Indaptus Therapeutics (NASDAQ: INDP) , a clinical-stage biotechnology company, has reported its financial results for the fourth quarter and fiscal year 2024, highlighting progress in its Phase 1 trial of Decoy20 and outlining strategic goals for 2025. According to recent updates, the company’s stock has surged, and new data demonstrates successful broad immune system activation in weekly dosing trials of its lead candidate.
Indaptus Q4 Financial Results
For the fourth quarter of 2024, Indaptus reported increased research and development expenses of $2.5 million, up from $2.0 million in Q4 2023, driven by higher costs associated with the Decoy20 Phase 1 clinical trial1. General and administrative expenses decreased to $1.7 million from $2.2 million in the same period last year, reflecting lower legal fees and administrative costs. The company’s cash position as of December 31, 2024, stood at $5.8 million, compared to $13.4 million at the end of 20231. To bolster its financial position, Indaptus secured additional funding through a $2.0 million private placement and established a $20 million equity line of credit with Yorkville in early 2025.
Decoy20 Clinical Progress
Significant strides were made in the Phase 1 trial of Decoy20, with over 20 patients enrolled in the weekly dosing cohort. Early data revealed promising results, including stable disease in some patients and favorable pharmacodynamic immune activation biomarkers1. The drug demonstrated a promising safety profile and potential efficacy as both a monotherapy and combination therapy2.
On March 18, building on these positive outcomes, Indaptus announced that it has advanced to a new expansion arm of its Phase 1b/2 clinical trial of Decoy20. This expansion will evaluate the combination of Decoy20 with BeiGene’s (NASDAQGS: ONC) PD-1 checkpoint inhibitor, tislelizumab, with a focus on safety, dose optimization, and early signs of anti-tumor activity.
Jeffrey Meckler, CEO, Indaptus Therapuetics, Inc. (NASDAQ: INDP)
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. While this initial phase will focus on safety and tolerability, we are laying the groundwork for what could be a game-changing approach to treating solid tumors. This combination trial is not just a milestone – it’s an opportunity to showcase our platform’s versatility and move one step closer to improving patient outcomes.” Indpatus further highlighted the following:
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Initial participants will first receive one week of Decoy20 monotherapy intravenously before starting the combination treatment with Decoy20 + tislelizumab.
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The first few patients in the combination phase will be enrolled sequentially to monitor safety.
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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.
Checkpoint inhibitors such as tislelizumab have improved outcomes in a variety of 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.
PD-1 inhibitors work by blocking the PD-1 (programmed death-1) receptor on T cells, preventing cancer cells from evading the immune system and restoring the body’s ability to fight cancer. Combining checkpoint inhibitors with immune system activators like Decoy20 could provide a more powerful and sustained anti-tumor response.
The Indaptus Approach
Indaptus is committed to advancing innovative therapies that harness the immune system to fight cancer. With the launch of this combination trial, the Company is taking a major step towards realizing the full potential of its Decoy platform. Their platform is based on the hypothesis that highly efficient anti-tumor immunotherapy will require safe activation of both innate and adaptive cellular immunity in both tumors and immune organs, and that this might be achieved with a multi-targeted package of bacterial PAMPs, in the form of attenuated and killed, intact but non-pathogenic bacteria delivered intravenously. While current therapies are increasingly becoming more and more personalized and costly, they are advancing an approach designed to be widely accessible, with broad anti-tumor and anti-viral activity not dependent on the targeting of specific tumor or viral antigens. Furthermore, generation and/or activation of the cells required for innate and adaptive anti-tumor and anti-viral immune responses takes place, to a significant extent, outside of the tumor or sites of infection, including in the spleen. Indataptus’ intravenous therapeutic candidates are expected to passively target the liver, spleen, and leaky vasculature of tumors, producing immune activation in an immune organ, as well as a common site for primary and metastatic cancer and HBV infection, the liver. As their therapeutic candidates are expected to be cleared very quickly by the liver and spleen, they anticipate a low risk of non-specific autoimmune side effects relative to other types of immunotherapies designed for continuous exposure.
Strategic Goals for 2025
Focusing on future growth and clinical advancement, Indaptus has outlined key objectives for 2025. The company plans to expand clinical trial sites to accelerate patient enrollment, aiming to provide regular updates on weekly dosing cohorts and initiate combination studies1. Additionally, Indaptus intends to nominate a new candidate for IND-enabling studies based on the expansion of their Decoy platform technology2. These strategic goals underscore the company’s commitment to advancing innovative immunotherapy approaches while maintaining financial discipline to support its ambitious growth trajectory.
CMO360 Summit April 7-8 Boston
Indaptus’ chief medical officer, Roger Waltzman, M.D., M.B.A. will be moderating a panel at the annual CMO360 Summit, being held April 7-8 in Boston. Dr. Waltzman’s panel, titled “Ensuring Effective and Efficient Trials Through Clinical Operations” will be Monday, April 7th from 4:05PM – 4:35PM ET. Jeffrey Meckler, Indaptus CEO, commented, “These opportunities serve as continued validation for our approach to clinical trial management, reinforcing its potential to enhance efficiency, an essential factor in our industry. We appreciate this esteemed conference’s recognition and look forward to Roger’s panel, anticipating valuable insights from the discussion.”
The CMO Summit 360° ®, operated by The Conference Forum, is the largest gathering of biotech Chief Medical Officers across indications, modalities, company stages, professional experience levels and geographic locations. This is the conference to connect with peers and develop the skills needed to succeed as a biotech CMO. The Conference Forum is a life science industry research, conference development and marketing firm. The company brings the full spectrum of executives together to share ideas and information on how to advance efficient medicine development and delivery, patient diversity and access.
