intara Therapeutics, Inc is developing advanced cancer therapies for patients with rare unmet medical needs. The company is currently developing two Phase 3-ready therapeutics: VAL-083 for treating glioblastoma (GBM), the most common and most aggressive form of primary brain cancer in adults and; REM-001 for treating cutaneous metastatic breast cancer (CMBC).
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 central nervous system, ovarian and other solid tumors in clinical trials sponsored by the US National Cancer Institute (NCI). It 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. Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM.
REM-001 therapy, meanwhile, 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. The MOA is similar to radiation therapy via the creation of oxygen radicals. With clinical efficacy of 80% complete responses of evaluable CMBC lesions and 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.
CEO Saiid Zarrabian said the GBM AGILE trial speeds up “Phase 3 development, while reducing costs” giving Kintara “three separate shots on goal unique to VAL-083”