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  1. FDA Technology Transfer Program

Improved Immunotherapeutic Compositions for Treatment, Diagnosis and Prevention of HIV

With the number of individuals infected with HIV approaching nearly one percent (1%) of the world's population, an effective vaccine is urgently needed. As an enveloped virus, HIV hides most of its proteins and genes from humoral recognition behind a protective lipid bilayer. An available exposed viral target for neutralizing antibodies is the envelope spike. Genetic, immunologic and structural studies of the HIV envelope glycoproteins have revealed extraordinary diversity as well as multiple overlapping mechanisms of humoral evasion, including self-masquerading glycan, immunodominant variable loops, and conformational masking. These evolutionarily-honed barriers of antigenic diversity and immune evasion have confounded traditional means of vaccine development. It is believed that immunization with effectively immunogenic HIV gp120 envelope glycoprotein can elicit a neutralizing response directed against gp120, and thus HIV. The need exists for immunogens that are capable of eliciting a protective immune response.

This application claims isolated immunogens, including variant gp120 polypeptides and the use of these polypeptides to induce an immune response to HIV. This application also claims virus-like particles including the variant gp120 polypeptides. More specifically, this application claims virus-like particles including variant gp120-HBsAg hybrid constructs, which may also include at least one TLR ligand.

Potential Commercial Applications:

Development of Human Immunodeficiency Virus (HIV) vaccines, therapeutics and diagnostics

Competitive Advantages:

VLP gp120 vaccine, use of HBsAg vector for delivery

Ira Berkower

Intellectual Property:
US Application No. 14/089,460
US Patent No. 8,628,782 issued 2014-01-14

I Berkower et al. Targeted deletion in the beta20-beta21 loop of HIV envelope glycoprotein gp120 exposes the CD4 binding site for antibody binding. Virology. 2008 Aug 1;377(2):330-338. PubMed abs

Licensing Contact:
Bill Ronnenberg, JD-MIP, MS
FDA Technology Transfer Program
10903 New Hampshire Ave.
Building WO1, Rm 4214
Silver Spring, MD 20993
Email: FDAInventionlicensing@fda.hhs.gov
Phone: 240-402-4561

OTT Reference No: E-299-2008/0
Updated: August 9, 2015