Articles from Vedanta Biosciences

Vedanta Biosciences, a late clinical-stage company developing defined bacterial consortia as oral therapies for gastrointestinal diseases, today announced the publication of additional results from the Phase 2 CONSORTIUM study for its lead candidate, VE303, which is being evaluated for prevention of recurrent Clostridioides difficile infection (rCDI). The new analyses were published this month in Nature Medicine and can be viewed online.

Vedanta Biosciences, a late clinical-stage company developing defined bacterial consortia as oral therapies with an initial focus on gastrointestinal diseases, today announced the oral presentation of additional analyses from its completed Phase 2 CONSORTIUM study of VE303, an orally administered defined bacterial consortium candidate that is being developed for the prevention of recurrent Clostridioides difficile infection (rCDI). These analyses document the positive impact of VE303 treatment on the levels of antibiotic resistance genes (ARG) in the gut microbiomes of patients enrolled in the CONSORTIUM study, revealing associations between higher dosage and colonization of VE303 strains with lower levels of ARGs. The late-breaking oral presentation will be given this Friday October 18, in Los Angeles, CA, as part of Infectious Diseases Week (IDWeek) 2024.

Vedanta Biosciences, a clinical-stage biopharmaceutical company developing medicines for the treatment of gastrointestinal diseases, today announced three appointments to its leadership team. Christof Marré, a seasoned biopharma marketing leader, joins the company as Senior Vice President and Head of Commercial. In addition, Steven Shiff, M.D., a pharmaceutical executive and physician specializing in gastroenterology, has been appointed as SVP, Clinical Research; and Jack Kyte has been promoted to SVP, Human Resources.

Vedanta Biosciences, a clinical-stage company that is developing a potential new category of oral therapies based on defined bacterial consortia, today announced that the first patient has been dosed in the global Phase 3 RESTORATiVE303 clinical study. VE303 is an orally administered defined bacterial consortium candidate that is being developed for the prevention of recurrent C. difficile infection (rCDI). The RESTORATiVE303 trial is evaluating the efficacy and safety of VE303 in patients with rCDI and is intended to form the basis for a Biologics License Application (BLA) to be filed with the U.S. Food and Drug Administration.

Vedanta Biosciences, a clinical-stage company that is developing a potential new category of oral therapies based on defined bacterial consortia, today announced that members of its executive team will participate at the following investor conferences:

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.

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.

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 Wells Fargo Virtual Private Biotech Symposium being held on Wednesday, November 1, 2023.

Vedanta Biosciences, a clinical-stage company that is developing a potential new category of oral therapies based on defined bacterial consortia, today announced the details of two poster presentations at IDWeek 2023, being held virtually and in person in Boston, MA on October 11-15. The analyses cover two defined bacterial consortium candidates and include additional results from the VE303 Phase 2 CONSORTIUM study and an assessment of VE707 for the prevention of infection caused by multidrug-resistant Gram-negative bacteria. The posters will be presented at the session: “Antimicrobial Novel Agents” on Saturday, October 14, from 12:15 to 1:30 pm E.T.

Vedanta Biosciences, a clinical-stage biopharmaceutical company pioneering the development of oral therapies based on defined bacterial consortia, today announced that members of its executive team will participate at the following investor conferences:

Vedanta Biosciences, a clinical-stage company that is developing a potential new category of oral therapies based on defined bacterial consortia, today announced that the first patient in the Phase 2 COLLECTiVE202 clinical study of VE202 was dosed. Vedanta also announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to Vedanta’s defined bacterial consortium candidate, VE202, for the treatment of ulcerative colitis (UC). Fast Track designation is a process designed to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need.

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 participate in a fireside chat and host investor meetings at the JMP Securities Life Sciences Conference being held May 15-16, 2023 at the New York Hilton Midtown in New York, NY.

Vedanta Biosciences, a clinical-stage company that is developing a potential new category of oral therapies based on defined bacterial consortia, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to Vedanta’s defined bacterial consortium candidate, VE303, for the prevention of recurrent Clostridioides difficile infection (rCDI). Fast Track designation is a process designed to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need. Vedanta also announced the details of a podium presentation of research informed by the VE303 Phase 2 CONSORTIUM study at Digestive Disease Week (DDW) 2023, held in Chicago, Illinois, May 6-9.

Vedanta Biosciences, a clinical-stage company that is developing a potential new category of oral therapies based on defined bacterial consortia, today announced that it has raised $106.5 million to support pivotal-stage development of its lead candidate, VE303, for the prevention of recurrent Clostridioides difficile infection (CDI), and a Phase 2 study of VE202 for ulcerative colitis, among other development activities. The VE303 study would be the first pivotal Phase 3 study of a therapeutic candidate based on a defined bacterial consortium, which Vedanta is pioneering as a next-generation approach to microbiome therapy. Defined bacterial consortia are products of standardized composition manufactured from cell banks, bypassing the need to rely on donor fecal material of inconsistent composition.

Vedanta Biosciences, a clinical-stage company that is developing a potential new category of oral therapies based on defined bacterial consortia, today announced the publication of Phase 2 study results from its lead program, VE303, in the Journal of the American Medical Association (JAMA), as well as a late-breaker oral presentation at the European Congress of Clinical Microbiology in Infectious Diseases (ECCMID) annual event. The publication includes analyses of safety, efficacy, in preventing recurrence of Clostridioides difficile infection (rCDI), and VE303 strain colonization data from the successfully completed Phase 2 study of VE303. The ECCMID presentation offers more in-depth scrutiny of VE303 strain colonization dynamics and its relationship to the observed clinical effect. Colonization dynamics is analogous to traditional drug pharmacokinetics and refers to the growth and persistence over time of bacterial strain populations in the human gut.

