Why is it in the news?

• Recently, India reached out to Australia to procure monoclonal antibody doses to combat the Nipah virus outbreak in Kerala.
• Notable researchers like Niels K. Jerne, Georges J.F. Köhler, and César Milstein were awarded the Nobel Prize in 1984 for their work on monoclonal antibodies.

Monoclonal antibodies (mAbs)

• Monoclonal antibodies are laboratory-made proteins designed to mimic the behaviour of antibodies produced by the immune system.
• They target specific antigens, usually disease-causing molecules, to help the immune system eliminate them from the body.
• mAbs are engineered to attach to particular antigens, such as viral proteins.
• 4 Monoclonal Antibody:
  • 4 is a “potent, fully human” monoclonal antibody that neutralizes Hendra and Nipah viruses.
  • It has passed phase-one clinical trials, demonstrating safety and effectiveness.
  • The drug is used on a ‘compassionate use’ basis when no other authorized treatment is available.
  • It was initially developed by Dr. Christopher Broder and his team at the Uniformed Services University of the Health Sciences (USU) with support from the U.S. National Institutes of Health (NIH).
• Working of Monoclonal Antibodies:
  • Monoclonal antibodies are engineered to target specific diseases by binding to antigens, often proteins.
  • They prevent the antigen from performing its regular functions, including infection of other cells.
  • Initially, hybridoma technology was used to produce monoclonal antibodies in mice, but today, recombinant DNA technology is employed for their production.
• Binding to Nipah Virus: 4 monoclonal antibody binds itself to the immunodominant receptor-binding glycoprotein of the Nipah virus, potentially neutralizing it.
• Phase-One Clinical Trial:
  • A successful clinical safety trial with 40 volunteers was conducted between March 2015 and June 2016 for m102.4.
  • The study, led by Geoffery Playford of Princess Alexandra Hospital in Brisbane, Australia, demonstrated safety, tolerability, and immunogenicity.
  • It was a double-blind study with participants randomly receiving m102.4 or a placebo.
  • The most common side effect was a headache, and no severe effects or deaths were noted.
  • Results showed that single and repeated doses of m102.4 were well-tolerated and safe.
• Regulatory Status:
  • The antibody has been available in Queensland State, Australia, since 2010 for treating Hendra virus infections.
  • As of 2020, it had been administered to 13 people on compassionate grounds.
  • Both Hendra and Nipah viruses are bat-borne Paramyxoviridae and are considered priority diseases by the World Health Organization.