Indaptus Therapeutics Presents Positive Mechanism of Action Data at the American Association for Cancer Research Annual Meeting
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The data presented by Indaptus Therapeutics regarding their Decoy platform introduces a noteworthy approach to cancer immunotherapy. By leveraging non-pathogenic bacteria to activate multiple immune cell types, the technology aims to enhance the body's innate and adaptive responses to tumors. This is particularly significant as it addresses a dual approach: direct tumor cell killing and the modulation of the immune system to overcome suppression mechanisms.
From an immunological perspective, the engagement of natural killer cells, T cells and dendritic cells is critical. These cells are essential for the identification and elimination of cancer cells. The synergy with IL-2 is also promising, as IL-2 is a well-known growth factor for T cells and has been used in cancer treatment. The potential to prime the immune system both directly and indirectly could result in a more robust and sustained anti-tumor response, which is a desired outcome in cancer therapy.
However, it is important to note that these results are preliminary. The transition from preclinical models to human efficacy is complex and many candidates fail despite early promise. The ongoing Phase 1 clinical trial will be more telling of the platform's potential efficacy and safety profile.
Indaptus Therapeutics' progression into the multi-dose cohort of its Phase 1 clinical trial in solid tumors represents a critical step in the development of its Decoy platform. The focus on solid tumors is relevant as these types of cancers often present significant challenges in treatment due to their complex tumor microenvironments and immune evasion tactics.
The company's confidence is bolstered by transient increases in cytokines and chemokines following single-dose administration, which are indicative of immune activation. However, it is essential to monitor how this translates into clinical benefits for patients. The safety, tolerability and determination of an optimal dosing regimen will be key factors in the success of the trial. Additionally, the long-term immune response and potential for durable clinical outcomes remain to be seen.
Investors and stakeholders should be cognizant of the inherent risks associated with early-stage clinical development. While the AACR presentation and engagement with the scientific community are positive indicators, the true test will come from rigorous clinical evaluation and peer-reviewed publication of data.
The presentation by Indaptus Therapeutics at the AACR meeting could have implications for the company's market position, especially if the Decoy platform continues to show promise. The biotechnology sector is highly competitive and innovative platforms that can demonstrate a clear mechanism of action and potential efficacy in hard-to-treat conditions like solid tumors can attract significant investor interest.
While the current findings may be encouraging, the biotech market is sensitive to both positive and negative clinical trial outcomes. Investors often react to trial data with volatility in stock prices. For Indaptus, successful Phase 1 results could lead to increased funding opportunities, partnerships and a rise in stock value. Conversely, any setbacks could have a detrimental effect on investor confidence and market perception.
Long-term implications for the company will depend on ongoing trial results, potential FDA approvals and market penetration of the Decoy platform if it reaches commercialization. The ability to overcome immune suppression and improve the efficacy of existing treatments could position Indaptus as a leader in the immunotherapy space, provided the clinical data continues to support the platform's potential.
Results Indicate Decoy Platform Broadly Boosts Immune System's Ability to Fight Tumors Directly and Indirectly
NEW YORK, April 11, 2024 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc, (Nasdaq: INDP), a clinical stage biotechnology company dedicated to pioneering innovative cancer and viral infection treatments, was proud to unveil its poster at the 2024 Annual Meeting of the American Association for Cancer Research (AACR) in San Diego on Wednesday, April 10th. The poster details mechanism of action data that demonstrates the Company’s Decoy platform successfully induces, matures or activates multiple immune cell types involved in anti-tumor responses.
The latest findings significantly enhance the Company’s understanding of its “Decoy” platform technology, which uses killed, non-pathogenic bacteria engineered to activate the immune system to attack tumors. The study highlights the platform's effectiveness in engaging key innate and adaptive immune cells, including, natural killer cells, natural killer T cells, dendritic cells, CD4+, and CD8+ T cells. In some settings, the platform also produced additive or synergistic activity in combination with IL-2, an approved cancer drug. Additionally, the data reveal that the Decoy platform may not only boost the immune system's ability to recognize and kill tumor cells, but potentially also overcome a mechanism that suppresses the immune response. The results suggest that the Company’s Decoy bacteria can both directly and indirectly prime the immune system to more effectively fight cancer.
Dr. Michael Newman, Indaptus’ Founder, Chief Scientific Officer, and lead author, commented, “The new data are consistent with our preclinical animal tumor model studies and provide evidence for our hypothesis that patented Decoy bacteria can activate a wide range of innate and adaptive human immune cells involved in fighting tumors. This aligns with what we’ve observed in our ongoing Phase 1 clinical trial of Decoy20 – broad immune activation, as evidenced by transiently increased levels of many key cytokines and chemokines following single dose administration. These findings bolster our confidence in Decoy20's potential as a multifaceted immunotherapy.”
The Company recently initiated the multi-dose cohort of its Phase 1 clinical trial in solid tumors.
