425: Kintara and TuHURA Announce Reopening of Enrollment in Kineta's VISTA-101 Clinical Trial

Kintara Therapeutics and TuHURA Biosciences announce that Kineta has reopened enrollment in its VISTA-101 Phase 1/2 clinical trial for KVA12123 in advanced solid tumor cancer patients.

Summary

• Kintara Therapeutics and TuHURA Biosciences have announced that Kineta has reopened enrollment in its ongoing VISTA-101 Phase 1/2 clinical trial.
• The trial is evaluating Kinetas KVA12123, a VISTA blocking antibody, in patients with advanced solid tumor cancer.
• TuHURA has an Exclusivity and Right of First Offer Agreement with Kineta for the potential acquisition of KVA12123.
• 30 of a projected 39 patients have been enrolled in the clinical trial to date.
• The trial includes a monotherapy arm with KVA12123 and a combination arm with KVA12123 and Merck's KEYTRUDA (pembrolizumab).
• Initial results showed partial response and stable disease in combination cohorts, and durable stable disease in monotherapy cohorts.
• KVA12123 has demonstrated a favorable safety and tolerability profile with no dose-limiting toxicities or cytokine release syndrome.
• TuHURA and Kintara have a definitive agreement for an all-stock merger, expected to close in the third quarter of 2024, pending customary closing conditions, including stockholder approval.
• The combined company will operate under the name TuHURA Biosciences, Inc. and trade on The Nasdaq Capital Market under the ticker HURA.
• Kineta received a $5 million nonrefundable payment from TuHURA under the Exclusivity and Right of First Offer Agreement.

Sentiment

Score: 7

Explanation: The sentiment is moderately positive due to the reopening of the clinical trial, the potential acquisition of a promising asset, and the planned merger. However, risks associated with the merger and clinical development temper the overall sentiment.

Positives

• Reopening of enrollment in the VISTA-101 clinical trial suggests continued progress in the development of KVA12123.
• The favorable safety and tolerability profile of KVA12123 is a positive indicator for its potential as a cancer treatment.
• The potential acquisition of KVA12123 by TuHURA could strengthen its oncology pipeline.
• The merger between TuHURA and Kintara aims to create a company with a diversified late-stage oncology pipeline.
• Initial results from the trial showed partial response and stable disease in combination cohorts, and durable stable disease in monotherapy cohorts.

Risks

• The merger between Kintara and TuHURA is subject to customary closing conditions, including stockholder approval, and may not be completed.
• The acquisition of Kinetas KVA12123 assets by TuHURA is not guaranteed and is subject to ongoing due diligence and negotiation.
• Forward-looking statements are subject to various risks and uncertainties that could cause actual results to differ materially.
• The clinical trial may not be fully enrolled by the end of 2024 as anticipated.

Future Outlook

The combined company, TuHURA Biosciences, Inc., will focus on advancing TuHURA's personalized cancer vaccine(s) and first-in-class bi-functional ADCs, with the merger expected to close in the third quarter of 2024.

Management Comments

• Dr. James Bianco, CEO of TuHURA, believes KVA12123 has the potential to be a promising new treatment alternative for patients with cancer and could be a promising addition to their pipeline.
• Thierry Guillaudeux, CSO of Kineta, is pleased to resume enrollment for VISTA-101 and is focused on the successful execution and working towards completing enrollment which they expect to do by the end of 2024.

Industry Context

The announcement highlights the ongoing interest and investment in novel immunotherapies, particularly those targeting immune checkpoints like VISTA, to overcome resistance to existing cancer treatments. The collaboration and potential acquisition reflect a trend of companies consolidating assets to build stronger pipelines.

Comparison to Industry Standards

• The VISTA-101 trial is evaluating KVA12123 both as a monotherapy and in combination with Merck's KEYTRUDA (pembrolizumab), a standard anti-PD1 therapy, which is a common approach in immuno-oncology clinical trials.
• The reported safety profile of KVA12123, with no dose-limiting toxicities and no evidence of cytokine release syndrome, is a key differentiator compared to some other VISTA-targeting therapies that have shown CRS in clinical trials.
• TuHURA's focus on personalized cancer vaccines and bi-functional ADCs aligns with the industry's broader efforts to develop more targeted and effective cancer immunotherapies.

Stakeholder Impact

• Shareholders of Kintara and TuHURA will be impacted by the proposed merger, requiring their approval.
• Patients with advanced solid tumor cancer may benefit from the continued development of KVA12123.
• Employees of Kintara and TuHURA will be affected by the integration of the two companies following the merger.

Next Steps

• TuHURA will continue its due diligence on Kinetas KVA12123 assets.
• Kineta will focus on completing enrollment in the VISTA-101 clinical trial by the end of 2024.
• Kintara and TuHURA will work towards closing the merger in the third quarter of 2024, pending stockholder approval and other customary conditions.

Key Dates