HIV vaccine technology based on HIV envelope protein (Env) have been less successful than anticipated to date. One possible reason for this is the potential conformational masking of neutralizing epitopes. The current technology combines HIV Env and cell surface polypeptides CD4 in non-covalent complexes to expose epitopes not present on the uncomplexed Env molecules. These complexes can thus be used to elicit neutralizing antibodies when used as vaccines, immunogenic compositions or immunotherapies. The CD4 inducing epitopes found in regions of the virus that are most conserved across clades are unmasked and immune sera generated with this technology neutralized primary HIV-1 viruses from several clades. Additionally, cell surface polypeptide CD4 is in its native conformation and masked by Env, therefore it is unlikely to induce autoantibodies.
The FDA Center for Drug Evaluation and Research is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this HIV Env-CD4 technology. Please contact Beatrice A. Droke at 301/827-7008 or firstname.lastname@example.org for more information.
Bill Ronnenberg, JD-MIP, MS
FDA Technology Transfer Program
10903 New Hampshire Ave.
Building WO1, Rm 4214
Silver Spring, MD 20993
OTT Reference No: E-173-2005/0
Updated: August 9, 2015