Vedanta Receives $25M Investment from Pfizer Inc

12 January 2021

 PureTech Health plc

PureTech Founded Entity Vedanta Biosciences Announces $25 Million Investment from Pfizer Inc.

Michael Vincent, M.D., Ph.D., Chief Scientific Officer, Inflammation & Immunology Research Unit at Pfizer, to join Vedanta's Scientific Advisory Board

PureTech Health plc (LSE: PRTC, NASDAQ: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercializing highly differentiated medicines for devastating diseases, is pleased to note that its Founded Entity, Vedanta Biosciences, today announced that Pfizer Inc. (NYSE: PFE) has made a $25 million investment in Vedanta, as part of the Pfizer Breakthrough Growth Initiative.

Vedanta intends to use the proceeds to fund a Phase 2 study of VE202 in inflammatory bowel disease (IBD), which it plans to initiate in 2021. Topline Phase 1 study data showed VE202 was generally safe and well-tolerated at all doses and demonstrated durable and dose-dependent colonization.

As part of the investment, Michael Vincent, M.D., Ph.D., Chief Scientific Officer, Inflammation & Immunology Research Unit at Pfizer, will join Vedanta's Scientific Advisory Board. Vedanta will retain control of all its programs and has granted Pfizer a right of first negotiation on VE202.

The full text of the announcement from Vedanta is as follows:

Vedanta Biosciences Announces $25 Million Investment from Pfizer Inc.

Michael Vincent, M.D., Ph.D., Chief Scientific Officer, Inflammation & Immunology Research Unit at Pfizer, to join Vedanta's Scientific Advisory Board

CAMBRIDGE, January 12, 2021 - 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 that Pfizer Inc. (NYSE: PFE) has made a $25 million investment in Vedanta, as part of the Pfizer Breakthrough Growth Initiative.

Vedanta intends to use the proceeds to fund a Phase 2 study of VE202 in inflammatory bowel disease (IBD), which it plans to initiate in 2021. Topline Phase 1 study data showed VE202 was generally safe and well-tolerated at all doses and demonstrated durable and dose-dependent colonization.

"We thank Pfizer for its investment in Vedanta and support of our IBD program and look forward to advancing microbiome modulation as a potential new treatment modality for IBD patients," said Bernat Olle, Ph.D., Co-Founder and Chief Executive Officer of Vedanta Biosciences.

"Inflammatory bowel disease has a daily, chronic impact on as many as 1.6 million Americans, and with cases on the rise in the U.S., patients urgently need new therapeutic options," said Michael Vincent, M.D., Ph.D., Senior Vice President and Chief Scientific Officer, Inflammation & Immunology Research Unit at Pfizer. "We believe Vedanta's approach to modulating the microbiome may hold promise for people living with IBD, and we are excited for its potential as this important study moves forward."

As part of the investment, Dr. Vincent will join Vedanta's Scientific Advisory Board. Vedanta will retain control of all its programs and has granted Pfizer a right of first negotiation on VE202.

About VE202

VE202 is a first-in-class orally administered investigational live biotherapeutic product (LBP) consisting of a defined bacterial consortium. 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. VE202 was designed to induce immune tolerance via the gut and thereby potentially treat inflammatory bowel disease. Results describing  the biology and candidate selection of VE202 were previously published in Science and Nature (multiple).

About Vedanta Biosciences

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. 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. 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 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. 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 was founded by PureTech Health (LSE: PRTC, Nasdaq: 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.

About PureTech Health

PureTech is a clinical-stage biotherapeutics company dedicated to discovering, developing and commercializing highly differentiated medicines for devastating diseases, including intractable cancers, lymphatic and gastrointestinal diseases, central nervous system disorders and inflammatory and immunological diseases, among others. The Company has created a broad and deep pipeline through the expertise of its experienced research and development team and its extensive network of scientists, clinicians and industry leaders. This pipeline, which is being advanced both internally and through PureTech's Founded Entities, as of the date of PureTech's most recently filed Registration Statement on Form 20-F, was comprised of 24 products and product candidates, including two that have received FDA clearance and European marketing authorization. All of the underlying programs and platforms that resulted in this pipeline of product candidates were initially identified or discovered and then advanced by the PureTech team through key validation points based on the Company's unique insights into the biology of the brain, immune and gut, or BIG, systems and the interface between those systems, referred to as the BIG Axis.

For more information, visit www.puretechhealth.com or connect with us on Twitter @puretechh.

Cautionary Note Regarding Forward-Looking Statements

This press release contains statements that are or may be forward-looking statements, including statements that relate to our product candidates and approach towards addressing major diseases, future prospects, developments, and strategies. 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, our expectations regarding the use of the investment and potential therapeutic benefits of VE202 and those risks and uncertainties described in the risk factors included in the regulatory filings for PureTech Health plc. 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. Each forward-looking statement speaks only as at the date of this press release. 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.