Le Lézard
Classified in: Health, Science and technology
Subjects: TRI, FDA

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

SEATTLE, July 27, 2021 /PRNewswire/ -- Kineta, Inc., a clinical stage biotechnology company focused on the development of novel immunotherapies in oncology, announced today 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.  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.

"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.

Kineta, Inc. is a clinical stage biotechnology company committed to developing disruptive life science technologies that address unmet patient needs.  We have leveraged our expertise in immunology to advance a focused pipeline of investigational drugs in oncology and neuroscience.  We actively collaborate with a broad array of private, government and industry partners to advance our innovative products.  For more information on Kineta visit our website, www.kinetabio.com, follow us on Twitter at @kinetabio, LinkedIn and Like us on facebook.com/KinetaBio.

NOTICE: This document contains certain forward-looking statements, including without limitation statements regarding Kineta's plans for pre-clinical and clinical studies, regulatory filings, investor returns and anticipated drug effects in human subjects. You are cautioned that such forward-looking statements are not guarantees of future performance and involve risks and uncertainties inherent in Kineta's business which could significantly affect expected results, including without limitation progress of drug development, ability to raise capital to fund drug development, clinical testing and regulatory approval, developments in raw material and personnel costs, and legislative, fiscal, and other regulatory measures. All forward-looking statements are qualified in their entirety by this cautionary statement, and Kineta undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.

Contact Jacques Bouchy
(206) 378-0400

SOURCE Kineta, Inc.

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News published on 27 july 2021 at 08:39 and distributed by: