Sonoma Biotherapeutics Announces FDA Clearance of Investigational New Drug Application for SBT115301, an Effector T Cell-Modulating Biologic for Autoimmune Diseases

Phase 1 study expected to be initiated in Q3 2022

SOUTH SAN FRANCISCO, Calif. & SEATTLE, WA – June 8, 2022 – 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 disease.

“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 and CEO of Sonoma Biotherapeutics. “We aim to restore immune tolerance with therapies that impact both sides of the immune balance— combining engineered Treg cell therapies with a biologic that can deplete and inactivate Teff cells. Our combinatorial approach holds the potential to transform the way we treat autoimmune and inflammatory diseases.”

Sonoma Biotherapeutics is pioneering Treg cell therapies alone and in combination with a Teff modulating therapy. The loss of immune system balance is correlated with Treg-resistant Teff cells. SBT115301 is a CD2-binding fusion protein that resets the microenvironment by selectively depleting and inactivating these Teff cells at the site of disease. As a combination therapy, SBT115301 is designed to pre-condition patients for optimal treatment with Treg cell therapies.

About Sonoma Biotherapeutics

Sonoma Biotherapeutics is an immune tolerance company developing engineered regulatory T cell (Treg) therapies to treat serious autoimmune and inflammatory diseases driven by an imbalanced immune system. Founded by pioneers in Treg biology and cell therapy, the company is employing proprietary platform technologies and approaches to develop a new generation of targeted Treg cell therapies designed to induce durable immune tolerance to treat and prevent autoimmune and inflammatory diseases. Sonoma Biotherapeutics is based in South San Francisco and Seattle. For more information visit and follow on Twitter and LinkedIn.

Media Contacts

Brian Crawford
Sonoma Biotherapeutics

Danielle Cantey
Evoke Canale