Ibalizumab

Last updated
Ibalizumab
Monoclonal antibody
Type Whole antibody
Source Humanized (from mouse)
Target CD4
Clinical data
Trade names Trogarzo
Other namesIbalizumab-uiyk; TMB-355, [1] TNX-355
AHFS/Drugs.com Monograph
MedlinePlus a618020
License data
Routes of
administration
Intravenous (IV)
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
ChemSpider
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KEGG
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Ibalizumab, sold under the brand name Trogarzo, is a non-immunosuppressive humanised monoclonal antibody that binds CD4, the primary receptor for HIV, [3] and inhibits HIV from entering cells. [4] It is a post-attachment inhibitor, blocking HIV from binding to the CCR5 and CXCR4 co-receptors after HIV binds to the CD4 receptor on the surface of a CD4 cell. Post-attachment inhibitors are a subclass of HIV drugs called entry inhibitors.

Contents

On March 6, 2018, the U.S. Food and Drug Administration (FDA) approved ibalizumab for multidrug-resistant HIV-1. [5] [6] It is used in combination with other antiretroviral drugs. [5] The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication. [7]

Medical uses

Ibalizumab, in combination with other antiretrovirals, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. [2] [5]

Development

Ibalizumab is being developed by TaiMed Biologics but was originally 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 for the intravenous (i.v.) infusion dosage form: [11]

In a Phase III trial with 48 weeks of follow-up, HIV patients with multi-drug resistance tolerated ibalizumab well in combination with other treatments, and 59% of patients achieved viral suppression. [13]

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References

  1. "Ibalizumab (TMB-355)". TaiMed Biologics. 2009-09-09. Archived from the original on 2009-08-20.
  2. 1 2 "Trogarzo- ibalizumab injection, solution". DailyMed. 29 September 2021. Retrieved 21 May 2022.
  3. Jacobson JM, Kuritzkes DR, Godofsky E, DeJesus E, Larson JA, Weinheimer SP, Lewis ST (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". Antimicrobial Agents and Chemotherapy. 53 (2): 450–7. doi:10.1128/AAC.00942-08. PMC   2630626 . PMID   19015347.
  4. "TNX-355 fact sheet". AIDSmeds.com. 2006-08-25.
  5. 1 2 3 "FDA approves new HIV treatment for patients who have limited treatment options". U.S. Food and Drug Administration (FDA) (Press release). 24 March 2020. Retrieved 21 May 2022.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  6. "Drug Approval Package: Trogarzo injection (ibalizumab-uiyk)". U.S. Food and Drug Administration (FDA). 6 March 2018. Retrieved 21 May 2022.
  7. New Drug Therapy Approvals 2018 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2019. Retrieved 16 September 2020.
  8. "Genentech Partners with Taiwan Company on AIDS Drug". Seeking Alpha. 2007-09-18.
  9. "Government pushes biotech industry". Taipei Times. 2007-09-15.
  10. "Tanox's AIDS Drug Survives". BioHouston. 2008-04-11. Archived from the original on 2011-07-25.
  11. "Ibalizumab (TMB-355) Intravenous Infusion". www.taimedbiologics.com. TaiMed. Retrieved 17 March 2018.
  12. "Ibalizumab Orphan Drug Designations and Approvals".
  13. Emu B, Fessel WJ, Schrader S, Kumar PN, Richmond G, Win S, Weinheimer S, Marsolais C, Lewis S (October 2017). "Forty-eight-week Safety and Efficacy On-treatment Analysis of Ibalizumab in Patients with Multi-drug Resistant HIV-1". Open Forum Infectious Diseases. 4 (suppl 1): S38–S39). doi:10.1093/ofid/ofx162.093. PMC   5632088 .