Kineta Announces Successful Completion of Pre-IND Meeting with the FDA for KVA12.1

On July 27, 2021 Kineta, Inc., a clinical stage biotechnology company focused on the development of novel immunotherapies in oncology, reported that it successfully completed a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding the manufacturing, preclinical and clinical development plan for KVA12.1 (Press release, Kineta, JUL 27, 2021, View Source;utm_medium=rss&utm_campaign=kineta-announces-pre-ind-meeting-for-kva12-1 [SID1234585217]). Kineta has gained alignment with FDA on the initial Phase 1/2 clinical trial of the safety and efficacy of Kineta’s KVA12.1 as a single agent and in combination with pembrolizumab in patients with unresectable or metastatic solid tumors.

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!

"We greatly appreciate the FDA’s guidance as we prepare to advance our novel anti-VISTA immunotherapy into the clinic next year", said Shawn Iadonato, PhD, Chief Executive Officer of Kineta. "The successful completion of this engagement with the FDA is an important milestone that provides regulatory clarity for KVA12.1 and confidence with the planned development program for this novel anti-cancer immunotherapy.

A pre-IND meeting provides an opportunity for an open communication between a drug development company and the FDA to discuss the IND development plan and to obtain the agency’s guidance for clinical studies of the company’s new drug candidate. The FDA reviewed the IND enabling preclinical data, manufacturing plan and phase 1/2 clinical study protocol synopsis for KVA12.1, provided guidance and addressed Kineta’s questions on the development plan. Kineta plans to initiate the Phase 1/2 first-in-human clinical studies in mid-2022.