Kintara Therapeutics Awarded $2.0 Million National Institutes of Health SBIR Grant to Support the Clinical Development of REM-001
SAN DIEGO, June 28, 2023 /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 that the Company has been awarded a $2.0 million Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH) to support the clinical development of REM-001, a second-generation photodynamic therapy photosensitizer agent for the treatment of cutaneous metastatic breast cancer (CMBC).
"We are delighted that the National Institutes of Health recognizes that Kintara's REM-001 program shows an opportunity to address an unmet medical need by significantly improving the quality of life and reducing co-morbidities for patients with CMBC," said Robert E. Hoffman, President and CEO of Kintara. "The support from the NIH validates the potential of our program to help patients with metastatic breast cancer who have little or no treatment options for this devastating disease. We look forward to advancing our REM-001 program with this grant."
Funds from the NIH SBIR grant will enable Kintara to restart the REM-001 CMBC program and generate clinical evidence to demonstrate proof of concept for the photodynamic therapy platform in CMBC. Completion of this study is intended to aid in the design of a planned phase 3 registrational study.
A 2003 meta-analysis of over 20,000 cancer patients found that 24% of breast cancer patients included in the analysis had developed cutaneous metastases, which was the highest rate of any cancer type. According to the American Cancer Society's estimates for 2021, it was projected that there would be approximately 281,550 new cases of invasive breast cancer diagnosed in women in the United States. Accordingly, the prevalence of CMBC may be in excess of 50,000 cases annually in the United States.
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 therapeutics for clear unmet medical needs with reduced risk development programs. The two programs are VAL-083 for glioblastoma (GBM) and REM-001 Therapy for 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 advancing VAL-083 in the Global Coalition for Adaptive Research registrational Phase 2/3 clinical trial titled Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) Study to support the development and commercialization of VAL-083 in GBM.
Kintara also has a 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, which consists of the laser light source, the light delivery device, and the REM-001 drug product, 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. In CMBC, REM-001 has a clinical efficacy to date of 80% complete responses of CMBC evaluable lesions and an existing robust safety database of approximately 1,100 patients across multiple indications. With the awarded NIH SBIR grant, Kintara will restart the REM-001 CMBC program.
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 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; the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies; global unrest; and the continued impact of the COVID-19 pandemic. 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, 2022, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.
The contents of this press release are solely the responsibility of the authors and do not necessarily represent the official views of the National Institutes of Health.
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Released June 28, 2023