The U.S. Food and Drug Administration (FDA) has announced clearance to Indaptus Therapeutics’ (NASDAQ:INDP) Investigational New Drug (IND) application for a Phase 1 clinical trial of its drug candidate Decoy20 in patients with advanced solid tumors where currently approved therapies have failed.
The Phase 1 clinical trial is dose escalation and expansion study evaluating the safety, tolerability and preliminary efficacy of Decoy20 in patients with advanced solid tumors.
Jeffrey Meckler, Chief Executive Officer, stated, “This is an important milestone for Indaptus, which brings us one step closer to our goal of demonstrating the utility of a multi-targeted and antigen-agnostic, systemic immunotherapy that primes and activates both innate and adaptive anti-tumor immune responses”.
The company anticipates to initiate the clinical trial in the second half of 2022.
Indaptus is trading high 18 percent at $2.95 in the pre-market session.