Indaptus Reports Positive Phase 1 Trial Outcomes and Advances to Multi-Dose Phase

Indaptus Therapeutics, a company focused on developing treatments for cancer and viral infections, has reported encouraging outcomes from the second group of participants in its Phase 1 clinical trial for a drug candidate called Decoy20. The independent Safety Review Committee endorsed moving forward to a phase involving multiple doses for the drug, based on the positive immune response data observed, which was consistent with the first group's results. The single-dose data is anticipated to be presented at a scientific event later this year.

The company, led by CEO Jeffrey Meckler, has confirmed that the safety criteria for advancing to a multi-dose phase have been met, citing positive safety from the initial dosing and anti-cancer effects from multi-dosing in pre-clinical studies. The upcoming phase aims to assess the safety of repeated Decoy20 administration and to explore its effectiveness across various cancer types. Decoy20 has demonstrated safety in animal models with multiple dosing schedules.

Dr. Michael Newman, the company's founder and Chief Scientific Officer, highlighted the potential of consistent multi-dose treatments to elicit strong immune responses against different tumor types. Dr. Roger Waltzman, the Chief Medical Officer, expressed optimism about the Phase 1 trial's ability to showcase the therapy's potential in humans and its implications for the transition to Phase 2.

Indaptus Therapeutics' approach is rooted in over a century of immunotherapy advancements, focusing on activating both innate and adaptive immune cells to combat tumors and viruses. The company's patented Decoy platform involves the use of specific bacteria strains to stimulate multiple immune responses with reduced toxicity. These candidates have shown activity against various cancers and infections, including pancreatic, colorectal, breast, hepatocellular carcinomas, and lymphomas, both as standalone treatments and in combination with other therapies.

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