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NEW YORK - Indaptus Therapeutics, Inc. (NASDAQ: INDP), a clinical-stage biotechnology company with a current market capitalization of $11.72 million, announced the progression of an expansion arm in its Phase 1b/2 clinical trial, assessing the safety and preliminary anti-tumor activity of its Decoy20 treatment in combination with BeiGene’s PD-1 inhibitor, tislelizumab. According to InvestingPro analysis, the company maintains a strong cash position relative to debt, which could support its ongoing clinical development programs. The trial aims to optimize dosing and observe early signs of efficacy in patients with advanced solid tumors.
The company’s CEO, Jeffrey Meckler, stated that this development signifies a crucial advancement for Indaptus and its Decoy platform. While InvestingPro data indicates the company is not currently profitable, with analyst forecasts suggesting continued losses this year, the combination trial is expected to build upon preclinical findings that suggest a synergistic effect when Decoy20 is used with a checkpoint inhibitor, potentially offering a new approach to treating solid tumors.
PD-1 inhibitors like tislelizumab have shown promise in improving cancer outcomes, yet there remains a patient population that does not respond or sustain long-term benefits. Decoy20 is designed to stimulate the immune system in a way that may significantly enhance the efficacy of such treatments.
The initial phase of the trial involves administering Decoy20 alone intravenously for one week, followed by a combination therapy with tislelizumab. The first few patients will be enrolled sequentially to ensure safety, with unrestricted enrollment to follow after a review by the trial’s Safety Review Committee. Participants may receive treatment for up to one year or until they experience disease progression, unacceptable toxicity, or choose to withdraw from the study.
Indaptus Therapeutics leverages over a century of immunotherapy advancements, focusing on activating both innate and adaptive immune responses. The company’s patented technology utilizes non-pathogenic, Gram-negative bacteria to create a platform that primes immune cells and pathways. This antigen-agnostic technology has shown potential in pre-clinical models against various cancers and chronic viral infections such as HBV and HIV.
The forward-looking statements in the press release reflect management’s expectations for the Phase 1 clinical trial of Decoy20 and the Phase 1b/2 combination study, emphasizing the anticipated effects of the product candidates. However, these statements are subject to risks and uncertainties that could cause actual results to differ materially.
This article is based on a press release statement from Indaptus Therapeutics, Inc. With analyst price targets ranging from $5 to $12, significantly above the current trading price of $0.81, investors seeking deeper insights into Indaptus’s financial health and growth prospects can access additional analysis through InvestingPro, which offers exclusive financial metrics and expert insights. For more information about the company, visit www.indaptusrx.com.
In other recent news, Indaptus Therapeutics, Inc. has announced the approval of patents in China, Japan, and Israel for its Decoy platform. These patents cover the use of Decoy bacteria compositions in the prevention and treatment of Hepatitis B virus (HBV) and human immunodeficiency virus (HIV). The company emphasized the significance of these patents in supporting the therapeutic potential of its approach. Meanwhile, Indaptus has also received authorization from Health Canada to expand its U.S. clinical trial for Decoy20 to Canadian sites. This expansion aims to accelerate patient enrollment and enhance research on the treatment of solid tumors. The trial will include Canadian patients under the existing protocol, with plans to propose a combination trial of Decoy20 with Beigene’s tislelizumab. Indaptus’s CEO expressed optimism about the inclusion of Canadian investigators and patients, which is expected to provide a more diverse data set. The company continues to focus on refining Decoy20’s dosing regimen and improving patient outcomes through enhanced trial infrastructure.
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