San Diego biotech Shoreline Biosciences announced Tuesday that it has raised $140 million to fund a one-size-fits-all strategy that would use genetically modified immune cells to kill cancer cells.
That’s a popular goal these days. The Food and Drug Administration has approved a growing list of so-called CAR-T therapies, which take a patient’s own immune cells, equip them to recognize and attack a certain cancer, and reinfuse those modified cells back into the patient.
This approach has proven life-changing for some people, but it’s got drawbacks. In some cases, CAR-T therapy triggers overwhelming inflammation that can be debilitating — even deadly. And making tailored treatments is expensive and time-consuming, sometimes taking several weeks. That’s time the sickest patients don’t have.
To avoid these issues, Shoreline’s taking a different tack, developing “off-the-shelf” immune cell therapies that could work across patients. To do so, the company is coaxing stem cells to grow into two types of immune cells in the lab. These are natural killer cells, which target cancerous and infected cells, and macrophages, which clear out dead cells, alert other immune cells and regulate wound healing and tissue repair.
CAR-T therapies use T cells, which can trigger strong immune responses but will also attack healthy tissue if used in a different patient. That’s why CAR-T is currently a bespoke treatment.
Shoreline’s idea is to equip natural killer cells and macrophages with proteins they’ll need to recognize and fight against different cancer types, including leukemias and lymphomas. The company plans to eventually target some inflammatory diseases, too.
“We want to ultimately use cell therapy in a community setting exactly like the way you take a pill for any chronic disease,” said CEO Kleanthis Xanthopoulos.
The company, founded in the spring of 2020, has raised more than $300 million. The latest
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“We have tons of money,” Xanthopoulos said. “If we cannot prove that we can do what our vision states, then we’re not worth, obviously, that investment.”
The company expects to begin clinical trials on at least one of its experimental treatments by the end of 2022 and hopes to have a steady stream of one to two drugs entering clinical trials each year that follows.
Shoreline struck deals in June with two other biotechs, Kite and BeiGene, to help turn its basic science into biomedical breakthroughs. The deal with California firm Kite, a Gilead subsidiary, has Shoreline conducting early-stage research on three blood cancer treatments for Kite, which will take over once the drugs are cleared to enter clinical trials. That deal could be worth $2.3 billion-plus royalties if all goes well.
The biotech is also working with China-based BeiGene on four cancer-immune cell therapies. Shoreline will have the option to retain the rights to develop and sell two of these products in the U.S. and Canada, and Xanthopoulos says the collaboration could bring the company up to $1.3 billion.
Shoreline has close ties with UC San Diego, and has licensed much of its technology from stem cell expert Dr. Dan Kaufman, UCSD’s director of cell therapy, who is one of the company’s co-founders, serves as chief scientific officer and sits on the firm’s board.
Other local companies are also developing off-the-shelf immune cell therapies against various cancers, including Fate Therapeutics, Poseida Therapeutics and Artiva Biotherapeutics.
Xanthopoulos says there’s plenty of space for everyone, likening this wide-open field to antibodies, which countless biotechs use in different ways for different diseases. The veteran biotech entrepreneur has been the founding CEO of four other San Diego life science firms: Regulus Therapeutics, Anadys Pharmaceuticals, Senté Labs and IRRAS. Regulus, Anadys and IRRAS all went public, with Roche later acquiring Anadys for $230 million.
Shoreline, headquarted in Sorrento Valley, has about 50 employees, though the company will double in size within the next year and has already signed a lease to expand its presence in the Sorrento area.