Advancing a new approach to restoring immune tolerance

We are developing precision regulatory T cell (Treg) therapies designed to restore immune balance.

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We are combining targeted engineering with proprietary manufacturing built to preserve Treg function in inflammatory environments.

Regulatory T Cells

Harnessing the body's natural regulators

Tregs maintain immune tolerance by controlling excessive immune responses and protecting healthy tissues. Unlike therapies that broadly suppress the immune system, Treg therapies aim to restore the body’s natural mechanisms of immune regulation.

Because immune tolerance is central to many autoimmune diseases, Tregs have the potential to become a powerful therapeutic approach across multiple indications.

SonomaBio Approach

Engineering precision immune regulation

Our approach combines precision engineering, optimized manufacturing, and targeted immune regulation.

Our lead program, SBT7101, is engineered to recognize citrullinated proteins associated with inflamed joints in rheumatoid arthritis. Importantly, our manufacturing process is designed to preserve regulatory function, so Tregs remain optimized to sustain their identity and activity in pro-inflammatory environments.

CAR

Citrullinated Proteins (Cit-P)

The CAR activates the Treg in response to the Cit-P’s in the inflamed joint.

Leukapheresis

Manufacturing

Isolate Tregs
Transduce with CAR
Expand & reactivate

Harvest

Cryopreserve

Patient Infusion

Manufacturing Matters

Building better Treg therapies

For Treg therapies, manufacturing is more than production. It’s a key determinant of product quality and performance.

Our proprietary process is designed to preserve Treg identity, maintain regulatory dominance, and support consistent, scalable manufacturing.

Built for Chronic Autoimmune Disease

Designed for long-term disease management

Autoimmune diseases are chronic conditions that often require ongoing treatment. Our approach reflects that reality.

SBT7101 is being developed without lymphodepletion or preconditioning, to support repeat dosing over time from a single patient collection, with the potential to simplify treatment while supporting outpatient administration and long-term disease management.

No preconditioning
No hospitalization
Repeat dosing, single collection

Future Applications

Extending immune tolerance across autoimmune disease

Our initial focus is poly-refractory rheumatoid arthritis, where patients have exhausted multiple treatment options and continue to experience active disease.

We see two paths for expansion: earlier and broader RA populations, and other immune-mediated diseases where immune tolerance is central to disease biology.

Because immune dysregulation underlies many autoimmune and inflammatory conditions, we believe our approach may extend beyond our initial focus, offering meaningful therapeutic benefit across a broader range of patients.