Castle Creek Biosciences

About Castle Creek Biosciences

Castle Creek Biosciences operates as a clinical-stage cell and gene therapy company, concentrating on the development and commercialization of treatments for rare diseases with limited or no therapeutic options. Founded in August 2015 as Castle Creek Pharmaceuticals and later renamed in February 2020, the company is a portfolio company of Paragon Biosciences, which was established by founder and chairman Jeffrey S. Aronin. The leadership team, including President and CEO Matthew Gantz, possesses extensive experience in the biopharmaceutical industry.

A pivotal moment in the company's history was the acquisition of Fibrocell Science, Inc. in December 2019, which significantly bolstered its focus on autologous cell-based therapies for skin and connective tissue diseases. This strategic move combined the late-stage development programs of both entities, particularly for conditions like epidermolysis bullosa (EB). The acquisition integrated key personnel and pipeline products, including the work of John Maslowski, who had served as CEO of Fibrocell and brought substantial experience in advancing cell and gene therapies through FDA approval.

The company's core business revolves around a proprietary autologous fibroblast platform. This platform is the foundation for creating personalized, targeted, and re-dosable gene therapies. Its business model is centered on advancing its product candidates through clinical trials to obtain regulatory approval and eventual commercialization. Castle Creek has secured significant funding through various rounds, including a $112.8 million preferred stock financing in May 2022 and a $75 million royalty financing in February 2025, to support its clinical trials and manufacturing capabilities.

The lead product candidate is dabocemagene autoficel (D-Fi), also known as FCX-007, an investigational gene therapy for dystrophic epidermolysis bullosa (DEB). DEB is a rare genetic disorder caused by mutations in the COL7A1 gene, leading to a deficiency of functional type VII collagen (COL7) and resulting in extremely fragile skin. D-Fi works by collecting a patient's own dermal fibroblasts, genetically modifying them *ex vivo* using a lentiviral vector to carry a functional COL7A1 gene, and then injecting these modified cells back into the patient's chronic wounds. The goal is for the modified cells to produce the needed COL7 protein, aiding in the formation of anchoring fibrils and promoting wound healing. D-Fi has received multiple FDA designations, including Orphan Drug, Rare Pediatric Disease, Fast Track, and Regenerative Medicine Advanced Therapy (RMAT). Another key candidate is FCX-013, being developed for moderate to severe localized scleroderma. The company operates its own commercial-scale cGMP manufacturing facility in Exton, Pennsylvania, which is crucial for producing its personalized therapies.