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 LipoADCplexTM 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.
