European Patent Office Approves Key Patent for Indaptus Therapeutics’ Platform Technology
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Insights
The granting of the European patent to Indaptus Therapeutics is a strategic milestone that could potentially fortify the company's intellectual property moat. This patent protection is critical in the biopharmaceutical industry, where research and development costs are substantial and the ability to exclusively capitalize on proprietary technologies can significantly impact a company's financial trajectory. The broad scope of the patent, covering any viral infection, suggests a wide array of applications, which could lead to multiple revenue streams if the technology proves effective and reaches commercialization.
For investors, the patent extends the period during which Indaptus can potentially generate returns without competition from generics, enhancing the long-term value proposition of the company. However, the actual impact on the stock will depend on the success of ongoing clinical trials and the ability of the company to translate this patent into marketable therapies.
The patent's coverage of a broad spectrum of viral infections, including hepatitis B, HIV and influenza, positions Indaptus Therapeutics in a substantial market with diverse opportunities. The global antiviral drugs market is projected to grow significantly, driven by the prevalence of viral diseases and the ongoing need for effective treatments. Indaptus's platform technology, if successful, could disrupt the market by offering a novel approach to viral infections that activates both innate and adaptive immune responses.
Market penetration will depend on the outcomes of the Phase 1 clinical trial and subsequent trials, regulatory approvals and the company's ability to establish partnerships or distribution channels. The anticipation of these developments may create speculative interest among investors, potentially influencing stock volatility in the short to medium term.
The mention of the ongoing Phase 1 clinical trial for solid tumors indicates that Indaptus's platform has potential applications beyond the current trial's scope. The successful patent application in Europe complements the company's strategy to diversify its pipeline and expand its therapeutic reach. However, investors should be aware that clinical trials are inherently risky, with no guarantee of success.
It is also important to note that the transition from Phase 1 to subsequent phases will require substantial investment and rigorous testing to ensure efficacy and safety. The patent grant provides a level of assurance that, should the trials prove successful, the company has secured a form of legal protection for its investment in the technology across a significant market.
Patent will provide additional protection covering a composition targeting any viral infection, including hepatitis B, HIV, and influenza
NEW YORK, Jan. 04, 2024 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP), a clinical stage biopharma company that utilizes a proprietary killed, non-pathogenic bacteria-based platform to generate stabilized packages of immune agonists to activate both innate (immediate) and adaptive (learned) cellular immune pathways, announces that the European Patent Office (EPO) has informed the company that it will grant a European patent related to the company’s platform technology, covering a composition that can be used in the prevention or treatment of viral infections.
The patent, titled “Methods of Treatment of Infections Using Bacteria,” (Application 19 866 580.4) provides protections for the application of the Company’s Decoy technology platform alone or in combination with standards of care for the prevention or treatment of any viral infection. The EPO patent will be the second patent granted to Indaptus outside the United States for this application.
Jeffrey Meckler, Indaptus Therapeutics CEO, commented, “The continued protection of our intellectual property both in the U.S. and abroad will provide a competitive advantage for the Company, which should ultimately drive significant shareholder value over time. We continue to explore the applications of our technology platform beyond solid tumors, for which we are currently engaged in a Phase 1 clinical trial, and look forward to updating our shareholders on scientific progress.”
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 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: our expectations and plans regarding our Phase 1 clinical trial of Decoy20, including the timing and design thereof and our expectations regarding the recommended Phase 2 doses for subsequent multi-dosing and combination studies and related timing; the anticipated effects of our product candidates, including Decoy20; the plans and objectives of management for future operations; our research and development activities and costs; the sufficiency of our cash and cash equivalents to fund our ongoing activities and our cash management strategy; and our assessment of financing options to support our corporate strategy. 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2023 filed with the SEC on November 6, 2023, our most recent Annual Report on Form 10-K filed with the SEC on March 17, 2023, 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.
Contact: investors@indaptusrx.com
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