The Sonoma Biotherapeutics pipeline (RA, rheumatoid arthritis; IBD, intestinal bowel disease; T1D, type 1 diabetes. Sonoma Image)

Seattle and South San-Francisco based preclinical biotech company Sonoma Biotherapeutics has raised $265 million in new funding, the company announced Wednesday.

The funding will be used to advance its programs aiming to treat autoimmune and inflammatory conditions such as rheumatoid arthritis and type 1 diabetes.

The company’s approach involves engineering a special type of immune cell, a regulatory T cell, to enhance its therapeutic potential. Such cells can quell an overactive immune system, thereby easing symptoms of disease. By adding in a CAR (chimeric antigen receptor), researchers can also target the cells to the right location in the body, where they are activated within the inflamed tissue.

“The idea is that we are taking cells out of the body of patients, and we’re manipulating them and putting back into the patients,” said CEO and president Jeff Bluestone, in a video, “So the cells become a therapy, they become the medicine.”

Sonoma Biotherapeutics CEO Jeff Bluestone. (Sonoma Photo)

Bluestone was previously head of the Parker Institute for Cancer Immunotherapy and founded the company in 2019 along with immune cell researchers Alexander Rudensky, Fred Ramsdell, and Qizhi Tang.

The company’s most advanced regulatory CAR T cell product is being developed for patients with rheumatoid arthritis that do not respond to current therapies. The company expects to submit an investigational new drug application to the U.S. Food and Drug Administration by middle of 2022, a key step towards a clinical trial.

Sonoma also is developing a biologic agent for type 1 diabetes that depletes active autoimmune cells and helps disarm the hostile immune environment in the body. That agent could potentially be used by itself or with the company’s engineered regulatory T cells. The company hopes to initiate clinical trials with this agent by the end of this year, according to a spokesperson.

The new funding will be used to advance these programs towards clinical trial and build up the company’s manufacturing capabilities. The company is also developing other potential therapies against a range of conditions, including Crohn’s disease.

Sonoma currently has about 50 employees, with office and lab space in both Seattle and at its headquarters in South San Francisco. The company plans to maintain both locations and expand to 75 employees by the end of the year, with additional growth planned beyond that.

Harnessing regulatory T cells as therapies has for years been studied in academic labs but lately the concept has formed the basis for several startups. Brisbane, Calif.-based Sangamo Therapeutics is expected to launch a clinical trial later this year testing regulatory CAR T cells in patients with kidney transplants, according to a report in Nature.

Other startups in the field include Boston-based GentiBio, which has a Seattle presence. Co-founders of GentiBio include Seattle Children’s Research Institute scientist David Rawlings, Jane Buckner, president of Seattle’s Benaroya Research Institute and Andrew Scharenberg, CEO of Seattle-based cell therapy company Umoja Biopharma.

The new, oversubscribed, Series B round at Sonoma builds on two previous Series A rounds which together raised $70 million. The new round is led by Ally Bridge Group. Other investors from this round include GV, ARCH Venture Partners, Casdin Capital, Vertex Ventures HC, 8 VC, Frazier Healthcare Partners, and JDRF T1D, a disease-focused venture philanthropy fund.

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