Vedanta Biosciences, a clinical-stage biopharmaceutical company pioneering the development of oral therapies based on defined bacterial consortia, today announced that members of its executive team will participate at the following investor conferences:

Vedanta Biosciences, a clinical-stage biopharmaceutical company pioneering the development of oral therapies based on defined bacterial consortia, today announced that Bernat Olle, Ph.D., Chief Executive Officer of Vedanta Biosciences, will present at the 9th International Human Microbiome Consortium Congress (IHMC), being held from November 8 – 10, 2022 in Kobe, Japan.

Vedanta Biosciences, a clinical-stage biopharmaceutical company pioneering the development of oral therapies based on defined bacterial consortia, today announced that members of its executive team will participate at the following investor conferences:

Vedanta Biosciences, a clinical-stage biopharmaceutical company pioneering the development of oral therapies based on defined bacterial consortia, today announced the opening of a new facility designed to manufacture clinical and commercial supply for its therapeutic portfolio, including for the planned Phase 3 study and potential commercial launch of its lead candidate, VE303, in Clostridioides difficile infection. The large-scale Current Good Manufacturing Practice (CGMP) facility builds on the company’s existing manufacturing capabilities and can produce multiple drug candidates in a manner compliant with global regulatory standards, supporting Vedanta’s clinical expansion. With this facility, Vedanta has CGMP capabilities from clinical development to commercial launch, underscoring its leadership in the discovery, development, and manufacture of drugs based on defined bacterial consortia.

Vedanta Biosciences, a clinical-stage company that is developing a potential new category of oral therapies based on defined bacterial consortia, today announced that Bernat Olle, Ph.D., Chief Executive Officer of Vedanta Biosciences, will participate in a fireside chat at the JMP Securities Life Sciences Conference being held June 15-16, 2022 at the Lotte New York Palace in New York, NY.

Vedanta Biosciences, a clinical-stage biopharmaceutical company pioneering the development of oral therapies based on defined bacterial consortia, today announced the details of three podium presentations of research informed by multiple clinical studies at Digestive Disease Week (DDW) 2022, being held both virtually and in person in San Diego, CA on May 21-24. The analyses cover several defined bacterial consortia candidates developed by Vedanta, and include assessments of safety, tolerability, efficacy, and the relationships between dosing regimen, consortium strain colonization, and restoration of a patient’s resident microbial community. These analyses further deepen Vedanta’s understanding of the clinical pharmacology and potential benefits of defined bacterial consortia and help inform future clinical research. This body of data builds on published analyses from earlier clinical work that identified key factors that drive colonization of Vedanta’s candidates.

Vedanta Biosciences, a leading clinical-stage company developing a potential new category of oral therapies based on defined bacterial consortia, today announced the publication in the journal Cell Host & Microbe of the results from a Phase 1a/1b study evaluating the safety, tolerability, and colonization dynamics of VE303 in healthy adults. VE303 is a potential first-in-class defined bacterial consortium candidate for the prevention of recurrent Clostridium difficile infection (CDI). The company will also share three research updates across its VE303 and VE202 (for inflammatory bowel disease) programs in podium presentations at Digestive Disease Week in May 2022.

Vedanta Biosciences, a clinical-stage company that is developing a potential new category of oral therapies based on defined bacterial consortia, today announced that Bernat Olle, Ph.D., chief executive officer of Vedanta Biosciences, will participate in a panel and present at the virtual Chardan Metagenomics and Microbiome Medicines Summit on Tuesday, March 1, 2022.

Vedanta Biosciences, a clinical-stage company that is developing a potential new category of oral therapies based on defined bacterial consortia, today announced the appointment of Simona Levi, Ph.D., J.D., as Chief Legal Officer and Corporate Secretary. Dr. Levi brings over 25 years of United States and international legal experience with private and public companies across the life sciences industry focusing on complex transactions, intellectual property law and litigation, and corporate governance.

Vedanta Biosciences, a leading clinical-stage microbiome company developing a new category of oral therapies using defined bacterial consortia manufactured from clonal cell banks, today announced additional results from a Phase 1 study in healthy volunteers of VE202, the Company’s 16-strain live biotherapeutic product (LBP) candidate for inflammatory bowel disease (IBD). The new data were presented at the International Human Microbiome Consortium Congress 2021 (IHMC), being held virtually from June 27-29th.

Vedanta Biosciences, a leading clinical-stage microbiome company developing a new category of oral therapies using rationally defined bacterial consortia manufactured from clonal cell banks, today announced that members of its management team will participate in the SVB Leerink Biopharma Private Company Connect Event being held virtually Thursday, May 6 - Friday, May 7, 2021.

Vedanta Biosciences, a leading clinical-stage microbiome company developing a new category of oral therapies using rationally defined bacterial consortia manufactured from clonal cell banks, today announced that Bernat Olle, PhD, Vedanta’s Chief Executive Officer, will participate in the Executive Perspectives on Current Challenges and Opportunities for Microbiome-Based Therapeutics Panel and give a formal presentation at the 2021 Jefferies Virtual Microbiome-Based Therapeutics Summit Thursday, April 22, 2021.