Indaptus Therapeutics Initiates Unrestricted Enrollment of Patients on Decoy20 Weekly Dosing Based on Encouraging Safety Data

Rhea-AI Summary

Indaptus Therapeutics (Nasdaq: INDP) has announced progress in its Phase 1 trial of Decoy20, its lead drug candidate for cancer and viral infection treatment. The Safety Review Committee has approved unrestricted enrollment of patients at the lower Decoy20 dose for weekly administration. The safety profile aligns with expectations, with the most notable treatment-related adverse events being Grade 2 Infusion Related Reaction and Grade 2 Hypotension, both transient.

Dr. Roger Waltzman, Chief Medical Officer, emphasized the importance of gathering more safety and efficacy data to guide combination therapy initiation next year. CEO Jeffrey Meckler expressed confidence in Decoy20's potential impact on cancer immunotherapy, with results expected in the coming months.

Positive

• Unrestricted enrollment approved for lower Decoy20 dose in weekly administration
• Safety profile aligns with expected mechanism of action
• Progression towards combination therapy initiation next year

Negative

• Occurrence of Grade 2 Infusion Related Reaction and Grade 2 Hypotension as adverse events

Insights

Medical Research Analyst

The initiation of unrestricted enrollment for weekly Decoy20 dosing marks a significant milestone in Indaptus Therapeutics' Phase 1 trial. This decision, based on encouraging safety data, allows for broader patient participation and accelerated data collection. The observed safety profile, with manageable Grade 2 adverse events, aligns with expectations and supports the drug's potential.

Key points to consider:

• The Safety Review Committee's approval indicates confidence in Decoy20's safety at the lower dose.
• Expanded enrollment will provide more comprehensive safety and efficacy data.
• This progress paves the way for planned combination therapy studies in 2025, a critical next step in Decoy20's development.
• The consistency between clinical and preclinical data strengthens the drug's potential in cancer immunotherapy.

For investors, this news suggests positive momentum in Indaptus' clinical program, potentially de-risking the asset and increasing its value proposition. However, as a Phase 1 trial, significant hurdles remain before potential commercialization.

NEW YORK, Oct. 15, 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 in its Phase 1 trial of lead drug candidate Decoy20.

The Safety Review Committee examined weekly administration data at the lower Decoy20 dose and cleared unrestricted enrollment of patients at this dose. The safety profile observed to date remains aligned with Decoy20’s expected mechanism of action. The most clinically relevant treatment-related adverse events include Grade 2 Infusion Related Reaction and Grade 2 Hypotension, both of transient duration.

“Unrestricted enrollment of patients at the lower Decoy20 dose will enable us to gather more safety and efficacy data, which is crucial for assessing the full potential of Decoy20. The data will guide how we initiate combination therapy next year, a critical phase in advancing Decoy20,” said Dr. Roger Waltzman, Indaptus Chief Medical Officer.

Jeffrey Meckler, Chief Executive Officer, added, “We continue to gather robust data on Decoy20, which remains consistent with our expectations from preclinical studies. We believe the continuation of this trial, and the eventual initiation of combination therapy studies presents an important opportunity to have a potentially significant impact on cancer immunotherapy. We look forward to sharing these results in the coming months.”

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

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FAQ

What is the latest update on Indaptus Therapeutics' (INDP) Phase 1 trial of Decoy20?

Indaptus Therapeutics has received approval for unrestricted enrollment of patients at the lower Decoy20 dose for weekly administration in its Phase 1 trial, based on encouraging safety data reviewed by the Safety Review Committee.

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

The most clinically relevant treatment-related adverse events observed in the Decoy20 trial include Grade 2 Infusion Related Reaction and Grade 2 Hypotension, both of transient duration.

When does Indaptus Therapeutics (INDP) plan to initiate combination therapy studies for Decoy20?

Indaptus Therapeutics plans to initiate combination therapy studies for Decoy20 next year, based on the data gathered from the current Phase 1 trial.

What is the significance of unrestricted enrollment in the Decoy20 trial for Indaptus Therapeutics (INDP)?

Unrestricted enrollment at the lower Decoy20 dose will allow Indaptus Therapeutics to gather more safety and efficacy data, which is important for assessing the full potential of Decoy20 and guiding future combination therapy studies.