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Ovasave is an antigen-specific autologous T regulatory somatic cell therapy developed for the treatment of inflammatory bowel disease, specifically refractory Crohn’s disease. It involves the use of ovalbumin-specific autologous regulatory T cells (Ova-Treg) administered intravenously to modulate immune response and reduce inflammation in patients with severe Crohn’s disease. The therapy aims to restore immune tolerance by expanding antigen-specific regulatory T cells that suppress pathological inflammation. Ovasave was developed by TxCell and has undergone clinical trials including a randomized controlled phase IIb study (CATS29) designed to evaluate its efficacy and safety in patients with refractory Crohn’s disease. The FDA granted Fast Track Designation to Ovasave for moderate to severe Crohn’s disease, reflecting its potential to address unmet medical needs in this patient population[3][5][6].
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