HighField Biopharmaceuticals announced positive preliminary safety and efficacy data from its ongoing Phase 1 clinical trial of HF1K16 (K16) in patients with refractory metastatic cancer. The data, presented at the European Society of Medical Oncology (ESMO) Congress in Barcelona, Spain, showed promising signals of immune modulation and efficacy, particularly in a cohort with relapsed/refractory (R/R) glioma.
HF1K16 is an immune modulating liposome that encapsulates all-trans retinoic acid (ATRA). The drug is designed to target myeloid-derived suppressor cells (MDSCs), which are immature immune cells that can inhibit the body's ability to fight cancer. By targeting MDSCs, HF1K16 aims to convert them into mature, active immune cells like dendritic cells, which can then activate T cells to attack cancer cells.
Phase 1 Trial Results
The Phase 1 dose escalation study (NCT05388487) enrolled patients with refractory and metastatic cancers. As of September 1, 2024, an expansion cohort focused on R/R glioma included 19 patients with Grade II, III, and IV tumors. Among the 10 patients with Grade II and III gliomas, the median overall survival (mOS) was 629 days. For the 9 patients with Grade IV glioblastoma, mOS was 315 days.
"We are excited about the preliminary safety and efficacy data from our ongoing Phase 1 study," said Dr. Yuhong Xu, CEO and Scientific Founder of HighField Biopharmaceuticals. "Using Highfield’s liposome technology, we were able to inject a highly concentrated ATRA offering more than 10 times higher than normal exposure in a patient, triggering the therapeutic mechanism. These patients have very advanced, heavily prior treated tumors."
Mechanism of Action
HF1K16 leverages a lipid bilayer structure to deliver ATRA, a vitamin A metabolite, directly to MDSCs. This targeted delivery aims to overcome the limitations of systemic ATRA administration, achieving higher drug concentrations at the tumor site and enhancing immune activation.
Future Directions
HighField Biopharmaceuticals plans to initiate Phase 2 trials to further evaluate HF1K16, either as a single agent or in combination with standard of care regimens, to determine the optimal indication for this novel immunotherapeutic approach.
