Sonoma Biotherapeutics, a privately held company developing regulatory T cell (Treg) therapies for autoimmune and degenerative diseases, launched today in South San Francisco, CA and Seattle, WA with $40 million in its Series A financing. Sonoma brings together next-generation research, development and manufacturing capabilities in cell therapy and genetic engineering with an accomplished team of executives, scientists, board members and investors with extensive experience in the fields of cell therapy and drug discovery.

"With this team and our assembled expertise and technologies, we are in an ideal position to move adoptive cell therapy beyond cancer, to establish safe, effective and long-lasting treatments for a range of conditions where current drugs and biologics are simply not good enough," said founder and CEO Jeffrey Bluestone, PhD. "As the immune system's master regulators of protecting the body against self-destruction, Treg cell therapy is perhaps the ideal means to shut down unwanted immune reactions and provide meaningful treatment for patients."

The financing involves an investor syndicate that includes Lyell Immunopharma, ARCH Venture Partners, Milky Way Ventures and 8VC. "Treg therapies have the potential to transform the treatment of autoimmune and degenerative diseases," said Robert Nelsen, managing partner and co-founder of ARCH Ventures Partners. "Sonoma Biotherapeutics has assembled the team and capabilities required to make this vision a reality for patients and their families."

The goal of Treg therapy is to restore a state of self-tolerance by halting harmful inflammatory responses in autoimmune diseases such as rheumatoid arthritis, inflammatory bowel disease and multiple sclerosis, along with degenerative diseases including amyotrophic lateral sclerosis (ALS) and Alzheimer's. Over 50 million Americans currently live with an autoimmune disease, and millions more with some form of degenerative diseases. For many, existing therapies are ineffective at controlling their disease.

Tregs have a clear role in many of these conditions. These cells' natural ability to migrate to inflamed tissues and control harmful immune responses make them ideal for treating a range of conditions. In addition, the ability to engineer Treg cells to target specific disease-causing antigens reduces the potential for unwanted systemic effects. The role of Tregs in tissue maintenance and repair offers the potential for effective, durable and restorative treatments.

Sonoma Biotherapeutics is co-founded by four of the foundational scientists in the Treg field:

Jeff Bluestone, PhD, UCSF faculty member and former CEO and President of the Parker Institute for Cancer Immunotherapy, is a leading immunologist who is credited with the discovery of the function of CTLA-4, a receptor that is a critical target of the new generation of cancer immunotherapies.

Qizhi Tang, PhD, is a translational immunologist and Director of the UCSF Transplantation Research Lab.

Fred Ramsdell, PhD, an immunologist with nearly three decades of biopharma experience, including early clinical development of immunotherapies, will serve as Sonoma's Chief Scientific Officer.

Alexander Rudensky, PhD, is a Howard Hughes Medical Institute Investigator and the Chair of Immunology Program at Memorial Sloan-Kettering Cancer Center, whose research has contributed to the fundamental understanding of the differentiation of Tregs and their role in immune response.

Collectively, the founding team brings expertise and proprietary methodologies across the Treg drug discovery and development process, including selection, manipulation, editing, regulation and translation for clinical use. Together, Drs. Bluestone and Tang have pioneered adoptive Treg cell therapy in some of its first clinical uses in type 1 diabetes, lupus and organ transplantation. Drs. Rudensky and Ramsdell co-discovered FOXP3, a critical transcription factor for Treg development and function, and in 2017 were awarded the Crafoord Prize by the Royal Swedish Academy of Sciences for their landmark studies. They are complemented by an experienced senior management team and seasoned board of directors.

"The Sonoma Biotherapeutics leadership are responsible for a significant portion of our understanding of the nature of Treg cells, their role in disease and their potential for use as a cell therapy," said Dr. Rick Klausner, CEO of Lyell Immunopharma and newly appointed Chair of the Sonoma Biotherapeutics Board of Directors. "Perhaps more importantly, they understand the requirements of a successful cell therapeutic and the corresponding challenges in defining the pathway to market. We look forward to a strong partnership between Lyell and Sonoma Biotherapeutics."

In this regard, Sonoma Biotherapeutics has entered into a strategic partnership with Lyell that provides both parties with access to technologies and know-how to enhance the durability, stability and specificity of cell therapies in their respective indications of focus. This partnership will further enable Sonoma's rapid translation of Treg therapies from target identification and discovery, through preclinical and clinical development.

Senior Management Team

Jeffrey Bluestone, PhD, Founder, CEO & President
Fred Ramsdell, PhD, Founder & CSO
Peter DiLaura, Chief Business & Strategy Officer
Joshua Beilke, MBA, PhD, VP Translational Development

Board of Directors

Rick Klausner, MD (Chair) - Founder & CEO, Lyell Immunopharma, Inc.
Maggie Wilderotter - CEO, Grand Reserve Inn; former board member, Juno Therapeutics
Toni Hoover, PhD - Director, Strategy, Planning and Management for Global Health, Bill & Melinda Gates Foundation
Terry Rosen, PhD - CEO, Arcus Biosciences
David Moskowitz, PhD - Principal, 8VC (observer)
Jeffrey Bluestone, PhD, CEO & President, Sonoma Biotherapeutics

About Sonoma Biotherapeutics

Sonoma Biotherapeutics is a privately held, San Francisco and Seattle-based company leading the development of adoptive Treg therapies cell for autoimmune and degenerative diseases. Using next generation 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.