HLB Therapeutics Announces Interim Results of Phase 2 Glioblastoma Trial: "Improved Survival Rate"

6-Month Survival Rate 75.8%
Exceeds Efficacy Evaluation Criterion of 60%

HLB Therapeutics Research and Development Image [Photo by HLB Therapeutics]

HLB Therapeutics' clinical phase 2 interim results for its glioblastoma (GBM) treatment showed improved patient survival rates.

HLB Therapeutics announced this at a shareholder meeting held on the 6th, revealing the clinical progress and interim analysis results of 'OKN-007,' a glioblastoma treatment developed by its U.S. subsidiary Oblato.

The phase 2 clinical trial involved 56 patients with recurrent glioblastoma and was conducted using a combination therapy of the standard treatment drug temozolomide (brand name Temodal) and OKN-007.

The interim analysis showed that the primary endpoint, the 6-month survival rate, reached 75.8%, exceeding the target benchmark of 60%. The company added that the 1-year survival rate analyzed so far was 34%. Furthermore, the current median overall survival (mOS) is 9.3 months, confirming an improvement of over 25% compared to past clinical results using temozolomide and integrated analyses of recent chemotherapy clinical trials for glioblastoma reported in the literature.

Glioblastoma, a malignant brain tumor, is a rare disease with a 5-year survival rate below 7%. There are approximately 20,000 patients in the U.S. alone, with about 12,000 new cases annually. Since the U.S. Food and Drug Administration (FDA) approved Temodal and Avastin as treatments for glioblastoma, no new drugs have been developed for nearly 14 years. According to the company, OKN-007 enhances treatment efficacy by inhibiting the production of TGF-β and HIF-1α, which reduce the effectiveness of immuno-oncology drugs and induce hypoxia, respectively, and by improving the tumor microenvironment.

At the shareholder meeting, interim analysis results from a researcher-initiated clinical trial on new brain glioma patients at the Stephenson Cancer Center of the University of Oklahoma were also disclosed. When OKN-007 was administered in combination with the standard treatment of radiation therapy plus temozolomide, the current mOS was 25.5 months, showing superior results compared to other treatments’ previous clinical outcomes of 14 to 20 months, HLB Therapeutics explained. The company is currently tracking survival periods for 12 out of the 27 enrolled patients.

HLB Therapeutics CEO Ki-Hong Ahn stated, "Using a European clinical statistical analysis firm, we statistically analyzed the differences in survival periods between our phase 2 interim clinical data and control groups from various GBM clinical trials conducted over the past 10 years, confirming clear clinical significance and excellent therapeutic effects." He added, "We will explore various strategic options such as technology licensing, partnerships with global partners, and expansion of combination clinical trials to enhance the value of OKN-007, while successfully completing the remaining clinical process to become a 'game changer' in the field of GBM, a representative intractable disease."