ICMR seeks tech transfer for its anti-malaria vaccine, AdFalciVax, likely taking 6-7 years for readiness, targeting severe malaria caused by P. falciparum.
The Indian Council of Medical Research (ICMR) has invited an expression of interest for technology transfer to commercialise its anti-malaria vaccine candidate that it is developing in partnership with the department of biotechnology, even though the vaccine is likely to take at least six to seven years to be ready for use, according to people familiar with the matter.
According to the projected timeline, accessed by HT, the “Good Manufacturing Practice (GMP) production and toxicology studies” will take approximately two years; “phase 1 clinical trial, including regulatory approval”, will take another two years; “Phase 2b and Phase 3 clinical trials” will take approximately two and a half years; and post-trial regulatory clearance and licensing for marketing would take approximately six months. (Each stage includes a buffer period of ± six months.)
The recombinant chimeric multi-stage malaria vaccine (AdFalciVax) is being indigenously developed against plasmodium falciparum— the parasite that predominantly causes severe and fatal malaria, according to ICMR. “In early stages, the vaccine candidate looks useful in preventing plasmodium falciparum infection in humans and minimising its community transmission,” it added.
Malaria continues to pose serious challenges to public health and economies, particularly in the tropical and subtropical regions around the world. According to data shared by the government, globally in 2023, there were almost 263 million estimated malaria cases in 83 malaria-endemic countries, an increase of 11 million cases compared with 2022. India accounted for half of all estimated malaria cases in the South-East Asia region in 2023.
ICMR has invited applications from organisations, companies, and manufacturers from across the country.
“ICMR-Regional Medical Research Centre, Bhubaneswar (ICMR-RMRCBB)— one of the constituent institutes of ICMR has led development of a technology entitled ‘A recombinant chimeric multi-stage malaria vaccine (AdFalciVax) against Plasmodium falciparum’… and ICMR-RMRCBB has technical know-how of process to produce this technology. The pre-clinical validation of this technology has been conducted in collaboration with ICMR-National Institute of Malaria Research (ICMR-NIMR), another constituent institutes of ICMR, and National Institute of Immunology (NII), New Delhi, an autonomous research institute of the Department of Biotechnology, Government of India,” the ICMR invite said.
AdFalciVax is the first indigenous recombinant chimeric malaria vaccine specifically designed to target two critical stages of plasmodium falciparum. Country’s biomedical research regulator, however, emphasised that the vaccine candidate is in its early research and development phases and is not yet available for any clinical use or commercialisation.
The vaccine has shown excellent efficacy in the preclinical stage of development, ICMR said in a statement.
“Preclinical data suggest that AdFalciVax may have advantages over existing single-stage vaccines (such as RTS,S/AS01 and R21/Matrix-M), including: Broader protection by targeting two vulnerable parasite stages; lower risk of immune evasion and potential for better long-term immunity; extended thermal stability with functionality maintained for over nine months at room temperature; and cost-effective formulation using pharmaceutically acceptable carriers,” the statement added.
ICMR further said that it intends to licence the technology for AdFalciVax to eligible organisations and manufacturers for further development, manufacture, and commercialisation under non-exclusive agreements. This approach aims to enable wider outreach and maximize public health benefits, and all collaborations will adhere to ICMR’s intellectual property policy.
ICMR would provide technical support through its team of experienced scientists in study planning, product development, development of study protocol, results or data analysis, outcome assessment, safety and efficacy assessment, product improvement, etc. “Subsequent to the execution of the agreement such companies/manufacturers shall be responsible to pay the Royalty @ 2% on Net sales, as applicable, according to the ICMR Guidelines for Technology Development Collaboration…,” the statement said.
It added that the introduction and rollout of malaria vaccines, such as RTS,S and R21/Matrix-M, have shown promise in reducing disease incidence, particularly among young children in high-burden areas. While significant progress has been made in combating malaria, the global burden remains substantial. In order to address the goal of malaria elimination, an improved vaccine with better efficacy needs to induce protection against infection in human hosts as well as block or reduce transmission to the mosquito vector.
