On June 13, 2023 HighField Biopharmaceuticals (HighField Bio), a clinical stage immuno-oncology company using immunoliposomes to treat cancer, reported that the U.S. Food and Drug Administration has granted clearance of the company’s Investigational New Drug (IND) application for HF158K1, a drug encapsulated immunoliposome containing doxorubicin (Press release, HighField Biopharmaceuticals, JUN 13, 2023, View Source [SID1234632682]).
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"It is recognition our immunoliposomes may offer effective alternatives to most current HER2 drugs that cannot target low HER2 tumors. HF158K1 is designed to bind and deliver the chemotherapeutic doxorubicin to tumor cells at even very low HER2 expression levels."
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The company will conduct a Phase 1 multi-regional, open-label, clinical trial in 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.
The trial, expected to begin this summer, will be conducted in the U.S., China and other countries. 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 HF158K1.
"The FDA’s clearance of this IND is another milestone for our company," said HighField Bio CEO Yuhong Xu. "It is recognition our immunoliposomes may offer effective alternatives to most current HER2 drugs that cannot target low HER2 tumors. HF158K1 is designed to bind and deliver the chemotherapeutic doxorubicin to tumor cells at even very low HER2 expression levels."
In addition, Dr. Xu said, "We believe our immunoliposomes represent a new generation of targeted chemotherapy drugs following the success of antibody drug conjugates (ADCs). Due to their unique features, our immunoliposomes may offer better safety with greater efficacy in treatment of a broad range of solid tumor types."
Unlike ADCs, HighField Bio’s immunoliposome can deliver larger doses of active drug and target tumor cells using multiple antibodies. This means they not only are suitable for less toxic API than ADCs, but may also deliver greater efficacy because they have larger drug to antibody ratios that result in wider therapeutic windows, targeting more cancer cells with less dose-limiting toxicities.
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.