Castle Creek gets $75M for DEB gene therapy Phase 3 trial
Ligand leads royalty financing agreement with $50M investment
Castle Creek Biosciences has secured $75 million in financing to support a Phase 3 trial testing its gene therapy to promote wound healing in people with dystrophic epidermolysis bullosa (DEB).
The royalty financing agreement for Castle Creek‘s treatment, D-Fi, was led by Ligand Pharmaceuticals, which made a $50 million investment. Ligand said the investors will get “a high single-digit royalty” on worldwide sales of the treatment if it is ultimately brought to market.
“We are pleased Ligand and our syndicate of investors recognized the potential of this critical therapy, which we believe represents a significant step forward in addressing the needs of patients living with DEB,” Matthew Gantz, president and CEO of Castle Creek, said in a Ligand press release. “Having a sophisticated investor like Ligand work closely with our extremely supportive equity partners made this transaction to support our Phase 3 clinical trial possible.”
DEB is caused by mutations in the gene COL7A1, which provides instructions to make a part of type VII collagen, a protein that acts like a scaffold to help give skin its structural integrity. People with DEB have reduced or absent type VII collagen, leading to symptoms such as frequent wounds that don’t heal well.
Fibroblasts are one of the cell types that make the type VII collagen protein. D-Fi, also known as FCX-007 or dabocemagene autoficel, works by taking patients’ fibroblasts and modifying them so that they carry a healthy version of the COL7A1 gene. The genetically modified cells are then injected into patients’ wounds, with the goal of producing healthy type VII collagen that can promote wound healing.
Orphan drug status
D-Fi was tested in six DEB patients in a Phase 1/2 clinical study (NCT02810951). According to Castle Creek, eight out of 10 treated wounds showed at least 90% healing within about three months after treatment with D-Fi. The six patients are being followed as part of an ongoing Phase 3 clinical trial (NCT04213261), which is set to run through 2037.
D-Fi has been granted U.S. Food and Drug Administration orphan drug status. This designation is given to experimental therapies for rare diseases, and is designed to incentivize companies to invest in rare-disease treatments.
“Partnering with Castle Creek is an exciting opportunity to advance an orphan drug-designated gene therapy for a serious unmet medical need through Phase 3 development,” said Todd Davis, CEO of Ligand. “This collaboration reflects our commitment to invest in groundbreaking de-risked treatments that can transform patients’ lives and expand our diversified portfolio of revenue-generating assets.”
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