Ibalizumab
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized (from mouse) |
| Target | CD4 |
| Clinical data | |
| Pregnancy category |
|
| Routes of administration | intravenous (IV) injection |
| ATC code | none |
| Legal status | |
| Legal status |
|
| Identifiers | |
| CAS Number |
680188-33-4  |
| ChemSpider | none |
| UNII |
LT369U66CE  |
| KEGG |
D09575 |
| NIAID ChemDB | 209859 |
| (what is this?) (verify) | |
Ibalizumab (TMB-355[1] 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.[2] It is being investigated as an HIV entry inhibitor[3] with the ability to block both CCR5- and CXCR4-tropic viruses,[4] and is undergoing a Phase II clinical trial with an estimated study completion date in December 2010.[5] Specific Research is also conducted at the Aaron Diamond AIDS Research Center under the direction of David Ho.[6][7]
Results from a previous Phase II of ibalizumab, reported by the original developer Tanox in 2006,[4] 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.[8][9][10]
Milestones: [11]
- 2003: completed a phase-1a clinical trial for i.v. infusion dosage form.
- 2003: granted fast track status by U.S. FDA.
- 2003: completed a phase-1b clinical trial for i.v. infusion dosage form.
- 2006: completed a phase-2a clinical trial for i.v. infusion dosage form.
- 2011: completed a phase-2b clinical trial for i.v. infusion dosage form.
- 2012: completed a phase-1 clinical trial for s.c. injection dosage form.
- 2013: initiated a phase-1/2 clinical trial for s.c. and i.m. injection dosage forms (on-going).
- 2014: granted orphan drug designation for HIV MDR patients by U.S. FDA.
- 2015: granted breakthrough therapy designation for i.v. infusion dosage form by U.S. FDA.
- 2015: initiated a phase-3 clinical trial for i.v. infusion dosage form (on-going).
- 2016: initiated and intended to complete a rolling BLA submission for i.v. infusion dosage form to U.S. FDA.
See also
References
- ↑ "Ibalizumab (TMB-355)". TaiMed Biologics. 2009-09-09.
- ↑ Jacobson JM, Kuritzkes DR, Godofsky E, et al. (February 2009). "Safety, Pharmacokinetics, and Antiretroviral Activity of Multiple Doses of Ibalizumab (formerly TNX-355), an Anti-CD4 Monoclonal Antibody, in Human Immunodeficiency Virus Type 1-Infected Adults". Antimicrob. Agents Chemother. 53 (2): 450–7. doi:10.1128/AAC.00942-08. PMC 2630626
. PMID 19015347. - ↑ "TNX-355 fact sheet". AIDSmeds.com. 2006-08-25.
- 1 2 "Tanox Reports 48-Week Results From TNX-355 Phase 2 Clinical Trial". AEGiS. 2006-05-02.
- ↑ "Dose-Response Study of Ibalizumab + OBR in Patients With HIV-1". ClinicalTrials.gov. 2008-10-30.
- ↑ Park, Alice (2010-01-25). "David Ho: The Man Who Could Beat AIDS". Time. Retrieved 2010-05-04.
- ↑ "Safety Study of Ibalizumab Subcutaneous Injection in Healthy Volunteers (TMB-108)". ClinicalTrials.gov. 2011-02-07.
- ↑ "Genentech Partners with Taiwan Company on AIDS Drug". Seeking Alpha. 2007-09-18.
- ↑ "Government pushes biotech industry". Taipei Times. 2007-09-15.
- ↑ "Tanox's AIDS Drug Survives". BioHouston. 2008-04-11.
- ↑ TaiMed - TMB-355 - Pipeline