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Dendritic Cell-Targeted HIV Vaccine Product

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44AI095159-02A1
Agency Tracking Number: R44AI095159
Amount: $1,988,027.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: PA13-088
Timeline
Solicitation Year: 2014
Award Year: 2014
Award Start Date (Proposal Award Date): 2014-06-15
Award End Date (Contract End Date): 2016-05-31
Small Business Information
119 4th Avenue
Needham, MA 02494-2725
United States
DUNS: 040793114
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 TIBOR KELER
 (908) 200-7501
 tkeler@celldex.com
Business Contact
 AVERY CATLIN
Phone: (781) 433-3148
Email: ccatlin@celldextherapeutics.com
Research Institution
N/A
Abstract

DESCRIPTION This proposal is a unique collaboration between a small but full capability biotechnology company and a premier academic institution and laboratory to develop a novel product for clinical trials to prevent HIV infection This proposal describes a vaccine product aimed to provide a feasible and nontoxic way to elicit strong immunity in humans to HIV proteins and it will provide an added arm to be combined vaccine strategies such as recombinant viral vectors The technology behind this product is based on our most recent understanding of immunology and vaccines First the product ensures for the first time that HIV envelope and gag antigens are efficiently targeted to antigen presenting dendritic cells by using recombinant antibody technology This vaccine product uses a human monoclonal antibody generated by the PIandapos s which can seek out and bind to the subjectandapos s dendritic cells expressing the molecule DEC In this way a large number of dendritic cells in lymphoid organs can present antigens to rare antigen specific T cells and efficiently initiate the immune attack agains HIV proteins
Second the product includes a stimulus or adjuvant that results in a strong innate response which in turn is required for the optimum immune response This product encompasses proprietary immune activator with clinical and pre clinical track record
Finally the product has carefully selected specific HIV envelope and gag antigens and has demonstrated feasibility of manufacturing and proof of concept in our Phase I program This project will now be focused on further demonstrating the value of a prime boost approach with a viral vector vaccine and manufacturing product for human use and other studies that will support a clinical trial in healthy volunteers for assessing the potential of the vaccine to preven HIV infection PUBLIC HEALTH RELEVANCE Dendritic cells are critical for the initiation of immunity This proposal will harness the capacities of dendritic cells to initiate antibody and cell mediated immunity against HIV In the phase I portion we produced an antibody that efficiently delivers two HIV proteins to dendritic cells and showed proof of concept for improved immunity by giving vaccine together with safe adjuvants to mice In the Phase portion we will confirm the increaded immunogenicity of a prime boost approach with a viral vector HIV vaccine and also make the product ready for clinical testing by conducting GMP manufacturing and performing the safety and animal studies to support the Investigational New Drug IND application This proposal therefore describes an innovative product that addresses the need to be able to use proteins in an effective and nontoxic way to elicit and boost immunity against HIV offering the potential of considerable impact in our country and worldwide

* Information listed above is at the time of submission. *

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