HLB "Immunomic, Brain Tumor Treatment Vaccine Phase 1 Clinical Trial US FDA Pre-IND Meeting"

[Asia Economy Reporter Hyunseok Yoo] HL Biopharma announced on the 5th that Immunomic Therapeutics successfully completed a Pre-IND meeting with the FDA to conduct a Phase 1 clinical trial in the United States for ITI-1001, a treatment vaccine for malignant brain tumor glioblastoma.

ITI-1001 is a DNA therapeutic vaccine developed for the treatment of glioblastoma based on Immunomic's UNITE platform technology. It is an anticancer immunotherapy targeting glioblastoma antigens p65, IE-1, and CMV antigen.

William Hull, CEO of Immunomic, said, "We have successfully completed the Pre-IND meeting with the FDA regarding ITI-1001," adding, "We will proceed with the clinical program according to the FDA's guidance to provide treatable options for brain tumor patients."

Immunomic is a U.S.-based company developing immunotherapies using the UNITE platform technology. An HL Biopharma official stated, "We are conducting a Phase 2 clinical trial of ITI-1000, an immunocellular therapy for glioblastoma, and the current clinical progress rate exceeds 80%," adding, "After completing Phase 2, we aim to obtain conditional marketing approval through breakthrough therapy designation."

Glioblastoma has approximately 26,000 to 27,000 new patients annually in the U.S. and Europe. Although Temozolomide, a cytotoxic chemotherapy drug approved in 2005, is used as the first-line treatment, the 5-year survival rate is only below 5%, indicating a high demand for new drugs, according to the company.

Meanwhile, HL Biopharma announced on the 19th that it invested $40 million in Immunomic and, following negotiations to increase its stake, ultimately plans to acquire up to 51% ownership.

This content was produced with the assistance of AI translation services.