TAMPA, FL - TuHURA Biosciences Inc. (NASDAQ:HURA) announced significant advancements in its pipeline of cancer immunotherapies, including an upcoming Phase 3 trial for its leading drug candidate IFx-2.0 and potential acquisition of a novel antibody from Kineta, Inc.
The company, focused on overcoming resistance to cancer immunotherapy, has reached a Special Protocol Assessment agreement with the FDA for a Phase 3 accelerated approval trial of IFx-2.0, targeting first-line treatment of Merkel Cell Carcinoma (MCC). The trial, integrating Overall Response Rate and Progression Free Survival endpoints, is scheduled to begin in the first half of 2025.
IFx-2.0, an innate immune response agonist, is designed to make tumor cells recognizable to the immune system, potentially overcoming primary resistance to checkpoint inhibitors. This upcoming trial will test IFx-2.0 in conjunction with Keytruda® (pembrolizumab) against a placebo combination.
TuHURA is also advancing discussions for the acquisition of KVA12123, a Phase 2 ready VISTA inhibiting antibody, under a non-binding letter of intent with Kineta. The merger would involve a combination of cash and TuHURA stock, expanding the company's portfolio with a candidate that has completed enrollment in its monotherapy arm.
Further, the company is developing tumor microenvironment modulators targeting Myeloid Derived Suppressor Cells (MDSCs) and progressing with IFx-3.0, a tumor-targeted mRNA agonist for aggressive B Cell Lymphoma.
The company has also fortified its leadership team with the appointment of Peter O'Neill as Vice President, Clinical Operations, and Michael Krsulich as Head of Quality Assurance, to drive strategic and operational execution.
Financially, TuHURA is well-positioned, having closed a $31 million financing round expected to fund operations into late 2025. This follows a $5 million raise to secure the rights to KVA12123, which will contribute to the acquisition if a definitive agreement is reached.
This news is based on a press release statement and contains forward-looking statements regarding the company's clinical trials, potential acquisitions, and financial projections.
In other recent news, Kintara Therapeutics has approved a 1-for-35 reverse stock split, ahead of its planned merger with TuHURA Biosciences. Following the merger, Kintara will trade under the new name TuHURA Biosciences, Inc. The reverse stock split will consolidate Kintara's existing shares from around 55.6 million to approximately 1.6 million. The company's shareholders have also approved the issuance of common stock in relation to the merger.
Kintara has amended the issuance of Contingent Value Rights (CVRs) to its shareholders, which will be distributed just before the reverse stock split. The company's recent Annual Meeting of Stockholders saw the election of four directors and the approval of the compensation of executive officers.
In the run-up to the merger, Kintara's REM-001 therapy for cutaneous metastatic breast cancer has shown positive results. Similarly, TuHURA Biosciences is making progress with its Phase 3 immuno-oncology pipeline, including its leading cancer vaccine candidate, IFx-2.0. These are the latest developments in the ongoing activities within Kintara Therapeutics and TuHURA Biosciences.
InvestingPro Insights
As TuHURA Biosciences Inc. (NASDAQ:HURA) advances its cancer immunotherapy pipeline, investors should consider some key financial metrics and insights from InvestingPro. The company's market capitalization stands at $158.03 million, reflecting its current valuation in the biotech sector.
InvestingPro data reveals that TuHURA's stock has experienced significant volatility, with a 40.32% price decline over the past three months. This aligns with an InvestingPro Tip indicating that the stock "has fared poorly over the last month." Despite the recent $31 million financing round mentioned in the article, which is expected to fund operations into late 2025, the company is not currently profitable. This is corroborated by an InvestingPro Tip stating that "analysts do not anticipate the company will be profitable this year."
Interestingly, while TuHURA is advancing its clinical trials and potential acquisitions, another InvestingPro Tip notes that the company "operates with a moderate level of debt." This could be seen as a balanced approach to financing its ambitious research and development plans.
For investors seeking a more comprehensive analysis, InvestingPro offers 8 additional tips for TuHURA Biosciences, providing a deeper understanding of the company's financial health and market position. These insights could be particularly valuable as the company progresses towards its Phase 3 trial and potential acquisition of KVA12123.
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