognized as a risk factor for immunoresistance to immunotherapy. MaaT033 is designed to restore microbiome balance and may help improve patients’ response��to��treatment,” said Lisa Derosa, MD, PhD at Gustave Roussy and coordinating investigator of the IMMUNOLIFE trial.

“We have built substantial evidence in our hemato-oncology programs that complex donor-derived products restore immune homeostasis in the context of pre-existing dysbiosis. This study represents an opportunity to further explore these findings in immuno-oncology in a well-defined patient population expected to show antibiotic-mediated dysbiosis,” said Hervé Affagard, CEO and co-founder of ��.

This trial, sponsored by Gustave Roussy, is part of ��’s exploratory strategy launched in 2022, which also includes the PICASSO trial, a Phase 2a randomized controlled trial sponsored by AP-HP in Paris evaluating Xervyteg^® (MaaT013) in combination with ICIs, ipilimumab (Yervoy^®) and nivolumab (Opdivo^®) for patients with metastatic melanoma. The Company has been informed by PICASSO’s academic sponsor that topline results could not be available in Q4 2025 (as previously announced) and could now be expected in H1 2026. Overall, IMMUNOLIFE and PICASSO studies aim to contribute to the ongoing assessment of the Company’s research strategy, including indication, treatment line, and patient population. This will also inform on the clinical development of MaaT034, a co-cultured microbiome-based therapy and the Company’s next-generation drug candidate, designed to target large indications in solid tumors.

In parallel, data already generated and to be generated during the IMMUNOLIFE consortium will also fuel the Company’s AI platform and support the development of all the Company’s microbiome-based drug candidates.

The IMMUNOLIFE consortium includes leading academic institutions such as Gustave Roussy, INSERM, Paris Saclay University, INRAe, Hospital-University Institute (IHU) Méditerranée Infection and biotech companies. The consortium aims to address the challenge of primary resistance to ICI observed in advanced NSCLC patients following antibiotic exposure. The IMMUNOLIFE consortium receives funding from the French National Research Agency (“ANR-21-5 RHUS-0017 IMMUNOLIFE”).

For more information on the IMMUNOLIFE (IMMUNOLIFE2) study:

About MaaT033

MaaT033, a standardized, donor-derived, high-richness, high-diversity oral Microbiome Ecosystem Therapy^TM containing anti-inflammatory Butycore^TM species, is currently being developed as an adjunctive therapy to improve overall survival in patients receiving HSCT and other cellular therapies. It aims to ensure optimal microbiota function and to address a larger patient population in a chronic setting. MaaT033 has been granted Orphan Drug Designation by the European Medicines Agency (EMA).

About MaaT034

MaaT034, currently in preclinical development, is a next-generation donor-independent full ecosystem synthetic microbiome therapy, dedicated to improving patient responses to immunotherapy in combination with Immune Checkpoint Inhibitors. Developed using the Company’s co-culturing proprietary MET-C platform, MaaT034 is optimized for large-scale production in oncology. Previous presented preclinical data showed that MaaT034 produced key metabolites, recognized as promoting gut barrier restoration and modulating immune responses, such as Short-Chain Fatty Acids (SCFA), secondary bile acids, and tryptophan derivatives. These data support the role of MaaT034 in gut barrier repair and in T cell reactivation either in combination with anti-PD1 or with anti-PD-L1. By enhancing gut barrier repair and modulating immune responses, MaaT034 is expected to complement the action of these immunotherapeutic agents, potentially improving their efficacy in treating solid tumors cancer.

About ��

�� is a leading, late-stage clinical company focused on developing innovative gut microbiome-driven therapies to modulate the immune system and enhance cancer patient survival. Supported by a talented team committed to making a difference for patients worldwide, the Company was founded in 2014 and is based in Lyon, France.

As a pioneer, �� is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, �� develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. �� has been listed on Euronext Paris (ticker: MAAT) since 2021.

Forward-looking Statements

All statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company’s control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as “target,” “believe,” “expect,” “aim”, “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could” and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company’s control that could cause the Company’s actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements.

Download the press release

The post January 20, 2026: �� 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 appeared first on ��.

Clinical Archives - ������

October 19, 2026: ������ Receives FDA Feedback Following Pre-IND Meeting Supporting Continued Development of MaaT034 in Solid Tumors

������ Receives FDA Feedback Following Pre-IND Meeting Supporting Continued Development of MaaT034 in Solid Tumors

September 21, 2026: ������ Announces Upcoming Pre-IND Meeting with the FDA and Advances MaaT034 Toward Clinical Development in Solid Tumors

������ Announces Upcoming Pre-IND Meeting with the FDA and Advances MaaT034 Toward Clinical Development in Solid Tumors

September 18, 2026: ������ Provides Update on MaaT013 (Xervyteg®) Potential Development Plan Following CHMP Negative Opinion After Re-examination

������ Provides Update on MaaT013 (Xervyteg®) Potential Development Plan Following CHMP Negative Opinion After Re-examination

September 15, 2026: ������ Receives Negative CHMP Trend Vote for MaaT013 (Xervyteg®) Following Re-Examination for its Conditional Marketing Authorization Application in Europe

������ Receives Negative CHMP Trend Vote for MaaT013 (Xervyteg®) Following Re-Examination for its Conditional Marketing Authorization Application in Europe

June 26, 2026: ������ Announces Plan to Request Re-Examination Following Negative CHMP Opinion for MaaT013 for the treatment of acute Graft-versus-Host Disease

������ Announces Plan to Request Re-Examination Following Negative CHMP Opinion for MaaT013 for the treatment of acute Graft-versus-Host Disease

May 20, 2026: ������ Provides an Update on the Application for Marketing Authorization of MaaT013 (Xervyteg®) in the treatment of acute Graft-versus-Host Disease

������ Announces Provides an Update on the Application for Marketing Authorization of MaaT013 (Xervyteg®) in the treatment of acute Graft-versus-Host Disease

April 1st, 2026: ������ Announces Publication of Retrospective Data in Third-Line Acute GvHD from the CHRONOS Study in Bone Marrow Transplantation Journal

������ Announces Publication of Retrospective Data in Third-Line Acute GvHD from the CHRONOS Study in Bone Marrow Transplantation Journal

March 23, 2026: ������ Presents the ARES Phase 3 Pivotal Trial Final Data During the Presidential Plenary Session at the 52nd Annual Meeting of the European Society for Bone and Marrow Transplantation

������ Presents the ARES Phase 3 Pivotal Trial Final Data During the Presidential Plenary Session at the 52nd Annual Meeting of the European Society for Bone and Marrow Transplantation

March 9, 2026: ������ to Present Four Abstracts at the 52nd European Bone Marrow Transplantation Annual Meeting and to Highlight Clinigen-Hosted Industry Symposium on acute GvHD Management

������ to Present Four Abstracts at the52nd European Bone Marrow Transplantation Annual Meeting and to Highlight Clinigen-Hosted Industry Symposium on acute GvHD Management

January 20, 2026: ������ 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

������ 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