TxCell SA, a biotechnology company developing innovative, personalized cellular immunotherapies using regulatory T-cells to treat severe chronic inflammatory and autoimmune diseases, announced the appointment of PCT, a Caladrius Company, as its contract manufacturing organization (CMO) in the US. The initial relationship could transition to a technology transfer, and to PCT having responsibility for the future manufacturing of TxCell’s clinical supply in the US.
PCT, a subsidiary of Caladrius Biosciences, Inc. is a leading development and manufacturing partner to the cell therapy industry. PCT has been set up to overcome fundamental challenges of its clients’ cell therapy manufacturing with a wide range of services, from process development to GMP manufacturing and logistics.
Initially, PCT will operate a preliminary strategic evaluation of the existing TxCell manufacturing processes. These processes were designed by TxCell for its first platform of antigen specific regulatory T cells products (the ASTrIA platform). Following completion, TxCell could start transferring its technology to PCT. This will achieve a source of clinical supply in the US for use when required.
“Entering into a strategic relationship with PCT for the future manufacturing of TxCell’s products in the US is yet another step in the advancement of the clinical development of TxCell’s product portfolio,” said Miguel Forte, MD, PhD, senior vice-president, chief operating officer of TxCell. “Ovasave, TxCell’s lead product developed in refractory Crohn disease, now has both an open IND as well as a Fast Track Designation in the US. In addition, Col-Treg, TxCell’s second most advanced product, has recently obtained Orphan Drug Designation status for the treatment of non-infectious uveitis in the US. TxCell is positioning itself to lever these regulatory statuses to conduct a first clinical trial with our products in the US with materials manufactured by PCT. TxCell also will plan to examine options for manufacturing in Asia, and specifically Japan.”
“PCT is proud that such an innovative cell therapy developer as TxCell has chosen PCT as its US external development and manufacturing partner. Their decision adds further credence to PCT’s international reputation as the partner of choice for cell-based therapy companies,” said Robert A. Preti, PhD, president of PCT and senior vice president, manufacturing and technical operations and chief technology officer, Caladrius Biosciences, Inc.
ASTrIA (Antigen Specific Treg for Inflammation and Autoimmunity) is a TxCell proprietary cellular immunotherapy product platform composed of autologous antigen specific Type 1 Regulatory T cells (Ag-Treg). Ag-Treg based products from the ASTrIA platform are produced from the peripheral blood of patients. After white blood cell isolation, CD4+ T cells are educated to recognize a specific antigen. Antigen educated Treg cells are then isolated and expanded ex-vivo. Ovasave, the first Ag-Treg product candidate from the ASTrIA platform, has been developed for the treatment of Inflammatory Bowel Disease (IBD) and is composed of ovalbumin-specific Type 1 Treg cells. Ovasave is currently in a European Phase IIb clinical study in severe Crohn's Disease, entitled CATS29. Col-Treg is the second candidate from the ASTrIA platform and is composed of type-2 Collagen-specific Type 1 Treg cells. Col-Treg is developed for the treatment of steroid-refractory non-infectious uveitis.