TuHURA Files Investigational New Drug Application for TBS-2025 in the Treatment of Blood-Related Cancers
Rhea-AI Summary
TuHURA (NASDAQ:HURA) filed an IND with FDA DHM1 on Feb 17, 2026 to study TBS-2025, a VISTA inhibiting antibody, combined with a menin inhibitor for mutNPM1 relapsed/refractory AML.
The company plans a Phase 2 Simon two-stage trial in menin inhibitor naïve patients, targeting initiation in early Q2 2026 and preliminary Stage 1 results in Q3 2026, pending FDA clearance. Management said success could prompt seeking accelerated approval guidance.
Positive
- IND filed with FDA DHM1 for TBS-2025 (Feb 17, 2026)
- Targets Phase 2 start in early Q2 2026
- Preliminary Stage 1 results targeted in Q3 2026
- Plans Simon two-stage design in menin inhibitor naïve patients
Negative
- Current CR/CRh rates for menin inhibitor class generally <25%
- Study start is dependent on FDA clearance, creating timing risk
- TBS-2025 is investigational with no proven clinical efficacy yet
News Market Reaction – HURA
In the Feb 17 session, HURA declined 15.04%, reflecting a significant negative market reaction. Argus tracked a trough of -22.7% from its starting point during tracking. Our momentum scanner triggered 21 alerts that day, indicating elevated trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Feb 02 | Orphan drug status | Positive | -3.0% | FDA granted Orphan Drug Designation for IFx-2.0 in melanoma. |
| Jun 24 | Phase 3 initiation | Positive | -7.1% | Started Phase 3 accelerated approval trial of IFx-2.0 with Keytruda. |
| May 05 | Phase 1b/2a launch | Positive | -0.5% | Initiated Phase 1b/2a trial of IFx-Hu2.0 plus Keytruda in MCCUP. |
| Apr 28 | Clinical data update | Positive | -3.2% | Presented updated data on anti-VISTA antibody and IFx-Hu2.0 responses. |
| Nov 25 | Phase 3 pathway | Positive | -10.6% | Outlined Phase 3 accelerated approval plan and broader pipeline advances. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Clinical and regulatory oncology updates have generally been followed by negative price reactions, with an average move of -4.89% despite constructive trial progress.
Over the past year, TuHURA has repeatedly reported clinical advancements under the clinical trial tag, including Phase 3 and Phase 1b/2a initiations in Merkel cell carcinoma, orphan drug designation for IFx‑2.0, and encouraging mechanistic data for VISTA‑targeting programs. Yet the stock typically traded down after these updates, with an average move of -4.89%. Today’s IND filing for TBS‑2025 in AML fits into this pattern of pipeline expansion amid muted or negative market reactions.
Key Terms
investigational new drug application regulatory
menin inhibitor medical
mutNPM1 medical
acute myeloid leukemia medical
VISTA inhibiting antibody medical
relapsed/refractory medical
accelerated approval pathway regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
TBS-2025 to be investigated in combination with a menin inhibitor in mutNPM1 r/r AML
The Company plans on initiating a Phase 2 study in menin inhibitor naïve patients with mutNPM1 r/r AML utilizing a Simon 2 stage design. Pending completion of FDA review and clearance, the Company currently targets initiating the Phase 2 study in early Q2 2026 with preliminary Stage 1 results in Q3 2026.
"There is a broad body of scientific evidence showing that leukemogenic mutations common in AML, such as mutNPM1, may drive the expression of VISTA on the surface of leukemic cells, which contribute to low response rates to therapy and markedly reduced overall survival," said Dr. James Bianco, President and Chief Executive Officer of TuHURA Biosciences.
"While the introduction of menin inhibitors for the treatment of mutNPM1 r/r AML has provided these patients with the first approved therapy, CR/CRh rates across the class are generally <
About TBS-2025
TBS-2025 is a unique VISTA-inhibiting monoclonal antibody acquired by the Company in its acquisition by merger with Kineta Inc. on June 30, 2025. VISTA is a novel checkpoint expressed on quiescent (resting) T cells and highly expressed on myeloid cells. Unlike the expression of VISTA on solid tumor cancers, its role is well established in hematological malignancies. Scientific evidence demonstrates that mutNPM1 and mutDNM3TA, two of the most common mutations in AML and other myeloid (blood related) malignancies, may drive the expression of VISTA on leukemic blasts and are reported to be the primary mechanisms by which AML has a poor response to and high relapse rate following current therapies. VISTA expression is linked to high relapse rates in AML due to its ability to allow leukemic blasts to evade immune recognition and attack by the patient's immune system. When VSIR, the gene that encodes for VISTA, is removed in murine models of mutNPM1 AML, an immune response is observed and survival is enhanced.
TBS-2025 was initially investigated by Kineta in a large Phase 1 trial either as monotherapy (n=24) or in combination with pembrolizumab (n=15) among patients with advanced, therapy refractory cancers, including breast, lung, colorectal, and ovarian cancer. The purpose of the study was to investigate its safety profile and determine the recommended Phase 2 dose. The drug demonstrated a favorable safety profile even at the highest dose level of 1,000mg administered every two weeks. Based on pharmacokinetics and pharmacodynamics, the Company believes the optimal Phase 2 dose is 750mg every three weeks.
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 acquired TBS-2025 in its acquisition by merger with Kineta Inc. on June 30, 2025. TBS-2025 is a VISTA inhibiting mAb moving into Phase 2 development in mutNPM1 r/r AML. In addition, 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, Section 21E of the 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. 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 are described in detail in our registration statements, reports and other filings with the SEC, 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.