Finch Therapeutics and Crestovo Announce Merger to Form Finch Therapeutics Group, a Leading, Fully Integrated Microbiome Company

Merged entity includes a diverse pipeline of Full-Spectrum Microbiota™ and Rationally-Selected Microbiota™ products, an innovative discovery platform, large-scale manufacturing capabilities and a broad IP portfolio

SOMERVILLE and CAMBRIDGE, MA—October 23, 2017—Finch Therapeutics, a privately held microbiome engineering company and Crestovo, a privately held, clinical-stage biopharmaceutical company, announced today the successful completion of a merger, creating a leading, fully integrated microbiome company. The new entity, Finch Therapeutics Group, combines Crestovo’s extensive IP assets and late-stage candidate for recurrent C. difficile infections, CP101, an oral Full-Spectrum Microbiota™ product, with Finch’s commercial-scale manufacturing capabilities, discovery platform for developing Rationally-Selected Microbiota™ and significant product pipeline. The new company is headquartered in Somerville and led by Chief Executive Officer Mark Smith, Ph.D., previously Finch’s President and Chief Executive Officer, and Chief Operating Officer Joseph Lobacki, previously Chief Operating Officer and interim CEO of Crestovo.

 “This combination of a potential first-in-class product candidate for recurrent C. difficile infections with a novel technology platform for developing Rationally-Selected Microbiota™ products uniquely positions Finch Therapeutics Group to deliver on both the near- and long-term promise of microbiome therapies to transform public health and quickly reach the patient populations we yearn to serve,” said Mark Smith, Ph.D., CEO of Finch Therapeutics Group. “With the network of collaborators from both companies driving patient recruitment in PRISM 3, an ongoing 240-patient placebo-controlled trial of CP101 in recurrent C. difficile infections, we look forward to accelerating the development of this important new class of therapy.”

Joseph Lobacki, COO of Finch Therapeutics Group added, “Finch Therapeutics Group is differentiated by our unique commercial-scale manufacturing operations, which through a collaboration with OpenBiome, already delivers microbiome treatments to thousands of patients each year. We are also leveraging our human-first discovery and machine-learning platform to develop Rationally-Selected Microbiota™ therapies for inflammatory bowel disease through our partnership with Takeda. At the same time, we continue to expand our pipeline of wholly-owned candidates for diseases impacted by the microbiome.”

“After more than three decades of clinical research on microbial therapies, I am thrilled that Finch Therapeutics Group is bringing together the critical components needed to scale this new class of medicine,” commented Tom Borody, M.D., an early pioneer of microbial therapeutics and a scientific co-founder joining Finch from Crestovo. “Finch is positioned as the partner of choice for researchers in this field.” Dr. Borody has made significant contributions to the company’s IP portfolio, including several patent families with priority dates as early as 2000.  

Key Strategic Features of the Merger:

Advanced Lead Program
CP101, an encapsulated, orally-administered, Full-Spectrum Microbiota™ product containing microbiota harvested from healthy human donors, is Crestovo’s potentially first-in-class treatment for patients with recurrent C. difficile infection (CDI). CP101 is being evaluated in PRISM 3, a 240-patient, placebo-controlled trial. PRISM 3 builds on the clinical success of Crestovo’s academic collaborators, Dr. Alexander Khoruts and Dr. Michael Sadowsky, who developed a leading early-stage oral formulation of a microbiota-based product in 2014. As published in The American Journal of Gastroenterology, Dr. Khoruts’ clinical team administered their product in a single center, open label study of 49 patients with recurrent CDI. Overall, 88% of patients achieved clinical success, defined as no recurrence of CDI over two months.

Largest-Scale Manufacturing in Industry
Finch currently operates one of the largest stool donation programs in the world and manufactures approximately 1,000 microbial treatments every month. Through its collaboration with OpenBiome, products manufactured by Finch are distributed to a network of more than 900 providers. Finch’s leading donor program and manufacturing capabilities will enable rapid scale-up upon commercialization of its Full-Spectrum Microbiota™ products.

Technology to Extend Pipeline of Rationally-Selected Microbiota™ Therapies
Finch’s machine-learning platform to reverse engineer clinical and molecular data is driving the development of Rationally-Selected Microbiota™ products. Finch is working with its partner, Takeda, to develop the first Rationally-Selected Microbiota™ product for ulcerative colitis.

Leading Patent Position
The combined company will have a broad and comprehensive intellectual property portfolio — with 26 issued U.S. and foreign patents and more than 50 filed patent applications — covering compositions of matter, methods of use and methods of manufacture.

About Finch Therapeutics
Finch Therapeutics, a mission-driven microbiome engineering company, is developing novel microbial therapies to serve patients with serious and unmet medical needs. Founded by data scientists, clinicians, and microbiologists from MIT and OpenBiome, Finch uses machine- learning algorithms informed by high-throughput molecular data to reverse engineer successful clinical experience with fecal transplantation. Rather than relying on in-vitro screening of a library of microbes, Finch uses this human-first discovery approach to identify strains that drive clinical outcomes and to develop therapies that deliver these microbial communities to patients. FIN-524, a collection of microbes grown in pure culture to treat IBD, is Finch’s first product candidate based on a Rationally-Selected Microbiota™.

