HANGZHOU, CHINA, (December 4, 2025) – HighField Biopharmaceuticals, a clinical stage company using lipid-based therapeutics to treat cancer and other diseases, presented analysis of clinical study patient samples, taken at times during treatment, revealing specific immune modulation mechanisms for two of its unique clinical stage products in Late Breaking Abstract Presentations at the Society for Immunotherapy of Cancer (SITC) 40^th Anniversary Meeting November 2025.

“HighField Bio aims to develop lipid-based products that focus on the different aspects of anti-cancer immunity for solid tumor treatment,” said CEO and Scientific Founder Yuhong Xu, Ph.D. “Lipid nanostructures have unique distribution properties in the solid tumor microenvironment. We think they may have great advantages in modulating the various immune cells residing inside tumor tissues to restore the compromised immune function against tumor cells.”

The HF50 data were presented in a poster titled “First-in-Human Evaluation of HF50, a Novel Liposomal HER2xCD3 T cell Engager with TLR Agonist Payload, Demonstrates Tolerability and Early Clinical Response.” HF50 is a lipid bilayer system fitted with two antibodies towards T cells and cancer cells respectively. The system also includes a immunomodulator encapsulated inside the liposomes.

The K16 data were presented in a poster titled “Targeting MDSCs with HF1K16 Unlocks Long-term Survival in Refractory Recurrent Glioma; an update of NCT05388487.” K16 is a liposome containing all-trans retinoic acid to promote immature myeloid-derived suppressor cells (MDSCs) differentiation into antigen presenting cells (APCs) for resecuring the cytotoxic immune response against cancer cells.

“Both therapies were found to be well tolerated with manageable safety profiles based on the Phase 1 data.” Dr. Xu said. “In addition, we are pleased to observe significant survival benefits in the K16 single agent study cohort. The up-to-date median survival data is 26.5 months and 17.7 months for Grade 2-3 and Grade 4 recurrent and refractory glioma patients respectively.”

She added, “K16 and HF50 are designed to interact with different immune cells in the cancer invaded immune response cascade. As shown in the schematics below, the normal tumor neoantigen presentation and anti-cancer immune circuits are distracted and disabled in cancer patients. Naïve T cells and T memory stem cells become indifferent and exhausted quickly as shown by the red arrows.”

Dr. Xu explained, “Unlike checkpoint inhibitors (represented by the green arrows), K16 and HF50 produce a different therapeutic response. K16 acts on the immature MDSCs and turns them into APCs to restore tumor recognition and cytotoxic T cell activities. HF50 has a broader scope. We observed activation of a variety of T cells, including T naïve cells and T memory stem cells in patients after HF50 administration.”

Based on these findings, Dr. Xu said, “We will continue pursing our goal of advancing HF50 and K16 to significantly improve medical outcomes for more cancer patients with fewer side effects.”