NEW YORK - Indaptus Therapeutics, Inc. (NASDAQ:INDP), a biotechnology firm engaged in developing treatments for cancer and viral infections, has announced positive outcomes from its Phase 1 INDP-D101 trial's second cohort, leading to the initiation of a multi-dosing cohort.
The independent Safety Review Committee, after examining preliminary results, endorsed the continuation of the trial and the enrollment of patients for multiple doses of Decoy20, the company's lead therapeutic candidate.
The Phase 1 trial aims to evaluate the safety of Decoy20 with multiple administrations to patients and to start assessing its efficacy across various cancer types. The decision to advance to multi-dosing was influenced by favorable safety data from the single dose regimen and pre-clinical models showing anti-cancer activity with multi-dosing.
Jeffrey Meckler, CEO of Indaptus, expressed confidence in the trial's progression, citing the safety profile and observed anti-cancer activity in pre-clinical models as key factors. Dr. Michael Newman, Founder and Chief Scientific Officer, emphasized the potential for multi-dosing to produce systemic immune responses and significant anti-tumor activity across multiple tumor types, as seen in pre-clinical studies.
The company's technology utilizes a multi-targeted package of immune system-activating signals delivered intravenously, based on the use of attenuated and killed, non-pathogenic Gram-negative bacteria. This approach aims to activate innate and adaptive immune cells and pathways to combat tumors and viral infections.
As the trial progresses, Dr. Roger Waltzman, Chief Medical Officer, anticipates valuable insights into the therapy's potential in humans, which will also inform the approach to Phase 2 of the trial.
Indaptus Therapeutics has a history rooted in immunotherapy advances. Its patented technology has demonstrated activity against various cancers and chronic viral infections like HBV and HIV in pre-clinical models.
The information presented in this article is based on a press release statement from Indaptus Therapeutics. The forward-looking statements in the press release reflect the company's expectations and intentions regarding its clinical trial and product candidates but involve risks and uncertainties that could cause actual results to differ. The company's filings with the SEC provide further detail on these risks.
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