(SEATTLE), February 4, 2020-- AGC Biologics, a global Contract Development and Manufacturing Organization (CDMO) for Biopharmaceuticals and Trefoil Therapeutics announce the execution of a manufacturing contract to supply their lead compound TTHX1114. Trefoil is developing products based on this engineered form of FGF-1 to restore lost vision in patients with corneal diseases by regenerating corneal tissue.
Trefoil Therapeutics selected AGC Biologics for their deep technical expertise and proven abilities in cGMP manufacture of protein-based therapeutics from pre-clinical to commercial production, after a three-month selection process. David Eveleth, Ph.D., CEO, Trefoil Therapeutics, commented, “AGC Biologics’ extensive experience in cGMP manufacturing makes them an ideal company to help us move TTHX1114 forward. We believe our engineered FGF-1, which is expected to enter clinical trials during 2020 in an intracameral formulation for the treatment of corneal endothelial dystrophies, has the potential to make a substantial difference in patients’ lives.”
Patricio Massera, CEO, AGC Biologics states, “AGC Biologics is delighted to assist Trefoil Therapeutics with the production of this life changing product. Our teams will work together in an open and collaborative manner and we are excited about the project’s potential.”
AGC Biologic’s global manufacturing footprint includes a cGMP-compliant facility in Heidelberg, Germany, which will begin manufacturing TTHX1114 in the coming months.
TTHX1114 is an engineered form of FGF-1 designed to stimulate proliferation and migration of corneal endothelial cells.The intracameral injectable formulation of TTHX1114, which is undergoing IND-enabling studies, is designed to regenerate the endothelial cell layer and reduce or eliminate the symptoms associated with endothelial dystrophy, the leading cause of cornea transplantation surgeries.The topical eye drop formulation of TTHX1114, in preclinical development, is designed for the treatment of ulcerative conditions on the front surface of the cornea.
About Trefoil Therapeutics:
Trefoil Therapeutics is a private biotechnology company focused on leveraging its engineered fibroblast growth factor-1 protein (eFGF-1) technology platform to develop first-in-class pharmacologic treatments for serious corneal endothelial diseases and epithelial disorders. Trefoil’s lead product TTHX1114 is an engineered from of FGF-1 designed to treat corneal disorders by stimulating cell proliferation and migration. For more information, visit www.trefoiltherapeutics.com.
About AGC Biologics:
AGC Biologics is a leading global Contract Development and Manufacturing Organization (CDMO), with a strong commitment to deliver the highest standard of service to our clients and partners. The company currently employs more than 850 employees worldwide. AGC Biologics extensive network spans three continents, with cGMP-compliant facilities in Seattle, Washington; Copenhagen, Denmark; Heidelberg, Germany; and Chiba, Japan.
AGC Biologics offers deep industry expertise and unique customized services for the scale-up and cGMP manufacture of protein-based therapeutics; from pre-clinical to commercial mammalian and microbial production. Our integrated service offerings include cell line development, bioprocess development, formulation, analytical testing, antibody drug development and conjugation, cell banking and storage, and protein expression - including our proprietary CHEF1® Expression System for mammalian production.