LYON, France--(BUSINESS WIRE)--MaaT Pharma announced today that leading hemato-oncological experts presented clinical data on the compassionate use of MaaT Pharmas lead full-ecosystem microbiome restoration biotherapeutic, MaaT013. The data included eight patients that developed gastrointestinal-predominant, acute Graft-versus-Host-Disease (GI aGvHD) after receiving an allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) to treat their hematologic malignancies. All patients were positively impacted by the MaaT013 treatment, with three patients achieving complete response. GvHD, a condition where the transplant donors immune cells attack the patients tissues, is one of the most serious complications of allo-HSCT, and its acute GI form is fatal in most cases. MaaT013 features a consistently high diversity and richness of microbial species in their natural environment. It aims to restore the symbiotic relationship between microbes in the gut and the immune system of the patient to correct the responsiveness and tolerance (homeostasis) of immune functions and thereby contain GI GvHD. The results were presented in a poster presentation on December 7, 2019 during the 61st American Society of Hematology (ASH) Annual Meeting and Exposition held in Orlando, Florida.
The GI aGvHD patients who were treated with MaaT013 had a very poor prognosis with no other therapeutic options. The results following MaaT013 administration showed a positive impact on all patients, commented Professor Mohamad Mohty, MD, PhD, Head of the Hematology and Cellular Therapy Department at Sorbonne University, Saint Antoine Hospital in Paris. The most impressive results were seen in those patients who achieved a complete response and who were able to taper and stop using steroids and other immunosuppressants without relapse of gastrointestinal symptoms.
In the presented evaluation, eight patients with a median age of 67 were treated for classical aGvHD, late-onset aGvHD or aGvHD with overlap syndrome that were either steroid-resistant or steroid-dependent following stem cell transplantation. These patients had previously been treated with and failed up to five lines of systemic therapy for aGvHD. Each patient received at least one and up to three doses of MaaT013 and treatment response was evaluated seven days after each administration and on day 28 after the first dose. Based on the best response to the treatment, all eight patients experienced at least a partial response with three patients achieving complete response, two patients with very good partial response and three patients with partial response. Overall, the data demonstrated that reintroduction of a full-ecosystem microbiota provided therapeutic effect and was tolerated in a satisfactory manner in these patients.
Herv Affagard, Co-founder and CEO of MaaT Pharma added, We provided our cGMP-manufactured lead biologic drug, MaaT013, to hospitals as part of a compassionate use program to give GI GvHD patients a therapeutic option where there are no other available treatments after steroids and additional lines of treatment. These findings indicate that reestablishing the gut microbiome improved outcomes in these patients.
Moreover, MaaT Pharma is currently conducting the HERACLES Phase II clinical trial (NCT03359980) to evaluate the safety and efficacy of MaaT013 in steroid-refractory, GI aGvHD patients, with more than half of the patients enrolled.
To date, a total of 46 patients with GI GvHD have been treated with MaaT013, including patients under compassionate use and patients enrolled in the Phase II clinical trial. MaaT Pharma is actively developing an oral formulation of MaaT013 (a capsule, MaaT033) to provide easier administration for patients while delivering a similar effect of regenerating the microbial ecosystem with the goal of restoring immune homeostasis in the gut.
The poster can be viewed on the companys website under News.
About HERACLES
The HERACLES study is a multi-center, single-arm, open-label study, enrolling 32 patients to evaluate the efficacy and safety of MaaT Pharmas lead microbiome restoration drug candidate, MaaT013, in steroid-resistant, gastrointestinal-predominant aGvHD patients. Acute GvHD is a serious, often fatal syndrome typically involving the gut, skin, and liver. Treatments up to now focused largely on suppressing the immune reaction that is induced by the donor cells derived from the hematopoietic stem cell graft reacting against the host. These strategies have remained clinically unsuccessful in most cases, with mortality rates around 80% after twelve months in steroid-resistant cases. Patients with hematological malignancies receive multiple courses of chemotherapy, antibiotics, and ultimately conditioning before HSCT, which are known to severely impact the gut microbial composition.
About MaaT013
MaaT013 is the first full-ecosystem, off-the-shelf, reproducible, enema formulation manufactured using MaaT Pharmas integrated Microbiome Restoration Biotherapeutic (MMRB) platform. The product has a stability of up to 24 months and is characterized by a high diversity and consistent richness of microbial species derived from pooled healthy donors and manufactured at the companys centralized European cGMP production facility. MaaT013 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and is already being administered in compassionate use.
About MaaT Pharma
MaaT Pharma, 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, MaaT Pharma has already achieved proof of concept in acute myeloid leukemia patients. Supporting the further expansion of our pipeline into improving outcomes of immunotherapy in solid tumors, we have built a powerful discovery and analysis platform, GutPrint, to evaluate drug candidates, determine novel disease targets and identify biomarkers for microbiome-related conditions. Our biotherapeutics are produced under the strictest cGMP manufacturing and quality control process to safely deliver the full diversity and functionality of the microbiome. MaaT Pharma benefits from the commitment of world-leading scientists and established relationships with regulators to spearhead microbiome treatment integration into clinical practice.
