Kineta clears additional cohorts in Phase 1/2 VISTA-101 trial

Kineta (KA) announced an update on its ongoing VISTA-101 Phase 1/2 clinical trial evaluating KVA12123 as monotherapy and in combination with Merck’s (MRK) anti-PD therapy, KEYTRUDA in patients with advanced solid tumors. KVA12123 cleared the fifth of six monotherapy dose levels and the second of four cohorts in combination with pembrolizumab. KVA12123 was well tolerated with no dose limiting toxicities or cytokine related adverse events at any dose level. Monotherapy Dose Escalation: Of 21 patients enrolled, 12 received at least one baseline and one follow up scan; Best overall response in 9 of 12 patients with at least one follow-up scan is stable disease with a mean duration of 15 weeks; One patient with non-small cell lung cancer that failed 6 prior lines of therapy, including checkpoint inhibitor therapy, has experienced stable disease lasting 28 weeks; Nine participants remain on-treatment. Combination Therapy Dose Escalation: Of 9 patients enrolled, 3 received at least one baseline and one follow-up scan; BOR in 2 of 3 patients with at least one follow up scan is: Stable disease in 1 CPI-failure renal cell carcinoma patient with a 24% reduction in target lesions; Partial Response in 1 patient with a PD-L1 negative mucoepidermoid carcinoma and a 54% reduction in target lesions and a complete response in non-target lesions; Eight patients remain on-treatment. Biomarkers: Dose-dependent induction of on-target pro-inflammatory cytokines and chemokines; Dose-dependent increases in non-classical monocytes, CD4+ and CD8+ T cells, and NK cells. Safety: No DLTs observed in any patient at any dose level; No evidence of cytokine release syndrome in any patient at any dose level. The Company recently announced its restructuring and that it is pursuing strategic alternatives to maximize shareholder value due to certain investors indicating they will not fulfill their April 2024 funding obligation in a private placement financing. As a result, the Company has suspended new patient enrollment into the Phase 1/2 VISTA-101 trial and will not be recruiting patients into either the sixth cohort in the monotherapy arm or the third cohort in the combination therapy arm. Patients currently enrolled in the trial will be permitted to continue to participate.