Indaptus Therapeutics Doses First Subject in its Ongoing Phase 1 Open Label Clinical Trial of Decoy20 in Patients With Advanced Solid Tumors

Indaptus Therapeutics, Inc. recently announced the dosing of the first subject in 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.

After Decoy20 dosing, the subject experienced expected and manageable adverse events believed to be related to the immune system activating components known to be in the product. A second subject in the first three-subject cohort is expected to be enrolled following final assessment of the safety and tolerability associated with dosing of the first subject, per the study protocol.

“Following dosing of our first subject in INDP-D101, we are optimistic regarding our expectations for this part of the trial,” said Michael Newman, PhD, the company’s Founder and Chief Scientific Officer. “Our hypothesis for the invention and development of Decoy20 was based on attenuation and killing of non-pathogenic bacteria to produce a product with a novel, less toxic and potentially more effective ratio of immune stimulating components. We are encouraged that the initial adverse event profile exhibited by our first subject appears to be consistent with this hypothesis.”

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 was initiated with a single dose escalation, which is planned to be followed by an expansion with continuous weekly administration of Decoy20. The study is enrolling patients with advanced/metastatic solid tumors, who have exhausted approved treatment options. More information can be found at www.clinicaltrials.gov.

The primary endpoint of the study is incidence, relatedness and severity of adverse events and treatment-emergent adverse events and determination of 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 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 (iv). Indaptus’ patented technology is composed of single strains of attenuated and killed, non-pathogenic, Gram-negative bacteria producing a multiple Toll-like receptor (TLR) agonist Decoy platform. The products are designed to have reduced iv toxicity, but largely uncompromised ability to prime or activate many of the cells and pathways of innate and adaptive immunity.

Decoy products 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 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 products 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 iv dose of Decoy product, with associated “cold” to “hot” tumor inflammation signature transition.

IND-enabling, nonclinical toxicology studies demonstrated safe iv 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 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.