(Boursier.com) — MaaT Pharma, a French late-stage biotechnology company, a pioneer in the development of drugs aimed at restoring the intestinal microbiota to improve the survival of cancer patients, today announces its business objectives and future milestones, creators of values, of its clinical development for 2022.
2022: expected milestones
Clinical development programs in hemato-oncology:
MaaT013: treatment of aGvH (orphan drug designation by the FDA & the EMA):
- MaaT013 is a Microbiome Ecosystem Therapy (MET) ready to use, standardized, administered by enema and derived from a combination of microbiota from healthy donors.
- MaaT013 is ready to enter a pivotal Phase 3 clinical study in Europe. MaaT Pharma has already obtained authorization from the regulatory authorities for this trial in France and Germany. The Company will communicate when the first patient is included.
- The start of clinical trials on MaaT013 in the United States will depend on the outcome of ongoing discussions with the Food and Drug Administration (FDA) in response to the Clinical Hold Letter of August 2021 concerning the IND application for MaaT013 in the United States.
- MaaT013 has been evaluated, with promising results, in a Phase 2 clinical study in patients with grade III-IV steroid-resistant aGvH and a compassionate access program in France in patients with grade II-IV gastrointestinal aGvH, for which previous treatments had failed.
- To date, more than 100 patients with aGvH have been safely treated with MaaT013, including:
- 24 patients in the Phase 2 clinical trial
- 96 patients under the compassionate access program in France (EAP). This program was also an opportunity for the Company to strengthen its supply chain and its production capacities in order to regularly and safely make the MaaT013 product available to 18 transplant hospitals.
- In addition, MaaT Pharma recently responded favorably to two compassionate use requests for MaaT013 from two other European countries.
MaaT033: prevention of complications following transplantation of allogeneic hematopoietic stem cells (allo-HSCT).
- MaaT033 is a Microbiome Ecosystem Therapy for oral administration, with high bacterial richness and diversity, standardized, ready to use and obtained from healthy donors.
- MaaT033 is currently in a Phase Ib study, aimed at evaluating the maximum tolerated dose in patients with acute myeloid leukemia (AML) who have received intensive chemotherapy.
- The independent monitoring and follow-up committee (DSMB) met four times to assess the safety of the trial and concluded in favor of continuing the study.
- In the first quarter of 2022, the Company will provide the interim results of the colonization data of MaaT033 in the intestine of patients for the Phase Ib clinical trial.
- Full results of this trial are expected in the first half of 2022 and a pivotal Phase 2/3 study could start in late 2022 to evaluate MaaT033 as a prophylaxis for patients with liquid tumors who received an allo-GCSH.
Clinical and non-clinical development programs in immuno-oncology
MaaT013: improvement of patient response to Immune Checkpoint Inhibitors (ICI) – proof-of-concept clinical trial sponsored by AP-HP
- A randomized, placebo-controlled Phase 2 clinical study evaluating the effect of MaaT013 on the response to ICI treatments in patients with metastatic melanoma is ready to start. AP-HP is the sponsor of the study and MaaT Pharma will make its drug candidates available and will also carry out analyzes of the patient’s microbiota using its proprietary gutPrint platform.
- The French regulatory authorities have authorized the clinical trial and the Company will communicate when the first patient is included.
MaaT03X: improved response to Immune Checkpoint Inhibitors (ICI) in patients with solid tumors
- MaaT03X is a Microbiome Ecosystem Therapy with high microbial diversity, produced by co-fermentation, for oral administration. It was designed based on the analysis of clinical and microbiological data from hundreds of patients.
- MaaT Pharma leverages its proprietary gutPrint computational biology platform and its whole-ecosystem microbiota co-fermentation technology to develop this next generation of drug candidates.
- The first drug candidate MaaT03X is currently in the non-clinical testing phase, and will be dedicated to improving the efficacy of anti-cancer treatments by ICI in a solid tumor indication, as yet undisclosed, presenting a strong medical need. The first clinical study is expected to start in the first half of 2023.
- In 2021, the MaaT03X development program obtained funding of 1.9 million euros to support its industrialization and associated processes.
Production capacities to cGMP standards
- MaaT Pharma has started negotiations with a potential partner in order to secure the expansion of its production capacities to cGMP standards, as indicated in a letter of intent signed in November 2021. A new factory meeting pharmaceutical standards and entirely dedicated to the production of Microbiome Ecosystem Therapies with high richness and diversity would be built in the Auvergne-Rhône-Alpes region, thus allowing the Company to produce using its own equipment and procedures while benefiting from the cGMP services and expertise of the partner. The contractualization should take place in the first half of 2022.
Financial calendar for 2022
- February 28, 2022 – 2021 revenue and cash position as of December 31, 2021
- April 15, 2022 – 2021 annual results
- May 5, 2022 – Q1 revenue and cash position
- May 23, 2022 – General Meeting
- July 28, 2022 – Q2 revenue and cash position
- September 29, 2022 – Half-year results (April – September)
- November 8, 2022 – Revenue and cash position in the 3rd quarter.
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