Kintara Therapeutics is developing innovative cancer therapies for rare, unmet medical needs

Two Phase 3-ready therapeutics Well capitalized to achieve clinical milestones Multiple US/EU Orphan Drug and Fast Track designations What Kintara Therapeutics does: Kintara Therapeutics, Inc (NASDAQ:KTRA) is developing advanced cancer therapies for patients with rare unmet medical needs. The San Diego-based 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). 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. 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. Kintara Therapeutics is led by CEO Saiid Zarrabian, who previously served as chairman of La Jolla Pharmaceutical Company. He has also served on numerous private and public company boards, including at Immune Therapeutics, Inc, eMolecules, Inc, and Penwest Pharmaceuticals. How is it doing: During 2020, Kintara acquired Adgero, a privately-held biopharmaceutical company focused on the development of a late-stage photodynamic therapy platform for the treatment of serious cutaneous oncology indications. As well, Kintara Therapeutics recently announced interim data from its two Phase 2 trials of VAL-083 as part of the ongoing study at the MD Anderson Cancer Center, which showed a median progression-free survival (PFS) of 10 months, compared to the historical Temozolomide (TMZ) control group of 5.3 months and 6.9 months, respectively. The company’s VAL-083 drug has also been included in the Global Coalition for Adaptive Research’s (GCAR) Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) study, an adaptive clinical trial platform in glioblastoma multiforme (GBM). Kintara said it will supply GCAR with the VAL-083 drug along with the funding to support the VAL-083 arm of the GBM AGILE registrational study.  And in early January 2021, Kintara’s VAL-083 arm initiated patient randomization as part of the GBM AGILE trial, joining Bayer’s Regorafenib and Kazia’s Paxalisib in the study.   Kintara said it is the only company approved to initiate trials for all 3 GBM patient groups, including newly-diagnosed unmethylated (>60% of GBM patients), newly-diagnosed methylated (<40% of GBM patients ><40% of GBM patients), and recurrent. On the financial side, the company closed a private placement financing in August 2020, in which it received net proceeds of approximately $21.6 million. Kintara noted that the financing was done at market with zero up-front warrants. Kintara Therapeutics ended 1Q 2021 with cash and equivalents of approximately $22.6 million as of September 30, 2020, which the company said provides its with sufficient capital to fully fund “multiple value-accretive clinical milestones.“ Inflection points: Top-line results from its Phase 2 Recurrent GBM study Initiation of its Phase 3 study for CMBC Top-line results from its Phase 2 Adjuvant GBM study What the boss says: Commenting on the company’s participation in the GBM AGILE trial, Kintara Therapeutics CEO Saiid Zarrabian said in a statement: “The opportunity to participate in the GBM AGILE trial is an important milestone for Kintara, as it provides VAL-083, our lead compound, with multiple shots on goal in this cost-effective, adaptive designed registration study with full FDA/regulatory support.” He added: “VAL-083 is the only therapeutic agent participating in the study being evaluated in all 3 patient subtypes, which may accelerate VAL-083’s time to pivotal trial completion and potential regulatory submission by up to 18 months.” Contact Sean at sean@proactiveinvestors.com