Rivka Abulafia-Lapid PhD, MBA and Henri Atlan MD, PhD, The Human Biology Research Center, Hadassah University Hospital
Background
Antiretroviral therapy decreases human immunodeficiency virus (HIV) viral load, increases the CD4 T-cell count, and dramatically improves survival. Different classes of antiretroviral drugs act at different stages of the HIV life cycle. Combination of several (typically three or four) antiretroviral drugs is known as Highly Active Anti-Retroviral Therapy (HAART).
Medical Need: However, a HIV infection can become resistant to standard HAART. Despite a significant decrease in viral load after long-term HAART therapy, many AIDS patients retain low levels of CD4 T-cell counts, which are partially attributed to an autoimmune process. HIV infection may provoke an autoimmune response against the CD4 molecule causing the destruction of uninfected CD4 T-cells. In seeking to develop safe and effective vaccines for HIV, one approach to a vaccine candidate is through the discoveries that arise from fundamental research on HIV. Such, T-cell vaccination has been studied in experimental animals and lately has been used clinically to down-regulate human autoimmune diseases such as Multiple sclerosis and Rheumatoid Arthritis.
Therapeutic vaccines are increasingly considered for use in anti-HIV therapy to restore the patient’s immune system.
Market
There are 40 million people in the world today who live with HIV/AIDS. Antiretroviral therapy had transformed AIDS from a death sentence into a manageable chronic illness for people who have access to the drugs. By the end of 2005, only 1.3 million people with HIV in poor countries had access to the drugs. Treatment reduced AIDS-related mortality by nearly 80 percent in the United States. Still, 90 percent of HIV-positive people in the world do not know they are infected. Global AIDS expenditures rose to $8.3 billion in 2005 from $4.7 billion in 2003.
The Innovation
The inventors have found that HIV infection is associated with anti-CD4 T cells autoimmunity exhibited in T-cell reactivity to humanCD4 molecule. T-cell proliferation responses to synthetic peptides from the human CD4 molecule were tested among CD4 positive responders. The use of immunogenic synthetic CD4 peptides to replace the complete CD4 molecule may therefore lead to a cost-effective T-cell vaccination (TCV) of HIV-positive patients exhibiting anti-CD4 autoimmunity, as well as to the development of complimentary T-cell Receptor peptides for future peptide vaccination.
R&D Program
- Optimization of synthesized immunogenic human CD4 derived peptides.
- A series of synthesized peptides will be used for T-cell vaccination in HIV-infected patients with anti-CD4 autoimmunity; large numbers of HIV-1 infected patients are tested to draw firm conclusions regarding the respective therapeutic efficacy.
- Establishment of one or two drug candidates; safety (toxicology) and pharmacological profiles for drug candidates;
- Confirmatory Phase II trial.
Contact
Yuval Kupitz,
Business Development, Pharmaceuticals
Tel: +972-2-6778364
Email: yuvalk@hadasit.co.il
