disufenton sodium (OKN-007) / HLB Bio Group - LARVOL DELTA

Open-label Study Investigating of OKN-007 Combined With Temozolomide in Patients With Recurrent Glioblastoma (clinicaltrials.gov) - P2 | N=57 | Completed | Sponsor: Oblato, Inc. | Active, not recruiting ➔ Completed

Trial completion • Brain Cancer • Glioblastoma • Glioma • High Grade Glioma • Oncology • Solid Tumor • MGMT

Sulfatase 2 inhibition sensitizes triple-negative breast cancer cells to paclitaxel through augmentation of extracellular ATP. (PubMed, Cancer Biol Ther) - "The highest incidence and cancer-related mortality rate among women worldwide is due to breast cancer. The co-treatment of chemotherapy and OKN-007 also attenuated cancer-initiating cells. This data implies that the combination of SULF2 inhibitors with chemotherapy augments eATP and decreases cell viability of TNBC greater than chemotherapy alone."

Journal • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • SULF1 • SULF2

Oklahoma nitrone-007 is an effective anticancer therapeutic agent targeting inflammatory and immune metabolism pathways in endometrial cancer. (PubMed, J Pharmacol Exp Ther) - "Our goal was to evaluate the preclinical efficacy and mechanism of action of the anticancer drug Oklahoma Nitrone-007 (OKN-007) alone and in combination with carboplatin and paclitaxel in endometrial cancer. SIGNIFICANCE STATEMENT: Women with advanced and recurrent endometrial cancer have limited therapeutic options. Oklahoma Nitrone-007 (OKN-007), which has minimal toxicity and is currently being evaluated in early-phase clinical trials for the treatment of cancer, is a potential new strategy for the treatment of endometrial cancer."

IO biomarker • Journal • Endometrial Cancer • Oncology • Solid Tumor • IDO1 • IFNG • mTOR • SULF2 • TGFB1

The nitrone compound OKN-007 delays motor neuron loss and disease progression in the G93A mouse model of amyotrophic lateral sclerosis. (PubMed, Front Neurosci) - "Further, we found no improvement in muscle atrophy or weakness phenotypes in OKN-007 treated G93A mice, and no effect on mitochondrial function or lifespan. Overall, our findings suggest that OKN-007 holds potential as a disease-modifying treatment for ALS, although further research is needed to optimize dosing regimens and understand its long-term effects."

Journal • Preclinical • Amyotrophic Lateral Sclerosis • CNS Disorders • Inflammation • IL1B • IL1R1

Study of Safety and Pharmacokinetic Properties of Oral OKN-007 in Patients with Recurrent High-Grade Glioma (clinicaltrials.gov) - P1 | N=16 | Active, not recruiting | Sponsor: Oblato, Inc. | Trial primary completion date: Dec 2024 ➔ May 2025

Trial primary completion date • Anaplastic Oligoastrocytoma • Astrocytoma • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Malignant Glioma • Oligodendroglioma • Oncology • Solid Tumor

Open-label Study Investigating of OKN-007 Combined With Temozolomide in Patients With Recurrent Glioblastoma (clinicaltrials.gov) - P2 | N=57 | Active, not recruiting | Sponsor: Oblato, Inc. | Trial completion date: Jan 2025 ➔ May 2025

Trial completion date • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Malignant Glioma • Oncology • Solid Tumor • MGMT

Study of Safety and Pharmacokinetic Properties of Oral OKN-007 in Patients with Recurrent High-Grade Glioma (clinicaltrials.gov) - P1 | N=16 | Active, not recruiting | Sponsor: Oblato, Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Aug 2024 ➔ Jun 2025 | Trial primary completion date: May 2024 ➔ Dec 2024

Enrollment closed • Trial completion date • Trial primary completion date • Anaplastic Oligoastrocytoma • Astrocytoma • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oligodendroglioma • Oncology • Solid Tumor

OKN-007 is an Effective Anticancer Therapeutic Agent Targeting Inflammatory and Immune Metabolism Pathways in Endometrial Cancer. (PubMed, J Pharmacol Exp Ther) - "Our goal was to evaluate the pre-clinical efficacy and mechanism of action of Oklahoma Nitrone 007 (OKN-007) alone and in combination with carboplatin and paclitaxel in endometrial cancer. Significance Statement Women with advanced and recurrent endometrial cancer have limited therapeutic options. OKN-007, which has minimal toxicity and is currently being evaluated in early-phase clinical trials for the treatment of cancer, is a potential new strategy for the treatment of endometrial cancer."

