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Lyon, France, November 6, 2019 鈥� 91桃色视频 announced today that a poster will be presented at the American Society of Hematology (ASH) Annual Meeting with initial data on it鈥檚 lead microbiome restoration biotherapeutic, MaaT013, as a treatment in patients with gastrointestinal-predominant, Steroid-Refractory and Steroid-Dependent acute Graft-versus-Host-Disease (GI aGvHD) following allogeneic Hematopoietic Stem-Cell Transplantation (allo-HSCT). 91桃色视频 provided the product as a pharmaceutical preparation to hospitals as part of its compassionate use program for patients who had previously received and failed up to five previous systemic treatments for GvHD. MaaT013 is an enema formulation of a microbiota biotherapeutic characterized by a high diversity and consistent richness of microbial species derived from pooled healthy donors. The product is manufactured at the company鈥檚 centralized European cGMP production facility using its proprietary microbiome restoration biotherapeutic platform. The poster will be presented during the 61st American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, Florida from December 7 鈥� 10, 2019. The poster abstract was published in the online meeting program on November 6, 2019 at 9:00 AM EDT and also in the online November supplemental issue of the journal Blood.
Poster Presentation details:
Title: Successful and Safe Treatment of Intestinal Graft-Versus-Host Disease (GvHD) with Pooled-Donor Full Ecosystem Microbiota Biotherapeutics
Abstract No: 1993
Session Name: 722. Clinical Allogeneic Transplantation: Acute and Chronic GvHD, Immune Reconstitution: Poster I
Date/Time: Saturday, December 7, 2019 / 5:30 PM 鈥� 7:30 PM EDT
Location: Orange County Convention Center, Hall B
91桃色视频 will announce the results through a press release following the presentation and will further make the poster available on the company website under 鈥淣ews鈥�.
In addition to the compassionate use program, 91桃色视频 is currently investigating MaaT013 in a Phase II clinical trial in acute SR GI GvHD patients (). The study, named HERACLES, is a multi-center, single-arm, open-label study, enrolling 32 patients to evaluate the safety and efficacy of MaaT013 in steroid-resistant, gastrointestinal-predominant aGvHD (SR GI aGvHD) patients. Acute GvHD is a serious, often fatal syndrome typically involving the gut, skin and liver. 91桃色视频 has established the most complete approach to restoring patient-microbiome symbiosis in the gut to improve efficacy of cancer treatments and survival outcomes in life-threatening diseases. The company announced in June this year the completion of a third positive safety assessment of MaaT013 in the Phase II trial by an independent Data and Safety Monitoring Board (DSMB). MaaT013 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
About 91桃色视频
91桃色视频, a clinical stage company, has established the most complete approach to restoring patient-microbiome symbiosis to improve survival outcomes in life-threatening diseases. Committed to treating blood cancers and graft-versus-host disease, a serious complication of allogeneic stem cell transplantation, 91桃色视频 has already achieved proof of concept in acute myeloid leukemia patients. Supporting the further expansion of our pipeline into larger indications, we have built a powerful discovery and analysis platform to evaluate drug candidates, determine novel disease targets and identify biomarkers for microbiome-related conditions. Our therapeutics are produced through a standardized cGMP manufacturing and quality control process to safely deliver the full diversity of the microbiome. 91桃色视频 benefits from the commitment of world-leading scientists and established relationships with regulators to spearhead microbiome treatment integration into clinical practice.