ATRA liposome

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:

Filing of a U.S. IND for HFG1 is scheduled for Q3/2024 HANGZHOU, China--(BUSINESS WIRE)-- HighField Biopharmaceuticals, a clinical stage company using lipid-based therapeutics to treat cancer, diabetes and other diseases, announced today that its abstract of preclinical data evaluating an mRNA-based GLP-1R agonist (HFG1) in diabetic monkeys has been accepted for a poster presentation at the American Diabetes Association (ADA) 84th Scientific Sessions June 21-24, 2024, in Orlando, FL. The abstract also will be published on the website of the ADA’s journal Diabetes. “We are very excited to introduce our unique lipid nanoparticle (LNP)-mRNA complex, HFG1, to the thousands of clinicians and researchers attending this year’s Scientific Sessions from around the world,” said HighField CEO and Scientific Founder Yuhong Xu, Ph.D. “The components of HFG1’s LNP complex were designed to provide consistent expression of a GLP-1R agonist for diabetes and weight loss. We believe HFG1 will require far fewer injections than existing GLP-1 products while providing steady-state agonist activity.” Abstract Title: Preliminary Study of Efficacy and Duration of an mRNA-Based GLP-1R Agonist in Diabetic Monkeys. (Poster presentation number 1860-LB in category 12-B Clinical Therapeutics-Incretin-Based Therapies). Presenter: Dr. Yuhong Xu, HighField CEO Presentation: Saturday, June 22, 2024, 12:30 pm – 1:30 pm EDT (The poster will be displayed Saturday, Sunday and Monday in the Poster Hall; and at a Networking Reception Friday evening.) 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: