On March 12, 2024 Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, reported an update on its ongoing VISTA-101 Phase 1/2 clinical trial evaluating KVA12123 as monotherapy and in combination with Merck’s anti-PD therapy, KEYTRUDA (pembrolizumab) in patients with advanced solid tumors (Press release, Kineta, MAR 12, 2024, View Source;utm_medium=rss&utm_campaign=kva12123-clears-additional-cohorts-in-monotherapy-and-in-combination-therapy-arms-in-the-phase-1-2-vista-101-clinical-trial-initial-clinical-response-data-reported [SID1234641068]). 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 (DLT) or cytokine related adverse events at any dose level.
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Monotherapy Dose Escalation (3 – 300 mg KVA12123 Q2W)
Of 21 patients enrolled, 12 received at least one baseline and one follow up scan
Best overall response (BOR) 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 (CPI) therapy, has experienced stable disease lasting 28 weeks
Nine participants remain on-treatment
Combination Therapy Dose Escalation (30-100 mg KVA12123 Q2W, 400 mg pembrolizumab Q6W)
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
"We are pleased with the progress of the study, the initial clinical response data, and the durability of patient benefit emerging from the study. We continue to be encouraged by the safety profile of KVA12123, supporting advancement to higher doses," said Thierry Guillaudeux, Ph.D., Chief Scientific Officer of Kineta. "KVA12123 has a best-in-class potential that may offer patients a novel approach to address immunosuppression in the tumor microenvironment to better manage solid tumor cancers."
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.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.