The trial is set to assess the therapy’s tolerability, safety, pharmacokinetic characteristics, preliminary efficacy, and immunogenicity. Credit: 89stocker/Shutterstock.

HighField Biopharmaceuticals has received clearance for its investigational new drug (IND) application from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) to commence an open-label Phase I trial of HF50, targeting individuals with advanced solid tumours.

The dose escalation and dose expansion trial is set to commence in the first quarter of next year. It will assess the therapy’s tolerability, safety, pharmacokinetic characteristics, preliminary efficacy, and immunogenicity.

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HF50 employs a unique lipid bilayer system, known as a T-cell Redirecting Antibody Fragment-anchored Liposome (TRAFsome), which harnesses T-cells to attack cancer cells.

It also includes Resiquimod, a compound that boosts the anti-tumour immune response. This approach builds on the company’s platform, LipoADCplex, which has already produced K1, a product that has demonstrated a favourable safety profile in clinical trials.

The IND application for HF50 was filed in September.

The TRAFsome T-cell engagers are designed to transform T-cells into a potent force against cancer while simultaneously releasing a payload within the tumour microenvironment to enhance immune reactions against the tumour.

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HighField Biopharmaceuticals CEO and scientific founder Dr Yuhong Xu said: “This is a highly significant milestone for our company and patients.

“Once we proved the LipoADCplex platform could be safer, cheaper and more effective than antibody-drug conjugates, the next logical step is to enlist immune cells with a second antibody to enable immunotherapy against the target cells.”

In July 2023, the company dosed the first subjects in its Chinese trial assessing its candidate for the treatment of recurrent and refractory glioma.