GTreeBNT Progressing Two Clinical Trials for Glioblastoma Patients

[Asia Economy Reporter Jang Hyowon] GTreeBNT announced on the 1st that the clinical trials for OKN-007, a glioblastoma (GBM) treatment under development, targeting both newly diagnosed and recurrent patients, are progressing smoothly.

GTreeBNT is currently conducting two clinical trials targeting newly diagnosed glioblastoma patients and recurrent glioblastoma patients. Both trials are open studies, allowing observation of efficacy during the clinical progress.

The clinical trial for newly diagnosed glioblastoma patients is an investigator-initiated trial conducted at the Stephenson Cancer Center of the University of Oklahoma in the United States, where OKN-007 is administered in combination with the standard treatments of radiation therapy and Temozolomide.

The dose-escalation phase to determine a safe dosage has been completed, and the expansion cohort phase to assess preliminary efficacy at the determined dose is underway. So far, 17 patients have been enrolled and administered the treatment.

Results from patients enrolled in the early dose-escalation phase show median progression-free survival and overall survival (approximately 7 months and 15 months, respectively) exceeding those of the existing standard treatments, with particularly positive outcomes where over 80% of patients survive more than two years.

Currently, GTreeBNT is monitoring cancer progression status and survival periods in the subsequently enrolled patients, and plans to present the interim results of this investigator-initiated trial at the SNO conference in November 2021.

The clinical trial for recurrent glioblastoma patients, developed through GTreeBNT’s U.S. subsidiary Oblato, is a Phase 2 trial combining OKN-007 and Temozolomide. It is being conducted at eight clinical institutions including Henry Ford Hospital in Michigan, U.S., with 15 patients enrolled and receiving treatment so far.

GTreeBNT stated, “The current clinical situation, consistent with the results of the previous Phase 1 trial, has not identified any safety issues in patients treated so far. We are closely monitoring efficacy indicators such as progression-free survival and overall survival, which are key evaluation metrics in anticancer drug development.” They added, “To accelerate the clinical progress, we plan to increase the number of clinical sites to 12 within this year and are currently in contact with candidate institutions.”

Additionally, GTreeBNT has been developing an oral formulation aimed at improving patient convenience and ensuring sustained drug exposure in the body, while securing development flexibility for expanding indications to other cancer types. The formulation development at the research stage has recently been completed, and pilot-scale production of the clinical product is planned to be completed in the third or fourth quarter.

If this pilot production is successful, the company plans to revise the FDA-approved oral clinical trial protocol to match the improved formulation, discuss it with the FDA, and enter oral clinical trials for recurrent glioblastoma patients in early 2022.

Regarding this, a company official said, “Discussions with the FDA will focus on the improved convenience of the formulation, so we expect clinical trial entry approval without any significant issues.”

They also added, “Last year, we received Orphan Drug Designation (ODD) for various malignant brain gliomas including diffuse intrinsic pontine glioma (DIPG). Along with the ongoing glioblastoma clinical trials, oral formulation development, and stepwise clinical trials for expanding to other cancer types, the value is expected to increase further.”