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Kineta updates KVA12123 clinical results from ongoing Phase 1/2 VISTA101 study
The Fly

Kineta updates KVA12123 clinical results from ongoing Phase 1/2 VISTA101 study

Kineta (KANT)announced at the Society for Immunotherapy in Cancer in Houston, TX 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-PD-1 therapy, KEYTRUDA, in patients with advanced solid tumors. KVA12123 cleared all six monotherapy dose levels and the second of four cohorts in combination with pembrolizumab. KVA12123 was well tolerated with no dose limiting toxicities and a favorable safety profile at all dose levels in both arms of the study. The poster presentation: “A phase 1/2 clinical trial of antiVISTA – KVA12123 alone and in combination with pembrolizumab in patients with advanced solid tumors” was presented by Dr. Jason Henry, M.D., Sarah Cannon Research Institute at HealthONE, Denver, CO, on Friday November 8, 2024 at 9 a.m. CST. The update included the following findings: Monotherapy Dose Escalation: Of the 24 patients enrolled in the six monotherapy dose cohorts, 19 patients had at least one follow-up scan and 13 of these patients experienced stable disease. Durable clinical outcomes have been observed in a number of monotherapy patients with one patient with non-small cell lung cancer that failed six prior lines of therapy, including checkpoint inhibitor therapy, experiencing stable disease lasting 60 weeks. Nine of 24 monotherapy patients had prior CPI exposure. Combination Therapy Dose Escalation: Nine patients have been enrolled in the two combination cohorts with at least one follow-up scan: iCR and iPR responses have been observed and the combination has been well tolerated. Confirmed Partial Response in one mucoepidermoid carcinoma patient with a 54% reduction in target lesions and a confirmed complete response in non-target lesions. Stable disease in one renal cell carcinoma patient that had progressed on prior CPI therapy with a 24% reduction in target lesions. Two remaining combination cohorts are expected to be fully enrolled by year-end. Safety: No DLTs observed in any patient at any dose level in either study arm. A very clean safety profile with few adverse events. On July 8, 2024, 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 $5 million nonrefundable payment from TuHURA in July 2024. In August 2024, Kineta announced that in collaboration with TuHURA, it reopened enrollment in the VISTA-101 clinical trial. Kineta and TuHURA continue to collaborate on the ongoing Phase 1 clinical program in patients with advanced solid tumor cancer. On October 2, 2024, Kineta announced that TuHURA was exercising its right to extend their exclusivity and right of first offer pursuant to the terms of the Agreement.

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