HLB Therapeutics Confirms Complete Remission in Phase 2 Clinical Trial of Glioblastoma Treatment

HLB Therapeutics announced on the 1st that a complete response (CR) case was confirmed in the Phase 2 clinical trial of the glioblastoma (GBM) treatment 'OKN-007' being developed by its U.S. subsidiary Oblato.

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

Glioblastoma is classified as Grade IV, the most malignant grade by the World Health Organization (WHO), and is considered one of the most aggressive brain tumors. The average 5-year survival rate is less than 7%. Despite approximately 12,000 new patients diagnosed annually in the U.S., no new drugs have been developed for nearly 14 years since the U.S. Food and Drug Administration (FDA) approved Temodal (active ingredient temozolomide) and Avastin (bevacizumab) as treatments, making it a difficult-to-treat disease.

HLB Therapeutics is currently conducting a Phase 2 clinical trial involving 56 patients with recurrent glioblastoma, testing a combination therapy of the standard treatment temozolomide and OKN-007. It was explained that the observation of a 'complete response,' where cancer lesions completely disappeared in recurrent patients, significantly increases the potential for development as a treatment.

OKN-007 works by inhibiting the production of transforming growth factor (TGF)-beta (β) and hypoxia-inducible factor (HIF)-1 alpha (1α), which reduce the therapeutic effect of immuno-oncology drugs, and improves the tumor microenvironment, resulting in high anticancer efficacy in combination therapy.

According to the interim analysis results of the Phase 2 trial disclosed at the shareholders' meeting on the 6th, the primary endpoint?the proportion of patients surviving at 6 months?reached 75.8%, exceeding the target benchmark of 60%. The company added that the 1-year survival rate analyzed so far reached 34%.

Furthermore, the current median overall survival (mOS) is 9.3 months, confirming an improvement of more than 25% compared to past clinical results using temozolomide and integrated analyses of chemotherapy clinical trials for glioblastoma reported in recent literature.

Kang Shin-wook, Vice President of Clinical Division at HLB Therapeutics, said, “The patient who showed complete response was first administered the drug in June last year at St. John's Cancer Hospital in the U.S. From 4 months after administration, the tumor size decreased to less than half compared to the baseline, and after 11 months, no tumor was observed on magnetic resonance imaging (MRI). Following the excellent therapeutic effects confirmed in the previous interim analysis, the observation of complete response this time has strengthened our confidence in the development potential of OKN-007 as a treatment for glioblastoma.”