FDA clears Investigational New Drug (IND) application for lead gene therapy product candidate, FT-001, for the treatment of a rare inherited eye disease leading to severe visual impairment that may result in blindness.
Investors in the $160 million Series B round include Boyu Capital, Sequoia China, and existing investors OrbiMed and Creacion Ventures, who were co-lead investors in the Series A round
BEDFORD, Massachusetts, and SUZHOU, July 19, 2022 — Frontera Therapeutics, a clinical-stage biotechnology company that seeks to develop novel and best-in-class gene therapy medicines to improve the lives of patients across multiple disease areas, today announced successful completion of a $160 million Series B funding round. The Series B investors include Boyu Capital, Sequoia China, OrbiMed, Creacion Ventures, and other investors.
In addition, Frontera announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application to initiate a first-in-human clinical trial of FT-001, a gene therapy candidate for the treatment of patients with a rare genetic retinal disease that leads to severe vision loss.
“We are very pleased by the strong support from leading international investment firms in the completion of this financing round as we strive to create value for both patients and shareholders,” said Yong Dai, Ph.D., founder and CEO of Frontera. “The recent clearance of the IND for FT-001 by the FDA, which took less than 2 years to accomplish from program inception, is a testament to our execution capabilities.”
“We are thrilled to support Frontera’s goal of expanding gene therapy to new potential patient populations in the global market,” said Carl Gordon, Ph.D., CFA, Frontera Board Member and Managing Partner at OrbiMed.
“FT-001’s IND clearance by the FDA is an exciting operational accomplishment for the Frontera scientific and management teams,” said Wei Li, Ph.D., Chairman, Founding Partner of Creacion Ventures. “Its potential success in the clinic would be an important step toward validating the broader APEX Technology & Manufacturing platform. By creating the first fully-integrated, efficient and scalable adeno-associated virus (AAV) gene expression system, Frontera has the opportunity to shorten the time between product discovery, clinical development, and ultimately approvals across multiple programs.”
Frontera Therapeutics has secured total financing of $195 million since its founding in 2019, with investments from OrbiMed and Creacion Ventures in an initial $35 million Series A round.
Frontera Therapeutics is a global, fully-integrated, clinical-stage biotechnology company leveraging its novel APEX Technology & Manufacturing platform to develop and manufacture superior gene therapy candidates across multiple disease areas. The platform is an innovative adeno-associated virus (AAV) gene expression system that aims to optimize both new and clinically validated AAV vectors to enhance the safety and efficacy profiles of gene therapy products. The in-house GMP manufacturing capabilities enables rapid production across the product lifecycle, and efficiently advance AAV therapies from research to clinical development. Frontera’s development pipeline spans not only orphan diseases, but also larger patient markets – including ophthalmology, hematology, neurology and metabolic diseases. Frontera Therapeutics has offices in the United States and China, allowing it to target global patient populations. For additional information about Frontera Therapeutics, please visit the company’s website at www.fronteratherapeutics.com.