HDT Bio

HDT Bio is a private, clinical-stage biotech founded in 2017, advancing a transformative RNA-based delivery platform called LION™. The company's pipeline includes candidates for infectious diseases and oncology, with its lead program, HDT-321, recently receiving FDA clearance to proceed into clinical trials for tick-borne disease prevention. HDT Bio operates through a partnership and licensing model, collaborating with entities like MalarVx to expand the application of its technology into areas such as malaria vaccines. The company's strategy centers on demonstrating the broad utility of its repRNA/LION™ platform to attract further development partnerships and advance its internal candidates.

LION™ (Lipid InOrganic Nanoparticle) formulation for delivery of self-amplifying replicon RNA (repRNA), designed for enhanced potency, safety, durability, and manufacturability of vaccines and therapeutics.

HDT Bio competes in the advanced RNA delivery space against large mRNA leaders (Moderna, Pfizer/BioNTech) and numerous biotechs developing next-generation lipid nanoparticles and other delivery systems. Its differentiation hinges on the clinical performance of its repRNA/LION™ combination, particularly regarding dose, durability, and tolerability.