MaaT Pharma indicates completion of Patient Recruitment for the Phase 2a Investigator-Sponsored Randomized Clinical Trial Evaluating MaaT013 in Combination with Immune Checkpoint Inhibitors in Metastatic Melanoma
05 März 2024 - 7:30AM
Business Wire
- Last patient randomized in Phase 2a PICASSO trial, sponsored by
AP-HP in collaboration with MaaT Pharma, INRAE and Institut Gustave
Roussy, evaluating MaaT013 in melanoma in combination with Immune
Checkpoint Inhibitors.
- Submission of the study's findings to a scientific journal is
anticipated in the last quarter of 2024 or the first quarter of
2025.
- Topline results are scheduled for communication in the last
quarter of 2024 or the first quarter of 2025.
Regulatory News:
MaaT Pharma (EURONEXT: MAAT – the “Company”), a clinical-stage
biotechnology company and a leader in the development of Microbiome
Ecosystem TherapiesTM (MET) dedicated to enhancing survival of
patients with cancer, informs today on the completion of patient
recruitment for the Phase 2a clinical trial1 sponsored by AP-HP2
and in collaboration with INRAE and Institut Gustave Roussy,
evaluating MaaT013, the Company’s lead product candidate, in
combination with immune checkpoint inhibitors (ICI), ipilimumab
(Yervoy®) and nivolumab (Opdivo®).
A total of 70 patients have been enrolled in 5 different centers
in France in the randomized controlled Phase 2a PICASSO trial,
which started in April 2022. The Company provided MaaT013 drug
candidate and placebo and will contribute to the microbiome
profiling of patients using its proprietary gutPrint® research
engine. The unblinding will be done at Week 27 (W27) to assess the
primary endpoint which is safety. In parallel, the first efficacy
data will be made available, assessed by the best overall response
rate, rated by immunological Response Evaluation Criteria in Solid
Tumors (iRECIST; 19).
Having reached this key recruitment milestone, the first
publication will be submitted at the end of 2024 or in the first
quarter of 2025.
The PICASSO trial is funded by the Directorate of Health Care
Supply (DGOS: Direction Générale de l’Offre de Soins) and operated
by the French National Cancer Institute (INCa: Institut National du
Cancer) as part of a call for projects (project PHRC-K19-183).
---
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
(GI)-predominant aGvHD. MaaT013 has been granted Orphan Drug
Designation by the US Food and Drug Administration (FDA) and the
European Medicines Agency (EMA).
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 launched, in
March 2022, an open-label, single arm, phase 3 clinical trial in
patients with acute GvHD (aGvHD), following the achievement of its
proof of concept in a phase 2 trial. Its powerful discovery and
analysis platform, gutPrint®, enables the identification of novel
disease targets, evaluation of drug candidates, and identification
of 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 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 NCT04988841: Prospective randomIzed clinical trial assessing
the tolerance and clinical benefit of feCAl tranSplantation in
patientS with melanOma treated with CTLA-4 and PD-1 inhibitors.
2 AP-HP: Assistance Publique - Hôpitaux de Paris
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MaaT Pharma – Investor Relations Guilhaume DEBROAS, Ph.D.
Head of Investor Relations +33 6 16 48 92 50
invest@maat-pharma.com
MaaT Pharma – Media Relations Pauline RICHAUD Senior PR
& Corporate Communications Manager +33 6 14 06 45 92
media@maat-pharma.com
Trophic Communications Stephanie MAY or Priscillia PERRIN
+49 151 7441 6179 maat@trophic.eu
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