Vedanta Biosciences, a clinical-stage company developing a new category of therapies for immune-mediated diseases based on rationally-defined consorti Vedanta Biosciences … 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. 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. Both consortia variants colonized the gut abundantly. Award is first-ever by BARDA directed to advance development of a microbiome drug. The forward-looking statements are based on current expectations and are subject to known and unknown risks and uncertainties that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, those risks and uncertainties described in the risk factors included in the regulatory filings for PureTech Health plc. PureTech Founded Entity Vedanta Biosciences Appoints Troy Ignelzi, Chief Financial Officer at Karuna Therapeutics, to … The Biomedical Advanced Research and Development Authority (BARDA), an agency within the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), provides a comprehensive, integrated, portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing infrastructure for vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. Vedanta’s IP portfolio contains over 40 patents with coverage through at least 2038. This press release contains statements that are or may be forward-looking statements, including statements that relate to the company's future prospects, developments, and strategies. Both single and multiple doses of the 11- and 16-strain consortia were generally safe and well-tolerated. Vedanta Biosciences is leading the development of a potential new category of oral therapies based on rationally-defined consortia of bacteria derived from the human microbiome. We believe restoration of the gut microbiota after antibiotic use is a new paradigm in infection control that could improve patient outcomes following a broad range of procedures that rely on antibiotics, as well as a key underappreciated potential strategy in antimicrobial stewardship.”. VE303 consists of a defined consortium of live bacteria designed to restore colonization resistance against gut pathogens, including C. difficile. The full text of the announcement from Vedanta Biosciences is as follows: Vedanta Biosciences Awarded Up to $76.9 Million Including $7.4 Million Upfront from BARDA to Advance the Development of VE303, a Defined Bacterial Consortium for Prevention of … 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. Vedanta Biosciences Announces Initiation of Phase 1 Clinical Study with Janssen of Microbiome-Derived Product Candidate for Inflammatory Bowel Disease. BARDA, a division within the Office of the Assistant Secretary of Preparedness in the U.S. Department of Health and Human Services, supports a diverse portfolio of emerging therapeutics and devices. Vedanta Biosciences announced the appointment of Troy Ignelzi as an independent member of its Board of Directors. 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. Vedanta Biosciences Awarded Up to $76.9 Million Including $7.4 Million Upfront from BARDA to Advance the Development of VE303, a Defined … VE202 was designed to induce immune tolerance via the gut and thereby potentially treat inflammatory bowel disease. Vedanta IP estate and scientific cofounder ranked among the top 20 most impactful in biotech in 2017 Join Our Team We are working to provide doctors and patients with an entirely new option to treat human disease: medicines based on live bacterial consortia that can colonize the human intestine. VE303 was granted Orphan Drug Designation in 2017 by the United States Food and Drug Administration (FDA) for the prevention of recurrent C. difficile infection (rCDI). “Current treatments for IBD block mediators of inflammation, but do not address the underlying alterations in the gut microbiota that may be driving the inflammation in the first place. VE202 is a first-in-class orally-administered investigational live biotherapeutic product (LBP) consisting of a defined bacterial consortium. The study is enrolling patients with a recent confirmed diagnosis of CDI who have completed a course of antibiotics but remain at high risk for recurrence. VE303 is an orally-administered, investigational live biotherapeutic product (LBP). “CDI accounts for approximately 12,800 deaths each year in the U.S. alone and are the result of damage to the gut microbiota caused by both necessary and unnecessary antibiotic use. 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 … 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 concept of rationally-designed live biotherapeutic products has strong merit for treating infectious diseases such as C. difficile,” said Gary Disbrow, Ph.D., BARDA Acting Director. Proprietary capabilities include deep expertise in consortium design, vast datasets from human interventional studies and cGMP-compliant manufacturing of oral, live biotherapeutics containing pure, clonally-derived bacterial consortia in powdered form. Vedanta Biosciences’ Silvia Caballero, Ph.D., Named to TIME 100 NEXT List for Innovative Leaders Business Wire CAMBRIDGE, Mass. For more information, visit https://www.phe.gov/about/barda/. Vedanta expects to begin a Phase 2 study in IBD patients in the next 12 months. Results describing the biology and candidate selection of VE202 were previously published in Science and Nature (multiple). “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. Except as required by law and regulatory requirements, neither the company nor any other party intends to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise. Vedanta’s pipeline includes four clinical-stage product candidates currently being evaluated for the treatment of high-risk C. difficile infection, IBD, food allergy and advanced or metastatic cancers (in combination with Bristol Myers Squibb’s checkpoint inhibitor Opdivo®). Opdivo® is a registered trademark of Bristol Myers Squibb Company. CAMBRIDGE, Mass.