PureTech Regulatory News (PRTC)

5 December 2019

PureTech Health plc

PureTech Affiliate Vedanta Biosciences Awarded $5.8 Million CARB-X Grant to Accelerate Development of VE707 for Multi-Drug Resistant Infections

PureTech Health plc (LSE: PRTC) ("PureTech"), a clinical stage biotechnology company dedicated to discovering, developing and commercialising highly differentiated medicines for devastating diseases, is pleased to note that its affiliate, Vedanta Biosciences, has been awarded a $5.8 million grant for its VE707 programme targeting multi-drug resistant infections. The grant was awarded by Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), a global non-profit partnership dedicated to accelerating early development in antibacterial R&D to address the rising global threat of drug-resistant bacteria. Vedanta Biosciences is eligible for $3.5 million in further funding upon completion of specific milestones.

Bharatt Chowrira, JD, PhD, president and chief of business and strategy at PureTech said: "Increasingly the human microbiome is being colonised by dangerous bacteria and other microorganisms that have developed resistance to antimicrobial drugs, mainly through poor global stewardship of antibiotics. This grant from CARB-X recognises Vedanta's unique platform and advanced understanding of the human gut microbiome for developing live biotherapeutic products with the potential to modulate the intestinal microbiome to address a range of significant human diseases and health issues, including drug-resistant pathogens."

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

Vedanta Biosciences Awarded $5.8 Million CARB-X Grant to Accelerate Development of VE707 for Multi-Drug Resistant Infections

Vedanta Biosciences eligible for an additional $3.5 million upon completion of certain milestones

Programme addresses significant unmet therapeutic need for major hospital-acquired infections caused by multi-drug resistant organisms

CAMBRIDGE, Mass., December 5, 2019 - Vedanta Biosciences, a clinical-stage biopharmaceutical company developing a new category of therapies for immune-mediated diseases based on defined bacterial consortia, today announced that it has been awarded a second research grant from CARB-X (Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator), a global non-profit partnership dedicated to accelerating early development in antibacterial R&D to address the rising global threat of drug-resistant bacteria, of $5.8 million. In addition to the initial grant, Vedanta Biosciences is eligible for $3.5 million in further funding upon completion of specific milestones.

The funding will be directed towards the development of VE707, Vedanta's preclinical human microbiome-derived discovery programme designed to restore a healthy microbiota as well as prevent infection and colonisation recurrence of several multi-drug resistant organisms (MDRO) that are responsible for hundreds of thousands of infections in high-risk patients in the United States and Europe each year.

"The addition of Vedanta's VE707 programme to the CARB-X portfolio expands the rich diversity of our pipeline and reflects a novel approach against drug-resistant infections," said Kevin Outterson, executive director of CARB-X. "Innovations such as VE707, if successful and approved for use in patients, could offer physicians broader treatment options that would strengthen a patient's ability to fight serious infections and limit the spread of drug-resistant bacteria."

VE707 is designed to prevent MDRO infections that can result in life-threatening treatment delays and death. These infections result in approximately $2 billion of additional healthcare costs relating to patient isolation practices alone.

"We are very pleased to partner with CARB-X for a second time and look forward to working with the CARB-X team to develop an alternative to antibiotics to help address the burden of MDRO infections," said Bernat Olle, PhD, chief executive officer of Vedanta Biosciences. "If we could get rid of intestinal carriage of these MDROs in high-risk patients, we could not only prevent infections, but also curb the transmission of these organisms and enable physicians to avoid using antibiotics that select for ever-more resistant bacterial strains."

Vedanta Biosciences received its first grant from CARB-X for $5.4 million in 2017 to support clinical testing of Vedanta's oral product candidate, VE303, for the potential treatment of recurrent Clostridioides difficile infection (rCDI).

About VE707

VE707 is Vedanta's preclinical discovery programme for the prevention of infection and colonisation recurrence of several MDROs. VE707 is designed to be administered orally and consists of a defined consortium of commensal bacteria. It is produced from pure, clonal bacterial cell banks, which yield a product of uniform composition and free of any pathogenic strains, bypassing the need to rely on faecal donor material with inconsistent composition. VE707 is designed to decolonise gut-dwelling multi-drug resistant organisms in patients at high-risk for developing infections. Specifically, VE707 is being developed to eliminate intestinal carriage of carbapenem-resistant Enterobacteriaceae (CRE), extended-spectrum beta lactamase producers (ESBL), and vancomycin-resistant Enterococci (VRE) to restore a healthy microbiota as well as prevent infection and colonisation recurrence. CRE, ESBL, and VRE infections are some of the most common hospital-acquired infections and are estimated to affect over 500,000 intensive care unit, dialysis, solid organ transplant, and haematopoietic stem cell transplant patients each year in the US and Europe. Infections with these organisms can result in life-threatening treatment delays or death and result in approximately $2 billion healthcare-associated costs due to patient isolation practices alone.

About CARB-X

Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) is a global non-profit partnership dedicated to accelerating early development antibacterial R&D to address the rising global threat of drug-resistant bacteria. CARB-X is led by Boston University and funding is provided by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the US Department of Health and Human Services, the Wellcome Trust, a global charity based in the UK working to improve health globally, Germany's Federal Ministry of Education and Research (BMBF), the Bill & Melinda Gates Foundation, and with in-kind support from National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH). A non-profit partnership, CARB-X is investing up to $500 million from 2016-2021 to support innovative antibiotics and other therapeutics, vaccines, and rapid diagnostics. CARB-X supports the world's largest and most innovative pipeline of preclinical products against drug-resistant infections. CARB-X is headquartered at Boston University School of Law. https://carb-x.org/. Follow us on Twitter @CARB_X.

About Vedanta Biosciences

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 non-pathogenic bacteria. 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 optimisation, vast datasets from human interventional studies and facilities for cGMP-compliant manufacturing of rationally-defined bacterial consortia in powder form.

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. These advances have been published in leading peer-reviewed journals, including Science (multiple), Nature (2013, 2019), Cell, and Nature Immunology. 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. This pipeline includes three clinical-stage product candidates currently being evaluated for the treatment of recurrent C. difficile infection and inflammatory bowel disease (in collaboration with Janssen Biotech, Inc.), and food allergy, as well as a fourth product candidate expected to enter the clinic in 2019 in patients with advanced or metastatic cancers (in combination with Bristol-Myers Squibb's checkpoint inhibitor OPDIVO®).

Vedanta's IP portfolio contains over 30 issued patents with coverage through at least 2031. Vedanta Biosciences was founded by PureTech Health (LSE: PRTC). 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.

About PureTech Health

PureTech is a clinical stage biotechnology company dedicated to discovering, developing and commercialising 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 affiliates, is comprised of 24 product candidates and one product that has been cleared by the US Food and Drug Administration (FDA). All of the underlying programmes 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.

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