425: TuHURA Biosciences to Present at H.C. Wainwright BioConnect Conference and Highlights Acquisition of Kineta

TuHURA Biosciences will present a company overview at the H.C. Wainwright BioConnect Conference, highlighting its Phase 3 program and the acquisition of Kineta, including its VISTA inhibiting monoclonal antibody program.

Summary

• TuHURA Biosciences, a Phase 3 immuno-oncology company, will present at the 3rd Annual H.C. Wainwright BioConnect Investor Conference on May 20, 2025.
• The presentation will include an overview of TuHURA's IFx-Hu2.0 Phase 3 program and its bi-specific immune modulating antibody drug conjugates targeting Myeloid Derived Suppressor Cells (MDSCs).
• TuHURA is acquiring Kineta, including rights to Kineta's KVA12123 antibody, through a merger transaction.
• The merger is targeted to close in Q2 2025, pending satisfaction of closing conditions.
• TuHURA is preparing to initiate a Phase 3 registration trial of IFx-2.0 as an adjunctive therapy to Keytruda for advanced or metastatic Merkel Cell Carcinoma under a Special Protocol Assessment (SPA) agreement with the FDA.
• Subject to the Kineta acquisition, TuHURA plans to initiate a randomized trial of menin inhibitor +/VISTA inhibiting antibody in relapsed or refractory AML in Q3 2025.
• TuHURA is also developing bi-specific immune modulating antibody drug conjugates (ADCs) and antibody peptide conjugates (APCs) targeting Myeloid Derived Suppressor Cells.

Sentiment

Score: 7

Explanation: The announcement is generally positive, highlighting upcoming presentations, clinical trial plans, and an acquisition. The sentiment is cautiously optimistic, as the success of these initiatives is not guaranteed.

Positives

• TuHURA has a Phase 3 immuno-oncology program (IFx-Hu2.0).
• The company is acquiring Kineta, which includes rights to a novel antibody (KVA12123).
• TuHURA has a Special Protocol Assessment (SPA) agreement with the FDA for its Phase 3 trial of IFx-2.0.
• The company is planning a randomized trial in relapsed or refractory AML.

Risks

• The merger with Kineta is subject to closing conditions and may not be completed.
• Clinical trials are subject to regulatory approval and may not be successful.
• Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially.

Future Outlook

TuHURA anticipates closing the acquisition of Kineta in Q2 2025 and initiating a Phase 3 trial of IFx-2.0 for Merkel Cell Carcinoma and a trial of menin inhibitor +/VISTA inhibiting antibody in relapsed or refractory AML in Q3 2025, subject to the Kineta acquisition.

Management Comments

• James A. Bianco, M.D., President and Chief Executive Officer of TuHURA, will present a company overview, including highlights of its IFx-Hu2.0 Phase 3 program, and its first-in-class bi-specific immune modulating Antibody drug, or peptide conjugates (ADCs, APCs) targeting Myeloid Derived Suppressor Cells (MDSCs), along with Kineta Incs. VISTA inhibiting monoclonal antibody program.

Industry Context

The announcement highlights TuHURA's focus on overcoming resistance to cancer immunotherapy, a significant challenge in the field. The acquisition of Kineta and its VISTA inhibiting antibody program aligns with the industry trend of targeting immune checkpoints to enhance anti-cancer responses.

Comparison to Industry Standards

• TuHURA's focus on overcoming resistance to checkpoint inhibitors aligns with the strategies of companies like Bristol Myers Squibb and Merck, which are also developing novel immunotherapies.
• The development of bi-specific antibodies and antibody-drug conjugates (ADCs) is a common approach in the industry, with companies like Roche and Seagen leading the way.
• The planned Phase 3 trial of IFx-2.0 with Keytruda is similar to other combination immunotherapy trials being conducted by companies like AstraZeneca and Pfizer.

Stakeholder Impact

• Shareholders may be impacted by the acquisition of Kineta and the progress of clinical trials.
• Patients with Merkel Cell Carcinoma and AML may benefit from the development of new therapies.
• Employees of TuHURA and Kineta may be affected by the merger.

Next Steps

• TuHURA will present at the H.C. Wainwright BioConnect Investor Conference on May 20, 2025.
• The company will work to close the acquisition of Kineta in Q2 2025.
• TuHURA plans to initiate a Phase 3 trial of IFx-2.0 for Merkel Cell Carcinoma.
• The company plans to initiate a randomized trial of menin inhibitor +/VISTA inhibiting antibody in relapsed or refractory AML in Q3 2025, subject to the Kineta acquisition.

Key Dates

Keywords

TuHURA Biosciences, Kineta, Immuno-oncology, IFx-Hu2.0, VISTA, KVA12123, Phase 3 trial, Merkel Cell Carcinoma, AML, Myeloid Derived Suppressor Cells, Antibody drug conjugates, H.C. Wainwright BioConnect Conference