TuHURA Biosciences, Inc. Reports Financial Results for Fiscal Year 2024 and Provides Corporate Update
Phase 3 IFx-2.0 accelerated approval trial as adjunctive therapy with Keytruda® (pembrolizumab) in 1st line therapy for advanced Merkel cell carcinoma (MCC) planning to initiate enrollment in Q2 2025
MCC Phase 3 trial to be conducted under Special Protocol Assessment (SPA) Agreement with FDA
Acquisition of Kineta's Phase 2 ready, VISTA inhibiting antibody targeted for completion in Q2 2025
Expanded discovery team for first-in-class immune modulating Antibody Drug or Peptide Conjugate Program
TAMPA, Fla., April 1, 2025 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 registration-stage immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, today provided financial results for fiscal year 2024 and provided a corporate update.
"2024 was a transformative year for TuHURA. We became a NASDAQ-listed Company, raised capital to meet FDA's manufacturing requirements to initiate our Phase 3 program anticipated for Q2 as forecasted and entered into a definitive agreement for, what we believe, is a best-in-class VISTA inhibiting antibody adding a Phase 2 program in AML to our development pipeline," commented James Bianco, President and CEO of TuHURA. "As we advance our late stage clinical programs in 2025 with the goal of completing enrollment in our Phase 3 trial next year, we are also making significant progress in the development of the first novel class of non-tumor targeting Antibody Drug or Antibody Peptide Conjugates that are demonstrating the potential ability to remove the immunosuppressive functions of key cellular populations that create an immunologic sanctuary for tumors leading to acquired resistance to cancer immunotherapies."
2024 Highlights
Successful SPA agreement with FDA
Single Phase 3 Accelerated Approval Trial1
Trial incorporates a key secondary endpoint (PFS) which, if achieved, may satisfy post approval confirmatory trial requirement
Entered into definitive agreement with Kineta Inc. to acquire Phase 2 ready VISTA inhibitor; Transaction targeted to close in Q2 2025
NASDAQ (HURA) listing via successful reverse merger with Kintara Therapeutics, Inc.
Raised $36 million in 2024 to fund development programs and operations through late fourth quarter of 2025 and secure right to acquire VISTA inhibiting antibody
Advancing Novel Technologies to Overcome Resistance to Cancer Immunotherapy
Innate Immune Agonists: TuHURA's IFx technology utilizes a proprietary plasmid DNA or messenger RNA ("mRNA") which, when introduced into or targeted to a tumor, results in the expression of a highly immunogenic gram-positive, bacterial protein (Emm55) on the surface of the tumor cell, making the tumor look like a bacterium. Gram-positive bacterium has molecular patterns, or motifs, preserved over evolution which are recognized by receptors on our immune cells called "toll like receptors" (TLR). TLR 2 specifically recognizes the pattern of gram-positive bacterial proteins, like Emm55, leading to the activation of antigen presenting cells (APCs). Once activated, APCs digest the tumor cell and present non-self, tumor neoantigens to newly produced T and B cells, activating a tumor-specific adaptive immune response. Through its activation of tumor-specific T cells, IFx-2.0 administration can potentially overcome primary resistance to checkpoint inhibitors.
TuHURA is preparing to initiate a single, randomized, placebo-controlled Phase 3 accelerated approval trial of IFx-2.0 administered as an adjunctive therapy to Keytruda® (pembrolizumab) versus pembrolizumab plus placebo in first line treatment for checkpoint inhibitor-naïve patients with advanced or metastatic MCC. The data from the Company's Phase 1b trial in patients with advanced or metastatic MCC who exhibited primary resistance to CPI was used to support a potential single registration directed trial. Consistent with the FDA's Project Front Runner Initiative, the FDA's Oncology Center of Excellence (OCE) recommended investigating IFx-2.0 in the first line setting rather than in patients progressing on first line therapy.
Project Front Runner is an FDA OCE initiative to encourage drug sponsors to consider when it may be appropriate to first develop and seek approval of new cancer drugs for advanced or metastatic disease, in an earlier clinical setting rather than the usual approach to develop and seek approval of a new drug for treatment of patients who have received numerous prior lines of therapies or have exhausted available treatment options.
The FDA also requested the Company to consider designing the trial to include a key secondary endpoint shown to be of clinical benefit ...
https://www.benzinga.com/pressreleases/25/04/n44582978/tuhura-biosciences-inc-reports-financial-results-for-fiscal-year-2024-and-provides-corporate-updat
