Biotechnology company TxCell has reported positive immuno-monitoring results from Phase I/II study in Crohn's disease (CATS1) with Ovasave.
The open label, multicentre Phase I/II study was designed to evaluate the tolerability and efficacy of Ovasave, an antigen-specific regulatory T cell-based immunotherapy.
The CATS1 study included 20 patients with severe chronic active Crohn's disease, who had failed current treatments, including multiple biologics.
The immuno-monitoring study results indicated that the Ovasave treatment impacted the immune system specifically in patients responding to Ovasave.
A decrease in blood pro-inflammatory monocytes subpopulations and an inhibition of the immune response to Ovasave-specific antigen were observed.
TxCell CEO François Meyer said in addition to the positive clinical results of the Phase I/II, the immuno-monitoring data adds important information to the mechanism of action of Ovasave.
"The confirmation of this antigen-specific suppressive activity in the planned Phase II clinical trial in the same refractory patient population could become an important marker to assess the patient's biologic response to treatment," Meyer added.
The correlation between a patient's clinical improvement and antigen-specific immuno-suppression supports the mechanism of action of Ovasave, the study reported.
TxCell chief scientific officer Arnaud Foussat said the immuno-monitoring results indicate that antigen-specific immune suppression was obtained in patients responding to the treatment.
TxCell SA develops cell-based immunotherapies for the treatment of severe chronic inflammatory diseases with high unmet medical need.
Ovasave is an antigen-specific type 1 regulatory T (Ag-Treg) cell-based immunotherapy.
The Ag-Treg cells utilised in Ovasave are isolated from whole blood of the patient, activated by the specific food antigen ovalbumin.
The cloned Ag-Treg cells are expanded ex vivo before their reinjection into that same patient. The injected Ag-Treg cells home to sites of inflammation and are activated locally by ovalbumin.