CEPI Funds Immunoscript to Advance Freezer Free RNA Vaccine Platform

Indian biotechnology firm Immunoscript Life Science has secured up to 8.9 million USD in funding from the Coalition for Epidemic Preparedness Innovations (CEPI) to advance clinical testing of its proprietary freezer-free RNA vaccine platform. The investment aims to address the logistical hurdles of the vaccine cold chain, which historically restricted the distribution of advanced messenger RNA vaccines during global health crises.

By developing a thermostable platform that bypasses the need for ultra-low temperature storage, the partnership seeks to make rapid-response vaccines accessible to remote and low-resource regions. This initiative aligns with the 100 Days Mission, a global preparedness strategy backed by G7 and G20 nations, including India, to develop safe and effective vaccines within 100 days of identifying a new epidemic threat.

During the COVID-19 pandemic, messenger RNA vaccines developed by companies such as Pfizer-BioNTech and Moderna proved highly effective and rapid to design. However, their reliance on lipid nanoparticles required transportation and storage at sub-zero, cryogenic temperatures. This requirement created a distribution paradox, leaving rural communities and developing nations without access to the most advanced preventative therapies due to a lack of specialized refrigeration infrastructure.

Immunoscript's proprietary CLNE platform offers an alternative formulation designed to bypass these cryogenic requirements. Instead of encapsulating delicate RNA molecules inside lipid nanoparticles, the CLNE technology binds the RNA directly to the outer surface of nanoemulsion droplets. This structural modification allows the vaccine formulation to be dried into a stable powder, which can then be stored and transported under standard refrigeration conditions of 2°C to 8°C.

Beyond temperature stability, the CLNE platform utilizes self-amplifying RNA, or saRNA, which represents a departure from conventional mRNA approaches. Traditional mRNA vaccines deliver a fixed set of instructions that cells read to produce a target protein before the vaccine molecules degrade. In contrast, self-amplifying RNA instructs the recipient's cells to actively replicate the vaccine RNA after administration, generating additional copies of the genetic instructions internally.

This self-amplifying mechanism means that a much smaller initial dose is required to stimulate a strong immune response. For public health agencies, this dose-sparing effect has major implications for manufacturing and logistics. During a sudden outbreak, production facilities could stretch their existing raw materials to manufacture a significantly higher number of doses, reducing overall production costs and accelerating the speed of mass immunization campaigns.

The newly secured CEPI funding will directly support an early-stage clinical trial designed to evaluate the safety and immunogenicity of the CLNE platform. To test the technology, researchers are developing a vaccine candidate targeting rabies, a disease that remains a severe public health threat in many developing regions. Rabies serves as a practical prototype to demonstrate the platform's viability and safety profile in human subjects before adapting it to other emerging pathogens.

To optimize the clinical trial, the development team plans to integrate artificial intelligence tools to assist in dose selection. This computational approach aims to analyze biological data rapidly, ensuring that the trial identifies the minimum effective dose required to trigger a protective immune response. The integration of machine learning with molecular biology represents a growing trend in modern biotechnology, aimed at reducing the time and cost of clinical development.

This partnership points to India's shifting role within the international pharmaceutical sector. While the country has long been recognized as a dominant global hub for low-cost vaccine manufacturing, domestic firms are increasingly moving into advanced genomic research and precision therapeutics. Immunoscript's focus on biological engineering and translational science reflects this broader transition toward high-value biotechnology innovation.

Successful development of a thermostable RNA platform within India could provide both strategic and economic advantages. By establishing domestic capability in next-generation RNA technologies, the country can strengthen its own health security while positioning itself as a critical supplier of stable, easily distributable vaccines for other developing nations. This capability is particularly vital as global health organizations monitor emerging threats like Mpox, Ebola, and Nipah virus.

The ultimate goal of the collaboration is to ensure that future vaccine rollouts do not repeat the inequitable distribution patterns seen in previous global health emergencies. Dr. Richard Hatchett, Chief Executive Officer of CEPI, emphasized that "equitable vaccine access remains a priority for global preparedness efforts." The organization views thermostable RNA vaccines as a potentially important tool in overcoming one of the major barriers to broader deployment of RNA vaccine technologies during outbreaks.

If the CLNE platform proves successful in clinical trials, its applications could extend far beyond emergency pandemic response. Thermostable RNA technology could be integrated into routine immunization programs for existing infectious diseases, simplifying the logistics of pediatric vaccination campaigns in remote areas. By removing the requirement for specialized freezers, public health authorities could integrate advanced RNA therapies into standard healthcare supply chains worldwide.

Moving forward, the immediate milestone for Immunoscript is the initiation of the early-stage clinical trial for the rabies vaccine candidate. This study will focus on establishing the safety profile of the CLNE platform in human subjects and verifying whether the self-amplifying mechanism performs as expected without causing adverse reactions.

Regulatory approvals and specific timelines for the trial's commencement remain subject to review by Indian clinical trial authorities. The data gathered from this initial human study will determine whether the platform can be safely adapted to target other high-priority pathogens under CEPI's broader epidemic preparedness portfolio.