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.