HighField Biopharmaceuticals Doses First Patient in Phase 1 Trial of HFK1, a Unique Immunoliposome, for Treatment of HER2 low and HER2+ Cancers

The company’s groundbreaking drug encapsulated immunoliposomes may represent a significant improvement over existing antibody drug conjugates

HighField Biopharmaceuticals, a clinical stage immuno-oncology company using lipid-based therapeutics to treat cancer, announced today the dosing of its first patient in its Phase 1 clinical trial of HFK1, a drug encapsulated immunoliposome containing doxorubicin for treatment of solid tumors.

The multi-regional, open-label, clinical trial is enrolling patients who have advanced refractory solid tumors with HER2 low and HER2+ expression. HER2 expressing solid tumors include breast, bladder, pancreatic, ovarian, stomach, colon, prostate, lung, uterus and cervix cancers.

This trial is being conducted in the U.S., China and other countries. The first patient was dosed at Mary Crowley Cancer Research in Dallas, TX. A Phase 1a dose escalation portion of the study will enroll 24 patients followed by Phase 1b dose expansion trial with up to 60 patients. Both the Phase 1a and 1b studies will assess the safety and preliminary efficacy of HFK1. Preliminary results are expected in the fourth quarter.

“Our immunoliposomes may offer effective alternatives to most current HER2 drugs that cannot target low HER2 tumors,” said HighField CEO Yuhong Xu. “HFK1 is designed to bind and deliver the chemotherapeutic doxorubicin to tumor cells at even very low HER2 expression levels.”

Minal Barve, MD, is the Chief Medical Officer/Executive Medical Director and the principal investigator at Mary Crowley Cancer Research, a specialized clinical research center that offers access to new investigational therapies. “It is important to treat the full range of HER2 cancer expression levels. It opens the possibility of reaching more cancer cells within the patient, not just those with high HER2 expression levels. I hope that HFK1 will provide a treatment option for a broad range of tumor types that have HER2 expression, not just the strongly HER2 positive tumors,” Dr. Barve said.

“At Mary Crowley Cancer Research, we are focused on rapidly advancing the discovery of potential new therapies that can positively impact the care of cancer patients in their lifetime,” Dr. Barve added. “We are grateful for our partnership with HighField to provide even more patients with hope.”

HighField’s immunoliposomes represent a new generation of targeted chemotherapy drugs following the success of antibody drug conjugates (ADCs). Due to their unique features, HighField’s immunoliposomes may offer better safety with greater efficacy in treatment of a broad range of solid tumor types.

“A key differentiating factor of our immunoliposomes,” observed HighField CBO Donald Wyatt, “is they not only are suitable for less toxic payloads than ADCs, but also are designed to have larger drug to antibody ratios that result in wider therapeutic windows, targeting more cancer cells with lower toxicity.”

In the Phase 1a dose escalation portion of the clinical trial, patients will be enrolled into one of six dose groups to determine the highest tolerated dose. The Phase 1b study will assess HF158K1 in two types of solid tumors, and patients will be enrolled in one of two dose groups based on the Phase 1a findings. For more information visit NCT05861895 on clinicaltrials.gov.

About HighField Biopharmaceuticals

HighField is a clinical stage immuno-oncology company focused on novel applications of liposome constructs to disrupt existing immuno-oncology technologies. The company also has a research and development center and a GMP-compliant production facility. HighField’s lead clinical development program is HF1K16, a drug encapsulated immune modulating liposome containing all-trans retinoic acid targeting myeloid-derived suppressor cells for treatment of solid tumors. The company’s pipeline also includes drug encapsulated immunoliposomes for solid tumor cancers. For more information visit https://highfield.bio.

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