Sonoma Biotherapeutics Announces FDA Clearance of Investigational New Drug Application

Sonoma Biotherapeutics, an immune tolerance company focused on the development of novel regulatory T cell (Treg) therapies for autoimmune and inflammatory disease, today announced that the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application to initiate a Phase 1 study of SBT115301 in healthy participants. SBT115301 is a biologic designed to eliminate highly activated effector T cells (Teff) that are dominant in autoimmune and inflammatory diseases.

This IND clearance is an important milestone as we move our programs into clinical development, including the SBT115301 program, which is a key piece of our therapeutic strategy,” said Jeff Bluestone, Ph.D., Co-Founder of Sonoma Biotherapeutics. “We aim to restore immune tolerance with therapies that impact both sides of the immune balance combining engineered T cell therapies with a biologic that can deplete and inactivate T cells. Our combinatorial approach holds the potential to transform the way we treat autoimmune and inflammatory diseases.”