MaaT Pharma Announces Oral and Poster Presentations at the 64th American Society of Hematology (ASH) Annual Meeting
2022年11月4日 - 02:00AM
ビジネスワイヤ(英語)
- Oral presentation will detail consolidated results from 81
patients with steroid-resistant, gastrointestinal, acute
Graft-versus-Host-Disease (GI-aGvHD) treated with MaaT013 as
salvage therapy, as part of an ongoing Early Access Program
(EAP).
- Poster will present detailed results from the Phase 1b clinical
trial of MaaT033 in patients with acute myeloid leukemia. MaaT033,
the Company’s first Microbiome Ecosystem TherapyTM (MET) for oral
administration, is being developed as adjunctive and maintenance
treatment for patients receiving allo-HCT1.
Regulatory News:
MaaT Pharma (EURONEXT:
MAAT – the “Company”), a French clinical-stage biotech and a
pioneer in the development of Microbiome Ecosystem TherapiesTM
(MET) dedicated to improving survival outcomes for patients with
cancer, announced today that extended results from its Early
Access Program (EAP) of MaaT013 in patients with GI-aGvHD have been
selected for oral presentation at the 64thAmerican Society of
Hematology (ASH) Annual Meeting held from December 10-13, 2022, in
New-Orleans, Louisiana, U.S.A. Additionally, detailed results of
the Phase 1b trial of MaaT033 in patients with acute myeloid
leukemia (AML) were selected for presentation in a poster session.
This is the sixth year in a row that the Company’s clinical data
are selected for presentation at the ASH Conference, the
world-leading event in malignant and non-malignant hematology, and
the third year in a row for an oral presentation.
In line with the conference embargo policy, MaaT Pharma will
detail the presented results through a press release on Saturday,
December 10, 2022. The Company will also host an investor webcast
on Monday, December 12th, 2022, at 6:00pm CET (additional details
will be provided at a later date).
The EAP results include data from 81 patients treated with
MaaT013, with steroid-resistant or steroid-dependent aGvHD with GI
involvement, who had previously failed 1 to 6 lines
(median: 2) of systemic therapy; MaaT Pharma provided the MET
product to hospitals under a compassionate access program in
France. In parallel, MaaT013 is currently being evaluated in a
pivotal, open-label, single-arm Phase 3 trial in Europe (n=75) in
GI-aGvHD patients refractory to corticosteroids and ruxolitinib; a
first data review is expected in the first half of 2023. As of
today, MaaT013 has been safely administered to more than 160
patients in Europe in clinical trials and in the Expanded Access
Program in France.
Oral Presentation: Title: Pooled Fecal Allogenic
Microbiotherapy for Refractory Gastrointestinal Acute
Graft-Versus-Host Disease: Results from the Early Access Program in
France Presenter: Professor Mohamad Mohty, hematology
professor and Head of the Hematology and Cellular Therapy
Department at the Saint-Antoine Hospital and Sorbonne University
Publication Number: 112 Session: 722. Allogeneic
Transplantation: Acute and Chronic GVHD, Immune Reconstitution:
Clinical Studies Exploring the Immunobiology of HCT Session
Date/Time: Saturday, December 10, 2022; 10:15am EST
Room: 252-254 (Ernest N. Morial Convention Center)
Poster Presentation: Title: Restoration Of Gut Microbiota
Diversity With Oral Pooled Fecal Microbiotherapy In Acute Myeloid
Leukemia Patients After Intensive Chemotherapy: The Phase 1b CIMON
Trial Presenter: Professor Mohamad Mohty, hematology
professor and Head of the Hematology and Cellular Therapy
Department at the Saint-Antoine Hospital and Sorbonne University
Poster number: 2765 Session: 616. Acute Myeloid
Leukemias: Investigational Therapies, Excluding Transplantation and
Cellular Immunotherapies Session Date/Time: Sunday, December
11, 2022: 6:00pm -8:00pm EST Room: Hall D (Ernest N. Morial
Convention Center)
Upcoming scientific conferences participations
- November 8-10, 2022 – 9th International Human Microbiome
Consortium (IHMC) Congress: Poster and oral
presentation
- November 9-11, 2022 – 21st Société Francophone de Greffe de
Moelle et de Thérapie Cellulaire (SFGM-TC) Congress - Booth #10
– poster and oral presentation
- December 10-13, 2022 - 64th American Society of Hematology
(ASH) Annual Meeting: Poster and oral presentation
About MaaT013 MaaT013 is a full-ecosystem, off-the-shelf,
standardized, pooled-donor, 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 (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-predominant aGvHD. MaaT013 has
been granted Orphan Drug Designation by the US Food and Drug
Administration (FDA) and the European Medicines Agency (EMA).
About MaaT033 MaaT033 is an oral, full-ecosystem,
off-the-shelf, standardized, pooled-donor, high-richness Microbiome
Ecosystem TherapyTM. MaaT033 is designed to restore the gut
ecosystem to full functionality to improve clinical outcomes as
well as to control adverse events related to conventional
treatments for liquid tumors. The capsule formulation facilitates
administration and allows the potential to treat larger patients’
population while maintaining the high and consistent richness and
diversity of microbial species, including anti-inflammatory
ButycoreTM species.
About MaaT Pharma MaaT Pharma, a clinical stage
biotechnology company, has established a complete approach to
restoring patient-microbiome symbiosis in oncology. Committed to
treating cancer and graft-versus-host disease (GvHD), a serious
complication of allogeneic stem cell transplantation, MaaT Pharma
has launched, in March 2022 in Europe, a Phase 3 clinical trial for
patients with acute GvHD, following the achievement of its proof of
concept in a Phase 2 trial. Its powerful discovery and analysis
platform, gutPrint®, supports the development and expansion of its
pipeline by determining novel disease targets, evaluating drug
candidates, and identifying biomarkers for microbiome-related
conditions. The company’s Microbiome Ecosystem Therapies are
produced through a standardized cGMP manufacturing and quality
control process to safely deliver the full diversity of the
microbiome, in liquid and oral formulations. MaaT Pharma benefits
from the commitment of world-leading scientists and established
relationships with regulators to support the integration of the use
of microbiome therapies in clinical practice. MaaT Pharma is the
first company developing microbiome-based therapies listed on
Euronext Paris (ticker: MAAT).
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.
1 Allo-HCT: allogeneic hematopoietic cell therapy
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version on businesswire.com: https://www.businesswire.com/news/home/20221103005951/en/
MaaT Pharma – Investor relations Hervé AFFAGARD
Co-Founder and CEO Siân Crouzet, COO/ CFO +33 4 28 29 14 00
invest@maat-pharma.com
MaaT Pharma -media relations Pauline RICHAUD Senior PR
& Corporate Communications Manager +33 6 07 55 25 36
prichaud@maat-pharma.com
Trophic Communications - Corporate and medical
Communications Jacob VERGHESE or Gretchen SCHWEITZER +49 89 23
88 77 31 maat@trophic.eu
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