See original here:
MaaT Pharma Announces the Presentation of Positive Data with Its Lead Microbiome Biotherapeutic in Intestinal-Predominant Acute...
- Systemic Lupus Erythematosus (Lupus) - Who gets it? | NIAMS - February 7th, 2025
- Systemic Lupus Erythematosus (Lupus) Basics - National Institute of ... - February 7th, 2025
- Long COVID: women at greater risk compared to men could immune system differences be the cause? - The Conversation - February 7th, 2025
- What is Pemphigus? Symptoms & Causes | NIAMS - February 7th, 2025
- How the immune system influences pancreatic cancer: New interactions provide therapeutic insights - Medical Xpress - February 7th, 2025
- Mitochondrias Secret Power Unleashed in the Battle Against Inflammation - SciTechDaily - February 7th, 2025
- WNT11 Promotes immune evasion and resistance to Anti-PD-1 therapy in liver metastasis - Nature.com - February 7th, 2025
- The role of the behavioral immune system in the expression of short and long-term orientation in young Chilean men during the COVID-19 pandemic - BMC... - February 7th, 2025
- Harvard nutritionist eats these 5 foods to keep her 'immune system strong' and 'energy high' - CNBC - February 7th, 2025
- Micro Immune Response On-chip (MIRO) models the tumour-stroma interface for immunotherapy testing - Nature.com - February 7th, 2025
- Personalized Therapeutic Vaccine Steers the Immune System to Fight Kidney Cancer | Newswise - Newswise - February 7th, 2025
- Identification of m6A methyltransferase-related WTAP and ZC3H13 predicts immune infiltrates in glioblastoma - Nature.com - February 7th, 2025
- Serotonin attenuates tumor necrosis factor-induced intestinal inflammation by interacting with human mucosal tissue - Nature.com - February 7th, 2025
- Identification of the immune infiltration and biomarkers in ulcerative colitis based on liquidliquid phase separation-related genes - Nature.com - February 7th, 2025
- FLASH radiation reprograms lipid metabolism and macrophage immunity and sensitizes medulloblastoma to CAR-T cell therapy - Nature.com - February 7th, 2025
- Young Innovators: U of S researcher uses bat immune systems to find next generation therapies - Saskatoon Star-Phoenix - February 7th, 2025
- World Cancer Day 2025: Chronic stress, immune system, and cancer risk- How are these connected? - The Times of India - February 7th, 2025
- New research unlocks key to long-lasting immune response in cancer and chronic diseases - The Peter Doherty Institute for Infection and Immunity - February 7th, 2025
- Microbial Dynamics and Immune Response to NTHi in COPD - Physician's Weekly - February 7th, 2025
- MHE Week in Review RFK Jr. Spotlight - Managed Healthcare Executive - February 7th, 2025
- Psoriasis Basics: Overview, Symptoms, and Causes - January 27th, 2025
- Vitiligo Symptoms, Treatment & Causes | NIAMS - January 27th, 2025
- The Surprising Connection Between Obesity, Parasites, and Your Immune System - SciTechDaily - January 27th, 2025
- Versatile 69p spice that boosts immune system can go in soups, smoothies and milk - Express - January 27th, 2025
- How the skins secret immune system could lead to needle-free vaccines - Gavi, the Vaccine Alliance - January 27th, 2025
- Fevers link with a key kind of immunity is surprisingly ancient - Science News Magazine - January 27th, 2025
- Immunology - The Scientist - January 27th, 2025
- Opinion: Immune System And Ageing Why We Get More Vulnerable As We Age - ABP Live - January 27th, 2025
- 'Forever chemicals' (PFAS) may weaken immune function in children, leading to more frequent infections - U.S. Right to Know - January 27th, 2025
- Cellular Signals That Wreak Havoc in Sepsis are Revealed - LabRoots - January 27th, 2025
- New Combination Immunotherapy Targets Melanoma and Breast Cancer with Promising Results - Inside Precision Medicine - January 27th, 2025
- New Research in The Journal of Poultry Science: Trained Immunity Offers Novel Poultry Disease Prevention Strategies - PR Newswire - January 27th, 2025
- Scientists uncover how cancer cells hijack T-cells, making it harder for the body to fight back - Medical Xpress - January 27th, 2025
- MiNK Therapeutics Targets Immune Reconstitution to Combat - GlobeNewswire - January 27th, 2025
- Mitochondria may be a promising therapeutic target for inflammatory diseases - Medical Xpress - January 27th, 2025
- Explainer: What is Guillain-Barr Syndrome and how it affects the immune system - Mathrubhumi English - January 27th, 2025
- Yes, Some Vaccines Contain Aluminum. Thats a Good Thing. - The New York Times - January 27th, 2025
- You Are What You Eat? MD Breaks Down The Science Of The Gut Microbiome - mindbodygreen - January 27th, 2025
- Potential gamechanger: Researchers discover basis for immunotherapy-induced myocarditis - Healio - January 27th, 2025
- Ozempic and Wegovy may boost health, from addiction to dementia - BBC.com - January 27th, 2025
