In the 800-patient study by the Global Coalition for Adaptive Research, the analyst firm noted that “Kintara’s VAL-083 is the only compound in the study that is going to be evaluated in all three major cancer types" -- newly diagnosed unmethylated (NDUM), recurrent glioblastoma (GBM), and newly diagnosed methylated MGMT.
Two other drug-makers will participate in the study, also called the GCAR Adaptive Study, which will split patients into three arms. Again, “each company will evaluate their respective therapeutic, but only VAL-083 will be evaluated in three active arms,” analyst Jason Kolbert wrote.
READ: Kintara Therapeutics says enrollment has begun for innovative Phase 2/3 trial of VAL-083 for glioblastoma
The study is now underway with 34 active sites and 357 screened patients, the analyst noted.
Meanwhile, Kolbert has a $4 price target on the stock -- which recently traded around $1.80 a share in New York.
VAL-083 is considered a first-in-class, DNA-targeting small molecule, mechanisms of action (MOA) in addendum, which is designed to cross the blood-brain barrier. It has demonstrated clinical activity against a range of cancers, including the central nervous system, ovarian, and other solid tumors in clinical trials sponsored by the US National Cancer Institute.
VAL-083 has been granted Orphan Drug Designation for GBM by the US Food & Drug Administration (FDA) and the European Medicines Agency (EMA) and has also been granted Orphan Drug Designations for medulloblastoma and ovarian cancer from the FDA. As well, the FDA has granted Fast Track Designation for VAL-083 in recurrent GBM.
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