Kineta Reports Initial Clinical Response Data at AACR 2024 of its Ongoing Phase 1/2 VISTA-101 Clinical Trial

Partial response and stable disease reported in combination cohort, and durable stable disease observed in monotherapy cohorts

Favorable clinical safety and tolerability profile observed with no dose limiting toxicities and no evidence of CRS-associated cytokines observed at any dose level

Cleared fifth of six monotherapy cohorts and second of four combination cohorts

SEATTLE, April 08, 2024 (GLOBE NEWSWIRE) -- Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, announced today at the American Association for Cancer Research (AACR) 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.

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 patients 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:
  • Partial Response in 1 mucoepidermoid carcinoma patient with a 54% reduction in target lesions and a complete response in non-target lesions
  • 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