On March 7, 2023 Indaptus Therapeutics, Inc. (Nasdaq: INDP, "Indaptus" or "the Company"), a biotechnology company focused on discovering and developing transformative therapeutics for patients, reported the dosing of the first subject in INDP-D101 (Press release, Indaptus Therapeutics, MAR 7, 2023, View Source;qmodStoryID=6511274850645070 [SID1234628271]). INDP-D101 is 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.
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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, Ph.D., 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.