- Regeneron Pharmaceuticals will work with startup Sonoma Biotherapeutics to develop treatments for autoimmune diseases, stepping further into the fast-growing field of cell therapy.
- Under the partnership, the companies will develop regulatory T cell, or “Treg,” cell therapies for ulcerative colitis, Crohn’s disease and two other unspecified diseases. They will split costs and any future profits, although Regeneron will have an option to lead global development with Sonoma retaining copromotion rights in the U.S.
- Regeneron is paying Sonoma $75 million upfront, $30 million of which is in the form of an equity investment, and could broaden the deal to include a fifth indication. Sonoma, meanwhile, is keeping rights to its other programs, including a rheumatoid arthritis treatment in preclinical testing. It’s also eligible for an additional $45 million milestone payment.
Regeneron became one of biotech’s most valuable companies through its success making antibody drugs. Its flagship technology, a way of testing potential medicines on genetically modified mice, has helped it unearth antibody treatments for eye diseases, autoimmune conditions, rare disorders and cancer.
More recently, Regeneron has shown interest in newer drugmaking methods, too. Alliances with Intellia Therapeutics and Alnylam Pharmaceuticals gave it rights to experimental gene editing and RNA interference medicines, respectively. A partnership with 2seventy bio has proved cell therapy — genetically altering human cells to fight disease — is on its radar as well.
Working with Sonoma enables Regeneron to “expand this toolkit further,” said Chief Scientific Officer George Yancopoulos, in a statement.
Sonoma is the most richly funded among a handful of startups developing cell therapies that involve a specialized type of immune cell known as a “Treg.” These Tregs help guard the body from attacking itself and prevent the malfunctions that lead to inflammatory conditions. They’re different from the immune defenders used in cancer therapies like Gilead’s Yescarta and Bristol Myers Squibb’s Breyanzi.
Companies like Sonoma aim to use Treg cell therapy to rebalance the immune systems of organ transplant recipients, or patients with inflammatory conditions. The hope is these effects would be long-lasting, if not permanent, and wouldn’t leave people with the weakened internal defenses associated with chronic therapy. In ulcerative colitis, for instance, typical treatments block inflammatory pathways that, in the process, can leave patients vulnerable to infections.
Treg cell therapy research remains in early stages and faces a number of scientific challenges, however. One of the most advanced experimental therapies, a kidney transplant treatment from Sangamo Therapeutics, is in a Phase 1 trial. All but one of Sonoma’s programs are in preclinical testing. The company hopes to bring a second prospect, a cell-based treatment for rheumatoid arthritis, into human trials later this year.
The deal extends what’s been a lucrative run for Sonoma in a difficult financing environment for biotech startups. The company has raised more than $330 million from investors including Arch Venture Partners, the venture arm of Eli Lilly and cell therapy biotech Lyell Immunopharma.
Jeff Bluestone, a prominent immunologist and Sonoma’s CEO, called the alliance a “true partnership,” as the companies will each play a role developing the treatments and split costs and profits. “That’s very important to us,” he said in an interview. “We’re looking to remain involved long-term as a free-standing company.”
Sonoma’s sizable war chest has also helped it weather the tough investment climate privately, allowing it to hold off on joining the public markets until it has made enough progress. Investors expect more from young drugmakers than they have in recent years, most notably ”that there be clinical data before going public,” Bluestone said.
“Market challenges have clearly changed the timelines and window for such efforts,” he said. But “when the tides turn, we will be in a great position.”