TuHURA Biosciences Provides First Look at Data from its Open-Label Study of IFx-2.0 as an Adjunctive Therapy to Keytruda® in First Line Treatment of Patients with Deep Seated Metastatic Merkel Cell Carcinoma

The study’s primary endpoint assesses safety and feasibility 49 days after the first IFx-2.0 dose.

Rhea-AI Summary

TuHURA Biosciences (HURA) reported preliminary partial tumor responses in the first three patients receiving IFx-2.0 alongside Keytruda for metastatic Merkel cell carcinoma. All three responses met RECIST v.1.1 criteria, a standardized measure of tumor response, and remained ongoing at the six-month assessment.

The Phase 1b/2a open-label study initially targets nine patients with deep-seated or bulky tumors, using CT- or ultrasound-guided injections in first-line treatment. TuHURA said continued high response rates could prompt exploration of expanded enrollment and FDA discussions about potentially supplementing its ongoing Phase 3 trial, provided that trial meets its primary endpoint.

4 points · 0 major

PositiveiHow this balance works

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0 major · 1 point

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointAll three patients achieved partial responses that remained ongoing at the six-month assessment.
• Minor pointImage-guided IFx-2.0 administration was safe and feasible in these patients, TuHURA said.
• Minor point. Forward-looking: it has not happened yet and may not happen.Expanded enrollment and FDA discussions may be explored if high response rates continue, with supplementation contingent on Phase 3 success.
• Minor point. Forward-looking: it has not happened yet and may not happen.Additional patient data are expected in coming months; TuHURA plans to seek a scientific presentation next year.

Negative

• Minor pointPreliminary results cover only three patients in an open-label study initially designed to enroll nine.

News Explained

The study’s primary endpoint is safety and feasibility, evaluated 28 days after the last IFx-2.0 dose (49 days after the first); tumor-response efficacy is secondary, assessed at three and six months.

Key Figures

Patients with partial response: 3 of 3 patients Response durability: 6 months Planned enrollment: 9 patients

Patients with partial response

3 of 3 patients

Initial data; partial response under RECIST v.1.1

Response durability

6 months

All three responses were ongoing at the protocol-specified assessment

Planned enrollment

9 patients

Initial study design

Key Terms

recist v.1.1, partial response, open-label, phase 1b/2a

4 terms

recist v.1.1 medical

"meeting the criteria for partial response (PR) under RECIST v.1.1 criteria"

RECIST v1.1 is a standardized set of radiology-based rules used in cancer clinical trials and regulatory reports to classify how solid tumors change over time. It specifies how to pick and measure ‘‘target’’ and ‘‘non‑target’’ lesions on imaging, and gives numeric thresholds for responses: complete response (disappearance), partial response (at least 30% decrease in the sum of longest diameters of target lesions), progressive disease (at least 20% increase in that sum with a minimum 5 mm absolute rise or appearance of new lesions), and stable disease for changes that fall between these limits. The rules apply to measurable solid tumors assessed by imaging and do not cover some cancer types or non‑imaging clinical signs, so clinicians may need other criteria for haematalogic malignancies, immune‑related patterns, or small/unmeasurable lesions.

partial response medical

"meeting the criteria for partial response (PR) under RECIST v.1.1 criteria"

A partial response is a clinical outcome where a treatment produces a clear, measurable improvement in a disease — for example a substantial shrinkage of a tumor or reduction in symptom measures — but does not eliminate the disease entirely. For investors it signals meaningful efficacy that can support regulatory progress, further trials, or commercial potential, like seeing a product gain market traction even though it hasn’t achieved a complete cure.

open-label medical

"its open-label study of IFx-2.0 as an adjunctive therapy"

Open-label describes a situation where everyone involved in a study or process knows the full details, such as who is receiving a treatment or intervention. For investors, understanding whether a project or product is open-label helps gauge the level of transparency and potential biases, influencing trust and decision-making. It’s like knowing whether a test or experiment is conducted openly or behind closed doors.

phase 1b/2a medical

"The Phase 1b/2a trial of IFx-2.0"

Phase 1b/2a is a combined early-stage clinical study that first tests safety and optimal dosing in a small group and then expands to look for initial signs that the drug works in the target patients. Think of it as a prototype test followed by a small pilot run: it helps companies decide whether to invest in larger, more expensive trials. Investors watch these results because they reduce scientific uncertainty and can sharply affect a drug’s value and development timeline.

