Ibalizumab Explained

Verifiedfields:	changed
Verifiedrevid:	458273983
Type:	mab
Mab Type:	mab
Source:	zu/o
Target:	CD4
Tradename:	Trogarzo
Dailymedid:	Ibalizumab
Routes Of Administration:	Intravenous (IV)
Atc Prefix:	J05
Atc Suffix:	AX23
Legal Us:	Rx-only
Legal Us Comment:	^[1]
Legal Eu:	Rx-only
Cas Number:	680188-33-4
Drugbank:	DB12698
Chemspiderid:	none
Unii:	LT369U66CE
Kegg:	D09575
Niaid Chemdb:	209859
Synonyms:	Ibalizumab-uiyk; TMB-355,^[2] TNX-355

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.

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. 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.

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]

• 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.^[12]
• 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)

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]

External links

• Web site: Ibalizumab . U.S. National Library of Medicine . Drug Information Portal .

Notes and References

1. Web site: Trogarzo- ibalizumab injection, solution . DailyMed . 29 September 2021 . 21 May 2022.
2. Web site: Ibalizumab (TMB-355) . TaiMed Biologics . 2009-09-09 . dead . https://web.archive.org/web/20090820202400/http://www.tmbinc.com/?page_id=23 . 2009-08-20 .
3. Daniel Kuritzkes. Jacobson JM, Kuritzkes DR, Godofsky E, DeJesus E, Larson JA, Weinheimer SP, Lewis ST . 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 . February 2009 . 19015347 . 2630626 . 10.1128/AAC.00942-08 .
4. Web site: TNX-355 fact sheet . AIDSmeds.com . 2006-08-25.
5. FDA approves new HIV treatment for patients who have limited treatment options . U.S. Food and Drug Administration (FDA) . 24 March 2020 . 21 May 2022.
6. Web site: Drug Approval Package: Trogarzo injection (ibalizumab-uiyk) . U.S. Food and Drug Administration (FDA) . 6 March 2018 . 21 May 2022.
7. New Drug Therapy Approvals 2018 . U.S. Food and Drug Administration (FDA) . January 2019 . PDF . 16 September 2020.
8. News: Genentech Partners with Taiwan Company on AIDS Drug. Seeking Alpha. 2007-09-18.
9. News: Government pushes biotech industry . Taipei Times . 2007-09-15.
10. News: Tanox's AIDS Drug Survives . BioHouston . 2008-04-11 . dead . https://web.archive.org/web/20110725073913/http://www.biohouston.org/en/rel/?18 . 2011-07-25 .
11. Web site: Ibalizumab (TMB-355) Intravenous Infusion. www.taimedbiologics.com. TaiMed. 17 March 2018.
12. Web site: 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 . Forty-eight-week Safety and Efficacy On-treatment Analysis of Ibalizumab in Patients with Multi-drug Resistant HIV-1. . Open Forum Infectious Diseases . October 2017 . 4 . suppl 1 . S38–S39) . 10.1093/ofid/ofx162.093 . 5632088 .