#United States #Tampa #KEYTRUDA #TuHURA Biosciences #IFx-Hu2.0

TuHURA Biosciences Initiates Groundbreaking Phase 1b/2a Study of IFx-Hu2.0

TuHURA Biosciences, Inc. has announced the initiation of a critical Phase 1b/2a clinical trial involving IFx-Hu2.0 aimed at treating metastatic Merkel cell carcinoma of unknown primary origin (MCCUP). This innovative study will examine the safety and feasibility of using IFx-Hu2.0 in conjunction with Keytruda® (pembrolizumab), particularly in patients whose tumors are deep-seated and do not exhibit associated cutaneous lesions.

The trial’s design is particularly noteworthy as it aims to provide vital data on the combination therapy’s effectiveness against metastatic deep tissues, which is a challenging area in cancer treatment. The study is set to enroll nine adult patients with non-cutaneous MCC, segmenting them based on their tumor location into three groups: liver, lungs, and retroperitoneum lesions. Each patient will receive an injection of IFx-Hu2.0 weekly for three weeks, followed by pembrolizumab injections starting 48 hours after the initial IFx-Hu2.0 dose.

Dr. James Bianco, President and CEO of TuHURA, highlighted the significance of the trial, stating that up to 30% of MCC cases present without skin lesions. This trial not only seeks to assess the safety and feasibility of the treatment combination but could potentially broaden the pool of patients who can benefit from the innovative therapy. The primary outcome measure will focus on safety and feasibility 28 days after the last dose of IFx-Hu2.0. Secondary outcomes will assess efficacy per RECIST 1.1 criteria at three and six months, providing critical insights into the treatment’s effectiveness.

The rationale for exploring IFx-Hu2.0 as a combination therapy centers on its potential to overcome primary resistance to checkpoint inhibitors like Keytruda. Previous trials have indicated that IFx-Hu2.0 can induce systemic anti-tumor immune responses, showcasing promising results in earlier studies with melanoma and metastatic Merkel cell carcinoma. If this new trial delivers satisfactory safety and efficacy data, TuHURA envisions extending enrollment to include other cancers that typically show poor responses to checkpoint inhibitors.

TuHURA's strategic approach aligns with the recent encouragement from the U.S. Food and Drug Administration (FDA), which is pushing the company to conduct accelerated trials for treatments that demonstrate significant promise, particularly in patients who haven’t previously responded to standard therapies. The anticipated data from the trial will be collected by late 2025 or early 2026, marking a hopeful milestone in the fight against hard-to-treat cancers.

As TuHURA prepares for this exciting project, it is also looking ahead to a Phase 3 randomized, placebo-controlled trial planned for Q2 2025, which aims to evaluate IFx-Hu2.0 against Keytruda plus a placebo in first-line therapy for similarly naïve patients with advanced or metastatic MCC. This ambitious research roadmap emphasizes TuHURA’s commitment to pioneering cancer treatments and underscores its position as a frontrunner in immune-oncology.

The landscape of cancer treatment continues to evolve, and with promising studies like the one TuHURA has set in motion, there is a renewed sense of hope for patients facing aggressive forms of cancer. For ongoing updates and more information, visit TuHURA's website or follow them on social media platforms.