ATRA liposome

The company’s groundbreaking drug encapsulated immunoliposomes may represent a significant improvement over existing antibody drug conjugates HANGZHOU, China--(BUSINESS WIRE)-- HighField Biopharmaceuticals (HighField Bio), a clinical stage immuno-oncology company using immunoliposomes to treat cancer, announced today 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. 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. About HighField Biopharmaceuticals HighField Bio 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 Bio’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 . View source version on businesswire.com: Contacts Media Contact: Dan Eramian Opus Biotech Communications danieleramian@comcast.net 425-306-8716 Business Development Contact: Donald Wyatt HighField Biopharmaceuticals dwyatt@hf-biopharm.com 206-356-8196 Source: HighField Biopharmaceuticals View this news release online at:

The abstract of preliminary data from a Phase 1a trial of HF1K16, which targets myeloid-derived suppressor cells (MDSCs), is published online at the 2023 ASCO Annual Meeting in Chicago, IL HANGZHOU, China--(BUSINESS WIRE)-- HighField Biopharmaceuticals (HighField Bio), a clinical stage immuno-oncology company using immunoliposomes to treat cancer, announced today the publication of an abstract including preliminary data from a Phase 1a clinical trial of HF1K16 in refractory metastatic cancer patients. It was published online at the American Society of Clinical Oncology (ASCO) Annual Meeting. HF1K16 is a drug encapsulated immune modulating liposome containing all-trans retinoic acid. The ASCO meeting is June 2 – 6, 2023, at the McCormick Place, Chicago, IL. The HighField Bio abstract is titled “Modulating MDSCs by HF1K16: a monotherapy Phase 1a study examining safety and preliminary efficacy in refractory and metastatic cancer patients.” “We are excited about the preliminary data,” said Yuhong Xu, CEO of HighField Bio. “The data show HF1K16 is well tolerated and patients have experienced significant progression-free survival.” The abstract also reports that of the 11 patients treated, three who suffer from recurrent and refractory glioma continued to experience progression-free survival. One patient has been on treatment for 348 days. The other two are 94 days and 52 days with progression-free survival from the start of treatment. Dr. Xu noted, “Four patients reached stable disease diagnosis based on RECIST 1.1 criteria. One patient experienced a reduction in size of the main brain lesion from 70mm to 23.7mm.” HF1K16 is a unique liposome construct of ATRA, a small molecule metabolite of vitamin A, administered by infusion, and travels through the blood stream and infiltrates the tumor microenvironment. ATRA is released and initiates the maturation of Myeloid-Derived Suppressor Cells (MDSCs). MDSCs are immature myeloid cells which have not differentiated. ATRA promotes the maturation and differentiation of MDSCs into functional cells, such as dendritic cells, which then summon T cells to attack the cancer. The preliminary data reported at ASCO is from an ongoing Phase 1a trial in China with patients suffering from a variety of refractory metastatic cancers. Based on the positive findings related to glioma, HighField Bio expects to begin a Phase 1b/2 trial in China for patients with refractory glioma in the next few weeks. About HighField Biopharmaceuticals HighField Bio is a clinical stage immuno-oncology company focused on novel applications of liposome constructs to disrupt existing immuno-oncology technologies. The company has a research and development center and a GMP-compliant production facility. HighField Bio’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. For more information visit . View source version on businesswire.com: Contacts Media Contact: Dan Eramian Opus Biotech Communications danieleramian@comcast.net 425-306-8716 Business Development Contact: Donald Wyatt HighField Biopharmaceuticals dwyatt@hf-biopharm.com 206-356-8196 Source: HighField Biopharmaceuticals View this news release online at: