Ibalizumab, sold under the brand name Trogarzo, is a non-immunosuppressive humanised
monoclonal antibody
A monoclonal antibody (mAb, more rarely called moAb) is an antibody produced from a cell lineage made by cloning a unique white blood cell. All subsequent antibodies derived this way trace back to a unique parent cell.
Monoclonal antibodie ...
that binds
CD4
In molecular biology, CD4 (cluster of differentiation 4) is a glycoprotein that serves as a co-receptor for the T-cell receptor (TCR). CD4 is found on the surface of immune cells such as helper T cells, monocytes, macrophages, and dendritic c ...
, the primary receptor for
HIV,
and
inhibits HIV from entering cells. It is a post-attachment inhibitor, blocking HIV from binding to the
CCR5
C-C chemokine receptor type 5, also known as CCR5 or CD195, is a protein on the surface of white blood cells that is involved in the immune system as it acts as a receptor for chemokines.
In humans, the ''CCR5'' gene that encodes the CCR5 p ...
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
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...
(FDA) approved ibalizumab for multidrug-resistant HIV-1.
[ ] It is used in combination with other antiretroviral drugs.
The U.S.
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...
(FDA) considers it to be a
first-in-class medication.
Medical uses
Ibalizumab, in combination with other antiretrovirals, is
indicated
In medicine, an indication is a valid reason to use a certain test, medication, procedure, or surgery. There can be multiple indications to use a procedure or medication. An indication can commonly be confused with the term diagnosis. A diagnosis ...
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
Genentech, Inc. is an American biotechnology corporation headquartered in South San Francisco, California. It operates as an independent subsidiary of holding company Roche. Genentech Research and Early Development operates as an independent cent ...
. 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.
Milestones for the intravenous (i.v.) infusion dosage form:
*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)
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.
References
External links
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