TuHURA Biosciences Receives New U.S. Patent Broadening Coverage for its VISTA Inhibitor, TBS-2025

Protection extends beyond the original antibody to modified forms and treatment methods outside cancer.

Rhea-AI Summary

TuHURA Biosciences (HURA) received a new U.S. patent broadening protection for TBS-2025, its antibody designed to inhibit VISTA.

Patent No. 12,760,104 covers antigen-binding fragments, antibody framework and Fc-region modifications, and antibodies targeting two or more targets across all human antibody classes. It also covers treatment with TBS-2025 alone or alongside radiation, chemotherapy, targeted therapies, tyrosine kinase inhibitors and immune checkpoint inhibitors, including PD-1 inhibitors. Treatment-method claims extend beyond cancer to autoimmune disease and infection. The patent term extends to February 18, 2042, before any potential patent term adjustment or regulatory extension.

Positive

• Minor pointNew U.S. patent broadens TBS-2025 protection to fragments, framework modifications and Fc-region modifications.
• Minor pointBispecific and multi-specific antibody coverage spans all classes of human antibodies.
• Minor pointTreatment coverage includes single-agent use and combinations with radiation, chemotherapy, targeted therapies and immune checkpoint inhibitors.
• Minor pointTreatment-method claims extend beyond cancer to autoimmune disease and infection.
• Minor pointPatent term extends to February 18, 2042, before potential patent term adjustment or regulatory extension.

Negative

• None.

Key Figures

Patent term: February 18, 2042

Patent term

February 18, 2042

Before any potential patent term adjustment and/or regulatory patent term extension

Historical Context

1 past event · Latest: Sep 14

1 event

1. Sep 14

   IND clearance

   24h Move

   +0.0%

   FDA cleared the IND for TBS-2025, enabling a Phase 1b monotherapy study in AML.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

antigen-binding fragments, tyrosine kinase inhibitor, immune checkpoint inhibitors, patent term adjustment

4 terms

antigen-binding fragments medical

"claims provide coverage for TBS-2025, TuHURA's VISTA inhibiting antibody, as well as antigen-binding fragments"

Antigen-binding fragments are portions of an antibody that contain the variable regions responsible for recognizing and binding a specific antigen; they are produced by cutting or engineering whole antibodies into smaller pieces (common types include Fab, F(ab')2 and single-chain variable fragments, scFv). Because they lack the antibody's Fc region, antigen-binding fragments retain target-specific binding but do not trigger Fc-dependent immune effector functions (such as complement activation or Fc receptor engagement) and generally have faster blood clearance and shorter half-lives than full antibodies.

tyrosine kinase inhibitor medical

"targeted therapies, tyrosine kinase inhibitor therapies, and immune checkpoint inhibitors"

A tyrosine kinase inhibitor is a type of drug that blocks specific proteins in cells that act like on/off switches for growth and survival signals, often used to stop cancer cells from multiplying. For investors, these drugs matter because their clinical trial results, regulatory approvals, safety profiles, and patent status drive sales potential and company valuation—think of them as precision tools whose effectiveness and market exclusivity determine commercial success.

immune checkpoint inhibitors medical

"tyrosine kinase inhibitor therapies, and immune checkpoint inhibitors, including PD-1 inhibitors"

Drugs that release the immune system’s natural “brakes,” allowing immune cells to recognize and attack cancer cells; imagine taking the safety off a guard dog so it can chase intruders. They matter to investors because they can become high-value treatments with large sales potential, but their commercial success depends on clinical trial results, regulatory approval, competition and side-effect management, which all affect a company’s valuation.

patent term adjustment regulatory

"prior to any potential patent term adjustment and/or regulatory patent term extension"

Patent term adjustment is extra time added to a patent’s normally fixed expiration to compensate for delays caused by the patent office during examination. For investors, it changes how long a company can legally exclude competitors and earn monopoly-style profits from a product, much like extending a store’s exclusive sales license when regulators hold up approval. Longer adjustments can increase projected cash flow and valuation for patent-dependent businesses.

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Patent extends coverage to include bispecific/multi-specific antibodies across all classes of human antibodies

TAMPA, Fla., Oct. 13, 2026 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 immuno-oncology company developing novel therapeutics to overcome resistance to cancer immunotherapy, today announced that the United States Patent and Trademark Office (USPTO) has issued Patent No. 12,760,104 entitled, "Anti-VISTA Antibodies and Uses Thereof."