- Neutrophil diversity and function in health and disease - Nature.com - December 6th, 2024
- Harnessing the Power of the Immune System for Breast Cancer Treatment - Breast Cancer Research Foundation - December 6th, 2024
- Study Examines Neoantigen Landscapes and Their Role in Immunotherapy Efficacy - Consult QD - December 6th, 2024
- The 5 Best Teas to Support Your Immune System This Cold & Flu Season - EatingWell - December 6th, 2024
- Engineered immune cells may be able to tame inflammation - Medical Xpress - December 6th, 2024
- Hybrid model of tumor growth, angiogenesis and immune response yields strategies to improve antiangiogenic therapy - Nature.com - December 6th, 2024
- Opioids interfere with cancer immunotherapy, but another type of drug could help - Medical Xpress - December 6th, 2024
- RANKL cytokine restores thymus cells in old mice, reducing tumor growth and improving T cell immune response - Fierce Biotech - December 6th, 2024
- Predictive role of neutrophil percentage-to-albumin ratio, neutrophil-to-lymphocyte ratio, and systemic immune-inflammation index for mortality in... - December 6th, 2024
- Immuno-Oncology Strategic Industry Research Report 2023-2024 & 2030: Approval of Pembrolizumab (Keytruda) and Nivolumab (Opdivo), which Target... - December 6th, 2024
- Study cracks the cold case of immunotherapy resistance - News-Medical.Net - December 6th, 2024
- New immune therapy improves survival and reduces tumor burden in glioblastoma - News-Medical.Net - December 6th, 2024
- Identification of immune-related hub genes and potential molecular mechanisms involved in COVID-19 via integrated bioinformatics analysis - Nature.com - December 6th, 2024
- Immune Cell Breakthrough: Scientists Discover a Hidden Ally in the Fight Against Cancer - SciTechDaily - December 6th, 2024
- Rising temperatures impact the immune system of wild monkeys - Earth.com - December 6th, 2024
- Study declaring Alzheimer's to be a "brain disease" proven to be fabricated - Earth.com - December 6th, 2024
- Warming temperatures impact immune performance of wild monkeys, U-M study shows - University of Michigan News - December 6th, 2024
- New study explores heart risks of cancer immunotherapy - News-Medical.Net - December 6th, 2024
- 'Incredible' way to boost your immune system naturally and ward of colds and flu this winter - The Mirror - December 6th, 2024
- Tis the Season to Boost Your Immune System - Mix93.3 - December 6th, 2024
- A mathematical model simulating the adaptive immune response in various vaccines and vaccination strategies - Nature.com - October 14th, 2024
- Fox Chase Cancer Center Researchers Find Gene That Triggers Immune Response in Treatment-Resistant Small-Cell Lung Cancer - Fox Chase Cancer Center - October 14th, 2024
- What Does It Mean to Be Immunocompromised? - The New York Times - October 14th, 2024
- Scientist hopes to cure Type 1 diabetes by disguising stem cells - The University of Arizona - October 14th, 2024
- Watching an infection unfold with a sphingolipid probe - Drug Discovery News - October 14th, 2024
- The cells that protect your brain against infection could also be behind some chronic diseases - BBC.com - October 14th, 2024
- On Nutrition: Foods that help strengthen the immune system - LimaOhio.com - October 14th, 2024
- An integral T cell pathway has implications for understanding sex-based immune response - Medical Xpress - October 14th, 2024
- Immune Response Linked to Lewy Body Formation - Neuroscience News - October 14th, 2024
- Are vaccines the future of cancer prevention? - Genetic Literacy Project - October 14th, 2024
- The Gut Microbiome and Autoimmunity - Inside Precision Medicine - October 14th, 2024
- Researchers discover how oral cancer cells may block the body's immune response - News-Medical.Net - September 21st, 2024
- Are Vaccines More Effective When You Believe in Them? - Greater Good Science Center at UC Berkeley - September 21st, 2024
- Researchers discover immune response to dengue can predict risk of severe reinfections - Medical Xpress - September 21st, 2024
- Texas Researchers Find Acid Walls That Shield Cancer Tumors from Bodys Immune System Response - DARKDaily.com - Laboratory News - September 21st, 2024
- Lysosomes in the immunometabolic reprogramming of immune cells in atherosclerosis - Nature.com - September 21st, 2024
- A new way to reprogram immune cells and direct them toward anti-tumor immunity - MIT News - September 21st, 2024
- Unravelling the many mysteries of the immune system - Cosmos - September 21st, 2024
- Long COVID patients maintain robust immune memory two years after infection - News-Medical.Net - September 21st, 2024
- Nutraceuticals and pharmacological to balance the transitional microbiome to extend immunity during COVID-19 and other viral infections - Journal of... - September 21st, 2024