HLB Therapeutics Begins Phase 1 Dosing of Oral Glioblastoma Treatment

HLB Therapeutics announced on the 21st that the first patient dosing for the Phase 1 clinical trial to develop the oral formulation of 'OKN-007,' a glioblastoma (GBM) treatment developed by its U.S. subsidiary Oblato, has begun.

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

HLB Therapeutics explained that dosing of subjects in the Phase 1 clinical trial of the oral OKN-007 formulation started on the 17th (local time). This trial is being conducted separately from the ongoing clinical trial of the injectable formulation.

The oral formulation improves patient convenience and is advantageous for maintaining continuous drug efficacy. Additionally, it offers high flexibility in new drug development, such as being favorable for combination therapy with other drugs when expanding indications to other cancer types in the future. HLB Therapeutics is conducting dose escalation and pharmacokinetic analyses through the Phase 1 trial at four hospitals in the United States. Based on these results, the appropriate dosage for the Phase 2 clinical trial of the oral OKN-007 formulation will be determined.

The company also stated that the clinical trial of the injectable form of OKN-007, which started earlier, is progressing smoothly. The Phase 2 clinical trial, conducted as a combination therapy with oral temozolomide (TMZ) for patients with recurrent glioblastoma, completed patient recruitment in October last year and is currently monitoring patients’ cancer progression and survival periods alongside drug administration.

OKN-007 is known to improve the tumor microenvironment by inhibiting the production of key factors that hinder immune checkpoint inhibitor therapy, such as TGF-β, and hypoxia-inducing factor HIF-1α, while normalizing tumor blood vessels to suppress angiogenesis and growth of cancer cells. Furthermore, it has been reported in the Journal of Nuclear Medicine and Molecular Imaging that OKN-007 temporarily opens the blood-brain barrier, improving permeability for other substances and thus significantly enhancing drug delivery.

Gi-Hong Ahn, CEO of HLB Therapeutics, stated, "In the GBM field where unmet medical needs are high, we decided to develop an oral formulation to enhance patient convenience and increase market competitiveness alongside rapid commercialization in the future. Following the recent start of patient dosing for the neurotrophic keratitis (NK) treatment, the GBM clinical trial is also accelerating, and I am confident that our corporate value will be further strengthened this year."