--(BUSINESS WIRE)-- 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 positive topline data from two Phase 1 studies in healthy volunteers of VE202, the Company’s orally-administered live biotherapeutic … The Phase 1 studies of VE202 enrolled 105 healthy volunteers in single and multi-dose cohorts, and evaluated two variants of VE202, with either 11 or 16 bacterial strains forming the consortia. Vedanta Biosciences was founded by PureTech Health (LSE: PRTC) and a global team of scientific co-founders who pioneered Vedanta’s modern understanding of the cross-talk between the microbiome and the immune system. Its scientific co-founders are world-renowned experts in immunology and microbiology who have pioneered the fields of innate immunity, Th17 and regulatory T cell biology. Vedanta Biosciences Announces Positive Topline Data from Two Phase 1 Studies of VE202, a Rationally Defined Bacterial Consortium Being … Press release content from Business Wire. The AP news staff was not involved in its creation. 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. The primary endpoint is prevention of infection recurrence at eight weeks. The studies showed that VE202 was generally safe and well tolerated at all doses and demonstrated durable and dose-dependent colonization. These threats include chemical, biological, radiological, and nuclear threats, pandemic influenza and emerging infectious diseases. These investigational therapies are grounded in pioneering research – published in leading journals including Science, Nature, and Cell  –  to identify beneficial bacteria that live symbiotically within the healthy human gut, fight pathogens and induce a range of potent immune responses. Vedanta Biosciences announced the appointment of drug development leader Jeffrey Silber, M.D., as chief medical officer, who will guide the advancement of … The AP news staff was not involved in its creation. In subjects who were dosed for 14 days, VE202 strains were detected at high abundances 12 weeks after dosing ended, suggesting substantial durability of colonization. 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®). The grant from BARDA includes $7.4 million of guaranteed initial funding and up to an additional $69.5 million, subject to BARDA exercising multiple options under the award. -- … Award is first-ever by BARDA directed to advance development of a microbiome drug 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 … Vedanta plans to take the program forward into Phase 2 studies over the next 12 months. We’re enthusiastic about the opportunity to address both of these issues and proud to support clinical development of VE303.”. These consortia include several species of bacteria belonging to Clostridium Clusters IV and XIVa, which have been previously shown to play a role in induction of tolerance in IBD and are associated with disease remission. The ongoing Phase 2 study is a multi-center, randomized, double-blind, placebo-controlled trial designed to evaluate the safety and efficacy of two doses of VE303 compared to placebo in patients with high-risk CDI. It is produced under GMP conditions from pure, clonal bacterial cell banks, which yield a standardized drug product in powdered form and bypasses the need to rely on direct sourcing of fecal donor material of inconsistent composition. “We have now seen across three Phase 1 studies for VE202 and VE303, which collectively recruited 143 volunteers, that our LBPs appear to be safe and have the intended effect of robustly and durably colonizing and changing the gut microbiome composition in a targeted manner,” said Bernat Olle, Ph.D., chief executive officer of Vedanta Biosciences. 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 Jeffrey Silber, M.D., as chief medical officer. The patent issuances follow the 2019 decision of the Opposition Division of the EPO to uphold Vedanta’s foundational patent EP2575835 (the “Honda patent”), strengthening Vedanta’s IP position in the area of live bacterial therapeutics. A previous Phase 1a/1b study demonstrated rapid, durable, dose-dependent colonization and accelerated restoration of gut microbiota in healthy volunteers who were pretreated with antibiotics. 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. Sep 30, 2020. Cambridge, Massachusetts, July 10, 2018 - Vedanta Biosciences, an affiliate of PureTech Health (LSE: PRTC) developing a new category of therapies for immune-mediated and infectious diseases based on rationally defined consortia of human microbiome-derived bacteria, today announced that it has received funding from the Crohn's & Colitis Foundation, a non-profit organization dedicated to finding the cures … 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 … as Chief Medical Officer Jun 9, 2020 PureTech Health plc (LSE:PRTC) (“PureTech Health”), an advanced biopharmaceutical company developing novel medicines for dysfunctions of the Brain-Immune-Gut (BIG) axis, is pleased to announce that the European Patent Office has issued a decision to uphold Vedanta Biosciences’ foundational patent EP2575835 (the “Honda patent”). Programs supported by BARDA have