In November 2022 HDT Bio Corp. and the University of Texas Medical Branch (UTMB) revealed that they had been awarded a project agreement worth up to $87.4 million. The US Department of Defence’s (DOD) Joint Programme Executive Office for Chemical, Biological, Radiological, and Nuclear Defence (JPEO-CBRND) and BARDA have awarded this for the “development of a vaccine technology against advanced and emerging viral threats”. The two viruses that will be targeted specifically are Crimean-Congo haemorrhagic fever virus (CCHFV) and Nipah virus (NiV) for their “significance to military personnel”.  

Phase I funding 

UTMB has reportedly partnered with HDT Bio to “leverage the company’s self-amplifying RNA (saRNA) vaccine platform technology and proprietary LION delivery system”. The project will cover the development of vaccine candidates, HDT-321 (CCHFV) and HDT-331 (NiV) through Phase I clinical trials. HDT Bio will receive $49 million as a “sub-performer” for the development of these vaccine candidates.  

HDT Bio CEO Steve Reed is “grateful” to DOD and HHS for their support.  

“We look forward to working with our partners and the MCDC to protect our military personnel and the American people as a whole from biological threats”.  

Two zoonotic threats 

The CDC states that CCHF is caused by infection with a tick-borne virus (Nairovirus) of the Bunyaviridae family. It was first identified in the Crimea in 1944 and later recognised in 1969 as the cause of illness in the Congo. It is found across Europe, Africa, the Middle East, and the Indian subcontinent. The death rate ranges from 9% to 50%.  

NiV is associated with mild illness to encephalitis to death. Fruit bats are the animal reservoir. The CDC suggests that outbreaks occur “almost annually” in parts of Asia. HDT Bio indicates that death rates can be up to 61%.  

“Both of the viruses contain multiple antigen targets that have previously been associated with protective immunity, which affords an opportunity to design and develop vaccines against more than one vulnerability using a multi-antigen approach.” 

Shifting vaccination approaches 

UTMB Co-PI Dr Robert Cross suggests that the COVID-19 pandemic has “clearly demonstrated” a “shift” in vaccination approaches. RNA-based vaccines were “instrumental” in this pandemic and can be applied to “other high priority viruses with pandemic potential”. For HDT Bio’s PI, Dr Jesse Erasmus, “next-generation technologies are urgently needed” to fight diseases in a “safe and tolerable manner”.  

“With the recent emergency use authorisation of our LION/saRNA platform for COVID-19, the first saRNA technology to reach this milestone, we are poised to unlock this modality’s dose-sparing capacity to achieve multi-target protective immunity in humans.”  

For more on emerging infectious diseases and how vaccines can address them, come to the World Vaccine Congress in Washington next year.