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vedanta biosciences press release

The company’s clinical-stage pipeline includes product candidates being evaluated for the treatment of high-risk C. difficile infection, inflammatory bowel diseases, advanced or metastatic cancers and food allergy. Colonization was most effective with vancomycin pre-treatment followed by multiple doses of the consortia. Vedanta Biosciences Announces Positive Topline Data from Two Phase 1 Studies of VE202, a Rationally Defined Bacterial Consortium Being … The funding will support completion of an ongoing Phase 2 trial and further clinical development of VE303, a rationally-defined, orally-administered live biotherapeutic product (LBP) consisting of eight well-characterized commensal bacterial strains designed to effect robust and durable therapeutic changes in a patient's gut microbiota. Vedanta expects to begin a Phase 2 study in IBD patients in the next 12 months. There were no serious adverse events related to VE202. VE202 is a first-in-class orally-administered investigational live biotherapeutic product (LBP) consisting of a defined bacterial consortium. Vedanta Biosciences Announces Initiation of Phase 1 Clinical Study with Janssen of Microbiome-Derived Product Candidate for Inflammatory Bowel Disease. Vedanta Biosciences is a clinical-stage microbiome leader developing a new category of therapies for immune-mediated diseases based on rationally-defined consortia of human microbiome-derived bacteria. Vedanta Biosciences Presents Positive Expanded Data from Phase 1a/1b Study of VE303 at Digestive Disease Week Expanded data on rapid, durable, … CAMBRIDGE, Mass., September 30, 2020 – 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, today announced it has been awarded funding of $7.4 million, with the potential for up to an additional $69.5 million, from the Biomedical Advanced Research and Development Authority (BARDA) to advance clinical development of VE303 for high-risk Clostridioides difficile infection (CDI). There is significant evidence of the role of the microbiome in IBD, which underscores the need for safe approaches that address this aspect of the disease.”. The primary endpoint is prevention of infection recurrence at eight weeks. Additionally, the European Patent Office (EPO) recently granted Vedanta Biosciences three patents in its foundational intellectual property (IP) family covering the use of bacterial consortia of clostridium species  in autoimmune diseases, including IBD. We’re enthusiastic about the opportunity to address both of these issues and proud to support clinical development of VE303.”. Results describing the biology and candidate selection of VE202 were previously published in Science and Nature (multiple). First clinical study of a rationally-defined bacterial consortium for an immune-mediated disease. Vedanta’s IP portfolio contains over 40 patents with coverage through at least 2038. CAMBRIDGE, Mass., Dec. 10, 2019 — Vedanta Biosciences, Inc. (Vedanta Biosciences, Vedanta or the Company), a clinical-stage biopharmaceutical company developing a new category of therapies for immune-mediated diseases based on defined bacterial consortia, today announced the initiation of a first-in-patient clinical study of VE800 in combination with Bristol-Myers Squibb's programmed death-1 … For more information, visit https://www.phe.gov/about/barda/. Vedanta Biosciences announced the appointment of drug development leader Jeffrey Silber, M.D., as chief medical officer, who will guide the advancement of … “We are honored to be the first-ever recipient of a BARDA award in the microbiome field and look forward to collaborating with the U.S. Government to advance the clinical development of VE303 and to potentially fulfill its promise in public health and biodefense,” said Bernat Olle, Ph.D., co-founder and chief executive officer of Vedanta Biosciences. The studies showed that VE202 was generally safe and well tolerated at all doses and demonstrated durable and dose-dependent colonization. Vedanta Biosciences' pioneering work, in collaboration with its scientific co-founders, has led to the identification of human commensal bacteria that induce a range of immune responses – including induction of regulatory T cells, CD8+ T cells, and Th17 cells, among others. Vedanta Biosciences’ Silvia Caballero, Ph.D., Named to TIME 100 NEXT List for Innovative Leaders Business Wire CAMBRIDGE, Mass. CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vedanta Biosciences, a leading clinical-stage company developing a new category of therapies for immune-mediated diseases based on rationally-defined consortia of human microbiome-derived bacteria, today announced the appointment of Troy Ignelzi as an independent member of its Board of Directors. PureTech Founded Entity Vedanta Biosciences Appoints Troy Ignelzi, Chief Financial Officer at Karuna Therapeutics, to … News Release Details PureTech Health Affiliate Vedanta Biosciences Announces First Patient Enrolled in VE416 Phase 1b/2 Food Allergy Clinical Study 2019-07-01 … This pipeline includes four clinical-stage product candidates currently being evaluated for the treatment of high-risk C. difficile infection, inflammatory bowel disease, food allergy and advanced or metastatic cancers (in combination with Bristol Myers Squibb’s checkpoint inhibitor Opdivo®). Vedanta also announced the receipt of $12 million in additional capital and R&D collaboration funds from new and existing investors, including JSR Corporation, bringing the total Series C/C-2 funding to $71.1 million. Award is first-ever by BARDA directed to advance development of a microbiome drug. Vedanta’s proprietary capabilities include what is believed to be the largest collection of human-gut associated bacteria, assays and bioinformatics techniques for consortia design and optimization, vast datasets from human interventional studies and facilities for cGMP-compliant manufacturing of rationally-defined bacterial consortia in powder form. Programs supported by BARDA have received a total of 55 FDA approvals, licensures or clearances. The AP news staff was not involved in its creation. Vedanta Biosciences was founded by PureTech (LSE: PRTC). News Release Details PureTech Health Affiliate Vedanta Biosciences Announces Expanded Data from Successful Phase 1a/1b Study of VE303 at Digestive Disease Week 2019-05 … VE303 consists of a defined consortium of live bacteria designed to restore colonization resistance against gut pathogens, including C. difficile. Vedanta Biosciences has harnessed these biological insights and its capabilities to generate a pipeline of investigational live biotherapeutic products (LBPs) in infectious disease, autoimmune disease, allergy, and immuno-oncology. These forward-looking statements are based on assumptions regarding the present and future business strategies of the company and the environment in which it will operate in the future. 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