Ibalizumab

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Ibalizumab
Monoclonal antibody
TypeWhole antibody
SourceHumanized (from mouse)
TargetCD4
Clinical data
Trade namesTrogarzo
SynonymsIbalizumab-uiyk; TMB-355,[1] TNX-355
Pregnancy
category
  • unknown; not enough clinical trial data yet
Routes of
administration
intravenous (IV) injection
ATC code
Legal status
Legal status
Identifiers
CAS Number
ChemSpider
  • none
UNII
KEGG
NIAID ChemDB
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Ibalizumab (trade name Trogarzo) is a non-immunosuppressive humanised monoclonal antibody that binds CD4, the primary receptor for HIV, [2] and inhibits HIV from entering cells.[3] 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 sub-class of HIV drugs called entry inhibitors.

In a Phase 3 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.[4]

On March 6, 2018, FDA approved ibalizumab for multidrug-resistant HIV-1.[5] It is administered intravenously every 14 days by a trained medical professional. It is used in combination with other antiretroviral drugs.[6]

Development[edit]

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.[7][8][9]

Milestones for the intravenous (i.v.) infusion dosage form:[10]

  • 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.
  • 2016: completion of a phase-3 clinical trial for i.v. infusion dosage form
  • 2017: completion of BLA submission and pre-approval inspection for i.v. infusion dosage form to U.S. FDA
  • 2018: U.S. market approval (trade name: Trogarzo)

See also[edit]

References[edit]

  1. ^ "Ibalizumab (TMB-355)". TaiMed Biologics. 2009-09-09. Archived from the original on 2009-08-20.
  2. ^ 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.
  3. ^ "TNX-355 fact sheet". AIDSmeds.com. 2006-08-25.
  4. ^ 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.
  5. ^ "Ibalizumab". 2018-03-07.
  6. ^ "FDA Approves Ibalizumab for Multidrug-Resistant HIV-1". 2018-03-07.
  7. ^ "Genentech Partners with Taiwan Company on AIDS Drug". Seeking Alpha. 2007-09-18.
  8. ^ "Government pushes biotech industry". Taipei Times. 2007-09-15.
  9. ^ "Tanox's AIDS Drug Survives". BioHouston. 2008-04-11. Archived from the original on 2011-07-25.
  10. ^ "Ibalizumab (TMB-355) Intravenous Infusion". www.taimedbiologics.com. TaiMed. Retrieved 17 March 2018.