About Crestovo
Crestovo is a clinical-stage biopharmaceutical company developing Full-Spectrum Microbiota™ (FSM™) that harnesses the human gut microbiome. Crestovo is advancing the foundational clinical research of the company’s academic collaborators, Dr. Thomas Borody, Dr. Alexander Khoruts and Dr. Michael Sadowsky, which demonstrated in-human validation of an orally-available, microbiota-based product across a variety of serious diseases and unmet medical needs, including recurrent CDI. Crestovo’s lead Full-Spectrum Microbiota™ (FSM™) product, CP101, is currently being evaluated in the PRISM 3 clinical trial in patients with recurrent CDI.

Media Contact
BMC Communications
Lauren Parikhal
lparikhal@bmccommunications.com
(646) 513-3117

 

 

Finch Therapeutics and Takeda Announce Global Collaboration to Develop Microbiome Therapeutics in Inflammatory Bowel Disease (IBD)

The collaboration agreement grants Takeda an exclusive worldwide license to FIN-524, a synthetic microbiome therapy for IBD, and rights to follow-on products in IBD

Osaka, Japan and Somerville, MA – Finch Therapeutics, a privately held microbiome engineering company, and Takeda Pharmaceutical Company Limited (“Takeda”) (TSE: 4502), today announced a global collaboration agreement to jointly develop FIN-524.  FIN-524 is a live biotherapeutic product in pre-clinical research. It is composed of cultured bacterial strains that have been linked to favorable clinical outcomes in studies of microbiota transplantations in IBD. The collaboration combines Finch’s unique discovery platform with Takeda’s strength in drug development for gastrointestinal (GI) diseases to advance a new class of microbial therapy.

“Takeda’s deep GI expertise and recent success in bringing therapies to IBD patients complements our own expertise in microbiome engineering,” said Mark Smith, Ph.D., CEO of Finch. “Our human-first discovery platform uses data from successful clinical experiences with fecal transplants to design novel microbiome therapeutics for IBD and other diseases. Working with Takeda, we’re well positioned to bring a potentially transformative and scalable new therapy to patients.”

“We partner with the most innovative scientists and companies in GI research to speed the discovery and development of new therapeutic options for patients with GI diseases,” said Gareth Hicks, Ph.D., head of gastroenterology drug discovery for Takeda. “The truly innovative approach to therapeutic design established by Finch and the foundation of clinical evidence underlying FIN-524 make us excited to be working with our new partners in this rapidly developing field of medicine.”

Under the terms of the agreement, Takeda will make an upfront payment of $10 million to Finch for the exclusive worldwide rights to develop and commercialize FIN-524 and rights to follow-on products in IBD. Finch will be eligible for development, regulatory and commercial financial milestones and tiered royalties on worldwide net sales. Finch and Takeda may elect to extend this collaboration to additional, related indications on similar terms. Further details of the agreement were not disclosed.

About Finch Therapeutics
Finch Therapeutics is a mission-driven microbiome engineering company that aims to develop novel microbial therapies serving patients with serious and unmet medical needs. Founded by data scientists, clinicians, and microbiologists from MIT and OpenBiome, Finch uses machine learning algorithms informed by high-throughput molecular data to reverse engineer successful experiences with fecal transplantation. Rather than relying on in-vitro screening of a library of isolates, Finch uses this human-first discovery approach to identify strains that drive clinical phenotypes of interest and to develop therapies that deliver these microbial communities to patients. FIN-524, a collection of microbes grown in pure culture to treat IBD, is Finch’s first product candidate based on a synthetic ecology of microorganisms.

Takeda’s Commitment to Gastroenterology
Takeda is a global leader in gastroenterology. With expertise spanning more than 25 years, the company’s dedication to innovation continues to evolve and have a lasting impact. Beginning in the 1990’s Takeda pioneered gastroenterological breakthroughs in proton pump inhibitors. Since that time, Takeda’s global capabilities have expanded into the specialty care market in gastroenterology and biologics with a focus on ulcerative colitis and Crohn’s disease. Takeda's expertise also remains focused on therapeutic agents that work to reduce the production of acid in the stomach, and options for the treatment of chronic idiopathic constipation, irritable bowel syndrome with constipation and opioid-induced constipation. Through specialized and strategic in-house development, external partnerships, in-licensing and acquisitions, Takeda currently has a number of promising early stage GI assets in development, and remains committed to delivering innovative, therapeutic options for patients with gastrointestinal and liver diseases.

About Takeda Pharmaceutical Company
Takeda Pharmaceutical Company Limited is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its R&D efforts on oncology, gastroenterology and central nervous system therapeutic areas plus vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. New innovative products, especially in oncology and gastroenterology, as well as our presence in Emerging Markets, fuel the growth of Takeda. More than 30,000 Takeda employees are committed to improving quality of life for patients, working with our partners in health care in more than 70 countries. For more information, visit www.takeda.com/news.

