HLB announced on the 25th that its U.S. subsidiary Immunomic Therapeutics has begun patient dosing for the Phase 1 clinical trial of its self-developed therapeutic vaccine 'ITI-1001' targeting newly diagnosed glioblastoma patients.
ITI-1001 is a plasmid DNA (pDNA) vaccine developed for glioblastoma treatment based on Immunomic's UNITE platform technology. It targets the PP65 protein of cytomegalovirus (CMV), a major cause of glioblastoma, activating dendritic cells, one of the key immune cells, to induce an immune response.
The ongoing clinical trial at the Dana-Farber Cancer Institute in Boston, Massachusetts, aims to determine the optimal dose (8 mg) of ITI-1001, as well as to evaluate the drug's safety and immunogenicity.
Glioblastoma is a representative malignant rare disease with an average 5-year survival rate of less than 7%. It is known that approximately 12,000 new patients are diagnosed annually in the United States alone. Since the U.S. Food and Drug Administration (FDA) approved Temodal and Avastin as treatments, no new drugs have been developed for nearly 14 years, making it a typical intractable disease.
Terry Hyland, Chief Scientific Officer of Immunomic, said, "The dosing of the first patient has proceeded smoothly, marking a new milestone in our drug development journey dedicated to glioblastoma treatment. We will do our best to provide effective and safe therapies to patients in the glioblastoma field, where treatment alternatives are extremely limited, through this clinical trial."
Donggeon Kim, Head of HLB USA, also stated, "While Immunomic's other cellular vaccine, ITI-3000, is entering the final stages of Phase 1 for Merkel cell carcinoma, a malignant skin cancer, the Phase 1 dosing for newly diagnosed glioblastoma has also begun, increasing the technological value of the UNITE platform. As HLB's U.S. subsidiaries continue to achieve steady results in various indications such as liver cancer, glioblastoma, and hematologic cancers, HLB's corporate value will continue to grow in the long term."
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