July 16, 2025 | HighField Bio Press Release
HighField Biopharmaceuticals Dosed First Patient in Phase 1 Trial of Liposomal T Cell Engager HF50 (TCEplex)
HF50 is a T cell engager derived from HighField’s unique immunoliposome platforms.
As a T cell engager, HF50 mobilize T cells to find and attack solid tumor cells
HANGZHOU, China – July 16, 2025 –HighField Biopharmaceuticals, a clinical stage company using lipid-based therapeutics to treat cancer, diabetes and other diseases, announced today that the first patient has been dosed in its Phase 1 trial of HF50 to treat patients with HER2 high and HER2 low advanced solid tumors.
The Phase 1 open label, dose escalation trial in China will assess safety, tolerability, pharmacokinetic characteristics, immunogenicity, and preliminary efficacy. It will also establish a recommended dose for the Phase 2 trial. Details of the study design and contacts are on ClinicalTrials.gov (NCT06822998).
HighField CEO and Scientific Founder Yuhong Xu, Ph.D., said, “HF50 is a new type of cancer therapeutics designed to use a lipid bilayer and physical forces to link antibody binding domains and payloads.”
Dr. Xu added, “HF50’s advantages over bispecific antibodies and CAR T cells involve its integration of multiple functions. One is to activate T cells in a controllable way and facilitate their interaction with cancer cells. The other is to carry payload to turn immunologically ‘cold’ tumors ‘hot’ for higher anti-tumor efficacy.
About HighField Biopharmaceuticals
Highfield is a clinical stage company focused on novel applications of liposome constructs directed to immuno-oncology and gene therapy. HighField’s lead products in clinical trials are K1, derived from its ADCplexTM platform, folloed by HF50, derived from its TCEplexTM platform. The company’s pipeline also includes K16, a drug encapsulated immune modulating liposome targeting myeloid-derived suppressor cells in clinical trials for refractory cancers; and HFG1, derived from its tLNPplex™ platform, for mRNA expression of a GLP-1R agonist for weight loss and diabetes. For more information visit https://highfieldbio.com
Media Contact:
Dan Eramian
Opus Biotech Communications
danieleramian@comcast.net
425-306-8716