Sonoma Biotherapeutics’ platform and product candidates aim to restore immune system balance through complementary regulatory T cell (Treg) therapy and effector T cell (Teff) conditioning

Series B financing comprised of strong syndicate of leading life science investors

Financing supports the advancement of Sonoma Bio’s Treg therapy platform, a novel Teff conditioning therapy and the build-out of a robust processing and manufacturing facility

SOUTH SAN FRANCISCO, Calif. & SEATTLE–(BUSINESS WIRE)–Sonoma Biotherapeutics, an immune tolerance company focused on the development of regulatory T cell (Treg) therapies, has announced an oversubscribed $265 million Series B financing. Proceeds from the financing will be used to advance Sonoma Bio’s Treg cell therapy platform and a novel Teff conditioning biologic into the clinic to treat multiple, severe autoimmune and inflammatory diseases and to further invest in and scale up manufacturing operations in order to support supply for initial clinical studies.

“We are ushering in a new era of medicine, using immune cells as living therapies that persist in the body, providing a lasting and potentially curative activity to treat autoimmune and inflammatory diseases,” said Jeffrey Bluestone, Ph.D., Co-founder and CEO of Sonoma Biotherapeutics. “We are laser focused on applying this approach to the vast unmet medical need that exists in immune-driven diseases, where engineered Treg cell therapies can help restore and reset the immune system when it goes awry.”

Marquee life sciences and healthcare-focused investors participated in the Series B, led by the global life science-focused investment group Ally Bridge Group, with participation from new investors including ArrowMark, Avidity Partners, Casdin Capital, Deep Track Capital, Fidelity Management & Research Company LLC, Frazier Healthcare Partners, GV, Janus Henderson Investors, Mirae Asset, NS Investment, Osage University Partners, Piper Heartland Healthcare Capital, Vertex Ventures HC and an undisclosed global investment fund. Existing investors also supported this financing, including 8VC, ARCH Venture Partners, Alexandria Venture Investments, the JDRF T1D Fund, LifeForce Capital, Lilly Asia Ventures Biosciences and Octagon Capital. Since its founding in 2019, Sonoma Bio has raised more than $335 million.

“We’re proud to lead Sonoma Bio’s Series B financing and support their game-changing efforts to fundamentally change the treatment of autoimmune diseases,” said Frank Yu, Founder, CEO and CIO at Ally Bridge Group. “Sonoma Bio, which creates a new therapeutic paradigm, has assembled a leading world-class team who are pioneering technology to unlock this novel cell therapy approach for autoimmune and inflammatory diseases.”

“The Sonoma Bio team possesses the creativity and breadth of experience to realize the promise of Treg cell therapy for people living with autoimmune and inflammatory diseases,” said Rick Klausner, M.D., Chairman of Sonoma Bio’s Board of Directors. “With the backing of an incredible syndicate of established life science investors, Sonoma Bio has the capital resources, the talent, the technology and the passion to completely transform treatment for patients with these diseases.”

Sonoma Bio’s Platform & Pipeline

Sonoma Bio is pioneering Treg adoptive cell therapies alone and in combination with Teff conditioning therapy to promote immune tolerance in a variety of autoimmune and inflammatory conditions.

The two most advanced programs are:

  • SBT-77-7101, a novel CAR-based Treg cell therapy for patients with refractory rheumatoid arthritis. SBT-77-7101 CAR-Treg cells adapt the clinically proven paradigm of CAR-Teff cells in cancer to specifically direct the regulatory immune system and develop a powerful new tool to treat autoimmune diseases. CAR-Treg cells possess multiple therapeutic activities within a single medicine, a so-called poly-pharmaceutical, that works directly at the site of inflammation for a durable, lasting clinical response.
  • SBT-11-5301, a Teff conditioning biologic designed to help clear the inflammatory environment and make Treg cell therapies more effective. SBT-11-5301 is being investigated as a conditioning agent to be used as a monotherapy for the treatment of Type 1 diabetes as well as in combination with the Sonoma Bio Treg cell therapy platform.

Additional Treg cell therapy discovery programs are also underway targeting other autoimmune and inflammatory diseases.

World-class Founding & Management Team

Sonoma Bio’s founding team is world renowned in the field of immune tolerance and Treg biology. Co-founders Drs. Alexander Rudensky and Sonoma Bio’s Chief Scientific Officer, Fred Ramsdell, co-discovered FOXP3, a critical transcription factor for Treg development and function. Drs. Bluestone and Qizhi Tang have pioneered adoptive Treg cell therapy in autoimmune disease and organ transplantation. They are complemented by an experienced leadership team and board of directors to bring Sonoma Bio’s vision together – possessing the genetic engineering, development and manufacturing capabilities in cell therapy needed to translate the Company’s approach into the clinic and beyond.

Addressing Significant Unmet Need

Autoimmune diseases are conditions in which the body’s immune system mistakes its own healthy tissues as foreign and attacks them. Most autoimmune diseases cause inflammation that can affect many parts of the body. Scientists have identified more than 80 autoimmune diseases. Some are well known, such as rheumatoid arthritis, Type 1 diabetes, inflammatory bowel diseases, and multiple sclerosis. According to the National Institute of Health, collectively, autoimmune diseases affect more than 24 million people in the United States. Globally, approximately 4 percent of the world’s population is impacted.

Despite advances in the development of therapies to treat autoimmune diseases, existing medicines often have short-lived efficacy, need to be chronically delivered and are generally ineffective at treating the underlying causes of disease. Patients with these diseases are dramatically underserved, as the standard of care typically consists of cycling on and off of various treatments that are ineffective for long-term use and are often toxic or immunosuppressive. Treg cell therapies show promise in fundamentally changing how we treat these patient populations – resetting immune tolerance and helping patients to eliminate toxic treatments and no longer face a lifetime of disease management at significant costs to the healthcare system.

About Sonoma Biotherapeutics

Sonoma Biotherapeutics is a South San Francisco and Seattle-based company leading the development of adoptive Treg cell therapies for autoimmune and inflammatory diseases. Using genome editing and target-specific cell therapy, Sonoma is focused on developing its best-in-class platform across the entire spectrum of Treg cell therapeutic capabilities. Founded by pioneers in Treg biology and cell therapy, the company brings together leading expertise and proprietary methodologies for the discovery and development of disease-modifying and curative therapies. More information at