India ramps up Disease X preparedness with $8.9 million funding boost for its freezer-free mRNA vaccine

PUNE/OSLO, 9 SEP—Indian biotechnology company Immunoscript Life Science will receive up to US$8.9 million from the Coalition for Epidemic Preparedness Innovations (CEPI)to advance clinical testing of its thermostable next-generation saRNA vaccine platform, marking an important boost to India’s growing RNA medicine sector while potentially expanding the reach of RNA vaccines to communities where cold-chain infrastructure is limited.

Messenger RNA (mRNA) vaccines played a key role in response to the COVID-19 pandemic. Fast and flexible in their design compared to other types of traditional vaccine approaches, the technology is today being adapted to potentially protect against other infectious threats. The vaccine platform is therefore considered pivotal to the 100 Days Mission, the goal spearheaded by CEPI and backed by India and other G20 and G7 nations, to develop vaccines against emerging diseases in as little as 100 days. 

However, despite their promise, conventional mRNA-based vaccines must be stored and transported at ultra-low temperatures to remain stable and effective. During an outbreak, this can impact access to doses in low-resource or remote settings that lack the equipment needed to prevent vaccines from spoiling, hindering efforts to save lives and contain the spread of disease. 

The proprietary CLNE™ self-amplifying RNA (saRNA) vaccine platform developed and authorised in India during the COVID-19 pandemic and now owned by Immunoscript, is an alternative world-first technology using a ‘nanoemulsion’ design that can help overcome such temperature challenges*. CEPI’s investment in the Pune-based research company will further develop the platform. 

“Ensuring equitable access to vaccines is a priority for CEPI, and freezer-free RNA vaccines would help overcome one of the biggest barriers to broader use of this vaccine technology in outbreak settings, potentially helping to get life-saving shots to millions more people around the world – regardless of where they live” says Dr. Richard Hatchett, CEO of CEPI. “India already serves as one of the world’s major vaccine hubs. Today’s further backing of Immunoscript’s next-generation CLNE™ saRNA vaccine platform pushes their pioneering science sector forward, better preparing both India and the world against deadly emerging threats including a future ‘Disease X’.”

With the new investment, Immunoscript scientists will conduct an early-stage trial in people to assess the safety of the CLNE™ saRNA vaccine technology and the immune response elicited after vaccination against the Rabies virus. The pathogen will serve as a prototype virus to further demonstrate the capacity of the technology against diseases other than COVID-19. The study is expected to launch in India, with researchers using cutting-edge AI tools to determine the optimal dose of the vaccine candidate in people.

The work builds on prior CEPI-backed research which supported the preclinical evaluation of the platform. 

"The success of mRNA vaccines during the pandemic demonstrated not only their safety and efficacy, but also the unprecedented speed at which vaccines can be designed, developed, and manufactured. We believe this has ushered in a new era of vaccinology, where innovative RNA technologies can fundamentally transform how the world prepares for and responds to infectious disease threats," said Dr. Sanjay Singh, Founder and CEO, Immunoscript.

“Through our partnership with CEPI, Immunoscript is contributing to the 100 Days Mission, an ambitious global effort to accelerate vaccine development against future epidemic and pandemic threats. At the same time, we are committed to extending the benefits of these technologies beyond pandemic preparedness by advancing next-generation vaccines for diseases that continue to impose a significant public health burden. Our rabies vaccine program is aligned with the WHO’s 'Zero by 30' initiative, reflecting our broader commitment to democratizing access to innovative vaccine technologies and advancing health equity through scalable, affordable, and accessible solutions worldwide."

The investment forms part of CEPI's broader efforts to advance a new generation of RNA technologies under its next strategic plan which aims to transform the world's ability to prevent, contain and respond to epidemic and pandemic threats. 

CEPI’s funding serves as a structural investment building resilience against future outbreak threats in India and low- and middle-income countries. CEPI’s funding includes a commitment to sharing any commercial benefits arising from the research outside of low- and middle-income countries and investing this in epidemic and pandemic preparedness efforts. Should the project be successful, CEPI has the option to explore providing further funding to Immunoscript for further development of its vaccine platform.

Project results, including related data, will be published open access for the benefit of the global scientific community.

ENDS

About the CLNE™ saRNA platform 

*Rather than encapsulating fragile RNA molecules inside of lipid nanoparticles, as is the standard approach of RNA in traditional mRNA vaccine designs, the CLNE™ platform binds RNA molecules directly to the outer surface of, nanoemulsion droplets. This enables the vaccine to be dried into a powder form for stable storage and transport at 2°C to 8°C.

Alongside its thermostability, Immunoscript’s CLNE™ vaccine platform holds potential as it uses a self-amplifying RNA (saRNA) technology. By acting as a built-in photocopier teaching the body how to safely make more RNA, this could help extend the supply of doses in an emergency, while reducing the cost of the vaccine.

CEPI is already separately supporting research into the vaccine technology against Nipah virus.

About CEPI 

CEPI is an innovative partnership between public, private, philanthropic and civil organisations. Its mission is to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic threats so they can be accessible to all people in need. Central to CEPI’s pandemic-beating plan is the ‘100 Days Mission’ to develop safe, effective and accessible vaccines against new threats in just 100 days. CEPI is seeking $2.5 billion to execute CEPI 3.0, its 2027-2031 strategy which will systematically reduce the likelihood, impact and cost of epidemics and pandemics by driving the 100 Days Mission towards an operational reality. Learn more at CEPI.net.

About Immunoscript Life Science

Immunoscript is an innovation-driven biotechnology company based in Pune, India, focused on advancing RNA-based technologies, vaccines, and immunotherapies for global health applications. Through strategic collaborations with global partners, Immunoscript is building sustainable manufacturing capabilities and strengthening regional innovation ecosystems to improve preparedness, resilience, and equitable access to advanced healthcare technologies. Learn more at https://www.immunoscript.bio