Kintara Therapeutics Announces Issuance of New US Patent Related to VAL-083 & MGMT Resistance: Implications for Targeting Brain Tumor Stem Cells

Kintara Therapeutics, Inc. recently announced the US PTO has issued to Kintara United States Patent No. 11,234,955 covering a method of treating brain tumors including glioblastoma (GBM), medulloblastoma, and cancer brain tumor stem cells that has O6-methylguanine-DNA methyltransferase (MGMT)-driven drug resistance.

The patent allows for claims recognizing the unique anti-neoplastic activity of VAL-083 on malignant brain tumor cells, in particular those cells that express the DNA repair enzyme MGMT. The MGMT repair enzyme is the principal resistance mechanism that limits significant therapeutic benefit for GBM patients receiving temozolomide (TMZ), the current first line therapy. VAL-083’s activity is independent of MGMT and provides clinical treatment opportunities for newly-diagnosed patients who express the enzyme as well as recurrent patients who fail TMZ treatment. Moreover, MGMT is a biomarker used in the diagnosis of a patient’s brain tumor and helps clinicians to understand the patient’s prognosis.

In addition to the antiproliferative activity in GBM, the patent covers the significant activity of VAL-083 for medulloblastoma, another deadly form of brain tumor, as well as the opportunity to target brain tumor stem cells, perhaps the ultimate cause of brain tumor therapy resistance. Medulloblastomas are invasive, rapidly growing, and are a common type of brain tumor in children.

“The effect of VAL-083 on brain tumor stem cells represents a unique advance,” Dennis Brown, PhD, Kintara’s Chief Scientific Officer said. “These undifferentiated stem cells are resistant to radiation and chemotherapy and are thought to represent the source of most brain tumor recurrences. We believe the ability to target these stem cells with VAL-083 may offer clinicians additional approaches to improve patient treatment outcomes.”

Located in San Diego, California, Kintara is dedicated to the development of novel cancer therapies for patients with unmet medical needs. Kintara is developing two late-stage, Phase 3-ready therapeutics for clear unmet medical needs with reduced risk development programs.  The two programs are VAL-083 for Glioblastoma Multiforme (GBM) and REM-001 for Cutaneous Metastatic Breast Cancer (CMBC).

VAL-083 is a first-in-class, small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (eg, NSCLC, bladder cancer, head and neck) in US clinical trials sponsored by the National Cancer Institute (NCI). Based on Kintara’s internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently advancing VAL-083 in the GBM AGILE study to support the development and commercialization of VAL-083 in GBM.

Kintara is also advancing its proprietary, late-stage photodynamic therapy platform that holds promise as a localized cutaneous, or visceral, tumor treatment as well as in other potential indications. REM-001 therapy has been previously studied in four Phase 2/3 clinical trials in patients with CMBC who had previously received chemotherapy and/or failed radiation therapy. With clinical efficacy to date of 80% complete responses of CMBC evaluable lesions, and with an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing. For more information, visit www.kintara.com.