Selecta Biosciences, Inc., a biopharmaceutical company developing a new class of synthetic vaccines and immunotherapies, 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 has the potential to become the first nanoparticle vaccine that is synthetically engineered, distinct from conventional biological vaccine manufacturing processes.
"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... Selecta Biosciences' Press Release -
