TAMPA, Fla. - TuHURA Biosciences, Inc., in collaboration with Kintara Therapeutics, Inc. (NASDAQ:KTRA), has announced positive results from a Phase 1b trial of its leading cancer vaccine candidate, IFx-2.0. The trial included patients with advanced Merkel Cell Carcinoma (MCC) or Cutaneous Squamous Cell Carcinoma (cSCC) who had not responded to standard immune checkpoint inhibitor (ICI) therapies.
The study, presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL, revealed that IFx-2.0 was safe and well-tolerated. Notably, 80% of ICI-naïve patients with advanced MCC who had previously not responded to pembrolizumab or avelumab therapy achieved a durable Complete Response (CR), pathologic CR, or Partial Response (PR) after treatment with IFx-2.0 and a subsequent rechallenge with an anti-PD(L)-1 checkpoint inhibitor.
Dr. James Bianco, CEO of TuHURA, highlighted the significance of the findings, stating that the ability of IFx-2.0 to overcome resistance to ICI in 63% of patients with advanced MCC is encouraging, especially considering that many of these patients had progressed on multiple therapies before receiving IFx-2.0.
The promising results have set the stage for a planned Phase 3 registration-directed clinical trial. This upcoming trial will examine IFx-2.0 as an adjunctive therapy with Keytruda® (pembrolizumab) to improve tumor response rates compared to Keytruda® plus placebo in first-line treatment of ICI-naïve patients with advanced or metastatic MCC. Enrollment for this trial is expected to commence in the second half of 2024 under the FDA's Accelerated Approval Pathway.
IFx-2.0, TuHURA's personalized cancer vaccine product, involves the injection of a small amount of plasmid DNA (pDNA) into a patient's tumor. This pDNA is designed to encode for an immunogenic bacterial protein that, when expressed on the surface of the patient's tumor, helps the immune system recognize and attack the cancer cells.
The announcement also comes as TuHURA prepares to merge with Kintara in an all-stock transaction, aiming to create a combined company with a diversified late-stage oncology pipeline. This merger is expected to close in the third quarter of 2024, subject to customary closing conditions, including approval from both companies' stockholders.
This article is based on a press release statement. For further details on TuHURA's Phase 1b IFx-2.0 study, individuals can refer to clinicaltrials.gov using the identifier NCT04160065.
InvestingPro Insights
Kintara Therapeutics, Inc. (NASDAQ:KTRA) has recently made headlines with its collaboration on the cancer vaccine candidate, IFx-2.0. As investors digest the news and consider the implications for Kintara's future, certain financial metrics and expert tips from InvestingPro provide additional context for evaluating the company's stock.
InvestingPro Tips indicate that Kintara holds more cash than debt on its balance sheet, which could be a positive sign of financial stability as it moves forward with its clinical trials and planned merger. Additionally, the company is noted for its high price volatility, which suggests that investors should be prepared for potentially significant price swings.
From the InvestingPro Data, several metrics stand out. Kintara has a market capitalization of approximately $17.17 million USD, which reflects its size and market value within the biotechnology sector. Notably, the company has experienced a significant return over the last week, with a 1 Week Price Total Return of 84.76%.
This surge in price performance could be linked to the positive trial results and merger news. However, it is essential to consider that the company's P/E Ratio (Adjusted) for the last twelve months as of Q3 2024 stands at -1.8, reinforcing that Kintara is not currently profitable.
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In summary, while the clinical trial results and the upcoming merger present opportunities, investors should also weigh the financial health and market performance of Kintara Therapeutics as part of their overall assessment.
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