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Preliminary results demonstrate major objective tumor responses in first 3 patients at 6 months 

Company to host a webcast today, October 26, 2026, at 8:30 am ET

TAMPA, Fla., Oct. 26, 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 initial data from the first three patients in its open-label study of IFx-2.0 as an adjunctive therapy to Keytruda® in first-line treatment of metastatic Merkel Cell Carcinoma (MCC). Results showed that each patient achieved a major objective anti-tumor response, with all three responses meeting the criteria for partial response (PR) under RECIST v.1.1 criteria. All responses were durable, as each of the responses were ongoing at the protocol-specified six-month assessment.

The Phase 1b/2a trial of IFx-2.0 is a multicenter, open-label trial designed to assess the safety and feasibility of IFx-2.0 as adjunctive therapy to Keytruda® (pembrolizumab) when administered into deep seated and/or bulky tumors accessible with CT or ultrasound guided administration in the front-line treatment of adult patients with metastatic MCC. The trial is designed to initially enroll a total of nine patients with visceral tumors including hepatic, pulmonary, or retroperitoneal or other deep seated locations using CT or ultrasound guided administration where standard-size injection needles are unable to effectively administer the intended dose of IFx-2.0.

Each patient received IFx-2.0 (0.1 mg) injected into a single deep-seated or bulky tumor once a week for three weeks. Within 48 hours of the first IFx-2.0 injection, patients received Keytruda®, followed by Keytruda® every three weeks until the earlier of disease progression, toxicity, or 2 years. Keytruda® is approved as the front-line standard of care for patients with advanced or metastatic MCC.

The primary endpoint of the study is safety and feasibility of IFx-2.0 therapy evaluated 28 days following the last dose of IFx-2.0, which is 49 days from the first IFx-2.0 infusion. The study will also evaluate key secondary endpoints, including efficacy per RECIST1.1 criteria at three and six months.

"While preliminary and only reported in 3 patients, these results highlight that it is feasible to utilize CT or ultrasound guided administration of IFx-2.0 safely to patients with large bulky and or deep-seated tumors. This is also the first time we have administered IFx-2.0 with Keytruda® in the front line treatment setting of patients with metastatic MCC and may serve as a proxy to the potential response rates in the ongoing randomized placebo controlled Phase 3 trial, which is also being conducted in the front line treatment of patients with advanced or metastatic MCC as an adjunct with Keytruda®," said Dr. James Bianco, President and Chief Executive Officer at TuHURA Biosciences. "Approximately 30% of patients with metastatic MCC present without cutaneous or superficial nodal involvement. If we continue to see this high response rate in patients in this trial, we will explore the potential to expand the number of patients in the trial and discuss with the FDA its potential to supplement the ongoing Phase 3 trial, should that study successfully meet the primary endpoint. We look forward to additional patient data in the coming months, and we will seek to present the data at an appropriate scientific conference next year."

Webcast Information

TuHURA will host a webcast today, October 26, 2026, at 8:30AM Eastern Time, to discuss the initial data from the open label Phase 1b/2a study of IFx-2.0.  Investors and interested stakeholders may access the webcast by clicking HERE.

A replay of the webcast will be available on the Events portion of the Company's Investor Relation's website.

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 also 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 ongoing Phase 3 study of IFx2.0 are 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 ongoing Phase 3 study of IFx.20 and the general risks associated with continuing the development of IFx2.0 and 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

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What did TuHURA’s IFx-2.0 and Keytruda study show in metastatic Merkel cell carcinoma?

Each of the first three patients achieved a partial response under RECIST v.1.1 criteria, with all responses ongoing at six months. These are preliminary findings from an open-label Phase 1b/2a study.

How are IFx-2.0 and Keytruda administered in TuHURA’s Phase 1b/2a study?

Each patient received 0.1 mg of IFx-2.0 injected into one deep-seated or bulky tumor weekly for three weeks. Keytruda began within 48 hours of the first injection and continued every three weeks until disease progression, toxicity, or two years, whichever occurred first.

What is the primary endpoint of TuHURA’s IFx-2.0 study with Keytruda?

The primary endpoint is safety and feasibility, evaluated 28 days after the last IFx-2.0 dose, or 49 days after the first dose. Secondary endpoints include tumor response under RECIST v.1.1 criteria at three and six months.