ATRA liposome

HANGZHOU, China--( BUSINESS WIRE )-- HighField Biopharmaceuticals , a clinical stage company using lipid-based therapeutics to treat cancer, diabetes and other diseases, announced today its CEO and Scientific Founder Yuhong Xu, Ph.D, presented positive safety and efficacy findings from an ongoing Phase 1 clinical trial of HF1K16 (K16) in refractory metastatic cancer patients at the European Society of Medical Oncology (ESMO) Congress in Barcelona, Spain, September 13 – 17, 2024. K16 is an ATRA-encapsulated immune modulating liposome combining a lipid bilayer structure and all-trans retinoic acid (ATRA). It targets immature immune cells, called myeloid-derived suppressor cells (MDSCs), inducing them to become mature active immune cells, such as dendritic cells, which summon T cells to attack cancer. Presentation of the poster titled, “ A Phase 1 study of the Myeloid-derived suppressor cells modulator HF1K16 in refractory and metastatic cancer patients: preliminary efficacy and safety ,” was on Saturday, September 14 in the Investigational Immunotherapy session. “We are excited about the preliminary safety and efficacy data from our ongoing Phase 1 study,” said Dr. Xu. “ATRA is a highly active vitamin A metabolite commonly found in the body. Using Highfield’s liposome technology, we were able to inject a highly concentrated ATRA offering more than 10 times higher than normal exposure in a patient, triggering the therapeutic mechanism. These patients have very advanced, heavily prior treated tumors.” The Phase 1 dose escalation study ( NCT05388487 ) showed significant signals of desirable immune modulation and efficacy. The expansion cohort, currently recruiting, is focused on R/R glioma. As of Sept 1, 2024, 19 patients having Grade II, III and IV tumors have been enrolled. Among the 10 patients with Grade II and III gliomas, median overall survival (mOS) is 629 days. For the 9 patients with Grade IV or glioblastoma, the most aggressive brain tumors, mOS is 315 days. The next step will be to determine the indication that is most beneficial either as a single agent or in combination with other standard of care regimen in a Phase 2 study. About HighField Biopharmaceuticals Highfield is a clinical stage company focused on novel applications of liposome constructs directed to immuno-oncology and gene therapy for other diseases. The company also has a research and development center and a GMP-compliant production facility. HighField’s lead clinical development program is HFK16, a drug encapsulated immune modulating liposome. The company’s pipeline also includes an LipoADCplex TM platform comprised of drug encapsulated immunoliposomes for solid tumors as well as LNP therapeutics for gene delivery and gene therapy. For more information visit https://highfieldbio .

HFK1 is the company’s groundbreaking drug encapsulated immunoliposome for solid tumors with HER2 low expression HANGZHOU, China--(BUSINESS WIRE)-- HighField Biopharmaceuticals, a clinical stage company using lipid-based therapeutics to treat cancer, diabetes and other diseases, will present positive clinical and preclinical data of HFK1, a drug encapsulated immunoliposome for treatment of solid tumors, at the American Society of Clinical Oncology annual meeting May 31 – June 4, in Chicago, IL. The poster presentation describes preliminary findings from the company’s Phase 1a study of HFK1 for HER2 low expression cancers. The first patient dosed suffers from lung metastasis of a rare HER2 low cancer. The patient has been treated with HFK1 for more than five months with no dose-limiting toxicity and stable disease. The clinical and preclinical data, which will be presented by HighField CEO and Scientific Founder Yuhong Xu, Ph.D., also includes study results comparing HFK1 to other antibody drug conjugates (ADCs) and PEGylated liposomal doxorubicin (PLD). The findings demonstrate HFK1 improves significantly on the safety and efficacy of ADCs and PLD. In particular, HFK1 exceeded ADCs in expanding the drug therapeutic window and reducing tumor growth. “We look forward to sharing the encouraging data of our HFK1 studies at ASCO,” said Dr. Xu. “They confirm our confidence that our unique drug encapsulated immunoliposomes will offer a new alternative for targeting HER2 low cancers with lower off-target toxicities and wider therapeutic windows.” The poster, titled “The design, preclinical study and Phase 1 dose escalation of a HER2 targeted immunoliposome (HF-K1) for HER2 low solid tumor treatment,” will be presented Saturday, June 1, 2024 (9am -12pm CDT). HighField’s Phase 1 open-label clinical trial is enrolling patients who have advanced refractory solid tumors with HER2 low expression. The Phase 1a dose escalation portion will be followed by a Phase 1b dose expansion phase. Both the Phase 1a and 1b studies will assess the safety and preliminary efficacy of HFK1. For more information visit NCT05861895 on clinicaltrials.gov. 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. About HighField Biopharmaceuticals HighField is a clinical stage company focused on novel applications of liposome constructs to disrupt existing immuno-oncology and other disease 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 and lipid therapeutics for gene delivery and gene therapy. 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: