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Indaptus Therapeutics Activates Emory Winship Cancer Institute as Trial Site in INDP-D101, Its Ongoing Phase 1 Open Label Clinical Trial of Decoy20 in Patients with Advanced Solid Tumors
NEW YORK, March 13, 2023 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP, “Indaptus” or “the Company”), a biotechnology company focused on
About this update from Indaptus Therapeutics, Inc.
[{"type":"text","content":"NEW YORK, March 13, 2023 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP, “Indaptus” or “the Company”), a biotechnology company focused on discovering and developing transformative therapeutics for patients, today announces that Atlanta, Ga.-based Emory Winship Cancer Institute (“Emory”) has become a new clinical trial site for INDP-D101. 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. Emory has begun screening patients. “Emory joining the INDP-D101 trial is both validation of the scientific concepts behind Decoy20 in early testing, as well as acknowledgement of the remaining unmet medical need, and the need for additional hope for patients with advanced solid tumors. Emory is a well renowned center, and we are grateful to include it among the other influential centers we have activated thus far. We hope to continue the pace at which we are activating trial sites in order to more rapidly advance the trial toward 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 Emory, 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 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 antibo...