EXCLUSIVE: Indaptus Therapeutics Starts Phase 1 Combination Study of Decoy20 With BeiGene's Cancer Drug For Advanced Solid Tumors

On Tuesday, Indaptus Therapeutics, Inc. INDP announced it advanced to a new expansion arm of its Phase 1b/2 clinical trial of Decoy20.

The expansion will evaluate the combination of Decoy20 with BeiGene Ltd's ONC PD-1 checkpoint inhibitor, tislelizumab, focusing on safety, dose optimization, and early signs of anti-tumor activity.

• Initial participants will first receive one week of Decoy20 monotherapy intravenously before starting the combination treatment with Decoy20 + tislelizumab. 
• The first few patients in the combination phase will be enrolled sequentially to monitor safety. 
• After review by the trial's Safety Review Committee, unrestricted enrollment will begin. 

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Participants will receive both treatments for up to one year or until disease progression, unacceptable toxicity, or withdrawal from the study.

Jeffrey Meckler, CEO of Indaptus, commented, "This marks a pivotal step forward for Indaptus and our Decoy platform. Preclinical research has consistently shown that Decoy20 works synergistically with a checkpoint inhibitor, and we now have the opportunity to test that in patients for the first time."

The company says checkpoint inhibitors such as tislelizumab have improved outcomes in various cancers, but many patients still do not respond or ultimately do not experience a long-lasting effect.

Decoy20 is engineered to activate the immune system in a manner that is theorized to significantly enhance and broaden the effectiveness of checkpoint inhibitors.

As of December 31, 2024, the company had cash and cash equivalents of $5.8 million. In January 2025, the company conducted a private placement, resulting in net proceeds of $2.0 million.

In February 2025, the company established a $20 million equity line of credit with Yorkville.

The company expects its current cash and cash equivalents to support its ongoing operating activities into the second quarter of 2025. 

Price Action: At the last check on Tuesday, INDP stock was down 3.67% at $0.78 during the premarket session.

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