HF1K16 Phase 1a: Safe, Tolerated, and Effective in Solid Tumor Treatment

HighField Biopharmaceuticals, a company specializing in immuno-oncology treatments, has recently reported positive results from its Phase 1a clinical trial of HF1K16, a novel drug designed to combat cancer. The study, conducted in China, involved 14 patients with various types of metastatic solid tumors, including gliomas and cancers of the stomach, colorectal, liver, lung, and ovaries. Initiated in 2022, the trial administered HF1K16 at increasing doses to assess its safety and efficacy.

The drug, which contains all-trans retinoic acid encapsulated in a liposome, demonstrated a high level of tolerability, with only one instance of dose-limiting toxicity observed at the maximum dosage. Remarkably, the treatment duration correlated with the outcome, as evidenced by a glioma patient who achieved complete remission after 10 months and has remained cancer-free for two years. Additionally, a patient with grade IV duodenal cancer maintained stable disease for over five months.

The overall disease control rate for the trial participants was approximately 35%, with a median overall survival time of 8.5 months. Notably, the longest survival duration surpassed 24 months, and five individuals have survived for more than 10 months. Dr. Yuhong Xu, CEO of HighField, highlighted the significance of these results, particularly given the advanced disease state of the patients enrolled in the study.

Post-treatment analysis revealed substantial alterations in the patients' myeloid cell and T cell profiles, suggesting that HF1K16 may operate through a distinct mechanism. The drug's safety profile and potential are considered promising, leading HighField to plan future studies combining HF1K16 with chemotherapy and other immuno-oncology therapies.

HF1K16's unique formulation involves a small molecule metabolite of vitamin A, all-trans retinoic acid (ATRA), which is delivered via infusion. Once in the bloodstream, it penetrates the tumor microenvironment, where ATRA is released to induce the maturation of myeloid-derived suppressor cells (MDSCs). These immature myeloid cells, under the influence of ATRA, differentiate into functional cells capable of activating T cells to target cancer.

Further details on the Phase 1a trial can be found under the identifier NCT05388487 at clinicaltrials.gov. HighField Biopharmaceuticals, with its focus on innovative liposome constructs, aims to revolutionize immuno-oncology treatments. The company operates a research and development center alongside a GMP-compliant production facility, with HF1K16 as its lead clinical development program for the treatment of solid tumors.