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: In July, Kintara Therapeutics announced topline data results from the recurrent arm of its open-label, Phase 2 clinical study of its lead compound VAL-083 being conducted at the MD Anderson Cancer Center in Houston.  The Phase 2 trial is 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 recurrent arm of the study addressed patients who have been pre-treated with temozolomide prior to disease recurrence.  Kintara said the recurrent arm of the trial enrolled 89 patients, with 35 patients (35 efficacy evaluable) initially receiving a dose of VAL-083 at 40 milligrams/m2/day, and 54 patients (48 efficacy evaluable) initially receiving the treatment dose of 30 mg/m2/day on days 1, 2 and 3 of a 21-day cycle.  Median overall survival (mOS) for the 48 efficacy evaluable patients initially receiving the treatment dose of 30 mg/m2/day is eight months. While this is not a head-to-head trial, historically, lomustine, which is the most commonly used chemotherapy for these patients, has demonstrated mOS of 7.2 months. The company enrolled the final patient in the Phase 2 study in June and the US Food and Drug Administration (FDA) has also granted Fast Track Designation for VAL-083 in recurrent GBM.   On the financial front, Kintara closed its fiscal third quarter 2021 with cash and cash equivalents of about $15.7 million. That capital, the company said, is expected to be sufficient to fund its planned operations to the second quarter of calendar year 2022. Kintara said it achieved the healthy cash runway primarily due to the exercise of previously issued warrants as well as operational and resource synergies realized through the Adgero Biopharmaceuticals Holdings Inc acquisition in August 2020. And in the boardroom, the company appointed corporate finance veteran Tamara Seymour to its board. Seymour replaces John Liatos, who will continue in his role as Kintara's senior vice president of business development.  Inflection points: Top-line results from its Phase 2 Adjuvant GBM study First patient enrolled for its CMBC Lead-In study GCAR GBM AGILE Registration study graduation from Stage 1 to Stage 2 What the broker says: In a note to clients on July 6, analysts at Aegis Capital Corp maintained their ‘Buy’ rating and $7 price target on shares of Kintara Therapeutics, which they said is predicated on a discounted cash flow valuation model that contemplates future revenues from the company’s therapeutics VAL-083 for glioblastoma (GBM) and REM-001 for cutaneous metastatic breast cancer (CMBC).   “We think Kintara's VAL-083 represents an opportunity to benefit patients suffering from GBM, a highly lethal form of brain cancer. Given its unique mechanism of action, VAL-083 may be positioned to offer greater benefits to patients in the MGMT-unmethylated subset, which has historically responded poorly to standard of care,” the analysts wrote. “With that said, we think VAL-083 has multiple opportunities to demonstrate efficacy in conjunction with GCAR's GBM AGILE trial, including in newly diagnosed MGMT-methylated and unmethylated, and in patients with recurrent disease.”   The Aegis Capital analysts called Kintara’s recent Phase 2 results for VAL-083 in patients with recurrent GBM ”positive,”  noting the median overall survival (mOS) in the 30 milligram (mg) dosing regimen (48 efficacy evaluable patients) was 8.0 months, compared with 7.2 months for the chemotherapy drug lomustine, which they said is considered a beneficial outcome given the severity of the disease especially if the safety/tolerability profile of the drug is amenable. They also pointed to upcoming catalysts for Kintara that include: initial enrollment of patients in the lead-in study of REM-001; top-line results from the CMBC lead-in study and; GCAR GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment) registration study graduation from stage 1 to stage 2 (likely during 1Q 2022). 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 the author at sean@proactiveinvestors.com