On June 6, 2022 Zumutor Biologics, a next generation Tumor-Directed IO therapeutics reported that the Company has received a written response from the U.S. Food and Drug Administration (FDA) in regards to its pre-investigational new drug (PIND) application for its novel monoclonal antibody ZM008 developed to treat various locally advanced or metastatic solid tumours (Press release, Zumutor Biologics, JUN 6, 2022, View Source [SID1234616460]).

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The Company plans to initiate actions on the FDA’s recommendations and follow up with the FDA with an Investigational New Drug (IND) application by the Q3 of 2022 followed by Phase I studies.

Ms Kavitha Iyer Rodrigues Chief Executive Officer of Zumutor, commented, "We appreciate the FDA’s thoughtful guidance on the proposed chemistry, manufacturing and control (CMC), nonclinical and clinical development program of our novel monoclonal antibody ZM008. We intend to address the recommendations made by the FDA and are committed to the successful completion of the required clinical trials of ZM008 to provide an effective and safe therapy for various solid tumors."