Indaptus Therapeutics Provides Year-End Review and Outlook for 2025

Rhea-AI Summary

Indaptus Therapeutics (Nasdaq: INDP) has released its year-end review for 2024 and strategic goals for 2025, highlighting significant clinical progress and planned trials. The company's lead candidate, Decoy20, showed promising results in its Phase 1 trial. Key milestones include:

• March 2024: Second cohort results demonstrated broad immune response across multiple tumor types.
• May 2024: Initiation of weekly-dose cohort with no new significant adverse effects.
• September 2024: Higher-dose expansion following positive safety review.

Indaptus presented Decoy20’s potential at major conferences like AACR and ASCO and published research in peer-reviewed journals. A key achievement was a clinical supply agreement with BeiGene to evaluate Decoy20 in combination with tislelizumab, their PD-1 checkpoint inhibitor.

Financially, Indaptus raised $5.5 million in 2024 to support ongoing R&D. For 2025, the company plans to:

• Launch a combination cohort with Decoy20 and tislelizumab.
• Expand clinical sites beyond the current eight.
• Provide updates on higher-dose cohorts.
• Start dosing the first patients in the combination cohort.

CEO Jeffrey Meckler expressed optimism about the progress and potential of their platform to address challenging cancers.

Positive

• Indaptus raised $5.5 million in 2024, ensuring funding for ongoing R&D.
• Decoy20 showed broad immune response in multiple tumor types.
• No new significant adverse effects observed in weekly-dose cohort.
• Higher-dose expansion initiated after positive safety review.
• Clinical supply agreement with BeiGene to evaluate Decoy20 with tislelizumab.

Negative

• None.

Insights

Clinical Research Analyst

The clinical progress of Decoy20 demonstrates compelling developments in immunotherapy. The platform's ability to activate both innate and adaptive immune responses, coupled with favorable safety data across multiple cohorts, represents meaningful advancement. The weekly dosing regimen showing no significant adverse effects while maintaining immune activation is particularly noteworthy.

The upcoming combination trial with BeiGene's tislelizumab is strategically significant. Pre-clinical synergy between Decoy20 and PD-1 checkpoint inhibitors suggests potential for enhanced therapeutic outcomes. The $5.5 million raised provides runway for near-term milestones, though additional funding may be needed for extended development.

For a micro-cap biotech with $12 million market value, the clinical supply agreement with BeiGene adds considerable validation. The planned expansion to new clinical sites and higher dose cohorts in 2025 could accelerate patient enrollment and data generation.

Biotech Investment Specialist

This year-end review reveals several key value drivers for INDP. The clinical supply agreement with BeiGene is particularly strategic, as combination therapies represent a growing segment of the oncology market. The systematic dose escalation and expansion approach demonstrates prudent clinical development strategy.

Institutional validation through peer-reviewed publications and presentations at major conferences (AACR, ASCO, SITC) strengthens the scientific credibility. The expanded Decoy platform capabilities suggest potential pipeline diversification beyond the lead program.

For investors, the clear milestone pathway for H1 2025 provides measurable catalysts. However, the current market cap suggests significant undervaluation relative to the clinical progress and partnership potential, though this also reflects the inherent risks in early-stage biotech development.

Continued Strong Clinical Progress and Planned New Combination Trial Provide Significant Momentum for 2025

NEW YORK, Jan. 08, 2025 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus” or the “Company”), a clinical-stage biotechnology company pioneering innovative cancer and viral infection treatments, today highlights its accomplishments in 2024 and outlines the Company’s strategic goals for the year ahead.

Advancing Decoy20 in Clinical Trials
2024 was a year of meaningful progress for Indaptus’ lead clinical candidate, Decoy20, a novel immunotherapy designed to harness both innate and adaptive immune responses. Highlights from the Company’s Phase 1 clinical trial include:

• Second Cohort Results (March 2024): Building on the Company’s November 2023 findings, Decoy20 demonstrated a broad immune response across multiple tumor types in patients, underscoring the platform’s potential as a monotherapy.
• Weekly-Dose Cohort Initiation (May 2024): After receiving Safety Review Committee approval, the Company dosed its first patient in the weekly-dose portion of the trial. Notably, no new, clinically significant treatment-related adverse effects were observed.
• Higher Dose Expansion (September 2024): Following a positive safety review, Indaptus initiated a higher-dose weekly regimen, further expanding the scope of the trial to evaluate Decoy20’s safety and efficacy.
  

