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Sanofi 'Selecta's Early Stage Immunotherapy in $900M Deal

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By Marie Powers
Staff Writer

Nanomedicine specialist Selecta Biosciences Inc., which has moved with rapid-fire speed over the past two years, landed a potential $900 million deal with Sanofi SA to discover targeted, antigen-specific immunotherapies for food allergies.

More remarkable than the money, the agreement covers targets still in the discovery stage. Paris-based Sanofi gains an exclusive license to develop an immunotherapy designed to halt acute responses against an undisclosed, life-threatening food allergen and an option to develop two additional immunotherapeutic candidates for food or airborne allergens using Selecta's synthetic vaccine particle (SVP) platform.

Selecta, of Watertown, Mass., is eligible to receive preclinical, clinical, regulatory and sales milestones totaling $300 million per allergen indication for up to three candidates. Selecta also is entitled to tiered royalties into double digits as a percentage of net sales for each commercialized immunotherapy.

Werner Cautreels, Selecta's president and CEO, declined to offer additional details about the deal's financial structure or timetable.

"We have a research plan and a development plan as part of this collaboration agreement, but they are flexible," he said.

Selecta's SVP technology emerged from the lab of renowned Massachusetts Institute of Technology scientist and entrepreneur Robert Langer in collaboration with Harvard Medical School professors Omid Farokhzad, a nanotech researcher, and immunologist Ulrich von Andrian, all of whom remain scientific advisers. The platform uses nanoparticles to create synthetic vaccines with fully integrated vaccine components, including antigens and adjuvants, for highly effective targeting to immune cells, producing an optimal immune response.

The Sanofi deal covers an application known as targeted tolerogenic SVP, or t2SVP, nanoparticle immunotherapeutics, which induce antigen-specific tolerance. Products derived from t2SVP are designed to instruct the immune system to prevent and suppress pro-inflammatory responses against the antigen presented in a specific nanoparticle, enabling immune system modulation without causing global immune suppression.

The t2SVP technology was developed using expertise gained from a second SVP application known as induced tolerogenic dendritic cell (itDC) technology, in which immature dendritic cells are isolated and co-cultured with immunomodulators and antigen to induce antigen-specific tolerogenic dendritic cells. Once those cells are re-injected into the donor, the goal is to restore immune function by initiating immune tolerance in them.

Selecta has applied itDC to preclinical models of multiple sclerosis and asthma and has optimized its t2SVP immunotherapeutics in preclinical proof-of-concept studies for applications in autoimmune diseases, allergies and orphan indications.

The approach differentiates Selecta not only from antibody developers but also from other nanomedicine firms. Its manufacturing process enables the company to develop and test numerous variations to the components included in its nanoparticle-based vaccines, the ratio of those components, the release rate and other factors. The result is quick optimization and a streamlined path to the clinic for promising candidates.

"The Sanofi agreement endorses the potential of our technology," Cautreels told BioWorld Today. "But there are no delusions. We still have to do a lot of work."

'The Answer Will Come' from the Data

Selecta and Sanofi will design antigen-specific immunotherapies that address unmet medical needs defined by the pharma. The collaboration will leverage Sanofi's expertise in immunology and its Boston-based research and development capabilities.

"We both hope to gain from each other," said Cautreels, who joined Selecta in 2010 after Abbott acquired Solvay Pharmaceuticals Inc., where he was CEO. Selecta will contribute its expertise in nanoparticle-based immunotherapies and vaccines, while Sanofi will bring decades of experience in the allergy field, including work in relevant animal models. The combination "should get us ahead of the game," he said.

Privately held Selecta has moved like a shot since its founding in 2007, raising more than $32 million in three venture rounds before attracting the attention of Rusnano. Last year, the $10 billion Russian Federation fund joined Selecta's existing and other new investors in a $47.25 million financing to broaden the company's R&D capabilities and accelerate its pipeline, with Rusnano committing up to $25 million in several tranches. (See BioWorld Today, Oct. 28, 2011.)

In addition to the Sanofi deal, Selecta disclosed Wednesday that Selecta (RUS) LLC, its Russian subsidiary formed as part of the Rusnano financing, became the first biotech in Rusnano's portfolio to open a research center in Russia.

Selecta also has its own pipeline. Lead candidate SEL-068, a nicotine vaccine for smoking cessation and relapse prevention, uses the company's targeted SVP (tSVP) technology, designed to activate responses to a wide array of relevant antigens, including small molecules, peptides, oligosaccharides and proteins, by targeting the immune system's humoral or cellular pathways.

SEL-068, funded in part by a $3 million grant from the National Institute on Drug Abuse, is completing a double-blind, placebo-controlled, ascending-dose Phase I study. Final data are expected in the first quarter of next year.

The company also has a subcontract to develop a tSVP product for malaria. Preclinical proof-of-concept studies, funded through the National Institute of Allergy and Infectious Diseases, also are expected to report data in the first quarter of 2013. (See BioWorld Today, Aug. 31, 2011.)

In addition, early data from Selecta's work on CD8 T-cell cancer vaccines has attracted outside interest, and its research into a Type I diabetes vaccine helped draw Sanofi to the biotech. "Some of the basic research in antigen-specific tolerance was brought forward, so when Sanofi approached us about their general interest in this space and about allergies more specifically, there was a very good fit," Cautreels said.

As for the company's long-term game plan, Cautreels was refreshingly honest.

"I don't know," he admitted. "So many things are moving and changing in our industry. But I do know the answer will come out of the data we will generate in these different areas."