Advanced Design of a Nicotine Vaccine for Smoking Cessation

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R43DA033845-01
Agency Tracking Number: R43DA033845
Amount: $352,841.00
Phase: Phase I
Program: SBIR
Awards Year: 2012
Solicitation Year: 2012
Solicitation Topic Code: NIDA
Solicitation Number: PA10-123
Small Business Information
1616 Eastlake Ave E Ste 260, SEATTLE, WA, -
DUNS: 831016907
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (206) 819-9413
Business Contact
Phone: (206) 826-7954
Research Institution
DESCRIPTION (provided by applicant): Tobacco smoke is the primary cause of lung cancer, cardiovascular disease and premature death, with nearly 5 million people dying each year. Treatments that prevent smoking will have a major impact on global health andare attractive products for commercial development. Nicotine vaccines and antibodies represent an important strategy for preventing nicotine from reaching the brain, although current clinical-stage vaccines are ineffective and for most people the antibodyresponse is weak and short-lived. The challenge of inducing long- lasting antibodies titers requires a better method for presenting nicotine to the immune system. We hypothesize that targeted nicotine delivery to dendritic cells using agonistic mAbs to CD40 combined with a TLR4-based adjuvant will stimulate a superior antibody response. We will modify the rat anti-mouse CD40 mAb 1C10 for studies in mice and optimize its conjugation with derivatized nicotine. Mice will be vaccinated with ?CD40nic formulatedwith the TLR4-activating adjuvant GLA-SE. Anti-nicotine antibody titers will be benchmarked against mice vaccinated with a traditional vaccine, nicotine-KLH + alum. Vaccine potency will be determined using quantitative measures of antibody function including nicotine sequestration in blood and prevention of a nicotine abstinence response. Phase I SBIR funding will establish proof-of-concept in a relevant model and provide the justification for subsequent IND-enabling studies that will bring an innovative vaccine for smoking cessation into the clinic. PUBLIC HEALTH RELEVANCE: Tobacco smoke is the primary cause of lung cancer, cardiovascular disease and premature death. There is a strong unmet need for an effective aid to smoking cessation. To halt the addictive effects of nicotine and increase the success rate for smoking cessation, we have designed a novel vaccine that will prevent nicotine from crossing the blood-brain barrier.

* information listed above is at the time of submission.

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