Hangzhou-based HighField Biopharmaceutical, a specialist in immuno-oncology biotech focused on targeted lipid-based therapies, has revealed that it has received tacit clinical approval from the National Medical Products Administration (NMPA) for its drug candidate HF50. This T-cell redirecting antibody fragment-anchored liposomes (TRAFsomes) product will be tested in clinical trials for HER-2 positive or HER-2-low advanced solid tumors, marking a world-first entry into the clinics for this type of therapy.
HF50’s Mechanism of Action and Clinical Potential
HF50 is designed to modify liposomes through antibody targeted conjugate technology, combining HER2 expressed on the tumor surface with activated T cells to mediate T cell-specific killing of tumor cells. Additionally, HF50 carries TLR7/8 immune agonist small molecules, which can improve cell redirection efficiency and further enhance the tumor killing effect. This innovative approach offers a significant advancement in immuno-oncology, with the potential to improve treatment outcomes for patients with HER-2 positive or HER-2-low advanced solid tumors.
Advantages Over Traditional TCE Products
Compared to traditional T-cell engaging (TCE) products, HF50 demonstrates a stronger ability to activate the tumor microenvironment and achieve better anti-tumor effects. This unique capability positions HF50 as a promising candidate in the field of immuno-oncology, offering new hope for patients with limited treatment options.Fineline Info & Tech