Kintara Therapeutics, Inc. Reports Topline Results from Phase 2 Clinical Study of Val-083 as Adjuvant Therapy for Newly-Diagnosed GBM Patients
September 22, 2021 at 08:00 am EDT
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Kintara Therapeutics, Inc. announced topline data results from the newly-diagnosed adjuvant arm of its open-label, Phase 2 clinical study being conducted at the MD Anderson Cancer Center (MD Anderson) in Houston, Texas. The Phase 2 trial was a two-arm, biomarker-driven study testing VAL-083 in glioblastoma multiforme (GBM) patients who have an unmethylated promoter of the methylguanine DNA-methyltransferase (MGMT) gene. The Company previously announced (July 2021) topline data results from the recurrent GBM arm of the study which provided important safety and efficacy data to support the continued evaluation of VAL-083 as a treatment option for GBM. The newly-diagnosed adjuvant arm of the study addressed GBM patients requiring adjuvant therapy after chemoradiation with temozolomide. The trial arm enrolled 39 patients (36 efficacy evaluable) initially receiving a dose of 30 mg/m2/day on days 1, 2 and 3 of a 21-day cycle. The dosing regimen (30 mg/m2/day) of the MD Anderson study mirrors the trial design of the newly-diagnosed adjuvant study arm of the GBM AGILE study. GBM AGILE, which is sponsored by the Global Coalition for Adaptive Research (GCAR), is a revolutionary, patient-centered, registrational, seamless Phase 2/3 adaptive platform trial evaluating multiple therapies for patients with newly-diagnosed and recurrent GBM. VAL-083 currently represents the only therapeutic agent being evaluated in all three GBM patient subtypes: methylated MGMT, newly-diagnosed unmethylated MGMT, and recurrent. VAL-083 is independent of the MGMT resistance mechanism and has been assessed in over 40 Phase 1 and Phase 2 clinical trials in multiple indications sponsored by the U.S. National Cancer Institute (NCI). Published pre-clinical and clinical data indicate that VAL-083 has activity against a range of tumor types, including lung, brain, cervical, ovarian tumors and hematologic (blood) cancers. VAL-083 has been granted Orphan Drug Designation for GBM by the FDA and EMA and has also been granted Orphan Drug Designations for medulloblastoma and ovarian cancer by the FDA. In addition, the FDA has granted Fast Track Designation for VAL-083 in recurrent GBM. VAL-083 is approved as a cancer chemotherapeutic in China for the treatment of chronic myelogenous leukemia and lung cancer. VAL-083 has not been approved for any indications outside of China.
Kintara Therapeutics, Inc. is a clinical-stage biopharmaceutical company that is focused on the development and commercialization of new cancer therapies. It is focused on the development of novel cancer therapies for patients with unmet medical needs. Its two candidates include VAL-083 and REM-001. VAL-083 is a novel, validated, deoxyribonucleic acid (DNA)-targeting agent, for the treatment of drug-resistant solid tumors, such as glioblastoma multiforme (GBM) and potentially other solid tumors, including ovarian cancer, non-small cell lung cancer (NSCLC), and diffuse intrinsic pontine glioma (DIPG). REM-001 is a late-stage photodynamic therapy (PDT) for the treatment of cutaneous metastatic breast cancer (CMBC), basal cell carcinoma nevus syndrome (BCCNS), and access graft failure in hemodialysis patients. VAL-083 is being evaluated in all three GBM patient subtypes in the GBM AGILE Study: newly diagnosed methylated MGMT; newly diagnosed unmethylated MGMT, and recurrent.
KINTARA THERAPEUTICS, INC. 
