Indaptus Therapeutics (INDP) FDA Approvals

Indaptus Therapeutics' Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Indaptus Therapeutics (INDP). Over the past two years, Indaptus Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Decoy20. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Decoy20 FDA Regulatory Timeline and Events

Decoy20 is a drug developed by Indaptus Therapeutics for the following indication: Advanced Solid Tumors. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Dosing Update - June 2,2025

Phase 1b/2

• Drug: Decoy20
• Announced Date: June 2, 2025
• Indication: Advanced Solid Tumors

Indaptus Therapeutics, announces that the first patient has been dosed in the expansion arm of its Phase 1b/2 clinical trial evaluating Decoy20 in combination with BeOne's (formerly known as Beigene) PD-1 checkpoint inhibitor, tislelizumab.Inc.

Indaptus Therapeutics, a clinical-stage biotechnology company, announced a major milestone in its Phase 1b/2 clinical trial by dosing the first patient in the expansion arm of its study. This trial examines the combination of Decoy20 with BeOne’s PD-1 checkpoint inhibitor, tislelizumab, in patients with advanced solid tumors. The study is designed to evaluate safety, determine the optimal dose, and detect early signs of anti-tumor activity, particularly in patients whose tumors have not responded to previous checkpoint inhibitor therapies or are typically unresponsive.

Preclinical studies have shown that Decoy20 works well with checkpoint inhibitors, boosting immune responses against tumors. By combining these treatments, Indaptus aims to enhance cancer therapy and offer a promising new option for patients who do not benefit from existing treatments. This clinical milestone is an important step toward potentially improving outcomes for advanced cancer patients.

Provided Update - March 20,2025

Phase 1

• Drug: Decoy20
• Announced Date: March 20, 2025
• Indication: Advanced Solid Tumors

Indaptus Therapeutics, Inc. y provided an update on key pharmacodynamic findings from the weekly dosing cohort of its ongoing Phase 1 trial of Decoy20.

Indaptus Therapeutics, Inc. recently shared new findings from the weekly dosing cohort in its ongoing Phase 1 trial of Decoy20. The company enrolled more than 20 patients who received a 30-million cell dose, and the treatment was generally well-tolerated. Early data shows a favorable safety profile and hints of clinical benefit, as some patients experienced stable disease.

In addition to triggering short-term increases in key immune system biomarkers like cytokines and chemokines, Decoy20 demonstrated broad, blood-based immune cell trafficking. This result means that there are transient weekly changes in levels of important immune cells, suggesting that the cells are moving from the bone marrow or to tissues. These insights support the potential of Decoy20 to modulate the immune system and its promise in anti-tumor therapy.

Study Initiation - March 18,2025

Phase 1

• Drug: Decoy20
• Announced Date: March 18, 2025
• Indication: Advanced Solid Tumors

Indaptus Therapeutics Tells Benzinga Co. Initiates Phase I Combination Study Of Decoy20 With PD-1 Checkpoint Inhibitor Tislelizumab

Indaptus Therapeutics has advanced to a new phase in its clinical trial by studying a combination treatment of its Decoy20 with tislelizumab, a PD-1 checkpoint inhibitor. The Phase I trial aims to test the safety, optimal dosing, and initial anti-tumor activity of the drug pairing. Initially, patients will receive one week of Decoy20 as a stand-alone treatment. After this, they will begin a combination regimen with tislelizumab, with the first few patients enrolled sequentially to closely monitor safety before transitioning to unrestricted enrollment.

This study will help determine if Decoy20 can boost the body’s immune response and enhance the effectiveness of checkpoint inhibitors like tislelizumab in treating various cancers. The trial represents an important step to explore new treatment methods for patients who have limited or short-lived responses to existing cancer therapies.

Provided Update - March 13,2025

• Drug: Decoy20
• Announced Date: March 13, 2025
• Indication: Advanced Solid Tumors

Indaptus Therapeutics, Inc provides a corporate update.

Indaptus Therapeutics, Inc. provided a corporate update highlighting an important milestone in their Phase 1 trial for Decoy20. The company has enrolled over 20 patients in the weekly dosing cohort, and early clinical data shows promising signs, with several patients demonstrating stable disease. This encourages the company as it explores Decoy20’s potential in treating advanced solid tumors.

The update also mentioned plans to initiate a combination study with BeiGene's PD-1 inhibitor, tislelizumab, in 2025. Indaptus is expanding its clinical trial sites to boost patient enrollment and data collection. The company remains focused on advancing Decoy20’s development both as a standalone therapy and in combination with other treatments, while continuing to monitor the product’s favorable safety profile and further optimize its dosing strategies.

Provided Update - September 5,2024

• Drug: Decoy20
• Announced Date: September 5, 2024
• Indication: Advanced Solid Tumors

Indaptus Therapeutics, Inc. provides an update regarding key clinical advancements.

Indaptus Therapeutics, Inc. recently provided an update on key clinical advancements in its Phase 1 clinical trial of Decoy20. The independent Safety Review Committee reviewed safety data from two dosing schedules: a higher Decoy20 dose given as a single dose and a lower dose given weekly. The encouraging safety outcomes have led the Company to move forward by continuing to dose additional patients at the lower weekly dose while also initiating a weekly dosing schedule at the higher dose. The safety profile observed so far is in line with the drug's expected mechanism of action. Most treatment-related events, like infusion-related reactions and hypotension, have been mild-to-moderate and resolved quickly with simple treatments. The Company aims to gather more safety data to evaluate potential monotherapy activity and to prepare for combination therapy trials in the future.