425: TuHURA Biosciences and Kineta Present Promising Data on Cancer Therapies at AACR Annual Meeting

TuHURA Biosciences and Kineta presented updated results from clinical trials of KVA12123 and IFx-Hu2.0, showing potential in treating advanced melanoma and other cancers after failure of anti-PD-1 therapy.

Summary

• TuHURA Biosciences and Kineta presented data at the American Association for Cancer Research (AACR) Annual Meeting on two cancer therapies: KVA12123 and IFx-Hu2.0.
• Kineta's KVA12123, an anti-VISTA antibody, showed greater than 90% VISTA receptor occupancy at the 1,000mg dose level in the VISTA-101 Phase I-II trial.
• TuHURA's IFx-Hu2.0 demonstrated clinically meaningful anti-tumor responses and abscopal effect in patients with advanced melanoma who had failed checkpoint inhibitor (CPI) therapy.
• TuHURA plans to initiate a Phase 2 randomized study of the VISTA inhibiting antibody in relapsed AML in the fourth quarter of 2025, pending the closing of the proposed merger with Kineta.
• TuHURA is also targeting a Phase 3 accelerated approval trial of IFx-Hu2.0 in first-line treatment of advanced or metastatic Merkel cell carcinoma later this quarter.
• The merger between TuHURA and Kineta is targeted to close in Q2 2025, subject to certain closing conditions.

Sentiment

Score: 7

Explanation: The document presents positive clinical data and outlines future development plans, suggesting a favorable outlook for the company. However, the reliance on the successful closing of the merger with Kineta and the inherent risks associated with drug development temper the overall sentiment.

Positives

• KVA12123 was generally safe and well-tolerated in monotherapy and combination arms.
• IFx-Hu2.0 was generally safe and well-tolerated, with only mild Grade 1 and Grade 2 adverse events.
• IFx-Hu2.0 demonstrated stimulation of an innate immune response, with increased T cell and B cell production.
• The VISTA-101 study provided important PK data for determining the recommended Phase 2 dose of KVA12123.

Future Outlook

TuHURA anticipates initiating a Phase 3 trial for IFx-Hu2.0 in Merkel cell carcinoma and a Phase 2 trial for KVA12123 in relapsed AML, pending the closing of the merger with Kineta.

Management Comments

• James Bianco, M.D., President and Chief Executive Officer of TuHURA Biosciences, stated that the exclusivity payment allowed Kineta to restart and complete the Phase I study, providing important data.
• Dr. Bianco believes that 750mg Q2W dosing will be the recommended Phase 2 dose and schedule for KVA12123.
• Dr. Bianco noted the potential of VISTA in immunologic tolerance in blood-related cancers, particularly AML.
• Dr. Bianco noted the data generated in patients with advanced cutaneous malignancies like melanoma or Merkel cell carcinoma.

Industry Context

The announcement highlights the growing interest in overcoming resistance to checkpoint inhibitors in cancer immunotherapy. Both KVA12123 and IFx-Hu2.0 aim to address this challenge by targeting different mechanisms of immune evasion.

Comparison to Industry Standards

• Checkpoint inhibitors like Keytruda (pembrolizumab) are standard treatments for melanoma and Merkel cell carcinoma, but many patients develop resistance.
• The development of therapies like KVA12123 and IFx-Hu2.0 that can restore sensitivity to checkpoint inhibitors is a major focus in immuno-oncology.
• Companies like Bristol-Myers Squibb (Opdivo), Merck (Keytruda), and Roche (Tecentriq) are major players in the checkpoint inhibitor market.
• TuHURA's approach of targeting the tumor microenvironment to prevent T cell exhaustion is similar to strategies being pursued by other companies in the field.

Stakeholder Impact

• Positive clinical data could lead to improved treatment options for patients with advanced melanoma and other cancers.
• Successful development and commercialization of KVA12123 and IFx-Hu2.0 could create value for shareholders.
• The merger with Kineta could strengthen TuHURA's pipeline and create synergies.

Next Steps

• Initiation of a Phase 3 accelerated approval trial of IFx-Hu2.0 in Merkel cell carcinoma.
• Initiation of a Phase 2 randomized study of KVA12123 in relapsed AML.
• Closing of the proposed merger with Kineta.

Key Dates

Keywords

TuHURA Biosciences, Kineta, KVA12123, IFx-Hu2.0, VISTA, Melanoma, AML, Merkel cell carcinoma, Immunotherapy, Checkpoint inhibitor, Clinical trial, AACR