The new patent claims provide coverage for TBS-2025, TuHURA's VISTA inhibiting antibody, as well as antigen-binding fragments, modifications to the frameworks and Fc regions of the antibody, and bi-specific/multi-specific antibodies across all classes of human antibodies. Additionally, the patent provides coverage for use as a single agent or in combination with radiotherapy, chemotherapy, targeted therapies, tyrosine kinase inhibitor therapies, and immune checkpoint inhibitors, including PD-1 inhibitors. The new patent claims also provide coverage for methods of treatment that extend beyond cancer, expanding into new treatment areas like autoimmune disease and infection. The patent term extends to February 18, 2042, prior to any potential patent term adjustment and/or regulatory patent term extension.

"VISTA is increasingly becoming a critical target for intervention not only in AML and MDS but also in multiple myeloma where emerging scientific data links VISTA to treatment failure and importantly to myeloma related bone destruction," said Dr. James Bianco, President and Chief Executive Officer of TuHURA. "Having patent protection for TBS-2025 across a wide array of new molecular modifications allows us to expand our approaches to blood related cancers and widen potential therapeutic applications, including into autoimmune diseases and infection. This is of extraordinary value in not only protecting our VISTA franchise, but also in making TBS-2025 even more valuable to potential future corporate collaborators."

About TuHURA Biosciences, Inc.

TuHURA Biosciences, Inc. (NASDAQ: HURA) is a Phase 3 immuno-oncology company developing novel technologies to overcome primary and acquired resistance to cancer immunotherapy, two of the most common reasons cancer immunotherapies fail to work or stop working in the majority of patients with cancer.

TuHURA's lead innate immune agonist, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors. TuHURA has initiated a single randomized placebo-controlled Phase 3 registration trial of IFx-2.0 administered as an adjunctive therapy to Keytruda® (pembrolizumab) compared to Keytruda® plus placebo in first-line treatment for advanced or metastatic Merkel Cell Carcinoma.

In addition to its innate immune agonist product candidates, TuHURA is developing TBS-2025, its VISTA-inhibiting mAb in a Phase 1b clinical trial in patients with mutNPM1 r/r AML, a molecularly defined subgroup that represents approximately 35% of patients with AML. TuHURA is leveraging its Delta Opioid Receptor technology to develop first-in-class, bi-specific, bi-functional antibody drug conjugates (ADCs) targeting Myeloid-Derived Suppressor Cells to inhibit their immune-suppressing effects on the tumor microenvironment to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies.

For more information, please visit www.tuhurabio.com and connect with TuHURA on Facebook, X, and LinkedIn.

Cautionary Statement Regarding Forward-Looking Statements
This press release contains certain "forward-looking statements" within the meaning of, and subject to the safe harbor created by, Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and other future conditions. In some cases, you can identify these statements by forward-looking words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "could," "should," "would," "project," "plan," "expect," "goal," "seek," "future," "likely," or the negative or plural of these words or similar expressions. Our statements in this press release regarding our planned Phase1b study of TBS-2025 is an example of such forward-looking statements. You are cautioned that such statements are not guarantees of future performance and that actual results or developments may differ materially from those set forth in these forward-looking statements. Factors that could cause actual results to differ materially from these forward-looking statements include, among others, the risks associated conducting the planned Phase 1 study of TBS-2025 and the general risks associated with continuing the development of TBS-2025; risks related to patient enrollment, trial design, data outcomes and regulatory interactions; uncertainty regarding the timing and likelihood of regulatory approvals; and the other risks described from time to time in detail in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, as filed on March 31, 2026, and TuHURA's other reports and filings with the SEC from time to time, which are available on TuHURA's website and at www.sec.gov. 

The forward-looking statements and other information contained in this press release are made as of the date hereof, and TuHURA does not undertake any obligation to update publicly or revise any forward-looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws.

Investor Contact: 
Monique Kosse
Gilmartin Group
Monique@GilmartinIR.com

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SOURCE TuHURA Biosciences, Inc.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What does TuHURA's new TBS-2025 patent cover?

The new patent covers TBS-2025, antigen-binding fragments, antibody framework and Fc-region modifications, and bispecific or multi-specific antibodies across all human antibody classes. It also covers single-agent and combination treatment methods, with claims extending beyond cancer to autoimmune disease and infection.

When does TuHURA's new TBS-2025 patent term end?

The term of U.S. Patent No. 12,760,104 extends to February 18, 2042. That date is before any potential patent term adjustment or regulatory patent term extension.