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Castle Creek Raises $112.8 Million from Private Investors

May 23, 2022

Cell and gene therapy developer Castle Creek Biosciences, a portfolio company of Paragon Biosciences, has raised $112.8 million to advance its clinical pipeline.

Photo: Matthew Gantz, president and CEO of Castle Creek Biosciences

The company, which had filed to go public in July 2021 but withdrew it in December amid bearish market conditions on Wall Street, turned instead to parent investor Paragon and a group of private backers for the current round of cash, according to an SEC filing dated May 2.

Castle Creek Biosciences’s lead candidate FCX-007, or D-Fi (dabocemagene autoficel), is an experimental cell-based gene therapy that is administered intradermally and is in late-stage pivotal trials for the treatment of recessive dystrophic epidermolysis bullosa (RDEB), a severe skin disease characterized by very fragile skin that is prone to chronic blistering and wounds from normal friction or irritation.  

RDEB is caused by mutations in the COL7A1 gene and may be inherited in an autosomal dominant or autosomal recessive manner depending on the subtype. The disease impacts children from birth and has a high mortality rate. In severe cases it often involves widespread blistering that can lead to vision loss, disfigurement, and other serious medical problems. There are currently no approved treatment options for RDEB.

Castle Creek expanded its fibroblast platform in January with the acquisition of preclinical gene therapy biotech Novavita Thera, adding in vivo capabilities to its existing ex vivo approach and broadening its programs beyond skin and connective tissue disorders to rare liver diseases.

The acquisition gave the company a gene therapy for hereditary tyrosinemia type 1 (HT1), a rare inborn error of metabolism caused by a lack of the enzyme fumarylacetoacetate hydrolase (FAH) which leads to accumulation of tyrosine and its metabolites in the liver. HT1 leads to cirrhosis, liver failure, hepatocellular carcinoma, and is ultimately fatal if untreated. Liver transplantation is currently the only curative treatment available for HT1.

The experimental lentiviral gene therapy is designed to transduce hepatocytes and deliver the FAH enzyme that is deficient in these cells. Castle Creek plans to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for LV-FAH in HT1. Castle Creek will also continue to progress several additional candidates targeting other rare liver and metabolic diseases and skin and connective tissue disorders.

Author: Rare Daily Staff

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