The Indian Council of Medical Research (ICMR) is actively pursuing partnerships with Indian industry to develop and manufacture monoclonal antibodies aimed at treating the deadly Nipah virus. This initiative follows successful animal trials and aims to ensure rapid access to effective treatments during future outbreaks.
Monoclonal antibodies are engineered proteins that replicate the immune system”s response to harmful pathogens. With the Nipah virus posing a significant zoonotic threat to India, the ICMR”s recent Expression of Interest (EoI) emphasizes the urgent need for indigenous therapies, particularly as the virus has been linked to recurrent outbreaks since 2001.
The ICMR stated in the EoI, “We are open to collaboration with qualified organizations and manufacturers for the “Development and Manufacturing of Monoclonal Antibodies against Nipah Viral Disease.”” Although global research on vaccines and antiviral treatments is progressing, no licensed options are currently available.
The document highlights that various vaccine platforms are under investigation, including some supported by the Coalition for Epidemic Preparedness Innovations (CEPI). One promising candidate has advanced to mid-stage human trials, with India designated as a primary location for these studies. However, the timeline for availability remains uncertain, with monoclonal antibodies emerging as the most viable therapeutic option in the interim.
The most researched monoclonal antibody is m102.4, which targets the G glycoprotein of the Nipah virus. This antibody effectively blocks viral entry by interfering with receptors that the virus uses to infect cells. Animal studies have demonstrated m102.4″s protective capabilities, and it has shown safety in Phase 1 clinical trials. Although definitive efficacy data in humans is still pending, m102.4 has been utilized in compassionate use cases in Australia and made available during recent outbreaks in Kerala.
The ICMR underscored the critical importance of maintaining a stock of monoclonal antibodies for immediate deployment in India. With the Nipah virus presenting a high case fatality rate and lacking approved vaccines, monoclonal antibodies represent the only feasible biomedical response available. Their most significant utility lies in post-exposure prophylaxis for high-risk individuals, including healthcare workers and family members of those infected.
Administering these antibodies early in the disease course could potentially reduce viral load and limit disease progression, complementing critical supportive care measures. The ICMR emphasizes that ensuring access to monoclonal antibodies will enable swift action during outbreaks.
To facilitate this, the ICMR plans to establish pre-positioned stocks, streamline regulatory processes, and create defined clinical protocols for both prophylactic and therapeutic administration. This readiness, alongside enhanced surveillance and infection control measures, will be essential in mitigating the impact of future Nipah virus outbreaks.
Looking forward, the ICMR has expressed the necessity for India to cultivate its own indigenous medical countermeasures against the Nipah virus, particularly through monoclonal antibodies. Active collaboration with the Indian industry is seen as a pathway to creating an indigenous monoclonal antibody platform that will ensure timely access during crises and bolster national preparedness for emerging viral threats.
The ICMR-National Institute of Virology (ICMR-NIV) in Pune has already made significant progress in research and development in this area. Equipped with advanced laboratory facilities, including BSL-3 and BSL-4, the institute has expertise in various aspects of outbreak response, virological characterization, and conducting preclinical trials.
The EoI document indicates that the ICMR and its institutes will provide comprehensive guidance and technical support throughout all phases of research and development for the creation of monoclonal antibodies against Nipah viral disease.
