Sonoma Raises $265M to Advance Its T-cell Therapies

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by Steve Bryson, PhD |

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Sonoma Biotherapeutics has raised $265 million in investment funding to support the development and production of novel immune T-cell therapies to treat severe autoimmune and inflammatory diseases, such as multiple sclerosis (MS).

“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,” Jeffrey Bluestone, PhD, co-founder and CEO of Sonoma, said in a press release.

In autoimmune diseases, the immune system mistakenly attacks and damages healthy tissue. MS is characterized by an altered inflammatory response against myelin, a sheath that surrounds nerve fibers to increase the speed of nerve impulses. A loss of myelin leads to impaired nerve signaling and progressive nerve cell damage resulting in a range of disease symptoms.

Regulatory T-cells (Tregs) are a type of immune cell that actively suppress an overactive immune system, thus preventing altered inflammatory responses and autoimmune diseases.

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Sonoma has engineered enhanced chimeric antigen receptor (CAR)-based Tregs cells with multiple therapeutic effects — a so-called poly-pharmaceutical — which aim to rebalance the immune system at the site of inflammation with long-lasting effects.

“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,” Bluestone added.

The new funding comes from multiple investors through a Series B financing — a second round of investment funding that generally occurs when a company has met certain developmental milestones beyond the initial startup phase. The financing will support ongoing scientific development but also the scale-up of manufacturing operations to provide supply for initial clinical studies.

“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 and CEO at Ally Bridge Group, a life science-focused investment group that led the financing. “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.”

Sonoma’s Treg therapies can be used alone or in combination with another biologic therapy that conditions patients by eliminating effector T-cells (Teff) — cells involved in the excessive immune response. This helps clear the inflammatory environment, thereby making Treg treatment more effective.

Sonoma’s most advanced programs include SBT-77-7101, a novel CAR-based Treg cell therapy for patients with the autoimmune condition rheumatoid arthritis who fail to respond to current treatments. The other, SBT-11-5301, is a Teff conditioning therapy for type 1 diabetes, either alone or in combination with the Treg cell therapy platform.

Additional Treg cell therapy programs targeting other autoimmune and inflammatory diseases are currently in the validation phase of development, the company said.

“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, MD, chairman of Sonoma’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.”

In addition to Ally Bridge Group and existing investors, others who participated in this financing round include ArrowMark, Avidity Partners, Casdin Capital, Deep Track Capital, Fidelity Management & Research Company, Frazier Healthcare Partners, GV, Janus Henderson Investors, Mirae Asset, NS Investment, Osage University Partners, Piper Heartland Healthcare Capital, Vertex Ventures, and a global investment fund.

Since its founding in 2019, Sonoma has raised more than $335 million.

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