Welcome to our dedicated page for TuHURA Biosciences news (Ticker: HURA), a resource for investors and traders seeking the latest updates and insights on TuHURA Biosciences stock.
TuHURA Biosciences, Inc. (HURA) is a clinical-stage biopharmaceutical company pioneering novel therapies to overcome resistance in cancer immunotherapy. This page serves as the definitive source for official news and press releases related to the company’s advancements in immuno-oncology.
Investors and researchers will find timely updates on IFx-2.0 clinical trials, regulatory milestones, and strategic partnerships. Our curated news collection covers critical developments including Phase 3 trial progress, innovative approaches to tumor microenvironment modulation, and corporate expansions through mergers and acquisitions.
The repository features verified information on key areas: clinical trial designs under Special Protocol Assessment agreements, updates on innate immune response agonists, and advancements in combination therapies with checkpoint inhibitors. All content is sourced directly from company disclosures to ensure accuracy and compliance.
Bookmark this page for streamlined access to TuHURA’s latest scientific breakthroughs and corporate announcements. Regularly updated to reflect new developments, this resource supports informed decision-making for stakeholders tracking innovations in cancer treatment.
TuHURA Biosciences (NASDAQ:HURA) and Kineta presented updated results from two clinical studies at the AACR Annual Meeting. The first study, VISTA-101, evaluated KVA12123 (anti-VISTA antibody) alone and with pembrolizumab in advanced solid tumors. At 1,000mg dose every two weeks, KVA12123 achieved >90% VISTA receptor occupancy with no dose-limiting toxicities across 41 total patients.
The second study focused on TuHURA's IFx-Hu2.0 in advanced melanoma patients who previously failed checkpoint inhibitor (CPI) therapy. Three out of four heavily pre-treated patients achieved durable anti-tumor responses when rechallenged with CPI after IFx-Hu2.0 treatment. The therapy demonstrated increased T cell and B cell production with only mild Grade 1 and 2 adverse events.
TuHURA plans to initiate a Phase 3 trial in Merkel cell carcinoma and expects to close its merger with Kineta in Q2 2025, which includes acquiring rights to KVA12123.
TuHURA Biosciences (NASDAQ:HURA) announced two abstracts accepted for poster presentation at the 2025 AACR Annual Meeting in Chicago. The presentations will showcase:
1. Initial results from a Phase 1 study of KVA12123, an anti-VISTA antibody, both as monotherapy and in combination with pembrolizumab for advanced solid tumors, presented by Kineta's CSO.
2. Mechanistic insights into IFx-Hu2.0 therapy responses in patients with prior anti-PD-1 therapy failure in advanced melanoma, presented by Moffitt Cancer Center scientists.
The company also referenced its previously announced definitive agreement from December 11, 2024, to acquire Kineta, including rights to KVA12123, through a merger expected to close in Q2 2025, subject to funding and other closing conditions.
TuHURA Biosciences (NASDAQ: HURA) has appointed Dr. Bertrand Le Bourdonnec as Executive Vice President, Head of Drug Discovery, Early Development, and Program Management. Dr. Le Bourdonnec brings a 20-year career in drug discovery with impressive achievements, including 12 pre-clinical/clinical candidates and 7 investigational new drug applications.
His expertise in Delta Opioid Receptor (DOR) biochemistry and pharmacology aligns perfectly with TuHURA's Antibody Drug Conjugate (ADC) and Antibody Peptide Conjugate (APC) technology platform. Notable achievements include developing first-in-class spirocyclic DOR agonists licensed to Pfizer and leading the benevopran program to positive Phase IIb results, which led to Adolor 's acquisition by Cubist Pharmaceuticals.
Previously, he served as Chief Scientific Officer at HDAX Therapeutics and VP roles at Deciphera Pharmaceuticals and Cubist Pharmaceuticals, demonstrating successful leadership in drug development across multiple therapeutic areas including oncology, pain, and neurodegenerative diseases.
TuHURA Biosciences (NASDAQ:HURA) reported its fiscal year 2024 results and corporate updates. The company plans to initiate enrollment in Phase 3 IFx-2.0 trial for advanced Merkel cell carcinoma in Q2 2025, conducted under Special Protocol Assessment Agreement with FDA. The trial will test IFx-2.0 as adjunctive therapy with Keytruda®.
