Kineta reopens enrollment for VISTA-101 clinical trial of KVA12123

Kineta announced that enrollment has resumed for the Company’s ongoing VISTA-101 Phase 1/2 clinical trial, effective immediately. As previously announced on March 12, 2024, patient enrollment in the clinical trial was suspended due to certain investors indicating that they would not fulfill their funding obligation due in April 2024 pursuant to the previously disclosed private placement financing. To date, KVA12123 has cleared the fifth of six monotherapy dose levels and two of the four cohorts in combination with pembrolizumab. Initial results demonstrating partial response and stable disease in the combination cohorts and durable stable disease in the monotherapy cohorts were reported earlier this year at the American Association of Cancer Research (AACR) Annual Meeting 2024. Additionally, the initial results of KVA12123 showed a favorable clinical safety and tolerability profile with no dose limiting toxicities and no evidence of CRS-associated cytokines at any dose level. On July 8, Kineta announced that it had entered into an exclusivity and right of first offer agreement with TuHURA Biosciences, a Phase 3 registration-stage immuno-oncology company developing novel technologies to overcome resistance to cancer immunotherapy. As part of the Agreement, Kineta received a concurrent $5 million nonrefundable payment from TuHURA. Kineta and TuHURA are cooperating on the reinitiation of patient enrollment into this trial. Pursuant to the Agreement, among other things, Kineta has granted TuHURA an exclusive right to acquire Kineta’s worldwide patents, patent rights, patent applications, product and development program assets, technical and business information, and other rights and assets associated with and derived from its development program related to KVA12123, Kineta’s VISTA blocking immunotherapy. This exclusive right shall continue through the first to occur of the execution of any definitive agreement with respect to a potential transaction by TuHURA or one or more of its affiliates and 11:59 PM Eastern Time on October 1, 2024, subject to extension.