HLB Therapeutics Reveals Interim Analysis Results of Phase 2 Brain Cancer Clinical Trial at Shareholders Meeting

HLB Therapeutics announced on the 30th that it will hold a shareholder meeting on the 6th of next month to present the progress of the Phase 2 clinical trial and interim survival analysis results of ‘OKN-007,’ a treatment for glioblastoma (GBM), a type of brain cancer, being developed by its U.S. subsidiary Oblato.

HLB Therapeutics logo
Photo by HLB Therapeutics

The shareholder meeting is scheduled to take place on the afternoon of the 6th of next month at the Hanul Auditorium on the 1st floor of Korea Job World in Bundang, Seongnam-si, Gyeonggi Province.

Oblato has been conducting a Phase 2 clinical trial of a combination therapy of OKN-007 and the standard treatment drug temozolomide in patients with recurrent glioblastoma. The primary efficacy endpoint is set as the survival rate of patients surviving at 6 months, with the company’s target set at 60%. Patient enrollment of 56 was completed in October last year.

Glioblastoma, a malignant brain tumor, is a rare disease with a very low 5-year survival rate. Approximately 12,000 new patients are diagnosed annually in the United States alone. Despite this, it is considered a representative intractable disease where drug development is extremely difficult, as 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 efficacy. It inhibits the production of key factors that reduce the effectiveness of immuno-oncology drugs, such as transforming growth factor (TGF)-β and hypoxia-inducible factor (HIF)-1α, while normalizing tumor blood vessels to suppress angiogenesis and growth of cancer cells. Additionally, recent studies have confirmed that it temporarily opens the blood-brain barrier (BBB), raising expectations for future combination clinical trials with other anticancer agents.

Furthermore, a researcher-initiated clinical trial combining OKN-007, temozolomide, and radiation therapy in newly diagnosed glioblastoma patients is underway at the Stephenson Cancer Center at the University of Oklahoma, with patient enrollment completed in May.

Ahn Ki-hong, CEO of HLB Therapeutics
[Photo by HLB Therapeutics]

Gi-Hong Ahn, CEO of HLB Therapeutics, explained, “We are currently comparing and analyzing the results of our Phase 2 clinical trial with data collected from hundreds of patients who participated in various glioblastoma clinical trials conducted over the past decade as a control group. As the analysis progresses, we believe we have secured meaningful interim results for OKN-007.” He added, “To ensure the objectivity of the data, additional analysis by an external professional institution has been conducted, causing a delay of about one week from the original schedule. Through this shareholder meeting, we will be able to report on the excellence of OKN-007, the clinical progress and future strategy of the separately ongoing ophthalmic disease treatment (RGN-259), and the company’s vision related to the cold chain business, along with detailed clinical and management updates.”

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