A year after Ferring Pharmaceuticals agreed to a €76 million ($91.4 million) deal to commercialize the lead product of T cell immunotherapy developer TxCell—Ovasave® for inflammatory bowel diseases—the partners said today they will secure additional expertise from another entity of Ferring’s parent foundation.
TxCell and Ferring’s Ferring International Center assigned their Ovasave development agreement to Trizell Holding, an entity established by the Dr. Frederik Paulsen Foundation to help develop cellular and gene therapies through specialist management, scientific, and development know-how.
The partners said the assignment to Trizell would not change their collaboration, option, development, and license agreement, under which TxCell is to receive upfront and milestone payments, plus royalties tied to sales milestones.
“This assignment to the Foundation’s specialist company reinforces our increasing commitment to new products like Ovasave, which offer potential breakthroughs in the treatment for diseases with high unmet medical needs,” Michel Pettigrew, Ferring’s COO and president of the executive board, said in a statement.
Ovasave is indicated for the treatment of IBDs that include Crohn's disease and ulcerative colitis. In December 2014, TxCell said it enrolled the first patient in its Phase IIb clinical trial of Ovasave in refractory Crohn’s disease, titled the Crohn’s And Treg Study (CATS29). Top line results are expected at the end of 2016 or early 2017 for the trial, designed to compare response six months after a single intravenous injection of Ovasave compared with placebo in 160 severe refractory Crohn’s disease patients at 32 study sites in six European countries: Austria, Belgium, France, Germany, Italy, and the United Kingdom.
A Phase I/IIa study, CATS1, showed Ovasave was well-tolerated in patients and led to responses from 75% of patients studied—with 38% going into remission five weeks after treatment.
Dr. Paulsen, a Ph.D., established Ferring in 1950 under another name to develop and sell pharmaceutical products based upon natural peptide hormones, and later became the first company to produce synthetic peptide hormones on a commercial scale.
TxCell was founded in 2001 as a spin-off from France’s Institut National de la Santé et de la Recherche Médicale (INSERM) to commercialize autologous antigen-specific regulatory T lymphocytes developed through its own ASTrIA technology platform. The company has been funded privately since 2004 and has raised a total €36.8 million ($44.3 million) in three rounds of financing by five major investors: French public investment bank Bpifrance’s InnoBio fund, Auriga Partners, Seventure Partners, AXA Private Equity and Innovation Capital.