Pharma Focus Europe

HighField Biopharmaceuticals Initiates Phase 1 Clinical Trial for HFK1, a Novel Immunoliposome Targeting HER2 low and HER2+ Cancers

Tuesday, December 19, 2023

HighField Biopharmaceuticals, a company focused on immuno-oncology and utilizing lipid-based therapeutics for cancer treatment, has initiated its Phase 1 clinical trial for HFK1, an immunoliposome containing doxorubicin for solid tumor treatment.

The clinical trial is open-label and multi-regional, spanning the U.S., China, and other countries. It is enrolling patients with advanced refractory solid tumors expressing both low and high levels of HER2. These tumors include various cancer types such as breast, bladder, pancreatic, ovarian, stomach, colon, prostate, lung, uterus, and cervix cancers.

The first patient was dosed at Mary Crowley Cancer Research in Dallas, TX. The trial consists of a Phase 1a dose escalation segment with 24 patients, followed by a Phase 1b dose expansion trial enrolling up to 60 patients. Both phases aim to evaluate the safety and preliminary efficacy of HFK1, with preliminary results expected in the fourth quarter.

HighField CEO Yuhong Xu expressed optimism about the potential of their immunoliposomes, emphasizing their ability to effectively target low HER2 tumors. HFK1 is specifically designed to bind to tumor cells and deliver doxorubicin even at very low HER2 expression levels.

Dr. Minal Barve, Chief Medical Officer/Executive Medical Director and principal investigator at Mary Crowley Cancer Research, highlighted the importance of addressing a wide range of HER2 cancer expression levels. She hopes HFK1 will provide a treatment option for various tumor types beyond strongly HER2-positive tumors.

HighField's immunoliposomes, considered a new generation of targeted chemotherapy drugs, present advantages over antibody-drug conjugates (ADCs). These immunoliposomes offer potential benefits in terms of safety and efficacy across a broad spectrum of solid tumor types.

According to HighField CBO Donald Wyatt, a key differentiating factor is the suitability of immunoliposomes for less toxic payloads compared to ADCs. Additionally, their design allows for larger drug-to-antibody ratios, resulting in wider therapeutic windows and targeting more cancer cells with lower toxicity.

The Phase 1a segment involves enrolling patients into six dose groups to determine the highest tolerated dose. The subsequent Phase 1b study will assess HF158K1 in two types of solid tumors, with dosing based on Phase 1a findings. Additional information is available on under NCT05861895.



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