Indaptus Therapeutics Announces Positive Results From Second Cohort of Phase 1 Trial; Company Initiates Multi-Dose Cohort

Indaptus Therapeutics, Inc. recently announced positive results from the second cohort of its Phase 1 INDP-D101 trial. Patients continue to exhibit a broad immune response similar to the first cohort. The preliminary results of this study were reviewed by the company and an independent Safety Review Committee. Based on this review, it was recommended that the company continue the trial and enroll patients for multiple doses of its lead therapeutic candidate, Decoy20. The company has immediately started screening potential patients.

Jeffrey Meckler, Indaptus’ Chief Executive Officer, said “We have now confirmed the safety requirements necessary to advance our Phase 1 trial of Decoy20 to multi-dosing. The ability to do so is based on positive safety outcomes in the single dose regimen as well as the anti-cancer activity we observed from multi-dosing in our pre-clinical models.”

The primary goal of the next stage of the trial is to determine the safety of Decoy20 when administered multiple times to the same patient, and to begin to examine the efficacy across multiple types of cancer. In animal models, Decoy20 was shown to be safe in several multiple dosing schedules.

“The advancement to multi-dosing is our opportunity to potentially demonstrate what we saw in our preclinical models, namely, that multiple doses given consistently over time produce systemic immune responses that promote significant anti-tumor activity across multiple tumor types,” added Dr. Michael Newman, Indaptus’ Founder and Chief Scientific Officer.

Dr. Roger Waltzman, Indaptus’ Chief Medical Officer, also added, “While our Phase 1 trial is designed for safety and tolerability, it also provides our first opportunity to demonstrate the potential of our therapy in humans. We look forward to seeing how patients in this cohort tolerate and respond to Decoy20, which will also be instructive as we progress toward Phase 2.”

Indaptus Therapeutics has evolved from more than a century of immunotherapy advances. The company’s novel approach is based on the hypothesis that efficient activation of both innate and adaptive immune cells and pathways 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 producing a multiple Toll-like receptor (TLR), Nucleotide oligomerization domain (NOD)-like receptor (NLR) and Stimulator of interferon genes (STING) agonist Decoy platform. The product candidates are designed to have reduced i.v. toxicity, but largely uncompromised ability to prime or activate many of the cells and pathways of innate and adaptive immunity. Decoy product candidates represent an antigen-agnostic technology that have produced 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, pancreatic and non-Hodgkin’s lymphomas in standard pre-clinical models, including syngeneic mouse tumors and human tumor xenografts. In pre-clinical studies tumor eradication was observed with Decoy product candidates in combination with anti-PD-1 checkpoint therapy, low-dose chemotherapy, a non-steroidal anti-inflammatory drug, or an approved, targeted antibody. Combination-based tumor eradication in pre-clinical models produced innate and adaptive immunological memory, involved activation of both innate and adaptive immune cells, and was 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, nonclinical toxicology studies demonstrated i.v. administration without sustained induction of hallmark biomarkers of cytokine release syndromes, possibly due to passive targeting to liver, spleen, and tumor, followed by rapid elimination of the product. Indaptus’ Decoy product candidates have also produced significant single agent activity against chronic hepatitis B virus (HBV) and chronic human immunodeficiency virus (HIV) infections in pre-clinical models.