On April 21, 2025 HighField Biopharmaceuticals, a clinical stage company using lipid-based therapeutics to treat cancer and other diseases, reported that it has filed two investigational new drug (IND) applications (HF158K1 and HFK2) with China’s National Medical Products Administration for immunoliposomes carrying different cancer killing payloads (Press release, HighField Biopharmaceuticals, APR 21, 2025, View Source [SID1234652008]). The planned clinical study will evaluate the two drugs’ safety and pharmacokinetics as well as their combined therapeutic effects in solid tumor patients refractory to prior treatments.
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The two drugs are derived from HighField’s proprietary ADCplexTM platform, containing chemotherapy payloads inhibiting Topoisomerase I and Topoisomerase II activities respectively. HF158K1 (K1) and HFK2 (K2) are both fitted with HER2 antibodies for binding to cancer cell surface HER2 receptors in both HER2 high and low tumors.
K1 is being evaluated as a monotherapy in an ongoing Phase 1 trial in the US (NCT05861895). The planned Phase 1 open label, dose escalation trial of K1 and K2 in China will evaluate the safety and pharmacokinetics of K1 as a monotherapy and preliminary efficacy in combination with K2.
HighField CEO and Scientific Founder Yuhong Xu, Ph.D., explained, "The antibody-drug-conjugate (ADC) drugs are designed based on a great concept. Their specificity and efficacy in cell culture models are always perfect. However, in patients, the process of ADC tumor penetration, especially intracellular payload release inside cancer cells, is profoundly nonlinear. Therefore, increasing the dose may not lead to improved efficacy, but only increased toxicity."
Dr. Xu observed, "Upon modeling the tumor penetration and intracellular delivery process, we came up with the ‘golf cart’ approach. The liposomes ‘escort’ the payloads in a more efficient way than ADCs so there is a close to linear dose vs. intracellular delivery correlation. In this case, we can even combine two kinds of immunoliposomes carrying two different payloads and expect higher efficacy and low toxicity."
Preclinical efficacy studies in mouse tumor models showed greater efficacy from K1, K2 and the two combined than marketed ADCs with the same HER2 target. In addition, the efficacy to maximum tolerant dose (MTD) therapeutic windows are wider.