Key financial highlights include R&D expenses of $13.3 million (up from $9.4 million in 2023) and G&A expenses of $4.3 million (slight increase from $4.1 million in 2023). The company raised $36 million in 2024 to fund operations through late Q4 2025.
Notable developments include:
- Planned acquisition of Kineta's Phase 2 ready VISTA inhibitor, expected to close in Q2 2025
- NASDAQ listing achievement via reverse merger
- Expansion of discovery team for immune modulating Antibody Drug/Peptide Conjugate Program
TuHURA Biosciences (NASDAQ:HURA) has appointed Craig L. Tendler, M.D. to its Board of Directors effective March 10, 2025. Dr. Tendler, former Vice President of Oncology Clinical Development at Johnson & Johnson, brings significant expertise having overseen 30 major drug approvals and 13 FDA Breakthrough Designations.
This strategic appointment comes as TuHURA prepares to advance IFx-2.0 through its registrational Phase 3 clinical trial, planned for Q2 2025. The company focuses on developing novel technologies to overcome resistance to cancer immunotherapy. Dr. Tendler's experience includes overseeing worldwide approvals for treatments in prostate cancer, hematologic malignancies, lung cancer, and bladder cancer.
The appointment aligns with TuHURA's recent agreement with Kineta to acquire its VISTA inhibiting antibody, and their discovery of the delta opioid receptor's role in controlling immune suppressing capabilities of myeloid derived suppressor cells and tumor associated M2 polarized macrophages.
TuHURA Biosciences (NASDAQ:HURA), a Phase 3 registration-stage immuno-oncology company, has announced its participation in the 37th Annual ROTH Conference in Dana Point, CA. The company's President and CEO, James A. Bianco, M.D., will engage in a fireside chat on March 18, 2025, at 8:30 AM PT.
TuHURA, which focuses on developing novel technologies to overcome resistance to cancer immunotherapy, will make the presentation available via live webcast on their company website's Investors section. Additionally, the management team will be available for one-on-one meetings with qualified registered conference attendees.
TuHURA Biosciences (NASDAQ: HURA), a Phase 3 registration-stage immune-oncology company, announced its participation in the Virtual Investor 'Top 5 for '25' On-Demand Conference. During the event, CEO James Bianco presented the top five reasons why investors and industry colleagues should focus on TuHURA in 2025. The presentation is now available for viewing on the company's website and through a direct webcast link.
TuHURA Biosciences (NASDAQ:HURA) has entered into a definitive merger agreement to acquire Kineta, Inc. (OTC PINK:KANT), gaining rights to Kineta's novel KVA12123 antibody. The acquisition adds a Phase 2 novel checkpoint inhibitor to TuHURA's pipeline, with plans for a Phase 2a/b trial in mutated NPM1 AML in 2025.
KVA12123 is a VISTA-blocking immunotherapy administered as a monoclonal antibody infusion every two weeks. It has completed enrollment in its monotherapy arm, demonstrating safety at 1000mg dose level, and is finishing combination therapy trials with KEYTRUDA®. The transaction, following a $5 million exclusivity fee paid in July 2024, is expected to close in Q1 2025.
TuHURA Biosciences (Nasdaq: HURA) announced significant developments, including a Phase 3 accelerated approval registration trial for IFx-2.0 in first-line treatment of Merkel Cell Carcinoma, planned for first half of 2025. The company entered a non-binding letter of intent to acquire Kineta's KVA12123, a Phase 2 ready VISTA inhibiting antibody. TuHURA is advancing IFx-3.0, a tumor-targeted mRNA innate immune response agonist, and developing early discovery programs for bi-specific antibody drug conjugates. The company secured $31 million in financing through a merger with Kintara, funding operations into late 2025, and raised an additional $5 million for the potential Kineta acquisition.
TuHURA Biosciences (Nasdaq: HURA), a Phase 3 registration-stage immune-oncology company, announced its participation in the 2024 Maxim Healthcare Virtual Summit. Dr. James Bianco, President and CEO of TuHURA, was part of the Precision and Immune Oncology panel. The company focuses on developing novel technologies to overcome resistance to cancer immunotherapy. A webcast replay of the panel presentation is available for M-Vest members.
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