HDT Bio to Help Spearhead RNA Vaccine Development in National Pandemic Preparedness Initiative

HDT bio's Rapid-Response Roadmap for RNA vaccines (R⁴) project granted a five-year subaward for $2M per year

SEATTLE, Sept. 17, 2024 /PRNewswire/ -- HDT Bio Corp., a clinical-stage biopharmaceutical company specializing in advanced RNA vaccine technologies, is proud to announce its pivotal role in PROVIDENT (Prepositioning Optimized Strategies for Vaccines and Immunotherapeutics Against Diverse Emerging Infectious Threats), a national consortium led by Albert Einstein College of Medicine and funded by the National Institute of Allergy and Infectious Diseases (NIAID) as part of the Research and Development of Vaccines and Monoclonal Antibodies for Pandemic Preparedness (ReVAMPP) Network.

HDT Bio will focus on developing "road maps" for the rapid creation of RNA vaccines against pathogens with pandemic potential, harnessing the company's proprietary AMPLIFY™ self-amplifying replicon RNA (repRNA) platform and LION™ nanoparticle delivery system. The combination of these two technologies offers increased vaccine potency, durability, and stability, while simplifying production—critical features for addressing emerging infectious threats quickly and effectively.

"We are excited to contribute our expertise in RNA vaccine technologies to the PROVIDENT consortium," said Steve Reed, Ph.D., Chief Executive Officer of HDT Bio. "Our AMPLIFY™ and LION™ platforms have demonstrated their ability to rapidly generate potent, durable immune responses with a favorable safety profile. These innovations will be essential in preparing for future pandemics, where speed and flexibility in vaccine development will save lives."

As part of the PROVIDENT initiative, HDT Bio will develop a comprehensive strategy to create RNA vaccines capable of targeting pathogens across multiple viral families, focusing particularly on rapid adaptability to emerging "virus X" scenarios. This aligns with PROVIDENT's broader goals of safeguarding public health by advancing platforms that can be quickly tailored to respond to novel viral threats.

"It is currently unknown if the state-of-the-art approaches used to design vaccine antigens for traditional vaccine technologies can simply be co-opted for use in RNA vaccine technologies," said Jesse Erasmus, Ph.D., who is the principal investigator on the subaward. "In our project, Rapid-Response Roadmap for RNA vaccines, HDT Bio will address this unknown while generating prototype vaccine candidates for 8 different viruses across 3 virus families of pandemic potential, collaborating with other member institutions of PROVIDENT to design and characterize antigens using structure-guided and high-throughput mutagenesis approaches."

"We will also evaluate safety and immunogenicity against a diverse panel of viruses, and characterize efficacy in high-containment," Dr. Erasmus added.

The additional key contributors to these efforts at HDT Bio are:

• Amit Khandhar, Ph.D., Director of Formulations
• Taishi Kimura, Ph.D., Senior Scientist
• E. Taylor Stone, Ph.D., Scientist

HDT Bio will work with 12 teams in academia and government alongside 3 other projects titled, 1) "Discovery and dissection of virus-host interactions and pathogenetic mechanisms", 2) "Antigen design and immunological evaluation", and 3) Mining human antibody responses to inform vaccine and therapeutic design". More details on collaborating institutions and their key researchers can be found in Albert Einstein College of Medicine's description of the parent award.

HDT Bio's LION™/repRNA platform builds on the company's pioneering work in vaccine development, notably including emergency use authorizations for its vaccine during the COVID-19 pandemic. The company's innovative approach to RNA vaccine delivery, particularly through its LION™ nanotechnology, enhances the safety and efficacy of RNA-based vaccines while maintaining crucial logistical benefits such as refrigeration stability and simplified manufacturing.

"Our role in PROVIDENT exemplifies HDT Bio's mission to make RNA vaccines a cornerstone of future pandemic preparedness," added Dr. Reed. "By working in concert with academic, government, and industry partners, we aim to provide the tools needed to address unknown viral threats quickly and efficiently."

For more information on HDT Bio's AMPLIFY™ and LION™ platforms, visit www.hdt.bio.

About HDT Bio

HDT Bio is a Seattle-based, clinical-stage biopharmaceutical development company. With core technology and expertise in nucleic acid formulation, the company develops products that seek to harness host-directed immune responses. HDT Bio's work focuses on infectious disease and oncology vaccines and therapeutics through early-stage collaborations with partners worldwide. The company's vaccine platforms combine formulation and adjuvant ingredients to stabilize and deliver RNA to the immune system to stimulate responses. HDT Bio's repRNA/LION™ was the first self-amplifying RNA vaccine platform to ever receive a regulatory authorization.

SOURCE HDT Bio Corp.