Microbiome Report for Week Ending 5/11/19

Vedanta Biosciences Key Microbiome Patent Upheld in European Opposition Proceedings
Vedanta Biosciences, a clinical-stage company developing a new category of therapies for immune-mediated diseases based on rationally-defined consortia of human microbiome-derived bacteria, announced on 5/7/19 that the Opposition Division of the European Patent Office has upheld Vedanta’s foundational patent EP2575835 (the “Honda patent”), strengthening Vedanta’s intellectual property position in a key area of microbiome therapeutics. The patent is based on groundbreaking work by Dr. Kenya Honda, a scientific co-founder of Vedanta Biosciences, in identifying bacteria that induce significant immune responses. The upheld patent claims broadly cover compositions of clostridial bacterial species for use in infectious and allergic disease.

Clostridial bacterial species are abundant in the gut and are of high interest for use in the development of live biotherapeutic products designed to colonize and modulate a patient’s microbiome to therapeutic effect. The Honda patent is exclusively licensed to Vedanta under an agreement with the University of Tokyo and provides coverage through at least 2031.

The Honda patent, together with additional Vedanta patents, provide the company with a leading IP position in the microbiome field. Vedanta’s patents support the company’s therapeutic candidates for the treatment of autoimmune diseases, such as inflammatory bowel disease (IBD), food allergy, and infectious diseases. Vedanta’s portfolio contains 20 U.S. patents and numerous foreign issuances with coverage extending to 2037.

The Honda patent, EP2575835, was opposed by six parties: Seres Therapeutics Inc., Nestec SA (a subsidiary of Nestlé SA) as well as four anonymous parties. Minor formal claim amendments were entered during the oral proceedings. The patent is now issued in major commercial markets, including the United States, Europe, and Japan.

MaaT Pharma Announces Second Positive DSMB Safety Assessment of Phase II HERACLES Study in Acute GvHD
MaaT Pharma announced on 4/9/19 that the independent Data and Safety Monitoring Board (DSMB) recommended the continuation, without amendment, of the ongoing Phase II HERACLES study (NCT03359980). The HERACLES trial inverstigates the use of lead biotherapeutic MaaT013 in steroid-resistant, gastrointestinal-predominant, acute Graft-versus-Host-Disease (SR GI aGvHD) after allogeneic Hematopoietic Stem-Cell Transplantation (allo-HSCT). The second review assessed the safety of MaaT013 after 10 patients treated, reinforcing the absence of safety issues during the trial as confirmed after the first review. Enrollment of patients in the trial continues as planned with additional sites recently opened in Germany and Italy. As of today a total of 13 patients have been treated in the protocol.

MaaT013 is the first full-ecosystem, off-the-shelf, reproducible, enema formulation manufactured using MaaT Pharma’s integrated Microbiome Restoration Biotherapeutic (MMRB) platform. The product has a stability of up to 24 months and is characterized by a high diversity and consistent richness of microbial species derived from pooled healthy donors and manufactured at the company’s centralized European cGMP production facility. MaaT013 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and is already being administered in compassionate use.