Jeffrey Meckler, Indaptus’ Chief Executive Officer, added, “We are encouraged by the promising results observed in our preclinical studies and our ongoing Phase 1 clinical trial. The recognition and validation from prestigious organizations such as the AACR, coupled with the support and insights we are receiving from medical experts, partners and investors at the conference, inspire us to continue advancing our technology and demonstrating its significant therapeutic potential for the treatment of solid tumors.”
The full poster can be accessed on the Indaptus Therapeutics website by clicking here.
About Indaptus Therapeutics
Indaptus Therapeutics has evolved from more than a century of immunotherapy advances. The Company’s novel approach is based on the hypothesis that efficient activation of both innate and adaptive immune cells and pathways and associated anti-tumor and anti-viral immune responses will require a multi-targeted package of immune system-activating signals that can be administered safely intravenously (i.v.). Indaptus’ patented technology is composed of single strains of attenuated and killed, non-pathogenic, Gram-negative bacteria producing a multiple Toll-like receptor (TLR), Nucleotide oligomerization domain (NOD)-like receptor (NLR) and Stimulator of interferon genes (STING) agonist Decoy platform. The product candidates are designed to have reduced i.v. toxicity, but largely uncompromised ability to prime or activate many of the cells and pathways of innate and adaptive immunity. Decoy product candidates represent an antigen-agnostic technology that have produced single-agent activity against metastatic pancreatic and orthotopic colorectal carcinomas, single agent eradication of established antigen-expressing breast carcinoma, as well as combination-mediated eradication of established hepatocellular carcinomas, pancreatic and non-Hodgkin’s lymphomas in standard pre-clinical models, including syngeneic mouse tumors and human tumor xenografts. In pre-clinical studies tumor eradication was observed with Decoy product candidates in combination with anti-PD-1 checkpoint therapy, low-dose chemotherapy, a non-steroidal anti-inflammatory drug, or an approved, targeted antibody. Combination-based tumor eradication in pre-clinical models produced innate and adaptive immunological memory, involved activation of both innate and adaptive immune cells, and was associated with induction of innate and adaptive immune pathways in tumors after only one i.v. dose of Decoy product, with associated “cold” to “hot” tumor inflammation signature transition. IND-enabling, nonclinical toxicology studies demonstrated i.v. administration without sustained induction of hallmark biomarkers of cytokine release syndromes, possibly due to passive targeting to liver, spleen, and tumor, followed by rapid elimination of the product. Indaptus’ Decoy product candidates have also produced significant single agent activity against chronic hepatitis B virus (HBV) and chronic human immunodeficiency virus (HIV) infections in pre-clinical models.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act. These include statements regarding management’s expectations, beliefs and intentions regarding, among other things: expectations regarding the impact of the data to be discussed at AACR; expectations regarding reduction in toxicity; advancing our technology and demonstrating its utility; our expectations and plans regarding our Phase 1 clinical trial of Decoy20, including the timing and design thereof; the anticipated effects of our product candidates; the plans and objectives of management for future operations; and our research and development activities. Forward-looking statements can be identified by the use of forward-looking words such as “believe”, “expect”, “intend”, “plan”, “may”, “should”, “could”, “might”, “seek”, “target”, “will”, “project”, “forecast”, “continue” or “anticipate” or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to the following: our limited operating history; conditions and events that raise substantial doubt regarding our ability to continue as going concern; the need for, and our ability to raise, additional capital given our lack of current cash flow; our clinical and preclinical development, which involves a lengthy and expensive process with an uncertain outcome; our incurrence of significant research and development expenses and other operating expenses, which may make it difficult for us to attain profitability; our pursuit of a limited number of research programs, product candidates and specific indications and failure to capitalize on product candidates or indications that may be more profitable or have a greater likelihood of success; our ability to obtain and maintain regulatory approval of any product candidate; the market acceptance of our product candidates; our reliance on third parties to conduct our preclinical studies and clinical trials and perform other tasks; our reliance on third parties for the manufacture of our product candidates during clinical development; our ability to successfully commercialize Decoy20 or any future product candidates; our ability to obtain or maintain coverage and adequate reimbursement for our products; the impact of legislation and healthcare reform measures on our ability to obtain marketing approval for and commercialize Decoy20 and any future product candidates; product candidates of our competitors that may be approved faster, marketed more effectively, and better tolerated than our product candidates; our ability to adequately protect our proprietary or licensed technology in the marketplace; the impact of, and costs of complying with healthcare laws and regulations, and our failure to comply with such laws and regulations; information technology system failures, cyberattacks or deficiencies in our cybersecurity; and unfavorable global economic conditions. These and other important factors discussed under the caption “Risk Factors” included in our most recent Annual Report on Form 10-K filed with the SEC on March 13, 2024, and our other filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. All forward-looking statements speak only as of the date of this press release and are expressly qualified in their entirety by the cautionary statements included in this press release. We undertake no obligation to update or revise forward-looking statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events, except as required by applicable law.
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