The Access to Advanced Health Institute Develops Longer Lasting and Broadly Protective SARS-CoV-2 RNA Vaccine Candidate that is Stable at Room Temperature

SEATTLE–(BUSINESS WIRE)–Today, the Access to Advanced Health Institute (AAHI) announced results from a study of their new RNA vaccine against COVID-19. Preclinical studies published in NPJ Vaccines demonstrate the ability of AAHI’s unique SARS-CoV-2 self-amplifying RNA vaccine to elicit strong antibody and T cell immunity to multiple variants of SARS-CoV-2. This next-generation approach to RNA vaccine technology combines self-amplifying RNA (saRNA) with a unique nanostructured lipid carrier (NLC) delivery vehicle containing an adjuvant, and will be harnessed to drive longer lasting, broadly-protective immunity against pandemic pathogens. AAHI’s RNA vaccines can easily be freeze-dried for long-term room temperature or refrigerated stability (10+ months). The SARS-CoV-2 RNA vaccine candidate, AAHI-SC2, is currently being evaluated in liquid form in a first-in-human Phase 1 / 2 clinical trial sponsored by ImmunityBio in South Africa (NCT05370040).

The current RNA vaccine strategy endorsed by the US government in response to the COVID pandemic relies on continuous development and distribution of boosters against the newest variants of concern that will likely induce protection of six months or less. This rapidly waning protection leaves high-risk populations such as the elderly, children, and immunocompromised much more vulnerable. “We clearly need vaccines against COVID-19 that drive protection for more than a few months – both in high-resource and low resource regions – to truly bring this pandemic to an end,” said Emily Voigt, Principal Scientist and Manager of the RNA Vaccine Platform team at AAHI. “AAHI’s self-amplifying, adjuvanted RNA vaccine technology is not only easy to manufacture but has the potential to extend immune protection even in the face of an evolving virus – whether COVID-19 or the next pandemic virus.”

Further complicating the world’s ability to rapidly respond to pandemic threats are the low temperature requirements (-20°C and -80°C) for transportation and storage of available COVID RNA vaccines, which makes universal distribution of the current vaccines well-nigh impossible. AAHI-SC2 addresses these issues by inducing strong immune responses with a freeze-dried, also known as lyophilized, vaccine product. This lyophilized vaccine is demonstrated to be stable at standard refrigerated temperatures for at least 10 months and can be stored at room temperature for six months, as may be necessary during vaccine distribution. The improved temperature stability of AAHI-SC2 enables more equitable access to COVID RNA vaccines, especially in rural and remote communities where resources are limited.

“There is still a large vaccine equity gap – prices are high, manufacturing is complex, and deep cold chain logistics are a nightmare. This gap is widening as the vaccine wanes and emerging COVID variants evade protection, requiring continuous and updated boosters. AAHI is taking a pragmatic approach to RNA vaccine development so that everyone, including people in resource limited areas, will have rapid access to long lasting and broad protection,” said Corey Casper, MD, Chief Executive Officer at AAHI. “Our partnership with ImmunityBio has made our commitment to bringing this next-generation RNA vaccine technology to the people who need them most, a reality.”

AAHI continues to optimize its immune-enhancing RNA vaccine technology for enhanced functionality and accessibility, including by investigating alternative routes of administration such as nasal spray, to stop the virus at the gate of entry to the body and to curtail transmission, and exploring the potential for a dry powder RNA vaccine.

AAHI is a nonprofit biotech research institute located in Seattle, Washington that combines the high-quality science of an academic research organization with the product-development capabilities of a biotech company to help combat some of the world’s deadliest diseases, including COVID-19, cancer, fungal and parasitic infections, and other non-communicable diseases. For nearly three decades, AAHI, previously known as the Infectious Disease Research Institute, has focused on creating immune-enhancing technologies that improve the body’s natural response to disease. Through collaborations, AAHI brings innovation from the lab to the clinic to the people, furthering AAHI’s mission to bring together the best experts, technologies, and platforms to create accessible, high-quality products and solutions. AAHI is working to build a world in which every person has access to tools that harness their immune system and allow them to live a healthy life free of illness and disease. For more information, go to AAHI.org or follow us on LinkedIn.

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Casey Benadof

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