On December 10, 2022 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, reported data from the continuing compassionate use program (EAP) in France for MaaT013 at the Annual Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in New Orleans, U.S. To see the abstract, click here (Press release, MaaT Pharma, DEC 10, 2022, View Source [SID1234625025]).

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The EAP consolidated results, presented in an oral format on December 10 at 5:15 pm CET/ 10.15am CST by Prof. Mohamad Mohty, Head of the Clinical Hematology and Cellular Department at the Saint-Antoine Hospital and Sorbonne University, include data from 81 patients treated with MaaT013, the company’s high-richness, high-diversity lead Microbiome Ecosystem TherapyTM (MET) for hospital use in an acute setting. Patients developing refractory acute Graft-versus-Host Disease with gastrointestinal involvement (GI-aGvHD) following hematopoietic cell transplantation demonstrated an overall response rate (GI-ORR) of 56% at day 28 following MaaT013 treatment. In patients responding to MaaT013 therapy, the overall survival (OS) rate at 12 months was 59% (compared to 14% for non-responders) indicating a significant clinical benefit with MaaT013.

In aGvHD patients refractory to 1st-line (steroids) and 2nd-line (ruxolitinib) treatments (n=31) and receiving MaaT013 as a 3rd-line therapy, 65% demonstrated a GI-ORR at day 28. The 12-month OS rate in the MaaT013-responding group was 74%. This patient population resembles the ongoing Phase 3 ARES clinical trial (NCT04769895) being conducted in Europe.

"The clinical benefits we continue to observe with MaaT013 are promising and reinforce the potential for our MET to improve survival outcomes for aGvHD patients when early treatment lines are unsuccessful" said Hervé Affagard, CEO and co-founder of MaaT Pharma. "The year 2022 will be remembered as a turning point for the microbiome therapeutics industry as it continues to mature. We expect to see an acceleration in the field following the first FDA approval for a microbiome-based product in preventing C. difficile infection as well as promising clinical results in various infectious disease and oncology indications."

Prof. Mohamad Mohty added, "Patients with severe acute GvHD that have undergone several lines of treatments have a high mortality risk with no currently proven salvage treatment options. The results observed with MaaT013 are very encouraging especially in the 3rd-line setting where we see that the survival outcome is significantly improved. Since the patient population being treated with MaaT013 in the company’s Phase III ARES pivotal study in Europe is similar to those treated in the EAP, we are hopeful that the clinical trial results will corroborate these positive results and will provide an important benefit to all patients who are in need."

Key clinical findings with MaaT013 in compassionate use in France (Early Access Program or ‘EAP’)

In the EAP, 81 patients with steroid-dependent or steroid-resistant, Grade II-IV, gastrointestinal aGvHD were treated with MaaT013 from July 2018 to May 2022

45 out of 81 (56%) showed objective GI response at day 28 of which 30 patients (37%) had a complete response, 11 patients (14%) had a very good partial response, and 4 patients (5%) showed a partial response.
Overall survival (OS) in MaaT013-responding patients at the 12-month follow-up was 59%, compared to 14% in non-responders (OS in all included patients was 39% at 12 months).
Considering GvHD response in all organs (GI, skin, liver), 38 out of 78 patients (49%) showed an objective response rate (ORR) at day 28, of which 24 patients (31%) had a complete response, 11 patients (14%) had a very good partial response, and 3 patients (4%) showed a partial response.
At the time of treatment, all patients had either Grade II (11%), Grade III (51%) or Grade IV (38%) aGvHD (MAGIC Classification).
Patients received MaaT013 after 1 to 6 (median: 2; 66/81 received ruxolitinib) lines of treatment
68 out of 81 patients (84%) were steroid resistant of which 33 out of 68 (49%) showed an objective GI response at day 28; among these patients, 21 patients (31%) had a complete response, 9 patients (13%) had a very good partial response, and 3 patients (4%) showed a partial response.
66 out of 81 patients (81%) were refractory to ruxolitinib (any treatment line), of which, 37 out of 66 (56%) showed an objective GI response at day 28; of these 25 patients (38%) had a complete response, 9 patients (14%) had a very good partial response, and 3 patients (5%) showed a partial response
31 out of 66 patients were ruxolitinib-refractory in 2nd-line and MaaT013 was administered as a 3rd-line treatment; 20 out of 31 patients (65%) showed an objective GI response at day 28; among these patients, 19 patients (61%) had a complete response, and 1 patient (3%) had a very good partial response.
13 out of 81 patients (16%) were steroid-dependent of which 12 out of 13 patients (92%) showed an objective GI response at day 28; among these patients, 9 patients (69%) had a complete response, 2 patients (15%) had a very good partial response, and 1 patient (8%) showed a partial response.

Evaluation of MaaT013 in the Phase III pivotal clinical trial ARES

MaaT Pharma announced the first patient enrolled in the Phase III, open label, single arm, ARES pivotal trial for MaaT013 in March 2022, with a safety and data review by an independent data safety and monitoring board (DSMB), after enrollment of half of the patients in the study, 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. Indeed, additionally to clinical trials, MaaT Pharma has been pursuing, since 2019, the compassionate use program in France, approved by the ANSM, to faster access to MaaT013 for patients with unmet medical need, mainly for indications in acute Graft-versus-Host disease. This program also allows the Company to strengthen its supply chain and production capacities to safely provide MaaT013, on a regular basis to 24 transplantation centers in France.

About MaaT013

MaaT013 is a standardized, high-richness, high-diversity Microbiome Ecosystem TherapyTM containing ButycoreTM (group of bacterial genera known to produce immuno-regulatory metabolites). It 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 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). MaaT013 is an off-the-shelf, healthy-multi-donors-derived product intended for acute, hospital use.