Indaptus Therapeutics Reports Encouraging New Safety Data for Decoy20 Clinical Program; Company Expands Enrollment of Patients on Weekly Dosing at Two Different Doses

Rhea-AI Summary

Indaptus Therapeutics (Nasdaq: INDP) reports encouraging safety data for its Decoy20 clinical program. The independent Safety Review Committee has approved the continuation of dosing at a lower Decoy20 dose weekly and the initiation of dosing at a higher Decoy20 dose weekly. The safety profile aligns with Decoy20's mechanism of action, with mild-to-moderate treatment-related adverse events resolving quickly.

Dr. Roger Waltzman, Chief Medical Officer, states the company aims to evaluate patients receiving two distinct weekly doses to identify potential monotherapy activity and gather safety data for future combination therapy. CEO Jeffrey Meckler notes that enrolling multiple patients at two different weekly doses should accelerate trial progress. The company plans to provide further updates later in the year.

Positive

• Independent Safety Review Committee approves continuation and expansion of Decoy20 dosing
• Safety profile of Decoy20 consistent with its mechanism of action
• Treatment-related adverse events are mild-to-moderate and quickly resolved
• Expansion to weekly dosing at two different dose levels
• Potential for accelerated trial progress due to multiple patient enrollment at different doses

Negative

• None.

Insights

Medical Research Analyst

The safety data for Decoy20 is showing promise, allowing for expanded enrollment at two different weekly doses. This is a positive development in the clinical trial process. The mild-to-moderate adverse events that resolve quickly are encouraging, suggesting a manageable safety profile.

The progression to weekly dosing at both lower and higher doses is significant. It indicates confidence in the drug's tolerability and potential efficacy. The planned combination therapy trials next year, pending sufficient safety data, could be a important next step. Combination therapies often show enhanced efficacy in cancer treatment.

However, it's important to note that this is still a Phase 1 trial, primarily focused on safety. Efficacy data and potential market value are yet to be determined. Investors should remain cautious as many promising early-stage therapies fail to show significant benefits in later trials.

Financial Analyst

This update, while positive, doesn't provide concrete financial implications for Indaptus Therapeutics. The expanded enrollment and progression to weekly dosing are steps forward, but the revenue potential remains uncertain at this early stage.

Investors should consider that successful progression through clinical trials can increase a biotech company's valuation. However, Indaptus is still far from commercialization. The company will likely need additional funding rounds to support further clinical development, which could lead to dilution for current shareholders.

The planned combination therapy trials could potentially increase the addressable market for Decoy20, if successful. This could enhance the company's partnership or acquisition prospects in the future. However, it's important to remember that the majority of drugs in Phase 1 trials do not reach the market, so investment risk remains high.

NEW YORK, Sept. 05, 2024 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus” or the “Company”), a clinical stage biotechnology company dedicated to pioneering innovative cancer and viral infection treatments, provides an update regarding key clinical advancements.

The independent Safety Review Committee overseeing the Company’s Phase 1 clinical trial convened in August to review the safety data at the higher Decoy20 dose with single dose administration and the safety data at the lower Decoy20 dose with weekly administration. The encouraging data has led to the decision to:

• Continue dosing additional patients at the lower Decoy20 dose on a weekly schedule
• Initiate dosing patients at the higher Decoy20 dose on a weekly schedule

The safety profile being observed to date continues to be consistent with Decoy20’s mechanism of action. The most clinically relevant treatment-related adverse events -- infusion-related reaction and hypotension – have been mild-to-moderate in severity, and resolved quickly with i.v. fluids or over-the-counter therapy.

“We continue to be encouraged by the evolving safety profile of Decoy20 during the expansion part of our Phase 1 trial. Our goal is to continue to evaluate patients receiving two distinct weekly doses of Decoy20 to identify potential monotherapy activity, and to accumulate sufficient safety data to initiate combination therapy next year,” said Dr. Roger Waltzman, Indaptus Chief Medical Officer. “We ultimately believe that Decoy20’s broad but transient activation of multiple cytokines and chemokines responsible for stimulating both innate and adaptive immune pathways in concert with other therapies will enhance tumor regression.”

Jeffrey Meckler, Chief Executive Officer, added, “The clinical trial is progressing as planned. Enrolling multiple patients at two different weekly doses should accelerate the progress of our trials. We look forward to providing more updates later in the year.”

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 candidate, 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 candidate. Indaptus’ Decoy product candidates have also produced meaningful 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 expected immune responses as we dose more patients in the multi-dosing part of the trial; 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 June 30, 2024 filed with the SEC on August 12, 2024, 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.

Contact: investors@indaptusrx.com

Investor Relations Contact:
CORE IR
Louie Toma
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Media Contact:
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917-280-2497

FAQ

What is the latest update on Indaptus Therapeutics' (INDP) Decoy20 clinical trial?

Indaptus Therapeutics reports encouraging safety data for Decoy20, allowing continuation of lower dose weekly administration and initiation of higher dose weekly administration. The safety profile remains consistent with Decoy20's mechanism of action, with mild-to-moderate adverse events resolving quickly.

How is Indaptus Therapeutics (INDP) expanding its Decoy20 clinical program?

Indaptus is expanding enrollment of patients on weekly dosing at two different doses of Decoy20. This includes continuing dosing at the lower dose and initiating dosing at the higher dose on a weekly schedule.

What are the main treatment-related adverse events observed in the Decoy20 trial by Indaptus Therapeutics (INDP)?

The most clinically relevant treatment-related adverse events observed in the Decoy20 trial are infusion-related reactions and hypotension. These have been mild-to-moderate in severity and resolved quickly with i.v. fluids or over-the-counter therapy.

What are the next steps for Indaptus Therapeutics (INDP) in the Decoy20 clinical program?

Indaptus plans to continue evaluating patients receiving two distinct weekly doses of Decoy20 to identify potential monotherapy activity and accumulate sufficient safety data to initiate combination therapy next year. The company expects to provide more updates later in the year.