HighField Biopharmaceuticals, a clinical stage company using lipid-based therapeutics to treat cancer, diabetes and other diseases, announced today it has filed an investigational new drug (IND) application with China’s National Medical Products Administration to conduct a clinical trial of HF50, a first-of-its-kind immunoliposome that directs T cells to attack solid tumors and enhances the anticancer activity with an immune modulator.

HF50 is a lipid bilayer system with two different antibodies attached; the first bind to T cells and the second bind to tumor cells, engaging the T cells to destroy the cancer. This unique lipid structure is called a T cell Redirecting Antibody Fragment-anchored Liposome, or TRAFsome. It also carries a payload of Resiquimod, a small molecule compound that modulates T cell response, enhancing anti-tumor activity.

“Our TRAFsomes attach to receptors on the surface of T cells, externally coating the immune cells with tumor targeting antibodies, converting the T cells into an army of cancer destroyers,” said Yuhong Xu, Ph.D., HighField’s CEO and Scientific Founder. “HF50 also represents the first systemic use of Resiquimod, and data show that stimulating the immune T cells in this manner greatly enhances the anti-tumor activity.”

As a T cell engager of cancer, HF50 has multiple advantages over others such as bispecific antibodies and CAR T therapy, Dr. Xu added. “Bispecifics have very limited antibody conjugation schemes,” she explained, “limiting their efficacy in solid tumors. As for CAR T, the goal is to produce T cells expressing anti-tumor antibodies on their outer membrane. HF50 achieves this goal without the complex and expensive processing inherent in CAR T therapies.”

In addition, Dr. Xu observed, most existing T cell engagers have a higher risk of toxicity than HF50. “Our product has a liposome-based in vivo action process,” she said, “which is less distributed in normal tissues, but can concentrate in solid tumors through the enhanced permeability and retention effect.”

In preclinical studies, HF50 has shown to be a highly effective anti-cancer agent in both in vitro and in vivo. The data demonstrate that it processes a novel cell bridging function between T cells and tumor cells, with the capability of activating immune cells. HF50 effectively stimulates T cell activation and displays significant efficacy in humanized tumor-bearing mice models. Pharmacokinetic research also confirms HF50 successfully maintains drug levels in the bloodstream, and improves drug accumulation within tumor tissues.

About HighField Biopharmaceuticals

HighField is a clinical stage company focused on novel applications of liposome constructs directed to immuno-oncology and gene therapy for other diseases. The company also has a research and development center and a GMP-compliant production facility. HighField’s lead clinical development program is HFK16, a drug encapsulated immune modulating liposome. The company’s pipeline also includes an ADC platform comprised of drug encapsulated immunoliposomes for solid tumors as well as LNP therapeutics for gene delivery and gene therapy. For more information visit https://highfield.bio.

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