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Kintara Therapeutics Announces Expansion of REM-001 Clinical Study to Include Patients on Pembrolizumab

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Kintara Therapeutics expands REM-001 study in cutaneous metastatic breast cancer to include patients on pembrolizumab, funded by a $2.0 million SBIR grant from NIH.
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The expansion of inclusion criteria in Kintara Therapeutics' REM-001 study to incorporate patients already receiving pembrolizumab represents a strategic move to accelerate patient enrollment and enhance the diversity of the study population. This could potentially lead to a more robust dataset, which is critical for evaluating the efficacy and safety of REM-001 in combination with pembrolizumab in treating CMBC.

From a clinical research perspective, the addition of pembrolizumab, an established PD-1 inhibitor, suggests that Kintara is exploring the synergistic potential of REM-001 with immunotherapy agents. This could be indicative of a trend in oncology where combination therapies are becoming the norm, aiming to improve patient outcomes by attacking tumors on multiple fronts.

However, it is important to note that expanding inclusion criteria also introduces variables that could affect study outcomes. The interaction between pembrolizumab and REM-001 will need to be closely monitored for any unforeseen adverse effects or changes in efficacy.

The financial implications of Kintara's announcement are multifaceted. The utilization of a $2.0 million SBIR grant from the NIH to cover the majority of the study costs is a prudent use of non-dilutive funding, which preserves shareholder equity and demonstrates fiscal responsibility in the company's capital allocation strategy.

Furthermore, the mention of a 'strengthened balance sheet' by the CEO suggests recent improvements in the company's financial health, which could be a positive signal to investors. This financial stability, coupled with strategic options to maximize shareholder value, may indicate that Kintara is positioning itself for potential partnerships, licensing agreements, or even a sale.

Investors should monitor the progress of the REM-001 study closely, as successful Phase 2 results could be a catalyst for the company's stock price. However, the inherent risks of clinical trials, especially in oncology, should not be underestimated, as any setbacks could have a significant negative impact on the company's valuation.

SAN DIEGO, March 27, 2024 /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 the expansion of the inclusion criteria in the open label 15- patient REM-001 study in cutaneous metastatic breast cancer (CMBC) to include patients receiving pembrolizumab (KEYTRUDA®) for at least three months at screening.

CMBC patients are being screened and dosed in the 15-patient study which is evaluating REM-001, a second-generation photodynamic therapy (PDT) photosensitizer agent, and is designed to test the 0.8 mg dose as well as optimize the study design in advance of a Phase 3 trial initiation. The primary endpoint in the study is Best Overall Objective Response Rate (bORR) (complete response or partial response) of the target treatment fields at any time from treatment up to, and including, week 24. The majority of the costs to run this study will be covered by the $2.0 million Small Business Innovation Research (SBIR) grant Kintara was awarded from the National Institutes of Health (NIH).

"Expanding the inclusion criteria to include CMBC patients on pembrolizumab for at least three months at screening is expected to significantly increase enrollment in our REM-001 study" commented Robert E. Hoffman, Kintara's President and Chief Executive Officer. "With a strengthened balance sheet, we continue to evaluate strategic options with the goal of maximizing shareholder value."

ABOUT KINTARA

Located in San Diego, California, Kintara is dedicated to the development of novel cancer therapies for patients with unmet medical needs. Kintara develops therapeutics for clear unmet medical needs with reduced risk development programs. The Company's lead program is REM-001 Therapy for cutaneous metastatic breast cancer.

Kintara 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. For more information, please visit www.kintara.com or follow us on X at @Kintara_Thera, Facebook and LinkedIn.

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 Company's REM-001 15-patient clinical trial in CMBC patients. 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 Company's review of strategic alternatives; 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 status of the Company's clinical trials; the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies; and global unrest. 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, 2023, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.

CONTACTS

Investors:
Robert E. Hoffman
Kintara Therapeutics
rhoffman@kintara.com

Kintara Therapeutics logo (PRNewsfoto/Kintara Therapeutics)

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SOURCE Kintara Therapeutics

FAQ

What is Kintara Therapeutics announcing regarding the REM-001 study in cutaneous metastatic breast cancer?

Kintara Therapeutics is expanding the inclusion criteria in the REM-001 study to include patients receiving pembrolizumab for at least three months at screening.

What is the primary endpoint in the REM-001 study?

The primary endpoint in the study is the Best Overall Objective Response Rate (bORR) of the target treatment fields at any time up to, and including, week 24.

How is the REM-001 study funded?

The majority of the costs for the study will be covered by the $2.0 million Small Business Innovation Research (SBIR) grant awarded to Kintara from the National Institutes of Health (NIH).

Who commented on the expansion of inclusion criteria in the study?

Robert E. Hoffman, Kintara's President and Chief Executive Officer, commented on the expansion of inclusion criteria in the study.

What is the goal of Kintara Therapeutics with the strategic options evaluation?

Kintara aims to maximize shareholder value through the evaluation of strategic options with a strengthened balance sheet.

Kintara Therapeutics, Inc.

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