HANGZHOU, CHINA, (April 7, 2025) – HighField Biopharmaceuticals, a clinical stage company using lipid-based therapeutics to treat cancer and other diseases, announced today it has received clearance of its investigational new drug (IND) application from China’s National Medical Products Administration to conduct a Phase 2 clinical trial of HF1K16 (K16) in patients with locally advanced or metastatic pancreatic and non-small cell lung cancers, and glioblastoma. K16 is an innovative immune modulating liposomal drug targeting myeloid-derived suppressor cells (MDSC) in the tumor microenvironment

The Phase 2 study follows positive results of a Phase 1 trial in China of K16 for patients with recurrent and refractory glioma as well as metastatic solid tumors including stomach, colorectal, liver, lung and ovarian cancers.

Topline data from the Phase 1 study will be presented by HighField CEO and Scientific Founder Yuhong Xu, Ph.D. at the American Association for Cancer Research annual meeting April 25 – 30, 2025 in Chicago. Following are details of the presentation:

Title: Myeloid cell targeted immune modulation in solid tumor and brain tumor patients: an analysis of NCT05388487 Phase 1 study data.
Number: LB205.
Session: Late-Breaking Research: Clinical Research 1
Presentation Time: April 28, 2025 2:00 PM-5:00PM

K16 is a unique liposome construct of all trans retinoic acid (ATRA), a metabolite of vitamin A, administered by infusion. When the liposome construct infiltrates the tumor microenvironment, ATRA is released and initiates the differentiation and maturation of MDSCs.

MDSCs are immature myeloid cells that play an important role in constituting the immune suppressive environment in cancer development and progression. K16 promotes the differentiation of MDSCs into functional cells, such as dendritic cells, which then summon T cells to attack the cancer.

The Phase 2 open label, multicenter clinical trial will evaluate the safety and efficacy of K16 in combination with standard of care (SOC) chemotherapy in patients with non-small cell lung cancers (NSCLC), pancreatic cancer and glioblastoma. K16’s unique safety profile and mechanism of action, which is different from existing immunotherapy drugs, suggest that when combined with chemotherapy the anti-tumor efficacy may be even greater than results seen in a Phase 1 trial of K16 as a monotherapy. Data from the Phase 1 study are the subject of HighField’s presentation at the AACR meeting.

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 ADCplex^TM platform, followed by HF50, derived from its TCEplex^TM 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 highfieldbio.com

Media Contact:
Dan Eramian
Opus Biotech Communications
danieleramian@comcast.net

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