New Delhi: The ICMR has sought collaboration with Indian industry partners for manufacturing indigenously developed monoclonal antibodies for treating deadly Nipah Virus following the successful animal trials to ensure their timely access during outbreaks. Monoclonal antibodies are laboratory-made proteins that mimic the antibodies produced by the immune system to protect against foreign substances and harmful pathogens.
The Nipah virus (NiV), which has an extremely high fatality rate, has emerged as one of the most significant zoonotic threats to India, with repeated outbreaks recorded since 2001, according to the Expression of Interest (EoI) document issued by the Indian Council of Medical Research (ICMR).
The apex health research body has issued an EoI stating: "The ICMR is willing to collaborate with eligible organisations, companies, and manufacturers for the 'Development and Manufacturing of Monoclonal Antibodies against Nipah Viral Disease.'"
Globally, research and development efforts are advancing, but no licensed vaccine or antiviral is yet available.
The document stated that several vaccine platforms are under investigation, including those supported by CEPI, with one candidate having progressed to mid-stage human trials, with India identified as a key site. Similarly, research at other international institutes is ongoing to develop vaccine candidates.
"However, these are still years away from licensure. On the therapeutic front, monoclonal antibodies (mAbs) have emerged as the most promising option," the ICMR document said.
The best-studied candidate is m102.4, a fully human monoclonal antibody targeting the G glycoprotein of the Nipah virus, which prevents viral entry by blocking its interaction with ephrin-B2/B3 receptors, according to the ICMR.
The m102.4 antibody has shown strong protection in animal models and has been found safe in Phase 1 clinical trials, it said. Though definitive human efficacy data are lacking, the antibody has been used under compassionate protocols in Australia and was also made available to Kerala during recent outbreaks, the EoI document stated.
The importance of having monoclonal antibody stocks ready for deployment in India cannot be overstated, the apex health research body said. Given the very high case fatality rate and the absence of licensed vaccines, mAbs represent the only currently feasible biomedical countermeasure, it said.
Their greatest value lies in post-exposure prophylaxis for high-risk contacts, such as healthcare workers exposed without adequate protection, family members in close contact, or laboratory personnel with accidental exposure. Administered early, they can potentially prevent disease onset, as demonstrated convincingly in animal models.