Zumutor Receives FDA Response on Pre-Investigational New Drug (PIND) Application for its Novel NK cell Therapeutics ZM008 Against Locally Advanced or Metastatic Solid Tumors
– FDA provides very specific recommendation for the proposed ZM008 program
– Company intends to submit an IND application for ZM008 this year against locally advanced or metastatic solid tumours
Dated 6th June, 2022
Zumutor Biologics, a next generation Tumor-Directed IO therapeutics announced today 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.
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.”
About Zumutor Biologics
Zumutor is a next generation Tumor-Directed IO therapeutics company driving transformational change by harnessing the power of NK cells in modulating the Tumor Micro Environment (TME). Zumutor’s proprietary Antibody discovery platforms: INABLR® which combines phage and yeast surface display technologies to isolate human antibody molecules from a high diversity human antibody library. The rapid and robust INABLR® platform empowers Zumutor’s product pipeline and provides an end-to-end service for our partner’s programs – to discover and develop novel therapeutic mAbs against multiple disease targets. The lead asset ZM008 is well on its way to an IND filing by 2022 followed by Phase 1 studies. For more information, please visit Zumutor.com.
About Zumutor’s ZM008
ZM008 is a first-in-class, fully humanized immunoglobin G1 (IgG1) that targets LLT1 with high specificity and blocks the LLT1/CD161 interaction. As indicated by in vitro and in vivo nonclinical studies, ZM008 treatment induced NK cell activation and tumor cell cytotoxicity via the ADCC mechanism. Findings from the cell line-derived xenograft model (HuNOG-EXL) demonstrated the anti-tumor efficacy of ZM008. Moreover, no adverse effects in the specialized endpoints tested were observed in the non-GLP toxicology study in Cynomolgus monkeys. Currently CMC development and GLP toxicity study for ZM008 are near completion to generate data for IND submission.
Ms Kavitha Iyer Rodrigues