HighField Biopharmaceuticals Announces First Patient Dosed in Phase 1b/2 Trial of HF1K16 for Recurrent and Refractory Glioma

HF1K16 is a new immuno-oncology drug targeting myeloid-derived suppressor cells (MDSC) to treat cancer

HighField Biopharmaceuticals (HighField Bio), a clinical stage immuno-oncology company using immunoliposomes to treat cancer, announced today the first patient has been dosed in a Phase 1b/2 trial of HF1K16 for recurrent and refractory glioma. HF1K16 is a drug encapsulated immune modulating liposome containing all-trans retinoic acid (ATRA).

“This clinical trial follows our analysis of interim data from a Phase 1a study in which three out of five glioma patients responded to the single agent treatment. One achieved complete response (CR) and two more had stable disease (SD) diagnosis,” said Yuhong Xu, CEO of HighField Bio.

“That Phase 1a study is ongoing, and based on this promising clinical data, we are conducting a Phase 1b/2 trial that will enroll patients with recurrent and refractory glioma intended to establish the statistical significance of HF1K16’s efficacy,” Dr. Xu added.

Incidence of glioma worldwide varies by region and according to the American Society of Clinical Oncology an estimated 22,000 people in the U.S. will be diagnosed in 2023. Glioblastoma is the most common glioma and the most deadly. The patients with recurrent and refractory gliomas enrolled in HighField’s Phase 1b/2 trial have failed all other treatments.

HF1K16 is a unique liposome construct of ATRA, a small molecule metabolite of vitamin A. Administered by infusion, HF1K16 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. ATRA promotes the maturation and differentiation of MDSCs into functional cells, such as dendritic cells, which then summon T cells to attack the cancer.

HighField is developing next generation drug encapsulated immune modulating liposomes and cancer targeted immunoliposomes that are less toxic and more effective than existing immune-oncology drugs. In addition, the liposome constructs are more efficient so that the material costs to manufacture are much lower. This also could lead to lower priced therapies.

The Phase 1b/2 trial will be conducted in China and will assess safety and efficacy as well as evaluate changes in MDSC numbers and phenotypes. See NCT05388487 at clinicaltrials.gov.

About HighField Biopharmaceuticals

Highfield Bio 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 Bio’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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