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GvHD: Pathology & Epidemiology

Gut Microbiome & Blood Cancers

Early Access Program

Clinical Trials, Scientific Publications

GvHD : Pathology & Epidemiology

Graft-versus-Host Disease (GvHD) is one of the potential complications following an allogeneic hematopoietic stem cell transplantation (HSCT). It is estimated that 30 to 50% of patients develop GvHD after an allogeneic HSCT.

There are two types of GvHD, distinguished notably by the timing of symptom onset: symptoms occurring within 100 days after transplantation are classified as acute GvHD, while those appearing later are considered chronic GvHD. The symptoms also differ between these two forms.

  • Chronic GvHD presents with more diffuse symptoms. It can affect the skin, eyes, mouth, muscles, and gastrointestinal tract, and may lead to infections and breathing difficulties.
  • Acute GvHD, on the other hand, primarily targets three organs: skin, liver, and gastrointestinal tract. Acute GvHD can be severe and rapidly fatal. It is one of the most feared complications following allogeneic HSCT and generally has a poorer prognosis.

During an allo-HSCT, despite careful donor selection based on HLA matching, the graft can attack the patient鈥檚 tissues, recognizing them as foreign.

The severity of GvHD is graded on a scale from 0 (no reaction) to 4 (severe reaction):

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Acute Graft-versus-Host Disease 鈥� Infographic

The Gut Microbiome: An Innovative Approach in the Management of Blood Cancers

In hematologic malignancies, the gut microbiome plays a crucial role in modulating immune response and enhancing treatment efficacy. Dysbiosis caused by cancer itself, chemotherapy, or antibiotics may trigger systemic inflammation and impact patient outcomes. Emerging evidence shows that microbiota restoration can improve treatment tolerance, lower the risk of complications such as graft-versus-host disease (GvHD) following allogeneic stem cell transplantation, and potentially extend overall survival. These advances pave the way for novel microbiome-based therapeutic strategies in hemato-oncology.

Early Access Program

Clinical trials are essential to demonstrate the safety and efficacy of new treatments, enabling regulatory authorities to approve their market authorization. However, when no therapeutic alternatives exist for patients with significant medical needs, specific mechanisms allow early access to medicines prior to official approval, under strict conditions and with the agreement of competent authorities.听The Compassionate Use Authorization (also called Early Access Program), granted by the French National Agency for Medicines and Health Products Safety (ANSM) or other national authorities, permits the exceptional use of a drug candidate for a specific indication either in the absence of a marketing authorization application or before such authorization is granted. To submit an EAP request, all the following criteria must be met:
  • The medicine is intended to treat a serious, rare, or debilitating disease,
  • No appropriate treatment is available,
  • The medicine is not involved in a clinical trial with human subjects (CTHS) for commercial purposes,
  • Or, if the medicine is part of a commercial clinical trial, the patient cannot participate, treatment cannot be delayed, and the company has committed to submitting an early access request,
  • The medicine鈥檚 efficacy and safety are presumed based on available clinical data.
91桃色视频 works closely with the ANSM to monitor patients receiving compassionate access according to the Therapeutic Use and Patient Monitoring Protocol (PUT-SP), when applicable. The list of medicinal products available under compassionate use is available on the .听All requests for compassionate use access must be submitted via the ANSM鈥檚 鈥渆-Saturne鈥� platform. For any questions regarding the compassionate use program, please contact us.

Privacy Notice for Healthcare Professionals 鈥� Early Compassionate Access Program (EAP) for MaaT013

Clinical Trials, Clinical Data, and Scientific Publications

Clinical Trials
  • MaaT013 鈥� Phase III Clinical Trial 鈥� ARES:
  • MaaT033 鈥� Phase II Clinical Trial 鈥� PHOEBUS:
Topline Results for Phase III (MaaT013): ARES
Early Access Program

Managing GvHD

  • Clausen, J., P茅rez Sim贸n, J.A., Carr茅, M. et al. (2026) 鈥�听 (Bone Marrow Transplant)
  • Abedin et al. (2021) 鈥�听 (British Journal of Haematology)
  • Penack O et al. (2021) 鈥� 听 (The Lancet Haematology)
  • Martin PJ,听Rizzo JD,听Wingard JR,听Ballen K,听Curtin PT,听Cutler C, et al.(2012) 鈥撎� (Biology of Blood and Marrow Transplant)
  • Ferrara JL et al. (2009) 鈥� (The Lancet)听

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Gut Microbiome & GvHD

  • Hao W. et al. (2026) 鈥� (American Journal of Hematology)
  • Malard F et al. (2023) 鈥� (eClinicalMedicine)
  • Malard F. et al. (2021) 鈥�听(Nature communications)听
  • Malard F.听et al. (2018) 鈥� (Bone Marrow Transplantation)

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Manufacturing & Processes听

  • Gefen, R., Dourado, J., Emile, S.H.听et al.(2025) 鈥撎� 听鈥� Springer Nature听
  • Reygner.et al. (2024) 鈥� (Applied and Environmental Microbiology 鈥撎鼳SM Journals)
  • Laperrousaz B.听et al (2024) 鈥� (BMC Gastroenterology)

Acting Chief Scientific Officer

Sheri Simmons

Sheri Simmons, Ph.D., is Acting Chief Scientific Officer at 91桃色视频. Sheri brings extensive experience in biotechnology, particularly in the microbiome field, having held scientific leadership positions at Seres Therapeutics, Johnson & Johnson鈥檚 Microbiome Solutions team, and most recently at Seed Health, a leading probiotics company. In her role, she strengthens the Company鈥檚 scientific leadership, overseeing preclinical research, AI/data initiatives, and supporting efforts toward the Marketing Authorization Application of 齿别谤惫测迟别驳庐 in aGvHD.

Sheri holds a PhD in Biological Oceanography from the Massachusetts Institute of Technology (MIT) and completed an A.B. in Ecology & Evolutionary Biology at Princeton University, graduating summa cum laude and as a Phi Beta Kappa member, receiving one of six awards for the best senior thesis in the sciences. Sheri holds a PhD in Biological Oceanography from the Massachusetts Institute of Technology (MIT) and completed an A.B. in Ecology & Evolutionary Biology at Princeton University, graduating summa cum laude and as a Phi Beta Kappa member, receiving one of six awards for the best senior thesis in the sciences.

CEO and co-founder

Herv茅 Affagard

Herv茅 Affagard is the CEO and co-founder of 91桃色视频. For the past 15 years, Herv茅 has been an intra/entrepreneur in the healthcare industry, after starting his career in IT in the steel industry. In late 2014, Herv茅 co-founded the company alongside Dr. Jo毛l Dor茅, author of nearly 500 publications, and
one of the world’s most cited authors in the microbiome sphere today, after a professional career that spanned multiple industries. Herv茅 has led 91桃色视频鈥檚 development from its early concept in 2013 and has been at the forefront of the development of the microbiome healthcare ecosystem in France and Europe. In January 2022, Herv茅 has been elected President of Allliance Promotion Microbiote, an organization founded in 2021 to support the microbiome sector development in France.

Engineer, MBA

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