October 23, 2023 | HighField Bio Press Release

HighField Biopharmaceuticals Announces Positive Phase 1a Data of HF1K16, a new Immuno-Oncology Drug, For Patients with Recurrent and Refractory Glioma

HighField CEO Yuhong Xu and CBO Donald Wyatt are attending BIO-Europe, November 6 – 8, 2023 to discuss these significant early results and the company’s other lipid-based therapeutics for cancer
Results of a K16 Phase 1b/2 extension study with additional recurrent and refractory glioma patients expected in Q1 2024

HANGZHOU, CHINA, (October 23, 2023) – HighField Biopharmaceuticals, a clinical stage immuno-oncology company using lipid-based therapeutics to treat cancer, announced results of its Phase 1a study of HF1K16 showing three of five patients with recurrent and refractory glioma had maintained disease control for more than 8 months with one patient experiencing complete response. HF1K16 is a drug encapsulated immune modulating liposome containing all-trans retinoic acid.

“These encouraging results show HF1K16 is well tolerated and patients have experienced significant disease control,” said Yuhong Xu, CEO of HighField. “We are currently enrolling additional glioma patients in our Phase 1b/2 extension trial to confirm these outcomes and expect to have the results in the first quarter of 2024.”

Dr. Xu and HighField Chief Business Officer Donald Wyatt will attend BIO-Europe November 6 – 8, 2023, in Munich, Germany, to discuss the company’s unique lipid-based drug, including details of the Phase 1a trial. Dr. Xu and Mr. Wyatt can be contacted through the conference’s online Partnering platform.

Of the three patients who had experienced disease control, one patient achieved complete remission after 12 months of treatment and has been cancer free afterwards for 7 months. One of the other two patients, with grade IV glioblastoma, maintained stable disease for more than 4 months. The third patient had stable disease for nearly 3 months and survival to date for more than 9 months. HF1K16 was well tolerated with no high grade adverse effects at all dose levels.

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.

The Phase 1b/2 trial, underway 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 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.

Media Contact:
Dan Eramian
Opus Biotech Communications

Business Development Contact:
Donald Wyatt
HighField Biopharmaceuticals