Takeda’s Forward-Looking Statements
This press release contains “forward-looking statements.” Forward-looking statements include all statements other than statements of historical fact, including plans, strategies and expectations for the future, statements regarding the expected timing of filings and approvals relating to the transaction, the expected timing of the completion of the transaction, the ability to complete the transaction or to satisfy the various closing conditions, future revenues and profitability from or growth or any assumptions underlying any of the foregoing. Statements made in the future tense, and words such as “anticipate,” “expect,” “project,” “continue,” “believe,” “plan,” “estimate,” “pro forma,” “intend,” “potential,” “target,” “forecast,” “guidance,” “outlook,” “seek,” “assume,” “will,” “may,” “should,” and similar expressions are intended to qualify as forward-looking statements. Forward-looking statements are based on estimates and assumptions made by management that are believed to be reasonable, though they are inherently uncertain and difficult to predict. Investors and security holders are cautioned not to place undue reliance on these forward-looking statements.

Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Some of these risks and uncertainties include, but are not limited to: required regulatory approvals for the transaction may not be obtained in a timely manner, if at all; the conditions to closing of the transaction may not be satisfied; competitive pressures and developments; applicable laws and regulations; the success or failure of product development programs; actions of regulatory authorities and the timing thereof; changes in exchange rates; and claims or concerns regarding the safety or efficacy of marketed products or product candidates in development.

The forward-looking statements contained in this press release speak only as of the date of this press release, and neither Finch Therapeutics nor Takeda undertake any obligation to revise or update any forward-looking statements to reflect new information, future events or circumstances after the date of the forward-looking statement. If one or more of these statements is updated or corrected, investors and others should not conclude that additional updates or corrections will be made.

CONTACTS:

For Finch:
Andrew Noh
andrew@finchtherapeutics.com
+1-617-229-6499 x 701

For Takeda:
Tsuyoshi Tada – Japan
tsuyoshi.tada@takeda.com
+81-3-3278-2417

Julia Ellwanger – USA
julia.ellwanger@takeda.com
+1-224-554-7681

View the press release here.

Finch Therapeutics Announces Strategic Collaboration with OpenBiome to Develop Microbiome Therapies for FDA Approval

Finch Therapeutics, Inc., a microbiome therapeutics company, and OpenBiome, a leading public stool bank, today announced a collaboration to develop FIN-403, an orally administered microbial therapy for approval by U.S. Food and Drug Administration (FDA) in recurrent C. difficile infections.

Finch Therapeutics and Intract Pharma Announce Collaboration to Enable Targeted Delivery of Microbial Communities

Intract

London, UK and Somerville, MA - Finch Therapeutics, Inc., a microbiome therapeutics company based in Somerville, MA, and Intract Pharma, an oral drug delivery company based in London, UK, today announced that Finch will use Intract's Phloral® technology to develop a capsule for the  targeted delivery of microbial communities into the colon.

Phloral is the world’s only dual-action system for precise and reliable delivery to the large intestine, the predominant site of the gut microbiome. Traditional approaches to colon- targeting rely on a single mechanism to initiate drug release, such as changes in gastrointestinal pH, enzymatic activity, or prolonged transit time. However, given the considerable degree of individual variability in these parameters, these systems often fail, with drug release occurring prematurely, or in many cases, not at all. Phloral combines a pH-responsive polymer and natural polysaccharide as independent but complementary release mechanisms for fail-safe delivery. This cutting-edge technology has demonstrated consistent and clinically proven results in both healthy and diseased states.

“We are thrilled to incorporate a clinically superior and gold-standard gastrointestinal coating technology into our research and development platform,” says Andrew Noh, COO at Finch.

“This long-term partnership between Finch and Intract strengthens our ability to lead the industry in the development of therapeutics for microbiome-mediated diseases.”

“Finch’s innovative discovery platform presents an exciting new frontier in scientific research and represents a significant step in the development of microbial therapeutic products. We are delighted that Phloral will contribute to making these safer, more effective, and better suited to patient needs.” says Bill Lindsay, CEO at Intract.

The Phloral technology will enable the first-in-human discovery approach at Finch. "Phloral is an exciting technology for our research into the microbiome because it enables oral delivery of communities with the same precise targeting as traditional but less convenient colonoscopic delivery,” says Dean Glettig, Director of Product Development at Finch.

About Intract

Intract Pharma is a licensing and product development company offering state-of-art oral drug delivery formulation technologies and specialist gastrointestinal models to develop advanced new therapeutics. Intract is a spin-out from University College London (UCL) and has exclusive licence to oral delivery technologies developed by Professor Abdul Basit of the UCL School of Pharmacy and owned by UCL.

About Finch

Finch develops microbiome-based therapies via its human-first discovery platform. Discovery and product design begins with clinical proof of concept data in humans. Instead of relying on in vitro screening of a library of isolates, Finch mines molecular data collected from human interventional studies. Proprietary machine learning techniques enable Finch to build a clinically annotated library of strains that drive clinical phenotypes of interest.

contact:
 

For Finch Therapeutics
Andrew Noh, COO
media@finchtherapeutics.com

For Intract Pharma
Bill Lindsay, CEO
info@intractpharma.com