HighField Biopharmaceuticals Files IND in China for HF50 Clinical Trial to Treat Solid Tumors

HANGZHOU, China--HighField Biopharmaceuticals, a clinical stage enterprise specializing in lipid-based treatments for cancer, diabetes, and other conditions, has announced the submission of an investigational new drug (IND) application to China's National Medical Products Administration. This application is for a clinical trial of HF50, an innovative immunoliposome designed to enhance T cells' ability to target and eliminate solid tumors, augmented by an immune modulator.

HF50 is a sophisticated lipid bilayer system featuring two distinct antibodies. The first antibody binds to T cells, while the second targets tumor cells, facilitating the engagement of T cells to eradicate cancerous cells. This advanced lipid construction is termed a T cell Redirecting Antibody Fragment-anchored Liposome, or TRAFsome. Additionally, HF50 transports Resiquimod, a small molecule that amplifies T cell response and boosts anti-cancer effects.

Dr. Yuhong Xu, Ph.D., CEO and Scientific Founder of HighField, described the mechanism: “Our TRAFsomes latch onto receptors on T cells, externally coating these immune cells with tumor-targeting antibodies, effectively transforming them into cancer-fighting units. HF50 is also pioneering in its systemic application of Resiquimod, and studies indicate that this method of T cell stimulation significantly enhances anti-tumor activity.”

Dr. Xu further elaborated on HF50's advantages over existing treatments such as bispecific antibodies and CAR T therapy. Bispecific antibodies have limited conjugation capabilities, which reduces their effectiveness against solid tumors. CAR T therapy aims to produce T cells that express anti-tumor antibodies on their surface. HF50 achieves this objective without the complex and costly processes typical of CAR T therapies.

Furthermore, Dr. Xu pointed out that current T cell engagers often present a higher toxicity risk compared to HF50. “Our product employs a liposome-based in vivo action mechanism,” she noted, “which is less likely to affect normal tissues but can concentrate in solid tumors due to the enhanced permeability and retention effect.”

In preclinical assessments, HF50 has demonstrated considerable efficacy as an anti-cancer agent both in vitro and in vivo. The data illustrates its unique capacity to bridge interactions between T cells and tumor cells, thus activating immune cells. HF50 shows significant potential in stimulating T cell activation, proving highly effective in humanized tumor-bearing mouse models. Pharmacokinetic studies also validate that HF50 maintains adequate drug levels in the bloodstream and enhances drug accumulation within tumor tissues.

HighField Biopharmaceuticals is a clinical stage company dedicated to innovative uses of liposome constructs for immuno-oncology and gene therapy. The company boasts a research and development center along with a GMP-compliant production facility. HighField's leading clinical program, HFK16, involves a drug-encapsulated immune-modulating liposome. Their pipeline further includes an ADC platform of drug-encapsulated immunoliposomes for solid tumors and LNP therapeutics for gene delivery and therapy.

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