On April 8, 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 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in San Diego, CA an update on its ongoing VISTA-101 Phase 1/2 clinical trial evaluating KVA12123, an anti-VISTA monoclonal antibody, as monotherapy and in combination with Merck’s anti-PD1 therapy, KEYTRUDA (pembrolizumab), in patients with advanced solid tumors (Press release, Kineta, APR 8, 2024, View Source [SID1234641854]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

The poster presentation #CT068: "Interim results of the ongoing phase 1/2 clinical trial of KVA12123, an engineered IgG1 targeting VISTA, alone and in combination with pembrolizumab in advanced solid tumors" was presented Monday, April 8, 2024 and reported the following findings (the data cutoff date was February 28, 2024):

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:
o
Partial Response in 1 mucoepidermoid carcinoma patient with a 54% reduction in target lesions and a complete response in non-target lesions
o
Stable disease in 1 renal cell carcinoma patient that had progressed on prior CPI therapy with a 24% reduction in target lesions
•
Eight patients remain on-treatment

Biomarkers

•
Dose-dependent induction of on-target pro-inflammatory cytokines and chemokines
•
Dose-dependent increases in activated 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 to present our progress on the VISTA-101 clinical trial at AACR (Free AACR Whitepaper) this year, with the initial clinical response data and the durability of patient benefit emerging from the study. The safety profile of KVA12123 to date has been remarkable in the monotherapy as well as combotherapy cohorts, supporting advancement to the final monotherapy dosing cohort of KVA12123 and reaching the estimated optimal therapeutic dose," said Thierry Guillaudeux, Ph.D., Chief Scientific Officer of Kineta. "Initial read-outs demonstrated that KVA12123 is not only safe but exhibits potential clinical benefit for some patients as either monotherapy or combotherapy and may offer patients a novel approach to address immunosuppression in the tumor microenvironment and better manage solid tumor cancers." In February 2024, the company announced 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 the previously disclosed 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.