Kineta Inc. resumes VISTA-101 trial enrollment for KVA12123 in advanced solid tumors

Kineta Inc. has announced the resumption of patient enrollment in its VISTA-101 Phase 1/2 clinical trial, which is evaluating the efficacy of KVA12123 in treating advanced solid tumors. This decision follows a significant agreement with TuHURA Biosciences, Inc., which includes the potential acquisition of Kineta’s KVA12123 VISTA blocking antibody along with associated rights and assets. This move comes as part of TuHURA’s due diligence on the KVA12123 assets, highlighting the strategic collaboration between the two companies.

The VISTA-101 trial has achieved notable progress with KVA12123, a novel immunotherapy designed to inhibit the VISTA checkpoint, a known suppressor of T cell function in tumors. The trial has successfully cleared the fifth of six planned monotherapy dose levels and is assessing KVA12123 in combination with Merck’s anti-PD1 therapy, KEYTRUDA® (pembrolizumab). Early data from the trial, presented at the American Association of Cancer Research (AACR) Annual Meeting 2024, demonstrated partial responses and stable disease in combination cohorts, and durable stable disease in monotherapy cohorts. These results underscore KVA12123’s potential as a significant advancement in cancer immunotherapy.

Dr. James Bianco, Chief Executive Officer of TuHURA Biosciences, expressed strong confidence in KVA12123’s potential. He noted that the compound has shown promising synergy with TuHURA’s existing immunotherapy technologies, IFx and Delta receptor technologies. Dr. Bianco emphasized that the successful completion of Phase 1 enrollment and the advancement to Phase 2 could represent a critical milestone for the company’s pipeline. The collaboration with Kineta is seen as a strategic move to enhance TuHURA’s portfolio with a potentially groundbreaking checkpoint inhibitor.

Thierry Guillaudeux, Chief Scientific Officer of Kineta Inc., echoed these sentiments, highlighting the trial’s progress and the positive safety profile of KVA12123. He noted that the treatment has been well-tolerated with no dose-limiting toxicities or cytokine release syndrome (CRS), which is a significant achievement given the challenges associated with VISTA-targeted therapies. Kineta is focused on executing the trial successfully and aims to complete patient enrollment by the end of 2024.

As part of the agreement, TuHURA has made a $5 million nonrefundable payment to Kineta. The agreement grants TuHURA exclusive rights to negotiate the acquisition of Kineta’s global patents, patent rights, and other related assets. This exclusivity period is valid until October 1, 2024, with a potential extension of 20 days. TuHURA is actively engaging in due diligence to assess the potential acquisition.

KVA12123 represents a novel approach in cancer immunotherapy by targeting VISTA, a negative immune checkpoint that is associated with poor patient outcomes due to its suppression of T cell function. High VISTA expression in tumors correlates with decreased survival rates and limited responses to other immune checkpoint inhibitors. KVA12123 aims to address these challenges by inducing a robust immune response and enhancing anti-tumor activity without causing CRS, a common side effect associated with other therapies targeting VISTA.

The VISTA-101 trial also highlights the broader context of the ongoing developments in cancer immunotherapy. The combination of KVA12123 with Merck’s KEYTRUDA® is particularly noteworthy, as it represents an innovative approach to overcoming the limitations of current treatments. This trial is a part of a growing trend in oncology research focusing on novel checkpoint inhibitors and combination therapies to improve patient outcomes.

In addition to the VISTA-101 trial, TuHURA and Kintara are working towards a merger that will create a new entity focused on advancing late-stage oncology therapies. The merged company, expected to operate under the name TuHURA Biosciences, Inc. and trade on The Nasdaq Capital Market under the ticker “HURA,” will concentrate on developing personalized cancer vaccines and bi-functional antibody-drug conjugates (ADCs). This strategic move is designed to enhance the combined company’s capabilities and resources in addressing major challenges in cancer treatment.