Phase 1 Trial Data: HF1K16 is Safe, Shows Efficacy in Refractory Metastatic Cancers

HANGZHOU, China--HighField Biopharmaceuticals, a clinical stage company specializing in lipid-based therapeutics for the treatment of cancer, diabetes, and other diseases, has announced promising safety and efficacy results from its ongoing Phase 1 clinical trial of HF1K16 (K16). The findings were presented by the company's CEO and Scientific Founder, Dr. Yuhong Xu, at the European Society of Medical Oncology (ESMO) Congress in Barcelona, Spain, held from September 13 to 17, 2024.

K16 is a novel therapeutic leveraging a lipid bilayer structure to encapsulate all-trans retinoic acid (ATRA), a highly active vitamin A metabolite naturally prevalent in the body. This innovative formulation targets immature immune cells known as myeloid-derived suppressor cells (MDSCs), transforming them into mature immune cells like dendritic cells, which then activate T cells to fight cancer.

Dr. Xu presented a poster titled, "A Phase 1 study of the Myeloid-derived suppressor cells modulator HF1K16 in refractory and metastatic cancer patients: preliminary efficacy and safety," during the Investigational Immunotherapy session on September 14. According to Dr. Xu, “The preliminary safety and efficacy data from our ongoing Phase 1 study is highly encouraging. By using HighField’s liposome technology, we have managed to inject ATRA at concentrations exceeding normal levels by more than tenfold, thereby activating the therapeutic mechanism in patients with very advanced and heavily pre-treated tumors.”

The Phase 1 dose escalation study (NCT05388487) has demonstrated significant signs of effective immune modulation and efficacy. The ongoing expansion cohort is currently focused on recruiting patients with relapsed/refractory (R/R) glioma. As of September 1, 2024, 19 patients with Grade II, III, and IV tumors have been enrolled. For the 10 patients with Grade II and III gliomas, the median overall survival (mOS) is reported to be 629 days. In contrast, for the nine patients with Grade IV or glioblastoma, which are among the most aggressive types of brain tumors, the mOS is 315 days.

The next phase of the study aims to identify the most beneficial indications for K16, either as a standalone treatment or in combination with other standard care regimens. This will be pursued in a Phase 2 study to further validate the therapeutic potential of K16.

HighField Biopharmaceuticals is currently focused on pioneering novel applications of liposome constructs for immuno-oncology and gene therapy. The company operates a research and development center along with a GMP-compliant production facility. HighField's leading clinical development program centers around HFK16, a drug encapsulated in an immune-modulating liposome. Additionally, the company's pipeline includes the LipoADCplexTM platform, which comprises drug-encapsulated immunoliposomes for solid tumors, as well as LNP therapeutics for gene delivery and gene therapy.

The company remains optimistic about the future of K16 and its broader pipeline, which aims to address significant unmet needs in cancer treatment and beyond.