Cabaleta Bio Inc. (NASDAQ: CABA) has announced topline findings on biological activity from two lowest doses groups in the DesCAARTes Phase 1 clinical study of DSG3-CAART for mucosal pemphigus Vulgaris treatment.
Six patients completed the six months follow-up
Six patients had completed three to six months of follow-up to evaluate DSG3-CAART biologic activity as of December 12, 2021, representing the two lowest dose groups. Despite obtaining or having received systemic medication for the treatment of their mPV symptoms previous to enrolment, patients recruited reported mild to moderate illness severity before infusion. Persistence of DSG3-CAART, DSG3 autoantibodies change, mPV therapy change or requirement for new systemic rescue medication, and disease activity change are among the parameters being utilized in the study to assess possible biologic activity. In the absence of any protocol-directed additions to baseline medication, disease activity ratings improved in five out of the six subjects prior to infusion.
Chief Medical Officer David Chang said, “As the first targeted cell therapy clinical trial for patients with a B cell-mediated autoimmune disease, the DesCAARTes trial was designed with patient safety as the top priority. By starting with these low-dose cohorts, we have been able to administer the product to autoimmune patients, with no dose-limiting toxicities or clinically relevant adverse events observed to date. While clear signs of DSG3-CAART biologic activity were not observed to date in the two lowest cell dose cohorts, the emerging clinical and serological data in one of the six patients who has improved since DSG3-CAART infusion is notable.
Cabaleta to expand DesCAARTes study
Chang continued, “ Based on communications with the U.S. Food and Drug Administration (FDA) dating to the first half of 2021, as well as the safety data reported from our first three dosing cohorts, we plan to expand the DesCAARTes™ trial to evaluate higher dose cohorts and consolidated dosing regimens and, subject to an IND amendment, an enhanced manufacturing process. Our engagements and interactions with patients, investigators, and advocacy groups have given us confidence that patients with mPV are highly interested in a deep, durable, and potentially curative therapy.”
