January 8, 2024 | HighField Bio Press Release

HighField Biopharmaceuticals HF1K16 Phase 1a Data Suggests the New Immuno-Oncology Drug is Safe, Well-Tolerated and Efficacious in Solid Tumors

HANGZHOU, China–January 8, 2024–HighField Biopharmaceuticals, a clinical stage immuno-oncology company using lipid-based therapeutics to treat cancer, announced today it has completed its Phase 1a study of HF1K16. Treating patients having multiple tumor types, the data demonstrated that the drug, administered as a single agent, is well-tolerated with only one dose-limiting toxicity (DLT) at the highest dose level. HF1K16 is a drug encapsulated immune modulating liposome containing all-trans retinoic acid.

“We were especially encouraged by the outcome being correlated to the treatment duration, with the drug being tolerated for extended periods,” said Dr. Yuhong Xu, CEO of HighField. “One glioma patient experienced complete remission after 10 months of treatment, remained on the treatment for two years and is cancer free. Another patient, with grade IV duodenal cancer, maintained stable disease for more than 5 months.”

A total of 14 patients, suffering from a variety of refractory metastatic solid tumors such as gliomas and stomach, colorectal, liver, lung and ovarian cancers, were treated in China with HF1K16 at escalating doses beginning in 2022.

Overall, the disease control rate for the patients is about 35% with a median overall survival of 8.5 months. The maximum survival period has exceeded 24 months and five patients have survived more than 10 months.

“Given the disease state of the patients in the study, a monotherapy outcome of 35% disease control rate is impressive,” said Dr. Xu. “Moreover, we found significant changes in the patients’ myeloid cell and T cell profiling after treatment. Because it shows a new mechanism and excellent safety profile, our next step is to explore HF1K16 in combination with chemotherapy and other immuno-oncology therapies.”

HF1K16 is a unique liposome construct of ATRA, a small molecule metabolite of vitamin A. It is administered by infusion, travels through the blood stream and infiltrates the tumor microenvironment. ATRA is released and initiates the maturation of myeloid-derived suppressor cells (MDSCs).

MDSCs are immature myeloid cells which have not differentiated. ATRA promotes the maturation and differentiation of MDSCs into functional cells, such as dendritic cells, which then summon T cells to attack the cancer.

For more information on the Phase 1a open label trial see NCT05388487 at clinicaltrials.gov.

About HighField Biopharmaceuticals
HighField is a clinical stage immuno-oncology company focused on novel applications of liposome constructs to disrupt existing immuno-oncology technologies. The company has a research and development center and a GMP-compliant production facility. HighField’s lead clinical development program is HF1K16, a drug encapsulated immune modulating liposome containing all-trans retinoic acid targeting myeloid-derived suppressor cells for treatment of solid tumors. For more information visit https://highfield.bio.


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Dan Eramian
Opus Biotech Communications

Business Development Contact:
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HighField Biopharmaceuticals