Selecta/JDRF Collaboration Seeks Vaccine To Prevent Or Treat Type 1 Diabetes

JDRF will provide milestone-based financial support toward preclinical proof of concept for a tolerogenic vaccine candidate.

Selecta Biosciences, Inc. and the Juvenile Diabetes Research Foundation will collaborate to bring an experimental tolerogenic vaccine for type 1 diabetes through preclinical proof of concept.

In an arrangement announced June 9, JDRF will provide undisclosed milestone-based financial support to Selecta's efforts to produce a vaccine that specifically targets the antigen which causes type 1 diabetes.

Currently in the discovery phase, Selecta's type 1 diabetes vaccine is one of several applications of its Synthetic Vaccine Particles (SVP) technology. The Watertown, Mass., biotech also is working on vaccines for preventing and treating diseases in half a dozen other therapeutic areas, including infectious diseases (universal flu, pneumococcus bacterial infection, malaria), oncology (universal human papilloma virus and prostate cancer), and smoking cessation. It expects the latter, a small molecule program which creates a high concentration of antibodies against nicotine, to move into the clinic later this year. The HPV and flu programs are next furthest along and moving from lead optimization to preclinical studies.

The diabetes program is in earlier stages of discovery. Selecta says the antigen-specific vaccine for type 1 diabetes is a novel approach, which works to stop the patient's autoimmune response against the antigens that cause the disease. The vaccine actively eliminates or inactivates T cells that cause beta destruction while at the same time increases the number and function of beneficial T cells. Selecta's research in animal models to date has shown promise.

In diabetes, the vaccine targets several antigens in the beta cells and tolergenic vaccines generally comprise one or more of four beta cell-specific auto-antigens.

A key advantage of the vaccine, the company says, is that it acts only on disease-causing immune cells. "The rest of the immune system is unperturbed, which is important for people with diabetes who are otherwise healthy," Selecta said in an e-mail.

Prevention And Treatment Of Existing Disease Possible

While the vaccine is seen as a way to prevent type 1 diabetes, Selecta thinks it also could have application in patients who already have the disease. The company hopes to prove that a tolerogenic vaccine could preserve residual beta cell function that may be present in a recently diagnosed patient. The vaccine also could prevent destruction of newly regenerated insulin-producing beta cells or protect newly transplanted beta cells in diabetes patients. This latter approach would be adjunctive to regenerative or replacement therapies.

The Selecta vaccine technology consists of synthetic nanoparticles that can hold a variety of clinically validated, biodegradable components, including antigens, adjuvants, and biodegradable polymers, with the mix depending on the application. Partly because the nanoparticles travel to the lymph nodes in a package, they avoid the systemic side effects and safety issues related to traditional vaccines, which are delivered as depot injections.

JDRF is collaborating with Selecta on this program through its Industry and Development Partnership Program, which has provided roughly $75 million in funding for diabetes research at 32 companies since 2004.

The Selecta collaboration involves staged objectives beginning with creation of a work plan for the identification of a clinical candidate, the company says. Selecta did not specify the extent of JDRF's involvement other than financial support, but said the foundation will offer "insights and expertise."

JDRF is invested in several vaccine projects for type 1 diabetes that would inactivate the pathogenic effector cells of immune system that cause the disease, said Chief Scientific Officer Richard Insel. Besides Selecta, JDRF is backing Parvus Therapeutics, spun out from research conducted at the University of Calgary.

Karin Hehenberger, JDRF's senior VP of strategic alliances, stressed that the foundation supports a wide range of projects at various stages of development. "We participate from bench to bedside; our main goal is to deliver therapeutics, cures and preventive therapies for people with diabetes," she said. "We need to participate from discovery all the way through development as well as enabling these therapeutics to get to patients, so we also work with regulatory authorities and reimbursement agencies."

She would not specify how much money Selecta will receive under the partnership or many details about how the collaboration will be structured but did say JDRF will be more than just a financial backer. "In all our different collaborations, both with academic investigators as well as industry partners, we have a strategic approach where we develop a program together with our partner" she said. "We have a joint steering committee where we have representatives from JDRF and the company or academic institution and then we develop the program, structured around milestones contingent on the performance of the program."

Privately held, Selecta raised $15 million in a Series C last spring. CEO Werner Cautreels said the biotech has runway sufficient to last into mid-2012 ([See Deal]). Cautreels, who previously led the pharmaceutical business of Solvay until it was acquired by Abbott Laboratories in 2010, joined Selecta in August, Investors in Selecta include Flagship Ventures, Polaris Venture Partners, NanoDimension, Leukon Investments and OrbiMed Advisors, which led the C round.

Also on June 9, Selecta announced the appointment of Peter Keller as VP of business development and alliance management. Keller held the same title at Solvay Pharmaceuticals.

-Joseph Haas ([email protected])