French cancer-focused microbiome player is flush with 18M Series B injection – Endpoints News

Last year, the death of an immuno-compromised elderly patient in a fecal microbiota transplantation trial due to a donation that contained a rare type of E. coli bacteria sent shivers across the field. The incident marred an otherwise exploding field of drug development that backed replenishing the gut with good bacteria as a safe and effective means to fortify the immune system to fight disease.

For Frances MaaT Pharma, an oncology-focused microbiome company, the setback was almost reassuring.

Bottom line is if they would have used our product, this patient would not have died, chief Herve Affagard said in an interview with Endpoints News, suggesting that MaaTs rigorous testing standards include the screening of drug-resistant bacteria that would have precluded the use of the rogue donation.

On Wednesday the company whose lead experimental product is an enema formulation designed to help patients with acute graft-versus-host disease that have undergone stem cell transplantation scored 18 million in Series B financing as it works on proving its mettle in a field crowded with competitors focused on a raft of diseases.

Microbiome-based therapeutics today is a fecund field for drug developers big and small capitalizing on science that suggests flushing good gut bacteria into the system can treat a plethora of conditions from C. diff infections to obesity using different therapeutic modalities, some of which are designed to sidestep the ick factor associated with traditional stool transfer or fecal microbiota transplantation (FMT).

The concept of FMT was originally documented in China and has been used in the United States since the 1950s with little regulatory scrutiny. In the last decade, the FDA sanctioned the use of FMT as a last resort measure for recurrent C. diff, but the agency continues to consider it an investigational treatment. Globally, hundreds of trials are now underway testing the potential of FMT for patients suffering from various illnesses, from autism to cancer.

A few years ago, the spectacular failure of Seres Therapeutics seminal effort into developing a crapsule a synthetic, fermented microbiome therapeutic derived by a manufacturing process that does not require human donor material derailed an emerging field working to harness the insights gained from gut microbiota to develop drugs. However, the success of fecal transplant therapies to treat stubbornly recurrent C. diff infections has gained traction, attracting a bucket of biobucks and even inspiring the takeover of a key player, Rebiotix.

MaaT Pharma prides itself on its meticulous process of donor screening, quality control and diversity of bacteria in its product which like many others is formulated using feces from healthy donors.

The Lyon-based companys lead formulation MaaT013 is currently in a mid-stage study in GvHD patients. Data from this trial are expected by the end of the year.

Its a kind of an immuno-restoration, instead of immunosuppression, Affagard said of MaaT013, noting that all the drugs that have been developed so far for GvHD patients are immunosuppressive.

Late last year, MaaT reported encouraging MaaT013 data from 8 patients whose GvHD persisted despite up to five previous systemic treatments as part of a compassionate use program in hospitals. Each patient experienced at least a partial response after receiving MaaT013, while 3 out of 8 patients attained a complete response, the company said.

So we know our project is working, Affagard said. Those patients theyre receiving chemotherapy, stem cell transplantationtheir microbiome was destroyed many times during their journey.

Next-generation sequencing platforms and advanced bioinformatics approaches have stimulated research evaluating the role of the gut microbiome in cancer. In 2019, a consortium of experts convened to discuss the evidence underlying the association and found that while there are plausible mechanisms and supportive evidence from in vitro, murine and cross-sectional human studies direct evidence from large longitudinal cohort studies is lacking. In effect, the role of the human microbiome in the cause and subsequent development of cancer remains unproven, the panel concluded, although a majority of panelists nevertheless agreed with the hypothesis.

MaaT is going to use the fresh injection of funds to prove its bet on the association. The money will be used for the ongoing Phase II enema study, as well as a capsule formulation that is set to be tested in a trial this year. The company is also exploring the potential of restoring a balanced microbiome to improve the clinical outcomes of checkpoint inhibitors, with plans for a combination trial in solid tumors.

The Series B round included the participation of US investor SymBiosis as well as support from MaaTs existing investors Seventure Partners, Credit Mutuel Innovation and Biocodex.

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French cancer-focused microbiome player is flush with 18M Series B injection - Endpoints News