IO biomarker • Journal • Endometrial Cancer • Oncology • Solid Tumor • IDO1 • SULF2 • TGFB1

OU-SCC-Oblato-001: OKN-007 in Combination With Adjuvant Temozolomide Chemoradiotherapy for Newly Diagnosed Glioblastoma (clinicaltrials.gov) - P1 | N=27 | Active, not recruiting | Sponsor: University of Oklahoma | Trial completion date: Nov 2025 ➔ Nov 2026 | Trial primary completion date: Apr 2024 ➔ Apr 2025

Combination therapy • Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Phase 2 clinical trial of OKN-007 in recurrent malignant glioma (AACR 2024) - P2 | "OKN-007 plus Temozolomide (TMZ) increased survival in glioma-bearing mice compared to TMZ alone...Any second-line therapy was acceptable, excluding bevacizumab... Our data indicate that the combination therapy of OKN-007 and TMZ appears safe and, compared to standard lomustine therapy, may prolong OS in rGBM."

Clinical • P2 data • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

Open-label Study Investigating of OKN-007 Combined With Temozolomide in Patients With Recurrent Glioblastoma (clinicaltrials.gov) - P2 | N=57 | Active, not recruiting | Sponsor: Oblato, Inc. | Trial completion date: Mar 2024 ➔ Jan 2025 | Trial primary completion date: Jul 2023 ➔ Jun 2024

Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor • MGMT

Neuroprotective treatment with the nitrone compound OKN-007 mitigates age-related muscle weakness in aging mice. (PubMed, Geroscience) - "Mitochondrial function was improved by OKN-007 treatment, consistent with its potential antioxidative properties. Together, these exciting findings are the first to demonstrate that interventions through neuroprotection can be an effective therapy to counter aging-related muscle dysfunction."

Journal • Preclinical • Metabolic Disorders • Sarcopenia

Study of Safety and Pharmacokinetic Properties of Oral OKN-007 in Patients With Recurrent High-Grade Glioma (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Oblato, Inc. | Phase classification: P1b ➔ P1

Phase classification • Anaplastic Oligoastrocytoma • Astrocytoma • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oligodendroglioma • Oncology • Solid Tumor

OKN-007 in Combination With Adjuvant Temozolomide Chemoradiotherapy for Newly Diagnosed Glioblastoma (clinicaltrials.gov) - P1 | N=27 | Active, not recruiting | Sponsor: University of Oklahoma | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2025 ➔ Nov 2025 | Trial primary completion date: Dec 2023 ➔ Apr 2024

Combination therapy • Enrollment closed • Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

OKN-007 in Combination With Adjuvant Temozolomide Chemoradiotherapy for Newly Diagnosed Glioblastoma (clinicaltrials.gov) - P1 | N=6 | Recruiting | Sponsor: University of Oklahoma | Trial primary completion date: Jun 2023 ➔ Dec 2023

Combination therapy • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Study of Safety and Pharmacokinetic Properties of Oral OKN-007 in Patients With Recurrent High-Grade Glioma (clinicaltrials.gov) - P1b | N=16 | Recruiting | Sponsor: Oblato, Inc. | Initiation date: Dec 2022 ➔ Apr 2023

Trial initiation date • Anaplastic Oligoastrocytoma • Astrocytoma • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oligodendroglioma • Oncology • Solid Tumor

The inhibition of sulfation of heparan sulfate augments the chemotherapeutic response in triple-negative breast cancer (AACR 2023) - "TNBC cell lines MDA-MB 231, Hs 578t, and MDA-MB 468 and non-tumorigenic immortal mammary epithelial MCF-10A cells were treated with increasing concentrations of the chemotherapeutic agent paclitaxel in the presence of heparan sulfate and/or OKN-007, and eATP content and cell viability were evaluated. Our results showed that inhibiting the 6-O desulfation of heparan sulfate increases eATP accumulation, thereby, enhancing TNBC cell lines’ response to chemotherapy. These findings may lead to therapies for TNBC based on sulfatase 2 inhibition that results in more effective responses with fewer side effects."

Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • SULF2

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 (PRNewswire) - "Oblato...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....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."

Enrollment status • Brain Cancer • CNS Tumor • Glioma • Oncology • Solid Tumor

Clinical Trial of IV OKN-007 in a Pilot Cohort of Human Recurrent Malignant Glioma Patients (clinicaltrials.gov) - P1b | N=31 | Active, not recruiting | Sponsor: Oblato, Inc. | Trial completion date: Oct 2022 ➔ Oct 2023 | Trial primary completion date: Jun 2022 ➔ Jan 2023

Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioma • Oncology • Solid Tumor

Study of Safety and Pharmacokinetic Properties of Oral OKN-007 in Patients With Recurrent High-Grade Glioma (clinicaltrials.gov) - P1b | N=16 | Recruiting | Sponsor: Oblato, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Anaplastic Oligoastrocytoma • Astrocytoma • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oligodendroglioma • Oncology • Solid Tumor

[VIRTUAL] Phase 1b Clinical Trial of OKN-007 in Recurrent Malignant Glioma (SNO 2020) - P1b | "OKN-007 appears safe and, compared to standard therapy, may prolong OS in recurrent glioma."

Clinical • P1 data • Fatigue • Glioblastoma • Glioma • Infectious Disease • Nephrology • Oncology • Pain • Solid Tumor

[VIRTUAL] Feasibility pilot study of OKN-007 in combination with adjuvant Temozolomide chemoradiotherapy in patients with newly diagnosed glioblastoma (SNO 2020) - P1 | "The treatment plan in Cohort 1 appears safe and well-tolerated. Recruitment for Cohort 2 is ongoing and will be expanded to further evaluate safety. Once the outcome of Cohort 2 is known, the regimen for the expansion cohort will be determined."

Clinical • Combination therapy • Glioblastoma • Neutropenia • Oncology • Solid Tumor

Open-label Study Investigating of OKN-007 Combined With Temozolomide in Patients With Recurrent Glioblastoma (clinicaltrials.gov) - P2 | N=57 | Active, not recruiting | Sponsor: Oblato, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor • MGMT

Oblato announces that it has completed enrollment of patients for the Phase 2 recurrent glioblastoma multiforme clinical trial in the US (PRNewswire) - "Oblato, Inc....announced today that the enrollment of recurrent glioblastoma multiforme (GBM) patients for a Phase 2 clinical trial with its proprietary compound OKN-007 in the US has been completed. Thirteen institutions are participating in this clinical trial, and patients are being administered a combination of OKN-007 and temozolomide, an approved drug for GBM....The Company expects that the study results will be available in 2023....Two other trials for GBM are in progress. One is an investigator-initiated clinical trial using OKN-007 on naïve GBM patients at Stephenson Cancer Center, University of Oklahoma Health Sciences Center and 21 patients have been enrolled so far. Furthermore, Oblato has just started another Phase 1 clinical study for recurrent GBM patients with the dosage form of OKN-007 changed from the existing injectable to an oral formulation to improve both the administration to the patients and the efficacy of OKN-007."

P2 data • Trial status • Brain Cancer • CNS Tumor • Glioblastoma • Oncology

Investigation of Oral OKN-007 in Recurrent High-grade Glioma Participants (clinicaltrials.gov) - P1/2 | N=0 | Withdrawn | Sponsor: Oblato, Inc. | N=30 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Anaplastic Oligoastrocytoma • Astrocytoma • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oligodendroglioma • Oncology • Solid Tumor