Oblato Announces the First Enrollment in a Phase 1 Clinical Trial for an Oral Formulation of OKN-007 in Recurrent High-Grade Glioma Patients in the USA

PRINCETON, N.J., April 21, 2023 /PRNewswire/ -- Oblato, Inc. (the Company), a subsidiary company of HLB Therapeutics in Korea, has announced today the first enrollment for recurrent high-grade glioma patients in a Phase 1 clinical trial in the USA with an oral formulation of its proprietary compound OKN-007.  This is the first step using oral OKN-007 in glioblastoma clinical trials. Along with the ongoing clinical development of an injectable formulation, this Phase 1 trial is expected to broaden the possibility of a new drug approval for the treatment of glioblastoma, a rare and deadly disease.

The Company has been developing oral formulation of OKN-007 which have many advantages, including greater convenience for the patients, continuous exposure of drugs to the body, and flexibility in development when expanding indications to other cancer types.  A total of four hospitals, including Providence Saint John's Cancer Institute and Norton Healthcare, are participating in the clinical trial.  A dose escalation and pharmacokinetic analysis will be investigated in the trial. The Company will determine the dose of OKN-007 oral formulation to be used in future clinical development by integrating the safety and preliminary efficacy results from this study.

In addition, the Company is also conducting a Phase 2 clinical trial with recurrent glioblastoma multiforme (GBM) patients using a combination therapy of OKN-007 injectable formulation and temozolomide at thirteen institutions, including Henry Ford Health System. Patient enrollment was completed in October, 2022 and some patients are still being treated and follow-up for survival status is continuing.

Regarding the development of OKN-007 as a new anti-cancer drug, Ki Hong Ahn, CEO of the Company, stated, "We have decided to develop an oral formulation in consideration of convenience for the patient, which is an important aspect for future commercialization, and plan to have a strategy to increase the value of the new drug in the market with great unmet needs through diversification of treatment options.  Through discussions with the FDA, we have already incorporated their suggestions on the clinical study protocol.  Along with investigating the efficacy in existing clinical studies with the OKN injectable formulation, our plan for this Phase 1 clinical trial is to determine the safety of an oral dosage form of OKN-007 and define a dose for further clinical trials, thus allowing multiple options for future development".

About Oblato, Inc.

Oblato, Inc. (Oblato or the Company), a wholly-owned subsidiary of the Korean biotech company, HLB Therapeutics, is incorporated in Delaware, and has its principal place of business in New Jersey.  Since 2016, the Company has been developing a new drug, OKN-007, to treat brain cancers, especially glioblastoma multiforme (GBM) as a rare disease and diffuse intrinsic pontine glioma (DIPG) as a rare pediatric disease.  Currently, clinical trials are ongoing to investigate the safety and efficacy of a combination therapy with both OKN-007 and temozolomide for patients with newly diagnosed and recurrent GBM, respectively.  The Company has just started the enrollment of patients with recurrent high-grade glioma in a Phase 1 clinical study with an OKN-007 oral formulation.  Oblato has received both rare pediatric disease and fast track designations for DIPG. For additional information about Oblato, please visit www.oblatoinc.com.

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