On January 24, 2022 MaaT Pharma (EURONEXT: MAAT – the "Company"), a French clinical-stage biotech and a pioneer in the development of microbiome-based ecosystem therapies dedicated to improving survival outcomes for patients with cancer, reported that positive interim engraftment data from the first four cohorts of the CIMON trial with MaaT033, the Company’s high-richness, high-diversity, Microbiome Ecosystem Therapy for oral administration (Press release, MaaT Pharma, JAN 24, 2022, View Source [SID1234606708]). These results represent the first confirmation of MaaT033’s mechanism of action in humans. MaaT033 is the company’s second product in clinical development and is intended to improve survival in patients receiving allogeneic hematopoietic stem cell transplantation (allo-HSCT), which represents approximately 22,000 patients every year in the 7 major markets. Its oral formulation, designed for targeted delivery in the intestine, may support long-term, ambulatory use.

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In this dose-ranging study, data from four out of five intended cohorts showed satisfactory safety and good microbiome engraftment, which is characterized by the presence of microbial OTUs[1] in the gut as a result of product administration and that were not present at treatment start.

Based on this positive data, the Company will close the CIMON trial to enable faster than planned completion and evaluation of the full data from the trial, in order to advance MaaT033 towards a planned Phase 2/3 trial, which could start in the second half of 2022. Complete results from the Phase 1b CIMON trial are expected in the first half of 2022.

"These interim results are an important milestone for MaaT Pharma as MaaT033 is our second product, and our first oral formulation, to demonstrate proof of engraftment in humans. This expands the potential of our proprietary Microbiome Ecosystem Therapy (MET) platform to the ambulatory setting, after positive data achieved in aGvHD with MaaT013, an enema product for acute, hospital use. This is the first step towards treating larger patient populations that may benefit from orally-administered microbiome therapies, including patients receiving allo-HSCT, but also patients with solid tumors."

said Hervé Affagard, CEO and co-founder of MaaT Pharma.

MaaT033 is intended to improve survival outcomes in hemato-oncology patients receiving allo-HSCT by protecting and restoring their gut microbiome. In these patients, intensive chemotherapy and antibiotic treatments that are administered to prepare for the allo-HSCT procedure result in a severely damaged gut microbiome. Importantly, higher gut microbiome diversity at the time of allo-HSCT has been correlated to higher survival and lower risks of complications, including incidence of graft-vs-host-disease and multi-resistant infections[2].

"With a very satisfactory safety profile and very promising engraftment data in the first four cohorts of this trial, we believe we have the appropriate amount of data in hand to confidently move forward with MaaT033’s clinical development, without testing the highest planned dose of nine capsules a day. We look forward to further exploring the data from CIMON and preparing for a Phase 2/3 trial start."

added John Weinberg, MD, Chief Medical Officer at MaaT Pharma.

The CIMON Phase 1b trial (NCT04150393) is an open-label, dose-ranging study and has enrolled to date a total of 21 patients in four cohorts (up to three capsules a day for 14 days) across six sites in France. CIMON is designed to investigate the maximum tolerated dose of MaaT033, over 7 or 14 days of therapy, that supports optimal gut microbiome colonization in patients with acute myeloid leukemia or high-risk myelodysplastic syndrome who have undergone intensive chemotherapy. Overall, four Data and Safety Monitoring Board meetings have been conducted evaluating the safety of the trial. All concluded in support of the continuation of the study with the latest taking place in December 2021. Complete results from the trial will be submitted for a presentation at an upcoming key major conference in hemato-oncology as well as for peer-reviewed publication.

[1] OTU or Operational Taxonomic Unit is used to classify bacteria at the genus level, based on sequence similarity of the 16S marker gene. An OTU consists of a group of bacteria whose 16S marker gene shows a sequence identity of 97 percent and above.
[2] Peled, J.U. & al N Engl J Med 2020;382:822-34
About MaaT033

MaaT033 is an oral, full-ecosystem, off-the-shelf, standardized, pooled-donor, high-richness Microbiome Ecosystem Therapy. It is manufactured at MaaT Pharma’s centralized European cGMP production facility. 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 while maintaining the high and consistent richness and diversity of microbial species, including anti-inflammatory ButycoreTM species, which characterize MaaT Pharma’s Microbiome Ecosystem Therapies.