This section highlights FDA-related milestones and regulatory updates for drugs developed by TuHURA Biosciences (HURA).
Over the past two years, TuHURA Biosciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
IFx-2.0 and IFx-Hu2.0. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
IFx-2.0 - FDA Regulatory Timeline and Events
IFx-2.0 is a drug developed by TuHURA Biosciences for the following indication: In Advanced or Metastatic Merkel Cell Carcinoma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- IFx-2.0
- Announced Date:
- June 24, 2025
- Indication:
- In Advanced or Metastatic Merkel Cell Carcinoma
Announcement
TuHURA Biosciences, announced the initiation of its Phase 3 accelerated approval trial of IFx-2.0, TuHURA's lead innate immune agonist, in patients with advanced or metastatic Merkel cell carcinoma (MCC).
AI Summary
TuHURA Biosciences has announced the start of its Phase 3 accelerated approval trial for IFx-2.0, its leading innate immune agonist, aimed at patients with advanced or metastatic Merkel cell carcinoma (MCC). The study, conducted under a Special Protocol Assessment (SPA) agreement with the FDA, will enroll about 118 participants across 22–25 sites in the United States. IFx-2.0 is designed to overcome primary resistance to checkpoint inhibitors by stimulating the patient’s innate immune response, which may activate tumor-specific B cells and T cells. The trial will compare IFx-2.0 plus Keytruda® (pembrolizumab) against Keytruda® with a placebo, with the overall response rate (ORR) as the primary endpoint under the accelerated approval process. A key secondary endpoint is progression-free survival (PFS), which could support converting the accelerated approval into regular approval if successful.
Read Announcement- Drug:
- IFx-2.0
- Announced Date:
- June 9, 2025
- Indication:
- In Advanced or Metastatic Merkel Cell Carcinoma
Announcement
TuHURA Biosciences, announced that the FDA has removed the manufacturing-related partial clinical hold on the Company's Phase 3 accelerated approval trial for IFx-2.0, thereby allowing the trial to proceed as agreed to under the previously announced SPA Agreement with the FDA.
AI Summary
TuHURA Biosciences announced that the FDA has removed the manufacturing-related partial clinical hold on its Phase 3 accelerated approval trial for IFx-2.0. This key decision allows the company to move forward as planned under its existing Special Protocol Assessment (SPA) Agreement with the FDA. With the hold lifted, TuHURA can now initiate the trial’s clinical sites and begin patient enrollment for IFx-2.0, which is being studied as an adjunctive treatment alongside Keytruda® for advanced or metastatic Merkel cell carcinoma (MCC). The removal of the hold also unlocks the next tranche of funding from the company’s PIPE financing, supporting further clinical development. This development marks a crucial step in the progress of the trial and underscores the collaborative efforts between TuHURA and the FDA to advance innovative cancer immunotherapy treatments.
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IFx-Hu2.0 - FDA Regulatory Timeline and Events
IFx-Hu2.0 is a drug developed by TuHURA Biosciences for the following indication: For Metastatic Merkel Cell Carcinoma Of Unknown Primary Origin.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- IFx-Hu2.0
- Announced Date:
- May 5, 2025
- Indication:
- For Metastatic Merkel Cell Carcinoma Of Unknown Primary Origin
Announcement
TuHURA Biosciences, announced the initiation of its Phase 1b/2a trial of IFx-Hu2.0, TuHURA's lead innate immune agonist, in patients with MCCUP who would not be eligible for the Company's planned Phase 3 accelerated approval trial, which is targeted to begin enrollment later in Q2 2025.
AI Summary
TuHURA Biosciences has initiated a Phase 1b/2a trial for its lead innate immune agonist, IFx-Hu2.0, aimed at patients with metastatic Merkel cell carcinoma of unknown primary origin (MCCUP). This trial will test the safety and feasibility of IFx-Hu2.0 in combination with Keytruda®, especially in patients with deep-seated tumors in areas like the liver or lungs who are not eligible for the upcoming Phase 3 accelerated approval trial. The Phase 3 trial is targeted to begin enrollment in Q2 2025 for patients with accessible cutaneous tumors. By focusing on MCCUP patients with non-cutaneous lesions, TuHURA aims to expand the potential reach of the treatment to a broader group of individuals who might not benefit from current immunotherapies. This study could pave the way for future enrollment in non-MCC cancers known for poor responses to checkpoint inhibitors.
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