Selecta Biosciences, Inc., a biopharmaceutical company developing a new class of synthetic vaccines and immunotherapies, today announced that it has initiated a Phase 1 clinical trial to assess the safety, tolerability and pharmacodynamic profile of SEL-068, a nicotine vaccine candidate for smoking cessation and relapse prevention. SEL-068 is the first product candidate to enter clinical evaluation from Selecta's proprietary Synthetic Vaccine Particle (SVP™) platform, and it has the potential to become the first nanoparticle vaccine that is synthetically engineered, distinct from conventional biological vaccine manufacturing processes.
“We can now accelerate the development of our platform and bring forward our candidates in autoimmune, infectious diseases and cancer.”
"This is the first time ever that a fully integrated synthetic, nanoparticle vaccine is being tested in human clinical trials and is a very important milestone in the translation of Selecta's SVP technology," said Ulrich von Andrian, Ph.D., M.D., Edward Mallinckrodt Jr. Professor of Immunopathology at Harvard Medical School and Selecta co-founder. "Selecta has demonstrated its ability to rationally design immunotherapeutics and induce a robust targeted immune response. SVP technology will revolutionize the way vaccines will be designed, produced and applied."
The Phase 1 clinical study of SEL-068 is a double-blind, placebo-controlled, ascending dose study in healthy, non-smoking and smoking volunteers. In addition to safety, the study will evaluate the vaccine's potency through the measurement of concentrations of nicotine-specific antibodies. Selecta expects to report initial results from this Phase 1 study in the first half of 2012.
Because SEL-068 is fully synthetic, the immune response is entirely focused on nicotine and avoids off-target responses to biological carriers typically used with other vaccine technologies. The resulting high antibody concentrations induced by SEL-068 have the potential to absorb inhaled nicotine, preventing it from reaching the brain and triggering the addictive response.
"I'm extremely pleased with the pre-clinical results we have obtained with our SVP technology, and I expect SEL-068 to meet the requirements for a successful smoking cessation and relapse prevention vaccine. By entering into Phase 1 human clinical studies, Selecta has demonstrated its capability to scale production and demonstrate safety in toxicology studies," said Werner Cautreels, Ph.D., President and CEO of Selecta. "We can now accelerate the development of our platform and bring forward our candidates in autoimmune, infectious diseases and cancer."
Selecta's SEL-068 development program is funded in part with a grant from the National Institute of Drug Abuse (NIDA), an institute within the U.S. National Institutes of Health (NIH).
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