Indaptus Starts Phase 1 Study of Decoy20 with PD-1 Inhibitor Tislelizumab

Indaptus Therapeutics, Inc., a biotechnology company committed to pioneering new treatments for cancer and viral infections, has announced a significant advancement in its clinical research. The company is progressing to an expansion arm of its Phase 1b/2 clinical trial involving Decoy20, a promising therapeutic candidate. This trial will now explore the effects of combining Decoy20 with the PD-1 checkpoint inhibitor tislelizumab, provided by BeiGene. The primary goals of this study are to assess safety, optimize dosage, and observe preliminary anti-tumor activity.

Jeffrey Meckler, the CEO of Indaptus, highlighted the importance of this development, emphasizing the potential of Decoy20 to enhance the effectiveness of checkpoint inhibitors. While the initial focus of this phase is on safety and tolerance, it lays the foundation for what might become a transformative treatment for solid tumors. Meckler views this combination trial as not merely a milestone but as an opportunity to demonstrate the versatility of their platform and its potential to significantly improve patient outcomes.

Checkpoint inhibitors, such as tislelizumab, have yielded positive results across various cancers; however, a significant number of patients either do not respond or do not benefit from long-term effects. Decoy20 is designed to activate the immune system, potentially broadening the efficacy of checkpoint inhibitors.

In this combination trial, initial participants will receive one week of Decoy20 monotherapy before starting the combined treatment with Decoy20 and tislelizumab. The initial participants will be enrolled in a sequential manner to ensure safety, and following a review by the Safety Review Committee, unrestricted enrollment will commence. The trial permits participants to receive the combined treatment for up to one year, or until disease progression, unacceptable toxicity, or voluntary withdrawal occurs.

PD-1 inhibitors function by blocking the PD-1 receptor on T cells, which prevents cancer cells from evading the immune system. This blockage allows the body to regain its natural ability to combat cancer. By combining checkpoint inhibitors with immune activators like Decoy20, there is potential to create a more robust and enduring anti-tumor response.

Indaptus Therapeutics is devoted to advancing innovative therapies that leverage the immune system to fight cancer. The initiation of this combination trial marks a substantial step in realizing the potential of their Decoy platform.

Indaptus Therapeutics has a rich background rooted in over a century of immunotherapy advancements. The company's unique approach is based on the hypothesis that both innate and adaptive immune responses can be effectively activated through a multi-targeted package of immune signals, administered safely via intravenous means. Indaptus’ proprietary technology utilizes single strains of attenuated, non-pathogenic bacteria engineered to produce a variety of immune system activators.

The Decoy product candidates, including Decoy20, have been designed to maintain the ability to prime or activate numerous immune cells and pathways while reducing intravenous toxicity. This antigen-agnostic technology has shown promising results in pre-clinical models, demonstrating significant activity against various carcinomas and lymphomas both as a single agent and in combination with other therapies.

Pre-clinical studies have indicated that Decoy candidates, when combined with anti-PD-1 therapy, low-dose chemotherapy, or other treatments, can result in tumor eradication. These studies revealed the transition of tumor inflammation from a "cold" to "hot" signature, implicating the activation of immune pathways.

Indaptus’ Decoy candidates have also shown potential against chronic infections such as hepatitis B and HIV in pre-clinical trials, underscoring their broad therapeutic potential. The company’s efforts in developing these candidates reflect its dedication to addressing significant unmet needs in cancer and viral infection treatment.