Vedanta Biosciences, Inc.

CAMBRIDGE, Mass.--( BUSINESS WIRE )-- Vedanta Biosciences , a clinical-stage company that is developing a potential new category of oral therapies based on defined bacterial consortia, today announced that management will host investor meetings at the Leerink Partners 2024 Global Biopharma Conference being held in Miami, FL from Monday, March 11 through Wednesday, March 13, 2024. About Vedanta Biosciences Vedanta Biosciences is leading the development of a potential new category of oral therapies based on defined consortia of bacteria isolated from the human microbiome and grown from pure clonal cell banks. The company’s pipeline includes clinical-stage product candidates being evaluated for the prevention of recurrent C. difficile infection and inflammatory bowel diseases and a preclinical candidate for the prevention of Gram-negative infections. In addition, the company supports investigator-sponsored studies in various diseases. These investigational therapies are grounded in our team’s pioneering research – published in leading journals including Science , Nature , Cell , and JAMA – to identify beneficial bacteria that live symbiotically within the healthy human gut, fight pathogens, and induce a range of potent immune responses. Vedanta Biosciences controls a foundational portfolio of more than 80 patents and has built what it believes is the industry-leading platform for development of defined bacterial consortia drugs. This platform includes one of the largest libraries of bacteria derived from the human microbiome, vast datasets from human interventional studies, proprietary capabilities in consortium design, and end-to-end capabilities for CGMP-compliant manufacturing of oral drug candidates spanning cell banking, fermentation, lyophilization, and fill finish.

In the ASCO abstract, Genome & Co. said five of the 42 patients had confirmed partial responses. Genome & Co. has shared data from a midphase trial testing its bacterial strain in combination with a checkpoint inhibitor. The readout encouraged the biotech to plan further clinical studies to validate the combination as a third-line treatment. The idea of modulating the microbiome to improve the effects of checkpoint inhibition was in fashion a few years back. Bristol Myers Squibb teamed up with Enterome, Johns Hopkins University and Vedanta Biosciences in quick succession in 2017 and 2018, only for clinical setbacks to dent enthusiasm in 2021. That year, Seres Therapeutics and Vedanta were respectively hit by slow enrollment and lackluster data. Yet, while interest in the concept has waned at times, it has never gone away. Microbiotica struck a deal to test its live biotherapeutic product in combination with Merck & Co.’s Keytruda last year, and Genome & Co. has pushed ahead with a phase 2 trial of its candidate, GEN-001.  The Korean biotech posted “positive” interim results of the study last year without sharing data to back up its enthusiasm. That changed at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium, where Genome & Co. shared response and survival data in gastric cancer patients who received its single-strain bacteria in combination with the checkpoint inhibitor Bavencio. In the ASCO abstract, Genome & Co. said five of the 42 patients had confirmed partial responses. There was also one unconfirmed partial response. Genome & Co.’s accompanying press release said seven of the 42 patients had partial responses.  Three of the partial responses happened in the eight PD-L1-positive participants who had previously not responded to immunotherapy. Jeeyun Lee, M.D., a professor and co-author of the abstract, called the response rate in immunotherapy refractory subpopulation “particularly promising.” Median progression-free and overall survival were 1.7 months and 7.9 months, respectively. The ASCO abstract went public last week but Genome & Co. only sent an English-language press release about the news Wednesday. 

The three patents broadly cover therapeutic compositions of clostridial bacteria derived from the human microbiome and their uses in infectious disease, allergy, and autoimmune disease Vedanta’s claims were maintained as granted in all three cases Decision further solidifies Vedanta’s leading IP position in the maturing microbiome therapeutics field CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vedanta Biosciences, a clinical-stage company developing a potential new category of oral therapies based on defined bacterial consortia, today announced that the Opposition Division of the European Patent Office (EPO) has fully upheld Vedanta’s foundational patents EP3178483B1, EP3552613B1, and EP3539548B1 (the “Honda patents”) in oral opposition proceedings held in Munich over the course of three weeks. In all three cases, the originally granted claims of the patents were upheld without any modification and were deemed valid and supported by the EPO. Opponents included Nestlé SA as well as three anonymous parties. The Honda patents are based on groundbreaking work at the lab of Dr. Kenya Honda, a scientific co-founder of Vedanta, which identified clostridial bacteria that induce significant immune responses. Clostridial bacterial species are abundant in the gut and are of high interest for use in live biotherapeutic products designed to colonize and modulate a patient’s microbiome to therapeutic effect. All of Vedanta’s therapeutic candidates contain clostridial species. The Honda patents are exclusively licensed to Vedanta under an agreement with the University of Tokyo, provide coverage through at least 2031, and are now issued in major commercial markets, including the United States, Europe, Japan, and China. The upheld patent claims broadly cover compositions of clostridial bacterial species for use in infectious disease, allergy, and autoimmune diseases, such as inflammatory bowel disease. “These decisions by the EPO reinforce our long-standing belief in the validity and novelty of the Honda patents, in addition to supporting their relevance for the development and commercialization of microbiome drugs based on live bacteria at a time when the field is maturing,” said Bernat Olle, Ph.D., chief executive officer of Vedanta Biosciences. The Honda patents, together with additional Vedanta patents, provide the company with a leading IP position in the microbiome field. Vedanta’s portfolio contains 45 issued U.S. patents and 38 issued foreign patents in Europe, Japan, Australia, Brazil, Canada, China, Israel, Korea, Mexico, Russia, and Taiwan with coverage extending to 2039, and pending applications with coverage extending through 2043. About Vedanta Biosciences Vedanta Biosciences is leading the development of a potential new category of oral therapies based on defined consortia of bacteria isolated from the human microbiome and grown from pure clonal cell banks. The company’s pipeline includes clinical-stage product candidates being evaluated for the prevention of recurrent C. difficile infection and inflammatory bowel diseases and a preclinical candidate for the prevention of Gram-negative infections. In addition, the company supports investigator-sponsored studies in various diseases. These investigational therapies are grounded in our team’s pioneering research – published in leading journals including Science, Nature, Cell, and JAMA – to identify beneficial bacteria that live symbiotically within the healthy human gut, fight pathogens, and induce a range of potent immune responses. Vedanta Biosciences controls a foundational portfolio of more than 80 patents and has built what it believes is the industry-leading platform for development of defined bacterial consortia drugs. This platform includes one of the largest libraries of bacteria derived from the human microbiome, vast datasets from human interventional studies, proprietary capabilities in consortium design, and end-to-end capabilities for CGMP-compliant manufacturing of oral drug candidates spanning cell banking, fermentation, lyophilization, and fill finish.