Business
Indaptus Therapeutics Reports First Quarter 2022 Financial Results and Provides Corporate Update
Announces Submission of Investigational New Drug (IND) Application for Decoy20 On Track to Initiate Phase 1 Clinical Trial of Decoy20 for Treatment of Solid
About this update from Indaptus Therapeutics, Inc.
[{"type":"text","content":"Announces Submission of Investigational New Drug (IND) Application for Decoy20 On Track to Initiate Phase 1 Clinical Trial of Decoy20 for Treatment of Solid Tumors in Second Half of 2022 NEW YORK, May 12, 2022 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP) (\"Indaptus\" or the \"Company”), today announces financial results for the first quarter ended March 31, 2022 and provides a corporate update. “We are delighted to report the submission of our Investigational New Drug (IND) application for systemically administered Decoy20. The timing of this submission keeps us on track to initiate our first in human clinical trial this year and we look forward to working with the FDA as we move through the IND submission process,” said Jeffrey Meckler, Chief Executive Officer of Indaptus. “Decoy20, with its ability to activate both the innate and adaptive immune systems as a multiple Toll-like receptor (TLR) agonist, holds the promise to effectively combat solid tumor cancers, an area where even many of the new immuno-oncology approaches have failed.” “This is a significant milestone for Indaptus as it advances our approach to induce multiple immune system components as a mechanism to combat solid tumors. We look forward to dosing our first patient later this year and to gathering data in support of Decoy20’s fight against cancer,” continued Mr. Meckler. Recent Corporate Highlights Submission of Investigational New Drug Application Today, Indaptus announces the submission of its Investigational New Drug Application (IND) for Decoy20. The Company continues to expect to initiate a Phase 1 clinical trial for Decoy20 targeting solid tumors in 2022. Importantly, the Company has successfully completed GMP manufacturing and IND-enabling multi-dose toxicology studies that have not produced sustained induction of factors associated with cytokine release syndromes. Earlier pre-clinical data have demonstrated Decoy20’s ability to eradicate established tumors in a murine model of hepatocellular carcinoma in combination with either a non-steroidal anti-inflammatory drug (NSAID) or an anti-PD-1 agent, and more efficiently with both. Tumor eradication has occurred with a wide therapeutic index and has led to induction of 100% immunological memory. Mechanism of actions studies have demonstrated activation of innate and adaptive immune pathw...