Indaptus Therapeutics Activates Morristown Medical Center as Trial Site in INDP-D101, Its Ongoing Phase 1 Open Label Clinical Trial of Decoy20 in Patients With Advanced Solid Tumors

Indaptus Therapeutics, Inc. recently announced the addition of Morristown Medical Center, part of the Atlantic Health System, as a new clinical trial site for INDP-D101, the company’s first-in-human, open label, dose escalation and expansion, multicenter Phase 1 clinical trial of its lead compound Decoy20 in patients with advanced/metastatic solid tumors. Patient screening at the Morristown, NJ, hospital is expected soon.

“The continued expansion of trial sites will help to facilitate a potentially more rapid enrollment and get us to our initial data points, which, in turn will continue to facilitate the development of what we believe is a potentially important innovation in the treatment of solid tumors,” said Jeffrey Meckler, Indaptus Therapeutics’ CEO. “We look forward to collaborating closely with the investigators at Morristown Medical Center, and all of clinical trial sites, which we hope to be opening in succession in the coming weeks.”

The study’s objectives are to assess the safety and tolerability of Decoy20, to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D), as well as to assess Decoy20 pharmacokinetics (PK), pharmacodynamics and clinical activity.

The Phase 1 study will begin with a single dose escalation part followed by an expansion part with continuous administration of Decoy20. The study will enroll patients with advanced/metastatic solid tumors, who have exhausted the other known treatment options. More information can be found at www.clinicaltrials.gov.

Primary endpoint of the study is incidence, relatedness and severity of adverse events and treatment-emergent adverse events and determining the number of subjects per cohort with dose limiting toxicity-based adverse events.  Secondary endpoints include the incidence of anti-drug antibodies and neutralizing antibodies pre- and post-treatment, change in Decoy20 PK parameters over time, objective response rate in subjects with measurable disease and duration of response. More information can be found at www.clinicaltrials.gov.

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 the 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 to produce a multiple TLR agonist Decoy platform, with expected reduced systemic toxicity, and ability to prime or activate many of the cells and pathways of innate and adaptive immunity.

Decoy20 represents an antigen-agnostic technology that has produced in pre-clinical studies 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 with standard pre-clinical models, including syngeneic mouse tumors and human tumor xenografts. In those pre-clinical studies tumor eradication has been observed with Decoy products in combination with anti-PD-1 checkpoint therapy, low-dose chemotherapy, non-steroidal anti-inflammatory drug 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 iv dose of Decoy product, with associated “cold” to “hot” tumor inflammation signature transition. IND-enabling toxicology studies have demonstrated safe iv 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.