Key Scientific Presentations, Publications and Advancements
Indaptus showcased Decoy20’s potential through a variety of presentations at major industry conferences and peer reviewed journals:

• AACR Annual Meeting (April 2024): Demonstrated that Decoy activates multiple innate and adaptive immune cell types, highlighting its promise as an anti-tumor therapeutic.
• ASCO Annual Meeting (June 2024): Shared promising preliminary results, including immune marker activation in patients with advanced solid tumors following a single dose of Decoy20.
• STING & TLR Targeted Therapies Summit (June 2024): Dr. Michael Newman was named meeting Chairperson for the second year in a row, and presented pre-clinical and clinical Decoy data.
• Frontiers in Immunology (November 2024): Dr. Michael Newman’s groundbreaking research on the Decoy platform was published in Frontiers in Immunology, further validating the Company’s scientific foundation and enhancing visibility within the scientific community.
• Society for Immunotherapy of Cancer (SITC) (November 2024): Presented encouraging data highlighting consistent safety outcomes with weekly Decoy20 dosing, while demonstrating its sustained ability to activate the immune system over time.
• Decoy platform: The Company made significant progress expanding its Decoy platform, successfully producing engineered Decoy bacteria designed to activate targeted immune pathways, enhancing its potential for broader therapeutic applications.

Clinical Supply Agreement with BeiGene

In October 2024, Indaptus achieved a key milestone when it announced a clinical supply agreement with BeiGene to advance the evaluation of Decoy20 in combination with their PD-1 checkpoint inhibitor, tislelizumab. This agreement underscores the potential versatility of the Decoy platform as a standalone therapy and in synergy with an approved immunotherapy treatment modality. This clinical combination is important because, in pre-clinical animal models, Decoy20 demonstrated significant anti-tumor synergy in combination with a PD-1 checkpoint inhibitor.

Financial Strength
Indaptus raised a total of $5.5 million in 2024 through a series of strategic financing initiatives, ensuring funding to support ongoing research and development efforts into 2025.

2025 Outlook

Jeffrey Meckler, CEO of Indaptus Therapeutics, commented, “As we enter 2025, we remain committed to advancing Decoy20 through clinical trials and exploring its combination potential with BeiGene’s tislelizumab. We are excited about the progress we made in 2024 and optimistic about the transformative potential of our platform to address some of the most challenging cancers.”

Indaptus intends to maintain its commitment to robust data generation, with plans to share new findings at leading scientific forums as they become available, while actively pursuing opportunities to expand the applications of its Decoy platform.

The Company currently anticipates that it will achieve the following milestones in the first half of 2025:

• Launch of Combination Cohort: The Company plans to open an amendment to its clinical trial to include a combination cohort evaluating Decoy20 in conjunction with the PD-1 checkpoint inhibitor, tislelizumab.
• Expansion of Clinical Sites: Building on its progress in 2024, the Company intends to increase the number of participating clinical sites beyond the eight active locations at the end of last year, enabling broader patient enrollment.
• Higher Dose Cohort Update: The Company plans to provide an update on the patients treated in the higher dose expansion cohort, providing insights into safety and immune activation at this dose level.
• First Patient Dosed in Combination Cohort: The Company aims to start dosing the first patients in the combination cohort, marking an important step in evaluating Decoy20’s synergistic potential with checkpoint inhibitors.

The company believes these milestones, if achieved, will represent significant advancements in the clinical development of Decoy20 and the broader Decoy platform.

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 clinical supply agreement with BeiGene; our plans to advance clinical evaluation of the combination of BeiGene's anti-PD-1 antibody, tislelizumab, with Decoy20; our plans to seek FDA approval and to initiate a combination trial; the plans and objectives of management for future operations; our research and development activities; and the sufficiency of our cash and cash equivalents to fund our ongoing 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 filed with the SEC on November 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
louie@coreir.com

FAQ

What were the key clinical trial results for INDP in 2024?

In 2024, Indaptus' Decoy20 showed a broad immune response across multiple tumor types in its Phase 1 trial, with no new significant adverse effects observed in the weekly-dose cohort.

What is the significance of Indaptus' agreement with BeiGene?

The agreement with BeiGene will advance the evaluation of Decoy20 in combination with BeiGene's PD-1 checkpoint inhibitor, tislelizumab, showing potential anti-tumor synergy.

How much funding did Indaptus raise in 2024?

Indaptus raised $5.5 million in 2024 through strategic financing initiatives to support ongoing research and development.

What are Indaptus' plans for Decoy20 in 2025?

In 2025, Indaptus plans to launch a combination cohort with Decoy20 and tislelizumab, expand clinical sites, provide updates on higher-dose cohorts, and dose the first patients in the combination cohort.

What were the key presentations and publications for INDP in 2024?

In 2024, Indaptus presented Decoy20 data at major conferences like AACR and ASCO, and published research in journals such as Frontiers in Immunology.

What progress did Indaptus make with the Decoy platform in 2024?

In 2024, Indaptus expanded its Decoy platform by producing engineered Decoy bacteria designed to activate targeted immune pathways, enhancing its therapeutic potential.