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Principal Investigator: Haitao Hu
Organization: RNA THERAPEUTICS INC.
Fiscal Year: 2024
Award: $299,967
Funding agency: National Institute of Allergy and Infectious Diseases
ABSTRACT
The coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-
CoV-2), has impacted global public health in an unprecedented manner. Vaccination is considered one of the
most effective countermeasures against infectious diseases, including COVID-19. Although rapid development
of first-generation COVID-19 vaccines (principally targeting the viral Spike protein) provided early hope for
ending the pandemic, the emergence of SARS-CoV-2 variants has posed a constant challenge. A pan-COVID-
19 vaccine that provides broad protection against current and emerging variants is urgently needed to end
the pandemic and to prevent future recurrences.
mRNA formulated in lipid-nanoparticles (mRNA-LNP) has emerged as a safe and versatile vaccine delivery
platform. RNA Therapeutics, Inc. is a startup biotechnology company focused on the development of novel,
mRNA-based vaccines and therapeutics for infectious diseases. Its academic partner, Dr. Haitao Hu’s laboratory
at the University of Texas Medical Branch (UTMB), recently reported a promising pan-COVID-19 mRNA vaccine
candidate (Hajnik RL, STM 2022). The Hu laboratory generated an mRNA vaccine expressing the nucleocapsid
protein (N) of the ancestral SARS-CoV-2 strain, which is more conserved among variants (termed as mRNA-N).
Animal studies showed that mRNA-N is highly immunogenic and elicits strong T-cell and binding antibody
responses. The vaccine alone confers modest cross protection against SARS-CoV-2 Delta and Omicron variants
of concern (VOC). Interestingly, combining mRNA-N with the clinically proven ancestral spike mRNA vaccine
(mRNA-S) induces robust cross protection against both Delta and Omicron VOCs (mRNA-S+N). These data
support a hypothesis that a vaccine approach targeting conserved viral protein, in addition to S, will elicit cross-
reactive immunity and provide broad protection against SARS-CoV-2 variants.
With this technology in hand, RNA Therapeutics, Inc. and UTMB propose a Phase-I STTR application to further
develop the mRNA vaccine candidate through two specific Aims. Aim 1 will examine the durability of protective
efficacy of the vaccine in hamsters. Aim 2 will determine protective efficacy of mRNA-N as a component of
booster regimens. Impact: Upon successful completion of this Phase-I STTR, we will submit a Phase-II
application that will focus on advanced product development. Our project is expected to develop a pan-COVID-
19 mRNA vaccine that provides broad protection against emerging SARS-CoV-2 variants and the long-term goal
is to advance this vaccine to clinical testing and approval. Given the proven safety of mRNA-LNP, the vaccine
has high potential to be approved for human use in future.
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