10 June 2022 - - The US Food and Drug Administration has cleared an Investigational New Drug application to initiate a Phase 1 study of SBT115301 in healthy participants, US-based immune tolerance company Sonoma Biotherapeutics said.

SBT115301 is a biologic designed to eliminate highly activated effector T cells that are dominant in autoimmune and inflammatory disease.

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.

Sonoma Biotherapeutics is an immune tolerance company developing engineered regulatory T cell 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.