HLB Therapeutics Achieves Complete Remission in Recurrent Glioblastoma... Surpasses Target Survival Rate

AACR Presentation of Interim Analysis Results for Phase 2 Glioblastoma
Strategic Choices Including Technology Licensing and Direct Development
Announcement of Corporate Value Maximization Strategy Soon

As the Phase 2 clinical trial for recurrent glioblastoma (GBM) by HLB Therapeutics enters its final stage, the interim analysis results have been disclosed.

HLB Therapeutics' U.S. subsidiary, Oblato, will present the clinical trial results in poster form on the morning of the 9th at the American Association for Cancer Research (AACR 2024) held in San Diego, California.

HLB Therapeutics administered its GBM new drug candidate, ‘OKN-007,’ in combination with the existing chemotherapy agent temozolomide to patients with recurrent glioblastoma. The presented clinical results are based on the analysis conducted at the time of drug administration completion for all enrolled patients.

The Phase 2 trial was conducted on 57 glioblastoma patients at 13 specialized cancer hospitals in the U.S., including the Stephenson Cancer Center at the University of Oklahoma, Wake Forest University Hospital, and Henry Ford Health System.

According to the analysis conducted earlier this year, the 1-year survival rate was 38.9%, and the median overall survival (mOS) was 9.7 months, significantly improving patient survival compared to existing historical data. The 6-month progression-free survival rate also reached 23.6%, showing a groundbreaking effect approximately 1.8 times higher than the integrated analysis result of 13% reported in a recent publication (Linda M Liau et al., 2023) on chemotherapy clinical trials targeting glioblastoma. Safety of the OKN-007 and temozolomide combination therapy was confirmed with no issues up to the point when patient administration was completed.

The 6-month survival rate was 75.9%, greatly exceeding the initial clinical trial target of 60%. Complete remission was achieved in glioblastoma, a malignant brain tumor, and the 12-month survival rate including this was 38.9%, with the 24-month survival rate reaching 15.1%. Local clinicians also evaluated the confirmation of long-term life extension effects in this field, where new treatment options are urgently needed, as "very encouraging results."

Based on the successful results of the Phase 2 trial, HLB Therapeutics is reportedly preparing very detailed strategies and plans to maximize corporate value. While continuing to pursue technology licensing deals with global big pharma, the company is also in discussions with a U.S. nonprofit GBM-specialized clinical execution organization to directly obtain new drug approval.

This clinical institution integrates key stakeholders in the U.S. GBM field, including physicians, clinical researchers, pharmacists, and health authorities, and is developing and operating adaptive platforms and master protocols for glioblastoma patients. As a GBM master clinical sponsor institution, it can efficiently determine whether clinical treatments by developers like Oblato improve overall survival compared to standard therapies.

HLB Therapeutics CEO Ki-Hong Ahn said, "Based on the encouraging results of the Phase 2 trial, the company is proceeding with consideration of the best strategic options to maximize corporate value," adding, "We will do our best to announce the fruits of our deliberations as soon as possible."