The Indian Council of Medical Research (ICMR) has launched a strategic initiative to develop indigenous monoclonal antibodies against the deadly Nipah virus, seeking partnerships with Indian industry to ensure rapid production capabilities during future outbreaks. The apex health research body issued an Expression of Interest document stating its willingness to collaborate with eligible organizations and manufacturers for the development and manufacturing of monoclonal antibodies against Nipah viral disease.
Critical Need for Nipah Virus Countermeasures
The Nipah virus has emerged as one of India's most significant zoonotic threats, with repeated outbreaks recorded since 2001 and an extremely high case fatality rate. According to ICMR's documentation, globally, research and development efforts are advancing, but no licensed vaccine or antiviral is yet available for this deadly pathogen.
"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," the ICMR document stated. However, these vaccine candidates are still years away from licensure, making monoclonal antibodies the most feasible immediate countermeasure.
Monoclonal Antibodies as Leading Therapeutic Option
Monoclonal antibodies, which are laboratory-made proteins that mimic the immune system's natural antibodies, have emerged as the most promising therapeutic option for Nipah virus. The best-studied candidate is m102.4, a fully human monoclonal antibody that targets the G glycoprotein of the Nipah virus, preventing viral entry by blocking its interaction with ephrin-B2/B3 receptors.
The m102.4 antibody has demonstrated strong protection in animal models and has been found safe in Phase 1 clinical trials. Though definitive human efficacy data are lacking, the antibody has been used under compassionate protocols in Australia and was made available to Kerala during recent outbreaks, according to the ICMR documentation.
Strategic Deployment and Clinical Applications
ICMR emphasizes that the greatest value of monoclonal antibodies lies in post-exposure prophylaxis for high-risk contacts, including healthcare workers exposed without adequate protection, family members in close contact, or laboratory personnel with accidental exposure. When administered early, these antibodies can potentially prevent disease onset, as demonstrated convincingly in animal models.
Additionally, in patients presenting early during infection, monoclonal antibodies may offer therapeutic benefits by reducing viral load and limiting disease progression, thereby complementing supportive critical care. The importance of having monoclonal antibody stocks ready for deployment cannot be overstated, given the very high case fatality rate and absence of licensed vaccines.
Indigenous Development Initiative
"Looking ahead, India needs to build its own indigenous medical countermeasures against the Nipah virus, particularly monoclonal antibodies," ICMR stated. The initiative aims to move forward through active collaboration with Indian industry partners for developing an indigenous monoclonal antibody platform and manufacturing capabilities.
The ICMR-National Institute of Virology (ICMR-NIV) in Pune has already initiated research and development in this direction, with experimental work at an advanced stage. The institute possesses state-of-the-art laboratory infrastructure, including BSL-3 and BSL-4 facilities, and expertise in outbreak investigations, surveillance, virological characterization, and vaccine candidate development.
Preparedness and Future Outlook
Pre-positioned stocks, streamlined regulatory and ethical approvals, and defined clinical protocols for prophylaxis and therapeutic use would allow immediate deployment without delays that often occur when arrangements are attempted during active outbreaks. This readiness, combined with continued strengthening of surveillance, infection control practices, and One Health investigations of bat reservoirs, will be critical for limiting the impact of future Nipah virus outbreaks.
The ICMR and its institutes will provide expert guidance and technical support in all phases of research and development for creating monoclonal antibodies against Nipah viral disease, leveraging the infrastructure and resources available at ICMR-NIV for joint research, development, and preclinical studies.
