Kintara Therapeutics suspends development of VAL-083 after topline results

Kintara Therapeutics announced that preliminary topline results from the Glioblastoma Adaptive Global Innovative Learning Environment study showed that VAL-083 did not perform better than the current standards of care in glioblastoma. These topline results included preliminary safety data for VAL-083 that was similar to that of the current standards of care used to treat glioblastoma. With this study outcome, Kintara is suspending the development of VAL-083 and turning its focus to its second program, REM-001. In addition to focusing on its REM-001 program, Kintara will evaluate a range of strategic options aimed at potentially maximizing shareholder value. All development activities and related costs for VAL-083 will be suspended while the company awaits the full dataset from the GBM AGILE Study which is expected at the end of Q1/beginning of Q2 of 2024. At such time Kintara will analyze the full results as it seeks to maximize the value of the VAL-083 asset. Kintara expects to enroll the first subject in a 15-patient CMBC study around the end of calendar year 2023. The company was recently awarded a $2M grant from the National Institutes of Health which is expected to cover the majority of the cost to run the CMBC study. In November 2022, the FDA granted Fast Track Designation to Kintara’s REM-001 Therapy for the treatment of patients with CMBC.