received a total of 55 FDA approvals, licensures or clearances. News Release Details PureTech Health Affiliate Vedanta Biosciences Announces First Patient Enrolled in VE416 Phase 1b/2 Food Allergy Clinical Study 2019-07-01 … VE202 was generally safe and well-tolerated in healthy volunteers, with durable and dose-dependent colonization that will inform the Phase 2 dose regimen, Vedanta has regained full rights to the program and plans to advance it in a Phase 2 study within the next 12 months, Company also announces the issuance of three European patents including coverage of consortium compositions containing Clostridium bacterial strains for IBD, Company strengthens balance sheet with an additional $12 million in new equity and R&D collaboration funds, bringing the total Series C round to $71.1 million. BOSTON--(BUSINESS WIRE)-- Vedanta Biosciences, pioneering the development of a new class of therapies designed to modulate the human microbiome, today announced a … Award is first-ever by BARDA directed to advance development of a microbiome drug. 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. Vedanta Biosciences Announces the Appointment of Jeffrey Silber, M.D. Vedanta Biosciences received a $5.4 million research grant from CARB-X in 2017 and a grant from BARDA in 2020 to support clinical studies of VE303. Vedanta Biosciences Announces $16.6 Million Series C-2 Financing New funding brings total Series C and C-2 capital raised to $62.1 million Business Wire CAMBRIDGE, Mass. Vedanta Biosciences Awarded Up to $76.9 Million Including $7.4 Million Upfront from BARDA to Advance the Development of VE303, a Defined Bacterial Consortium for Prevention of C. difficile Infection in High-Risk Patients Sep 16, 2020 Vedanta Biosciences Announces the Appointment of Jeffrey Silber, M.D. “If successful, VE303 could prevent high-risk C. difficile and reduce our dependency on antibiotics, which would be a major win for public health. Milestone triggers $12 million in payments from Janssen. Colonization was most effective with vancomycin pre-treatment followed by multiple doses of the consortia. CAMBRIDGE, November 24, 2020 - 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. It is produced from pure, clonal bacterial cell banks, which yield a standardized drug product in powdered form and bypasses the need to rely on direct sourcing of donor fecal material of inconsistent composition. Preliminary data include: The trial was conducted by Janssen Research & Development, LLC; a more complete study dataset and analyses will be submitted to a peer-reviewed journal. as Chief Medical Officer Veteran IP attorney Nancy Chiu Wilker, Ph.D., J.D., joins … CAMBRIDGE, Mass., June 9, 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 positive topline data from two Phase 1 studies in healthy volunteers of VE202, the Company’s orally-administered live biotherapeutic product (LBP) candidate … Vedanta has regained full rights to the program and will owe Janssen single-digit royalty payments on net sales of a commercialized product. 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 Presents Positive Expanded Data from Phase 1a/1b Study of VE303 at Digestive Disease Week Expanded data on rapid, durable, … CAMBRIDGE, Mass., June 9, 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 positive topline data from two Phase 1 studies in healthy volunteers of VE202, the company’s orally-administered live biotherapeutic product … Each forward-looking statement speaks only as at the date of this press release. First clinical study of a rationally-defined bacterial consortium for an immune-mediated disease. Members of the media can contact ASPRMedia@hhs.gov. Vedanta Biosciences was founded by PureTech (LSE: PRTC). These advances have been published in leading peer-reviewed journals, including Science (multiple), Nature (multiple), Cell, and Nature Immunology. Bristol-Myers Squibb and Vedanta Biosciences Announce a New Clinical Collaboration to Evaluate OPDIVO (Nivolumab) and VE800 in Patients with Advanced or Metastatic Cancers. CAMBRIDGE, Mass., June 9, 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 positive topline data from two Phase 1 studies in healthy volunteers of VE202, the Company’s orally-administered live biotherapeutic product (LBP) candidate for inflammatory bowel disease (IBD). Vedanta Biosciences controls a foundational portfolio of more than 40 patents and has built what is believed to be the world’s biggest library of bacteria derived from the human microbiome. 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. 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). Vedanta Biosciences controls a foundational portfolio of more than 40 patents and has built what is believed to be the world’s biggest library of bacteria derived from the human microbiome. Nov 27, 2018. CAMBRIDGE, Mass., September 16, 2020 – 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 Jeffrey Silber, MD, as chief medical officer. The full text of the announcement from Vedanta Biosciences is as follows: Vedanta Biosciences Appoints Troy Ignelzi, Chief Financial Officer at Karuna Therapeutics, to … There were no serious adverse events related to VE202. 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. In Science and Nature ( multiple ) these issues and proud to support development. Human Microbiome-Derived bacteria Biosciences ’ Silvia Caballero, Ph.D., J.D., joins Press... To begin a Phase 2 study in IBD patients in the next months... 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