Itolizumab (INN, trade name Alzumab) is a 'first in class' humanized IgG1 monoclonal antibody developed by Biocon[1] and the Center of Molecular Immunology (CIM), Havana.[2]

Itolizumab
Monoclonal antibody
TypeWhole antibody
SourceHumanized
TargetCD6
Clinical data
Trade namesAlzumab
ATC code
  • none
Legal status
Legal status
  • Approved in India
Identifiers
CAS Number
ChemSpider
  • none
UNII
KEGG
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Mechanism of action

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It selectively targets CD6, a pan T cell marker involved in co-stimulation, adhesion and maturation of T cells. Itolizumab, by binding to CD6, down regulates T cell activation, causes reduction in synthesis of pro-inflammatory cytokines and possibly plays an important role by reducing T cell infiltration at sites of inflammation.[3]

Clinical trials

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A double blind, placebo controlled, phase III treat –Plaq study of itolizumab successfully met the pre-specified primary end-point of significant improvement in PASI-75 (Psoriasis Area and Severity Index) score after 12 weeks of treatment in patients with moderate to severe psoriasis compared to placebo.[4]

Applications

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Biocon received marketing authorization for the drug from the Drugs Controller General of India (DCGI) in January 2013 and marketing within India commenced in August 2013.[1][5]

In July 2020, Biocon received authorization in India for its use in the treatment of COVID-19.[6]

References

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  1. ^ a b Jayaramun K (December 2013). "Biocon's first-in-class anti-CD6 mAb reaches the market". Nat. Biotechnol. Vol. 31, no. 12. United Kingdom. pp. 1062–3. 
  2. ^ "India prepares to test Itolizumab, the drug credited for lowering Covid mortality in Cuba". May 30, 2020.
  3. ^ "Biocon Receives Marketing Authorization for its Novel Biologic Itolizumab for Psoriasis" (PDF). Biocon Limited. 8 January 2013.
  4. ^ Urs A (10 January 2012). "Biocon's test shows positive results for Itolizumab". @businessline.
  5. ^ "Biocon's psoriasis drug, Itolizumab receives DCGI marketing authorization". Pharmabiz.com. India: Saffron Media. January 8, 2013. Archived from the original on February 19, 2017. Retrieved January 10, 2013.
  6. ^ "Biocon's Itolizumab approved for COVID-19 treatment: All you need to know". The Economic Times. Retrieved 2020-07-14.