Indaptus Therapeutics Announces New Positive Data from Ongoing Phase 1 Trial of Decoy20

Rhea-AI Summary

Indaptus Therapeutics (Nasdaq: INDP) announced new data from its ongoing Phase 1 trial of Decoy20, presented at the ASCO Annual Meeting on June 1 in Chicago. The data shows that Decoy20 induces significant immune responses in patients with solid tumors, even at varying doses. The treatment was cleared from the blood within 120 minutes and resulted in manageable, lower-grade transient adverse events. Plasma biomarker analysis showed broad immune activation supporting the company’s 'pulse-prime' approach. CEO Jeffrey Meckler expressed optimism about the trial's progress, focusing on the potential anti-tumor activity as patient dosing increases.

Positive

• Decoy20 demonstrated broad immune activation in patients with solid tumors.
• The treatment showed rapid clearance from the blood within 120 minutes.
• Adverse events were manageable, lower-grade, and transient.
• Both lower and higher dose groups showed consistent immune response.
• The trial's results support the 'pulse-prime' approach for triggering broad immune responses.
• CEO Jeffrey Meckler indicated confidence in continued positive outcomes as patient dosing increases.

Negative

• The trial is still in Phase 1, indicating early-stage data that may not guarantee later success.
• Only 11 patients have been treated, which is a small sample size and may not be representative.

Insights

Oncology Doctor

The results from the ongoing Phase 1 trial of Decoy20, as presented at the ASCO Annual Meeting, are promising from an oncology perspective. The rapid clearance and broad immune activation observed in both lower and higher dose groups suggest a potential for effective immune modulation with a favorable safety profile. The quick induction of cytokines and chemokines, which are important for immune response, is particularly noteworthy because it demonstrates Decoy20’s capability to activate both innate and adaptive immunity.

In simpler terms, Decoy20 helps the body’s immune system to recognize and potentially fight cancer cells more effectively. The manageable adverse events also indicate that patients can tolerate the treatment, which is a significant positive compared to traditional treatments that often cause severe side effects. If further trials confirm these results, Decoy20 could become a valuable option in the arsenal against solid tumors, especially for patients with relapsed advanced solid tumors who have limited treatment choices.

Medical Research Analyst

From a clinical research standpoint, the data presented at the ASCO meeting validate Indaptus Therapeutics' 'pulse-prime' approach with Decoy20. The pharmacokinetic data showing rapid clearance within 120 minutes and the transient nature of immune cell changes are crucial. They suggest that Decoy20's mechanism is efficiently engaging the immune system without prolonged exposure, which could potentially minimize long-term side effects.

This is significant because it aligns with the goal of targeted therapies to elicit strong, short-term immune responses without causing extensive damage to the body. The emphasis on transient changes in immune cells and plasma biomarkers also provides a solid foundation for future multi-dose studies. If these results hold up in larger cohorts, Decoy20 could represent an innovative shift in how we approach cancer immunotherapy.

Financial Analyst

From a financial analysis perspective, the positive data from the Phase 1 trial of Decoy20 could have significant implications for Indaptus Therapeutics' stock performance. The successful demonstration of Decoy20's safety and immune activation could attract investor interest and potentially lead to increased funding or partnership opportunities. This trial’s outcomes could also positively influence the stock price as they reduce clinical risk and enhance the therapeutic's market potential.

Moreover, the promising results might drive further investments in the company's pipeline, strengthening its position in the competitive biotech sector. Investors should be cautious, however, as these are early-phase results and subsequent trials will be critical in determining the overall efficacy and safety of Decoy20. Nonetheless, the current data positions Indaptus Therapeutics favorably for the next stages of development and could translate into long-term value for shareholders.

Latest data from first and second cohorts support Company’s 'pulse-prime' approach, demonstrating rapid clearance, broad immune activation, and encouraging safety profile

Poster Presented at American Society of Clinical Oncology Annual Meeting

NEW YORK, June 03, 2024 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc, (Nasdaq: INDP), a clinical stage biotechnology company dedicated to pioneering innovative cancer and viral infection treatments, today announced updated data from its ongoing Phase 1 clinical trial of Decoy20 in patients with solid tumors. The data were featured in a poster presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting on June 1 in Chicago, Illinois.

Dr. Roger Waltzman, Chief Medical Officer of Indaptus, commented, “Our latest findings presented at ASCO demonstrate that the administration of Decoy20 in study participants at both higher and lower doses significantly induces dozens of cytokines and chemokines, many of which have been associated with innate and/or adaptive immune responses. Additionally, the adverse events associated with Decoy20 are generally lower-grade and transient, which is an improvement compared with traditional approaches using TLR and STING agonists. Given the limited effective treatments available for patients with relapsed advanced solid tumors, the promising results of Decoy20 offer hope for improving the immune response against cancer and potentially expanding treatment options.”

The poster presentation at ASCO included pharmacokinetic and safety data for patients in two single-dose cohorts. Eleven patients have been treated with Decoy20: four in Cohort 1 and seven in Cohort 2. Key findings from the ongoing study include:

• Manageable Adverse Events: All side effects related to the treatment were manageable and as expected.
• Rapid Clearance: In all patients, Decoy20 was mostly cleared from the blood within 120 minutes after the dose.
• Consistent Immune Response: Both lower dose and higher dose groups showed transient changes in blood immune cells, with a quick increase in an important type of white blood cell called neutrophils, and a decrease in other white blood cells, indicating that Decoy20 temporarily and effectively moves these cells around the body.
• Immune Activation: Blood tests (plasma biomarker analysis) showed that Decoy20 briefly activates a wide range of immune responses in both dose groups.
• Support for “Pulse-Prime” Hypothesis: The results continue to support the Company’s strategy of using Decoy20 to trigger the immune system in a short and broadly targeted way.
  
  

Jeffrey Meckler, Indaptus CEO commented, “We are excited by this latest single dose data in our ongoing Phase 1 trial. It gives us confidence that as we dose more patients in the multi-dosing part of the study, we will continue to see immune responses that are consistent with potential anti-tumor activity. We look forward to providing more updates this year.”

For more detail, the full poster presentation and underlying data can be accessed 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 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 March 31, 2024 filed with the SEC on May 8, 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
louie@coreir.com

Media:
Cuttlefish Communications
Shira Derasmo
shira@cuttlefishpr.com
917-280-2497

FAQ

What is the latest update from Indaptus Therapeutics' Phase 1 trial of Decoy20?

Indaptus Therapeutics reported new data from its ongoing Phase 1 trial of Decoy20, showing significant immune responses and manageable adverse events.

What were the key findings from the Decoy20 trial presented at ASCO?

The trial results showed broad immune activation, rapid clearance of Decoy20 from the blood, and manageable, lower-grade transient adverse events.

How many patients have been treated with Decoy20 in the Phase 1 trial?

Eleven patients have been treated with Decoy20, with four in Cohort 1 and seven in Cohort 2.

What is the 'pulse-prime' approach mentioned in the Decoy20 trial?

The 'pulse-prime' approach involves using Decoy20 to trigger a short, broad activation of the immune system.

What did CEO Jeffrey Meckler say about the Decoy20 trial results?

CEO Jeffrey Meckler expressed excitement and confidence in the trial's progress, anticipating continued positive immune responses with increased patient dosing.