Indaptus Therapeutics Announces FDA Clearance of Investigational New Drug Application to Initiate Phase 1 Clinical Trial of Decoy20 in Solid Tumors
May 19, 2022
NEW YORK (May 19, 2022) – Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus” or the “Company”), today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for a Phase 1 clinical trial in patients with advanced solid tumors where currently approved therapies have failed. The Company plans to initiate the clinical trial in the second half of 2022.
“We are excited to begin our first in human study of Decoy20, as there is still a significant unmet medical need for patients with advanced solid tumors. 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,” said Jeffrey Meckler, Chief Executive Officer of Indaptus.
“Tumors remodel and inhibit systemic immune responses and Indaptus’ Decoy technology is unique in its ability to mobilize both innate and adaptive anti-tumor immune pathways with systemic administration in pre-clinical tumor models, while at the same time not inducing sustained hallmarks of cytokine release syndromes in pre-clinical toxicology studies,” said Dr. Michael Newman, Founder and Chief Scientific Officer of Indaptus.
“The trial is a Phase 1, open-label dose escalation and expansion study evaluating the safety, tolerability and preliminary efficacy of Decoy20 in patients with advanced solid tumors. We look forward to demonstrating the safety profile of Decoy20 and developing an effective, novel therapy for cancers unresponsive to existing approved therapies,” continued Mr. Meckler.
About the Phase 1 Study
The Phase 1 study is designed to evaluate the safety, tolerability, and preliminary efficacy of Decoy 20 and will follow a 3+3 design of dose-escalation cohorts. The study protocol allows for exploration of additional dosing regimens, including continuous weekly administration after initial safety has been established. Decoy20 has the potential to treat a wide range of solid tumors including hepatocellular, colorectal and pancreatic carcinomas.
About Indaptus Therapeutics
Indaptus Therapeutics has evolved from more than a century of immunotherapy advances. The Company’s approach is based on the hypothesis that efficient activation of both innate and adaptive immune cells and associated anti-tumor and anti-viral immune responses will require a multi-targeted package of immune system activating signals that can be administered safely intravenously. Indaptus’ patented technology is composed of single strains of attenuated and killed, non-pathogenic, Gram-negative bacteria, with reduced i.v. toxicity, but largely uncompromised ability to prime or activate many of the cellular components of innate and adaptive immunity. Decoy20 represents an antigen-agnostic technology that has produced significant single agent activity against metastatic pancreatic and orthotopic colorectal carcinomas, single agent eradication of established, antigen-expressing breast carcinoma, as well as combination-mediated eradication of established hepatocellular carcinomas and non-Hodgkin’s lymphomas in standard pre-clinical models, including syngeneic mouse tumors and human tumor xenografts. Tumor eradication has been observed with Decoy products in combination with anti-PD-1 checkpoint therapy, low-dose chemotherapy or an approved targeted antibody. Combination-based tumor eradication produces innate and adaptive immunological memory, involves activation of both innate and adaptive immune cells and is associated with induction of innate and adaptive immune pathways in tumors after only one i.v. dose of Decoy product, with associated “cold” to “hot” tumor inflammation signature transition. IND-enabling toxicology studies have demonstrated safe i.v. administration, with no sustained induction of hallmarks of cytokine release syndromes, possibly due to passive targeting to liver, spleen and tumor, followed by rapid elimination of the product. Indaptus products have also produced significant single agent activity against chronic hepatitis B virus (HBV) and chronic human immunodeficiency virus (HIV) infections in pre-clinical models.
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