Immunology and Biotherapies

An experimental antibody significantly reduced HIV levels in infected people for as long as 28 days. The approach might help to combat a wide range of HIV strains.

 

In the current study, the researchers evaluated one of these promising monoclonal anti-HIV antibodies in people. The small phase 1 clinical trial included 29 volunteers—17 HIV-infected and 12 uninfected. The study was supported by the Bill and Melinda Gates Foundation, NIH’s National Institute of Allergy and Infectious Diseases (NIAID), and others. Results appeared online on April 8, 2015, in Nature.

 

The participants received a single intravenous dose (of 1, 3, 10, or 30 milligrams per kilogram of body weight) of the experimental antibody called 3BNC117. The antibody was well-tolerated by all participants. Among those infected with HIV, the 2 lower doses caused small and transient changes in blood HIV levels. The 8 participants who received the highest dose, however, had significant and rapid decreases in HIV. The virus’s resistance to the antibody was variable. In some people, HIV remained sensitive to 3BNC117 for 28 days.

Via Krishan Maggon

TMB-355(Ibalizumab) is a humanized monoclonal antibody (mAb) and a member of an emerging class of HIV therapies known as viral-entry inhibitors. This drug candidate is distinct from other entry inhibitors in that it binds to the CD4 molecule, the primary receptor for HIV infection, thereby interfering with the penetration of the virus into the cell. It is the first entry-blocking humanized mAb to treat HIV/AIDS. TMB-355 caught the attention of the scientific community in February 2003, when results from the phase-1, single-dose clinical trial showed a transient but clinically significant reduction in the patients’ viral load. Moreover, it was well tolerated with no evidence of adverse effects on CD4 T-cells of treated subjects unlike the majority of approved drugs for HIV. The U.S. FDA granted TMB-355 fast track status in October 2003. The phase-2a clinical trial was successfully completed in 2006, with the results showing a clean safety profile and clear antiviral activity (10-fold reduction in viral load).  The Phase-2b clinical trial was also successfully completed in 2011. TaiMed Biologics is concurrently developing a subcutaneous injection dosage form and a phase 1 human pharmacokinetics bridging study is completed in 2012. Currently, TMB is developing a phase I/II study for HIV-negative and new HIV-positive subjects to begin by the end of 2012.

Via Krishan Maggon