UTMB will collaborate with HDT Bio Corp. and the National Institute of Allergy and Infectious Diseases’ Rocky Mountain Labs to develop vaccines against Crimean-Congo hemorrhagic fever virus (CCHFV) and Nipah virus (NiV)
The 5-year $59M prototype project will develop vaccines through Phase 1 trials and includes another $28.4M in additional milestones
The University of Texas Medical Branch (UTMB) has been awarded a project agreement worth up to $87.4 million by the U.S. Department of Defense’s (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) and the U.S. Department of Health and Human Services’ (HHS) Biomedical Advanced Research and Development Authority (BARDA) within the Administration for Strategic Preparedness and Response (ASPR), through the Medical CBRN Defense Consortium (MCDC) Other Transaction Authority (OTA), for the development of a vaccine technology against advanced and emerging viral threats. Two deadly viruses of significance to military personnel will be targeted for vaccine protection. These are Crimean-Congo hemorrhagic fever virus (CCHFV) and Nipah virus (NiV).
The project covers development of the vaccines through successful completion of Phase 1 clinical trials. UTMB has partnered with HDT Bio Corp., a developer of immunotherapies for infectious diseases and oncology, to leverage the company’s self-amplifying RNA (saRNA) vaccine platform technology and proprietary LION™ delivery system to develop the vaccine candidates, identified as HDT-321 for CCHFV and HDT-331 for NiV.
HDT Bio will be allocated $49 million as a sub-performer for development of the NiV and CCHFV vaccine candidates.
“We are grateful to DOD and HHS for their support,” said HDT Bio CEO Steve Reed. “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.”
CCHFV is found in Europe, Africa, the Middle East and Asia and death rates range from 9% to as high as 50%. NiV outbreaks occur mostly in Asia with death occurring 61% of the time. There are no approved vaccines for these two potentially lethal viruses.
UTMB will lead the project (PI: Dr. Thomas Geisbert and Dr. Robert Cross) and work with HDT Bio (PI: Dr. Jesse Erasmus) on selection of the NiV saRNA vaccine candidates and assay development. Rocky Mountain Labs, Laboratory of Virology (PI: Dr. Heinz Feldmann), a National Institute of Allergy and Infectious Disease laboratory in Hamilton, MT, will collaborate on the selection of CCHFV saRNA vaccine candidates.
“The CoVID-19 pandemic has clearly demonstrated a shift in vaccination approaches, where RNA-based vaccines were instrumental in rapidly addressing the global need for a vaccine,” said UTMB Co-PI Dr. Robert Cross, “This partnership will build on the successes of HDT Bio to generate potent RNA vaccination technologies targeting SARS-CoV-2 in order to address other high priority viruses with pandemic potential.”
“The SARS-CoV-2 pandemic is an example of how quickly viruses can emerge and spread,” said UTMB Co-PI Dr. Thomas Geisbert. “An important mission of the Galveston National Laboratory is to develop medical countermeasures to combat highly lethal pathogens. We thank DOD and HHS for the opportunity to work with the MCDC and our colleagues at HDT Bio and Rocky Mountain Laboratories to develop vaccines that can protect against CCHF and NiV.”
CCHFV and NiV are zoonotic viruses but also can be transmitted from infected people through close contact with bodily fluids. CCHFV is transmitted by ticks with a variety of domestic and wild animals, such as cattle, sheep, goats and rabbits, serving as amplifying hosts for the virus. The virus can cause severe internal bleeding followed by organ failure and death. NiV is passed to humans from pigs and fruit bats. The virus causes encephalitis and severe respiratory disease, and outbreaks occur regularly in regions of Asia and India. NiV also poses a potential national security threat to the United States.
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.
“Next-generation technologies are urgently needed to enable multi-antigen RNA vaccine strategies to combat emerging infectious diseases in a safe and tolerable manner,” said HDT Bio’s PI Dr. Jesse Erasmus, “With the recent emergency use authorization 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.”