Hangzhou-based HighField Biopharmaceutical, a leader in immuno-oncology focused on innovative lipid-based therapies, has announced the initiation of dosing for the first patient in a clinical trial of its candidate HFK1. This investigational drug is an immunoliposome encapsulating doxorubicin, aimed at targeting various solid tumors. The trial is being conducted concurrently in China and the United States, with the inaugural dose administered at Mary Crowley Cancer Research in Dallas, Texas.
This multi-regional, open-label Phase I study targets patients with general solid tumors, including both HER2 low and HER2-positive types. The Phase Ia dose escalation phase will enroll 24 patients, while the subsequent Phase Ib dose expansion trial will include an additional 60 participants. Safety and efficacy will be assessed across both phases, with initial data readouts anticipated in Q4 2023.
HighField’s pioneering technology incorporates antibodies linked to lipids that encapsulate a chemotherapeutic agent, drawing comparisons to antibody-drug conjugates (ADCs). However, HighField’s immunoliposome therapies are engineered to accommodate less toxic payloads and feature higher drug-to-antibody ratios, promising broader therapeutic windows. This approach is expected to effectively target more cancer cells while reducing toxicity compared to traditional ADCs. HFK1 is designed to deliver therapeutic benefits even in tumors with minimal HER2 expression. This marks HighField’s second candidate to enter clinical trials, following HFK16, an immunoliposome encapsulating all-trans retinoic acid (ATRA), which reported favorable Phase Ia results in glioma patients earlier this month.- Flcube.com
