Fibrocell Science and Intrexon said today they will partner to develop genetically modified fibroblasts to treat chronic inflammatory and degenerative diseases of the joint, including arthritis and related conditions.

The companies’ latest collaboration could generate for Intrexon up to $52.5 million in milestone payments per product developed, on top of an upfront fee, payment for R&D expenses, and royalties.

The new collaboration is designed to marry Fibrocell’s fibroblast platform with Intrexon’s cellular engineering capabilities. The companies aim to generate cell-based therapeutics that have been modified to express one or more proteins at sites of joint inflammation. The treatments are intended to help overcome limitations of existing treatment approaches, which focus on limiting symptoms and slowing progression.

The companies already collaborate on the development of two Fibrocell gene therapy candidates now in preclinical phases—FCX-007, an orphan product candidate designed to treat recessive dystrophic epidermolysis bullosa (RDEB); and FCX-013, a candidate for linear scleroderma.

In July, the companies filed an IND application with the FDA to begin clinical trials for FCX-007. Two months later, Fibrocell and Intrexon disclosed that the FDA had requested an additional preclinical toxicology-specific study in which FCX-007 will be injected in non-grafted severe combined immunodeficiency (SCID) mice. Earlier, the companies submitted data of a hybrid pharmacology/toxicology study based on the injection of FCX-007 in RDEB human skin xenografted onto SCID mice, which showed no signs of toxicity.

“The synergy of our versatile fibroblast platform with Intrexon’s genetic engineering is readily apparent through two product candidates, FCX-007 and FCX-013, which have generated encouraging preclinical data across difficult-to-treat indications,” Fibrocell chairman and CEO David Pernock said in a statement. “We are excited by the expansion of our relationship with Intrexon and believe the power of our combined platforms will allow us to vie for leadership in this major therapeutic category and bring hope to patients and their families.”

Under the new collaboration, Fibrocell agreed to pay Intrexon a $10 million “technology access fee,” reimbursement for all R&D costs, up to $30 million per product in payments tied to achieving regulatory milestones, up to $22.5 million in commercial milestone payments per product, and a “low double digit” royalty based on net sales of products developed through the collaboration.

“With Intrexon's Better DNA® suite of proprietary technologies, our innovative engineered cell-based therapies may provide long-lasting effect while minimizing the repeated injections necessary with current treatments,” added Samuel Broder, M.D., svp and head of Intrexon’s Health Sector.








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