Ibalizumab

Ibalizumab

Monoclonal antibody
Type	Whole antibody
Source	Humanized (from mouse)
Target	CD4
Clinical data
Pregnancy category	unknown; not enough clinical trial data yet
Legal status	only available in clinical trials
Routes of administration	intravenous (IV) injection
Identifiers
CAS Number	680188-33-4 N
ATC code	none
UNII	LT369U66CE Y
KEGG	D09575 Y
NIAID ChemDB	209859
NY (what is this?)  (verify)

Ibalizumab (TMB-355 previously known as TNX-355) is a non-immunosuppressive monoclonal antibody that binds CD4, the primary receptor for HIV, and inhibits the viral entry process. It is being investigated as an HIV entry inhibitor with the ability to block both CCR5- and CXCR4-tropic viruses, and is undergoing a Phase II clinical trial with an estimated study completion date in December 2010. Specific Research is also conducted at the Aaron Diamond AIDS Research Center under the direction of David Ho.

Results from a previous Phase II of ibalizumab, reported by the original developer Tanox in 2006, showed that persons with HIV who received the drug, in combination with an optimized background regimen (OBR), maintained a considerably greater reduction in viral load and experienced a statistically significant increase in CD4+ cells than did patients given placebo in combination with OBR. Thus, pending results of further trials, it is one of a limited number of viable alternative strategies to contain the virus without recourse to antiretroviral drug cocktails or a vaccine.

Development

Ibalizumab is being developed by TaiMed Biologics but was first developed by Tanox, now part of Genentech. As part of Genentech's takeover of Tanox, the patent for ibalizumab was sold to TaiMed Biologics, a biotech company formed in 2007 with support from the Taiwanese Government through a $20 million investment by the state-owned National Development Fund.

See also

• HIV tropism
• T helper cell