Kintara Therapeutics Reports 10 Months Progression-Free Survival in Newly-Diagnosed MGMT-unmethylated GBM from Ongoing MD Anderson Cancer Center Phase 2 Study

Positive Data Updates Presented at the Society of Neuro-Oncology (SNO) Annual Meeting in Newly-Diagnosed, Recurrent, and First-Line GBM

– In the Newly-Diagnosed Treatment Setting, Promising Median Progression-Free Survival of 10.0 months with VAL-083 Compared to Temozolomide (TMZ) Historical Data (5.3 months* and 6.9 months**, respectively)

– Recurrent Patients Showing Promising Median Overall Survival of 8.5 Months on the Planned 30 mg/m2/day Phase 3 Initial Dose of VAL-083 Compared to Lomustine Historical Data (7.2 months***)

– Continued 8.7 Months Median Progression-Free Survival in Favor of VAL-083 as Compared to TMZ Historical Data (5.3 months* and 6.9 months**, respectively) in First-Line GBM on the Planned 30 mg/m2/day Phase 3 Initial Dose

SAN DIEGO, Nov. 19, 2020 /PRNewswire/ — Kintara Therapeutics, Inc. (Nasdaq: KTRA) (“Kintara” or the “Company”), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, today announced interim data on its two Phase 2 trials of VAL-083, the Company’s lead compound for the treatment of glioblastoma multiforme (GBM).  The data are to be presented in two posters at the 25th Annual Scientific Meeting of the Society for Neuro-Oncology (SNO) which will be held virtually due to the Covid-19 pandemic on November 19-21, 2020.

“I’m extremely pleased with the continual progress being achieved by both of these ongoing Phase 2 clinical studies evaluating VAL-083, as the results garnered thus far are an indicator of the compound’s potential to be an important therapeutic option for GBM patients in the recurrent, newly-diagnosed first-line, and newly-diagnosed adjuvant treatment settings,” commented Saiid Zarrabian, Kintara’s Chief Executive Officer. “It is a pleasure to present the data updates at the Society for Neuro-Oncology’s Annual Meeting, as these studies have provided valuable insight in initiating the VAL-083 arm of the Global Coalition for Adaptive Research GBM AGILE registrational study which is expected to occur later this year.”

Dr. John de Groot, professor, Department of Neuro-Oncology at The University of Texas MD Andersen Cancer Center and also a founding member of Kintara’s Scientific Advisory Board stated, “These data continue to confirm VAL-083’s compelling potential as a potent DNA targeting cytotoxic agent for the treatment of GBM.  I’m particularly encouraged by VAL-083’s continued ability to demonstrate a favorable progression-free survival trend as compared to TMZ historical data in newly-diagnosed GBM, and improvement in overall survival compared to lomustine historical data in the recurrent setting.”

At the SNO Annual Meeting, Kintara is to present posters updating two Phase 2 clinical trials evaluating VAL-083 in patients with MGMT-unmethylated GBM as follows:

Newly-Diagnosed and Recurrent GBM

The first poster outlined interim data from two groups of patients receiving VAL-083 in the open-label, Phase 2 study in recurrent and adjuvant unmethylated GBM settings being conducted at the MD Anderson Cancer Center in Houston. 

In newly-diagnosed patients receiving VAL-083 as adjuvant therapy following treatment with radiation and TMZ, for the 27 efficacy evaluable patients (of a planned up to 36 patients) as of the data cut-off of October 23, 2020, median progression-free survival (PFS) is currently 10.0 months (confidence interval: CI 7.6-10.8). While not a head-to-head study, this PFS data compares favorably to historical TMZ control of 5.3 months* and 6.9 months**, respectively.

For patients in the recurrent group receiving second-line therapy with VAL-083 following first-line TMZ failure, 84 patients have been enrolled as of the data cut-off of October 23, 2020 with 35 patients (34 efficacy evaluable) having received an initial dose of 40 mg/m2/day and 49 (43 efficacy evaluable) having received the planned Phase 3 initial dose of 30 mg/m2/day (on days 1, 2 and 3 of a 21-day cycle). Median overall survival (mOS) for the 77 efficacy evaluable patients who have completed at least once cycle of treatment was 7.6 months (CI 6.4-10.6 months). Additionally, for the 43 efficacy evaluable patients initially receiving the planned Phase 3 initial dose of 30 mg/m2/day, mOS is currently 8.5 months (CI 6.8-13.7 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***.

Consistent with prior studies, myelosuppression is the most common adverse event with VAL-083 in both the recurrent GBM and adjuvant treatment setting. In the 30 mg/m2/day starting dose cohort (the planned dose for the GBM AGILE pivotal study) three subjects have experienced a serious adverse event (SAE) possibly related to VAL-083 in the recurrent group and one patient has experienced a possibly drug-related SAE in the adjuvant group as of the relevant data cut-off dates.

First-Line GBM

The second poster outlined the open-label, Phase 2 study of VAL-083 as a first-line treatment in newly-diagnosed, unmethylated GBM patients being conducted at Sun Yat-sen University Cancer Center in China. For the 29 patients who had completed at least their first efficacy assessment as of the October 21, 2020 cut-off date, median PFS with VAL-083 is currently 9.3 months (95% CI 6.4-12.0 months). Additionally, for the 25 patients initially receiving the treatment dose that will be carried forward in the GBM AGILE pivotal Phase 3 study of 30 mg/m2/day on days 1, 2 and 3 of a 21-day cycle, median PFS was reported to be 8.7 months (CI 6.4-12.5 months). While not a head-to-head study, this PFS data compares favorably to historical TMZ control of 5.3 months* and 6.9 months**, respectively.  Multiple treatment cycles of VAL-083 at the 30 mg/m2/day dose in combination with standard radiation treatment (2 Gy/day, 5 days/week) was shown to be generally safe and well-tolerated.

*Hegi et al N Eng J Med 352; 997-1003 (2005)
**Tanguturi et al. NeuroOncol. 19(7): 908-917 (2017)
*** Wick et al N.Eng.J.Med . 377:1954 1963 (2017)

ABOUT KINTARA

Located in San Diego, California, Kintara is dedicated to the development of novel cancer therapies for patients with unmet medical needs.

Kintara is developing two late-stage, Phase 3-ready therapeutics for clear unmet medical needs with reduced risk development programs.  The two programs are VAL-083 for GBM and REM-001 for cutaneous metastatic breast cancer (CMBC).

VAL-083 is a “first-in-class”, small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g. NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the National Cancer Institute (NCI). Based on Kintara’s internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM.

Kintara is also advancing its proprietary, late-stage photodynamic therapy platform that holds promise as a localized cutaneous, or visceral, tumor treatment as well as in other potential indications. REM-001 therapy, 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. With clinical efficacy to date of 80% complete responses of CMBC evaluable lesions, and with 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. 

SAFE HARBOR STATEMENT

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including statements regarding the status of the Company’s clinical trials and the GBM AGILE study.  Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties.  The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the impact of the COVID-19 pandemic on the Company’s operations and clinical trials; the Company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the Company’s products and technology; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies.  These and other factors are identified and described in more detail in the Company’s filings with the SEC, including the Company’s Annual Report on Form 10-K for the year ended June 30, 2020, the Company’s Quarterly Reports on Form 10-Q, and the Company’s Current Reports on Form 8-K.

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