Sonoma Pharmaceuticals, Inc.

A small Chicago biotech looking to treat autoimmune diseases by activating regulatory T cells (Tregs) — an area that is fresh off a Nobel Prize win — has signed up Sanofi as its third pharma partner. The seven-employee startup, called EVOQ Therapeutics, made a pact worth potentially $500 million with the French drug giant, EVOQ CEO David Giljohann exclusively told Endpoints News . The duo has been in conversations for about two years, he said. The companies did not disclose a breakdown between upfront payment and biobucks. EVOQ’s technology works by placing antigens around the outside of lipid nanoparticles to activate Tregs. “Essentially, it comes down to a better activation of the immune system,” Giljohann said. The company’s experimental medicines are meant to be delivered subcutaneously, or under the skin, to get into lymph nodes, he said. While EVOQ isn’t directly creating Treg cell therapies, it’s adjacent to the field that was recognized in this year’s Nobel Prize in Physiology or Medicine. Startups such as Sonoma , RegCell and Tr1X are developing Treg programs. Money from the partnership will be crucial for EVOQ, which was founded in 2018 and has yet to raise a Series A. With Sanofi’s support, EVOQ should have runway for a couple more years, Giljohann said. EVOQ’s R&D engine has been fueled by some initial academic seed investors and payments from its collaborations with Gilead and Amgen. The Gilead partnership revolves around rheumatoid arthritis and lupus. The Amgen pact, which was inked in 2021 and extended in 2023 , concluded about a year and a half ago, Giljohann said. EVOQ has been able to buck the trend of requiring massive rounds of capital to get into the clinic. It expects to enter Phase 1 within a year with its lead internal program for celiac disease, Giljohann said. The company plans to have initial data from that Phase 1 in about two years, and it will be able to include celiac disease patients in that study in the US and Australia, he said. That means EVOQ should be able to gather safety and biomarker data relatively quickly. There are no approved treatments for celiac disease, which is spurred by undesired reactions to gluten. Other biotechs in the space include Topas Therapeutics and Anokion . Another Chicago-area biotech, COUR Pharmaceuticals , shipped its celiac treatment candidate to Takeda, which is now testing TAK-101 in Phase 2 . Beyond celiac, EVOQ also has interest in restoring immune tolerance for patients with type 1 diabetes, myelin oligodendrocyte glycoprotein antibody disease, and other autoimmune conditions.

This year’s Nobel Prize in Physiology or Medicine has been awarded to Mary Brunkow, Fred Ramsdell and Shimon Sakaguchi for their discoveries about how the immune system reins itself in. Sakaguchi in 1995 discovered a new type of immune cell called regulatory T cells, or Treg cells. They calm the activity of other immune cells in the body and are central to preventing the development of autoimmune diseases. Then, in 2001, while working at the biotech company Celltech, Brunkow and Ramsdell found out that mutations in the Foxp3 gene explained why a certain mouse strain was very vulnerable to autoimmune disease, and that the human equivalent caused a rare and serious autoimmune disease called IPEX syndrome. (Celltech, once a leading biotech in the UK, was acquired by UCB in 2004.) Finally, in 2003, Sakaguchi connected the findings, showing that the Foxp3 gene is a master regulator of Treg cells. “Their discoveries have been decisive for our understanding of how the immune system functions and why we do not all develop serious autoimmune diseases,” Olle Kämpe, chair of the Nobel Committee, said in a release. The three scientists are winning the award for their discoveries concerning peripheral immune tolerance. Sakaguchi, who is now a professor at Osaka University, and Ramsdell have both started biotech companies developing Treg cell therapies to treat autoimmune diseases. After co-founding Sonoma Biotherapeutics and serving as chief scientist, Ramsdell is now a scientific advisor to the company. Sonoma is studying Treg cell therapies for rheumatoid arthritis and hidradenitis suppurativa. Sakaguchi’s cell therapy biotech RegCell raised $46 million in March with plans to start clinical trials this year in a disease called pemphigus vulgaris, which occurs when the immune system attacks the skin and causes blisters. Sakaguchi believes therapies leveraging Treg cells can have wide applications. “Our ultimate goal is to convert the T cells mediating disease to Tregs,” Sakaguchi told Endpoints News earlier this year. “We can apply this technology not only to autoimmune disease, but also other inflammatory diseases, such as inflammatory bowel disease, or even transplantation setting, where the lymphocytes reject organ grafts,” he said. “The bad guys — bad lymphocytes — they can be converted to good guys, suppressing rejection.”

SOUTH SAN FRANCISCO, Calif. & SEATTLE--( BUSINESS WIRE )-- Sonoma Biotherapeutics, Inc. , a clinical-stage biotechnology company developing engineered regulatory T cell (T reg ) therapies for autoimmune and inflammatory diseases, announced today that it has received a $45 million milestone payment from Regeneron Pharmaceuticals, Inc., under the terms of its active collaboration to discover, develop and commercialize engineered T reg therapies for autoimmune diseases. “ This payment marks a significant milestone in our evolution as a company and our collaboration with Regeneron, which has been going extremely well,” said Jeff Bluestone, Ph.D., Chief Executive Officer of Sonoma Bio. “ The cutting-edge Regeneron technology for target identification and animal models, combined with Sonoma Bio’s T reg and cell therapy expertise, has enabled an effective collaboration in developing new treatment options for patients suffering from devastating autoimmune diseases.” In March 2023 , Sonoma Bio entered into a collaboration and license agreement with Regeneron to research, develop and commercialize T reg cell therapies for inflammatory bowel disease and two other undisclosed indications, with a Regeneron option for a fifth indication. The collaboration integrates Regeneron’s industry-leading VelociSuite ® technologies for the discovery and characterization of fully human antibodies and T cell receptors (TCRs) with Sonoma Bio’s pioneering approach to developing and manufacturing gene-modified T reg cell therapies. Under the terms of the agreement, Sonoma Bio received $75 million in upfront payments, which included a $30 million equity investment in Sonoma Bio by Regeneron. Sonoma Bio was also eligible to receive an additional $45 million development milestone payment, which has now been achieved. The parties are equally co-funding research and development for all potential products and will share equally any future commercial expenses and profits. Regeneron will have the option to lead late-stage development and commercialization on all products globally, with Sonoma retaining rights to co-promote all such products in the United States. Sonoma Bio continues to retain full ownership of its lead T reg cell therapy candidate, SBT-77-7101, and other programs in development. The company has two ongoing Phase 1 trials of SBT-77-7101 in rheumatoid arthritis and hidradenitis suppurativa. About Sonoma Biotherapeutics Sonoma Biotherapeutics is a clinical-stage biotechnology company developing engineered regulatory T cell (T reg ) therapies to treat serious autoimmune and inflammatory diseases by restoring balance to the immune system. Founded by pioneers in T reg biology and cell therapy, the company is employing proprietary platform technologies and approaches to develop a new generation of targeted and durable T reg cell therapies. Sonoma Biotherapeutics is based in South San Francisco and Seattle. For more information, visit sonomabio.com and follow on X , formerly Twitter, and LinkedIn .