Therini Bio Initiates First-In-Human Dosing in Phase 1 Trial of THN391, a Fibrin-Targeting Therapeutic Candidate for Alzheimer’s Disease

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Michael Quigley, Ph.D.

SOUTH SAN FRANCISCO, Calif.– Therini Bio, Inc., a biotech company focused on developing fibrin-targeted therapies to treat inflammatory neurodegenerative and retinal diseases, today announced the initiation of first-in-human dosing for a Phase 1 trial of its lead asset THN391, a fibrin-targeting therapeutic candidate for Alzheimer’s disease.

THN391 binds to the inflammation-driving component of fibrin that is known to activate pathological immune responses in neurodegenerative and ophthalmologic diseases. Importantly, based on preclinical studies to date, targeting this region does not impact or diminish fibrin’s critical role in blood clotting and coagulation. Key safety and proof of mechanism clinical data is expected by the end of 2024.

“Initiating first-in-human dosing for THN391 is a significant milestone and we’re excited about the approach that Therini Bio is taking towards treating Alzheimer’s disease and other inflammatory neurodegenerative and retinal diseases. As an early investor in Therini, we look forward to continue supporting the Company’s mission of developing potential first-in-class therapies targeting toxic fibrin accumulation for areas of significant unmet patient need,” said Laurence Barker, Partner, Dementia Discovery Fund (DDF).

As Therini Bio enters a new era of growth as a clinical-stage company, it has appointed industry veteran Frank D. Lee as Executive Chairperson of the Board at Therini Bio. Frank was most recently President and CEO of Forma Therapeutics until its acquisition by Novo Nordisk for $1.1B in 2022. He brings over 25 years’ global experience in product development and commercial leadership across a wide range of therapeutic areas within the biotech and pharmaceutical industry. He was also Senior Vice President, Global Product Strategy and Therapeutic Area Head for the Immunology, Ophthalmology and Infectious Diseases at Genentech, a member of the Roche Group, where he was responsible for driving development and commercial strategy for a broad portfolio of molecules in development and for global in-line product sales of more than $11B.

Frank’s 13-year career path at Genentech included leadership positions of increasing scope and responsibility for delivering transformative medicines to patients. Prior to joining Genentech, Frank spent approximately 13 years across Novartis, Janssen and Eli Lilly in engineering, manufacturing, sales/marketing and business development. Frank received a bachelor’s degree in Chemical Engineering from Vanderbilt University and an MBA in marketing and finance from the Wharton Graduate School of Business. He currently serves as chair of the board of Catamaran Bio and as an independent board member of Bolt Bio. He previously served on the board of directors of the Genentech Foundation.

“We are thrilled to announce the initiation of first-in-human dosing for THN391, our fibrin-targeting therapeutic candidate for Alzheimer’s disease. This is a major milestone for the Company, and as part of our continued growth, we are excited to welcome Frank as Executive Chairperson of the Board at Therini Bio. Frank’s extensive experience in product development and commercial leadership will be invaluable as we enter this new era as a clinical-stage company,” said Michael Quigley, Ph.D., President and CEO of Therini Bio.

“I am honored to be joining Therini Bio as Executive Chairperson of the Board, as the Company advances its first clinical candidate THN391 as a fibrin-targeting therapeutic candidate for Alzheimer’s disease,” said Frank D. Lee, Executive Chairperson of the Board, Therini Bio. “I look forward to working alongside the Therini Bio team to help advance this candidate and its pipeline of fibrin-targeted therapeutic candidates. Therini Bio has assembled a talented group of experienced pharma and biotech veterans with a deep commitment to improving patient outcomes, and I am thrilled to be a part of this effort.”

“Sanofi Ventures is passionate about supporting innovative companies that are developing breakthrough therapies for patients in need. We are thrilled to have Frank join Therini Bio as Executive Chairperson of the Board, as Therini Bio advances their fibrin-targeting therapeutic candidate for Alzheimer’s disease and retinal diseases. We look forward to working with the team throughout development in multiple indications,” said Laia Crespo, Partner, Sanofi Ventures.