PureTech Regulatory News (PRTC)

7 May 2019

PureTech Health plc

PureTech's Vedanta Biosciences Announces Favourable Decision for Key Microbiome Patent

European Patent Office decision further solidifies Vedanta's leading IP position in the microbiome therapeutic field

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 Bioscience's foundational patent EP2575835 (the "Honda patent"). This patent covers compositions of clostridial bacterial species for use in infectious and allergic disease, and is based on groundbreaking work by Dr Kenya Honda, a scientific co-founder of Vedanta Biosciences. The Honda patent is exclusively licensed to Vedanta under an agreement with the University of Tokyo and provides coverage through at least 2031.

This decision reinforces Vedanta's leadership position in the microbiome field as clostridial species are abundant in the gut and due to their immunomodulatory potential are of core interest for use in the development of live biotherapeutic products designed to colonise and modulate a patient's microbiome to therapeutic effect.

Bharatt Chowrira, JD, PhD, president and chief of business and strategy at PureTech Health, said: "In an emerging field as novel as microbiome therapies, capturing the value of groundbreaking discoveries is crucial to build a long-term foundation for IP leadership. Vedanta has always ensured its broad platform for therapeutic discovery and development has been supported by a strategic and comprehensive intellectual property portfolio, so this decision reflects both that long-term strategy and the truly novel contributions of Dr Honda."

The full text announcement from Vedanta is as follows:

Vedanta Biosciences Key Microbiome Patent Upheld in European Opposition Proceedings

Upheld patent EP2575835 covers therapeutic compositions of clostridial bacterial species derived from the human microbiome

Decision further solidifies Vedanta's leading IP position in the microbiome therapeutic field

CAMBRIDGE, Mass., May 7, 2019 - 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 that the Opposition Division of the European Patent Office has upheld Vedanta's foundational patent EP2575835 (the "Honda patent"), strengthening Vedanta's intellectual property position in a key area of microbiome therapeutics. The patent is based on groundbreaking work by Dr Kenya Honda, a scientific co-founder of Vedanta Biosciences, in identifying bacteria that induce significant immune responses. The upheld patent claims broadly cover compositions of clostridial bacterial species for use in infectious and allergic disease.

Clostridial bacterial species are abundant in the gut and are of high interest for use in the development of live biotherapeutic products designed to colonise and modulate a patient's microbiome to therapeutic effect. The Honda patent is exclusively licensed to Vedanta under an agreement with the University of Tokyo and provides coverage through at least 2031.

"We welcome this decision which affirms our belief that Dr Honda's breakthrough discoveries form the basis for a critical, foundational patent estate for the development and commercialisation of human microbiome drugs based on live bacteria," said Bernat Olle, PhD, chief executive officer of Vedanta Biosciences.

The Honda patent, together with additional Vedanta patents, provide the company with a leading IP position in the microbiome field. Vedanta's patents support the company's therapeutic candidates for the treatment of autoimmune diseases, such as inflammatory bowel disease (IBD), food allergy, and infectious diseases. Vedanta's portfolio contains 20 US patents and numerous foreign issuances with coverage extending to 2037.

The Honda patent, EP2575835, was opposed by six parties: Seres Therapeutics Inc., Nestec SA (a subsidiary of Nestlé SA) and four anonymous parties. Minor formal claim amendments were entered during the oral proceedings. The patent is now issued in major commercial markets, including the United States, Europe, and Japan.

About Vedanta Biosciences

Vedanta Biosciences is a clinical-stage company developing a new category of therapies for immune-mediated diseases based on rationally-defined consortia of human microbiome-derived bacteria. Vedanta Biosciences is a leader in the microbiome field with capabilities and deep expertise to discover, develop, and manufacture live bacteria drugs. These include what is believed to be the largest collection of human-gut associated bacteria, a suite of proprietary assays to select pharmacologically potent strains, vast proprietary 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 programmes in infectious disease, autoimmune disease, allergy, and immuno-oncology.

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, and include Ruslan Medzhitov, PhD, (Yale and Howard Hughes Medical Institute (HHMI)), Brett Finlay, PhD, (University of British Columbia and HHMI), Kenya Honda, PhD, (Keio University and RIKEN), Dan Littman, PhD, (New York University and HHMI), Alexander Rudensky, PhD, (Sloan Kettering and HHMI), and Jeremiah Faith, PhD, (Mount Sinai School of Medicine).

About PureTech Health

PureTech Health (LSE: PRTC) is an advanced biopharmaceutical company developing BIG medicines for dysfunctions of the Brain-Immune-Gut axis. The Company has gained deep insights into the connection between these systems and the resulting role in diseases that have proven resistant to established therapeutic approaches. By harnessing this emerging field of human biology, PureTech Health is developing new categories of medicines with the potential to have great impact on people with serious diseases.

PureTech Health is advancing a rich pipeline of innovative therapies with an unbiased, non-binary, and capital efficient R&D model across its affiliates and its internal labs. PureTech's affiliates include seven clinical-stage platforms, including one product that has been cleared by the US Food and Drug Administration (FDA) and a second product candidate that has been filed with the FDA for review, and several other novel preclinical programmes. The PureTech Health pipeline includes ground-breaking platforms and therapeutic candidates that were developed in collaboration with some of the world's leading experts.

PureTech's internal research and development is centred on tissue-selective immunomodulation for the treatment of oncology, autoimmune, and CNS-related disorders, with a near-term focus on targeting newly-discovered, foundational immunosuppressive mechanisms in oncology and novel approaches that harness the lymphatic infrastructure.

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

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