Cell therapies have reached the market as a new treatment option for some cancers. But the scientists of Sonoma Biotherapeutics say this approach also holds promise for autoimmune disorders, and the biotech startup has unveiled $40 million in financing to develop its technology.
The investors in Sonoma’s Series A round of funding include Lyell Immunopharma, ARCH Venture Partners, Milky Way Ventures, and 8VC.
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Cell therapy involves removing a patient’s immune cells, engineering them, and then infusing them back into the patient to perform their therapeutic tasks. The cancer cell therapies that have been approved by the FDA are made by engineering T cells, the frontline defenders of the immune system.
Sonoma, which splits its operations between South San Francisco and Seattle, is working with a different immune cell called a regulatory T cell (Treg). Whereas T cells target pathogens, Tregs target other immune cells, suppressing excessive immune responses, CEO and co-founder Jeff Bluestone tells Xconomy. Research by Sonoma’s scientific co-founders uncovered evidence, in studies in mice and humans, that the absence of these cells sparked the development of some autoimmune diseases. Those diseases led to death in about one year without a bone marrow transplant, Bluestone adds.
Sonoma is developing Treg therapies intended to shut down unwanted immune responses. The approach involves harvesting these cells from patients and engineering them with features that make them stable, durable, and targeted specifically to the site of inflammation. Those cells would then be infused into the patient to stop the autoimmune response. Bluestone says it’s too soon to talk about a lead disease target, but he adds that this approach has potential applications in rheumatoid arthritis, inflammatory bowel disease, and multiple sclerosis.
The hope is that a Sonoma cell therapy is a one-time treatment. Bluestone says that because these therapies are cells that multiply, they should survive in the patient on standby until they’re needed again to address an autoimmune response.
There’s another feature that could contribute to the longevity of a Treg treatment. When these cells shut down an autoimmune response, they influence other cells in the vicinity to join in, Bluestone explains. By “educating” these other cells to take up this immunosuppressive role, Bluestone says the effect of these therapies could be long lasting. But he cautions that the durability of a Treg therapy won’t be known until more tests are done in humans.
Bluestone’s knowledge about Tregs stems from his own research. He and another Sonoma co-founder, Qizhi Tang, studied Tregs at the University of California, San Francisco, for 12 years. Their research included diabetes, organ transplantation, and lupus, among other conditions. That work led to small patient studies testing the technology for safety.
In addition to his UCSF research, Bluestone was the president and CEO of the Parker Institute for Cancer Immunotherapy. Over the course of a career that has bridged academia and industry, Bluestone’s immunology research has led to the development and commercialization of immunotherapies for organ transplants and cancer. He says he is joining Sonoma now because “there’s only so far that you can get in an academic lab if you want to impact people’s lives.” Cell therapy could be the next major medicine for humans, he adds, and he wants to be involved as part of a company developing these treatments.
The other co-founders are Chief Scientific Officer Fred Ramsdell who, like Bluestone, joined Sonoma from the Parker Institute, and Alexander Rudensky, an immunologist at the Memorial Sloan Kettering Cancer Center. Ramsdell and Rudensky are credited as co-discoverers of the FOXP3 gene that is critical to the development and function of Tregs.
Bluestone says that Sonoma continues the Treg research that he and the other co-founders had done. The company also builds on the successes and failures in cancer cell therapy research. While those therapies can treat blood cancers, it’s been much harder to use them to treat solid tumors. Bluestone hopes that Lyell, a South San Francisco cell therapy company, can help the company get its therapies into tissues. In addition to being a Sonoma investor, Bluestone says Lyell will be a research partner, providing access to its technology and cell therapy insights.
Sonoma also aims to go beyond autoimmune diseases. Bluestone says the company’s approach could potentially address degenerative disorders, such as amyotrophic lateral sclerosis and Alzheimer’s disease. In the nearer term, Bluestone says the company will use the funding to better understand Tregs.
“The way we’re approaching this field is not to be in a hurry, in a sense of feeling this pressure or need to get into the clinic with these engineered cells as quickly as possible,” he says. “We want to spend the time to make sure we’re working with the best cells possible, that we understand the science and the biology, so that it has the best chance of success.”
Public domain image by Flickr user NIH Image Gallery