HLB Therapeutics to Announce Interim Results of Phase 2 Glioblastoma Treatment Next Month

Malignant Brain Tumors with Only a 3% 5-Year Survival Rate
Achieving the Goal of 60% 6-Month Survival Rate Is Crucial

HLB Therapeutics will hold a shareholder meeting on the 6th of next month to announce the clinical progress and interim survival analysis results of ‘OKN-007,’ a glioblastoma (GBM) treatment being developed by its US subsidiary Oblato.

Oblato is conducting a Phase 2 clinical trial of a combination therapy of OKN-007 and the standard treatment temozolomide in patients with recurrent glioblastoma. The primary endpoints are the 6-month survival rate, with the company aiming to achieve 60%. Patient enrollment was completed last October with 56 patients, making it possible to derive the primary endpoints.

Glioblastoma, a malignant brain tumor, is one of the rare diseases with a low 5-year survival rate. Approximately 12,000 new patients are diagnosed annually in the United States alone. It is a representative intractable disease for which no new drugs have been developed for nearly 14 years since the initial approval of Temodal and Avastin.

OKN-007 is a synthetic drug that improves the tumor microenvironment, a major obstacle in cancer treatment, thereby enhancing therapeutic effects. It inhibits the production of key factors such as TGF-β, which reduces the efficacy of immuno-oncology drugs, and HIF-1α, which induces hypoxia, while normalizing tumor blood vessels to suppress angiogenesis and growth of cancer cells. Recent studies have also confirmed that it temporarily opens the blood-brain barrier (BBB), raising expectations for future combination clinical trials with other anticancer agents.

Gi-Hong Ahn, CEO of HLB Therapeutics, stated, "We are comparing and analyzing the Phase 2 clinical trial results against data collected from hundreds of patients who participated in various GBM clinical trials conducted over the past 10 years as a control group." He added, "The schedule was delayed by about a week due to additional analysis by external specialized institutions to ensure data objectivity. Through the shareholder meeting, we will be able to inform shareholders of the excellence of OKN-007 along with detailed clinical and management status."

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