On August 25, 2022 Finch Therapeutics Group, Inc. ("Finch" or "Finch Therapeutics") (Nasdaq: FNCH), a clinical-stage microbiome therapeutics company leveraging its Human-First Discovery platform to develop a novel class of orally administered biological drugs, reported that it will regain full development and commercial rights to FIN-524 (previously known as TAK-524) and FIN-525 from Takeda Pharmaceutical Company Limited ("Takeda") (Press release, Takeda, AUG 25, 2022, View Source [SID1234618705]). Following a review of its pipeline, Takeda informed Finch of its decision to terminate its collaboration with Finch, effective November 17, 2022, resulting in the return to Finch of worldwide rights to develop and commercialize FIN-524, FIN-525, and any other microbiome product candidates for inflammatory bowel disease (IBD). FIN-524 and FIN-525 are investigational, orally administered targeted microbiome product candidates composed of bacterial strains selected for their potential immuno-modulatory properties.

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"We are grateful for Takeda’s substantial investment in the FIN-524 and FIN-525 programs and want to thank our dedicated colleagues at Takeda who have worked alongside us to develop these innovative product candidates. We look forward to exploring collaboration opportunities to continue the advancement of these assets, which we believe hold the potential to fulfill the need for a disease-modifying, orally delivered, well-tolerated therapy for IBD patients who are not well served by existing options," said Mark Smith, PhD, Chief Executive Officer of Finch Therapeutics. "We are currently conducting a review of our portfolio and assessing the financial and strategic impact of the discontinuation of our collaboration with Takeda."

Finch has received more than $44 million from Takeda during the course of the collaboration, including an upfront payment of $10 million, $4 million in milestone payments, and more than $30 million in reimbursement of research and development expenses. Upon termination, Finch will receive a royalty-free license to all data and intellectual property generated during the collaboration, including full rights to a large library of characterized bacterial isolates, data from multiple ex vivo and in vivo studies, a suite of pharmacokinetic and pharmacodynamic assays, and a significant body of chemistry, manufacturing, and controls (CMC) data generated during the investigational new drug (IND)-enabling phase of development.

About FIN-524 & FIN-525 for Inflammatory Bowel Disease

FIN-524 and FIN-525 are investigational, orally administered targeted consortia product candidates composed of both spore-forming and non-spore-forming bacterial strains selected for the treatment of ulcerative colitis and Crohn’s disease, respectively. The product candidates are designed to include strains that target multiple mechanisms of action combined with donor strains linked to remission following microbiota transplantation in patients with inflammatory bowel disease (IBD). The design of FIN-524 and FIN-525 leverage Finch’s machine-learning based platform and data from microbiota transplantation studies in patients with IBD. The manufacture of FIN-524 and FIN-525 is donor independent, with the strains grown from master cell banks.

About Inflammatory Bowel Disease

Ulcerative colitis and Crohn’s disease are the two most common types of inflammatory bowel disease (IBD), an autoimmune condition that causes inflammation of the gastrointestinal (GI) tract. Approximately 10 million people are affected by IBD worldwide, including approximately three million people in the U.S. Symptoms of IBD include severe, chronic abdominal pain, diarrhea, GI bleeding, weight loss, and fatigue. Current treatment options are ineffective for many people living with IBD.