Indaptus Therapeutics Announces Completion of First Patient to Receive Multiple Doses of Decoy20, the Company’s Broad-Based, “Pulse-Prime” Immuno-Oncology Therapy for Advanced Solid Tumors

Rhea-AI Summary

Indaptus Therapeutics announced the successful dosing of the first patient in the multi-dose phase of its Phase 1 clinical trial for Decoy20, a novel immuno-oncology therapy targeting advanced solid tumors.

The trial aims to determine the safety and efficacy of Decoy20 when administered multiple times. The initial single-dose phase was well-tolerated, and results will be presented at the ASCO meeting. Decoy20 activates both the innate and adaptive immune systems using broad immune agonists derived from Gram-negative bacteria, aiming to offer a new approach to cancer treatment.

CEO Jeffrey Meckler emphasized the potential of Decoy20 to address unmet medical needs in cancer therapy. The company plans to advance the therapy into combination studies with checkpoint inhibitors based on promising preclinical results.

Positive

• Successful dosing of the first patient in the multi-dose phase of the Phase 1 clinical trial for Decoy20.
• Initial single-dose phase identified a tolerable and recommendable dose.
• The trial aims to address unmet medical needs in advanced solid tumors.
• Decoy20 activates both innate and adaptive immune systems, offering a new approach to cancer treatment.
• Preclinical studies showed potent tumor-fighting responses with Decoy20.
• Results of the single-dose phase will be presented at the ASCO meeting, providing credibility.
• Plans to advance Decoy20 into combination studies with checkpoint inhibitors.

Negative

• The trial is still in early Phase 1, meaning full clinical efficacy and safety are not yet established.
• Ongoing trials mean there is no immediate revenue generation from Decoy20.
• Potential side effects and risks associated with new therapies remain unknown until later trial phases.

Insights

Medical Research Analyst

The completion of the first patient’s multi-dose administration in the Phase 1 trial of Decoy20 is an important milestone for Indaptus Therapeutics. This study is important as it not only evaluates the safety but also begins to examine the potential efficacy of Decoy20 across various cancer types. The innovation lies in the drug's unique mechanism, targeting both the innate and adaptive immune systems through broad immune agonists derived from Gram-negative bacteria. Such an approach could offer a substantial advantage over current therapies that typically focus on a limited set of immune pathways.

One of the unique aspects of Decoy20 is its ability to activate numerous cytokines and chemokines without inducing excessive toxicity, which is a significant concern in immunotherapy. The successful induction of an anti-tumor response, followed by rapid clearance from the body, minimizes potential adverse effects. This innovative mechanism could position Decoy20 as a first-in-class therapy for multiple advanced solid tumors, addressing a substantial unmet medical need.

For retail investors, understanding the potential breakthrough of Decoy20's strategy is key. If subsequent trials confirm safety and efficacy, the market potential could be substantial, given the wide range of cancers targeted and the current limitations of existing therapies.

Financial Analyst

From a financial perspective, the advancement in the Phase 1 trial is a positive signal for Indaptus Therapeutics. Early-phase clinical successes can significantly impact a biotech company’s valuation, as they often reduce perceived risks related to the drug’s development. Investors should note that Decoy20’s ability to target a broad spectrum of advanced solid tumors, if proven effective, could open up large market opportunities.

The announcement about presenting clinical data at the ASCO meeting is also noteworthy. ASCO is one of the most prestigious oncology conferences and a positive reception there could enhance investor confidence and potentially attract partnerships or funding, which are important for the continued advancement of clinical trials. While it's early days, the company’s commitment to progressing into combination studies with checkpoint inhibitors also suggests strategic foresight, aiming to enhance the therapeutic impact of Decoy20.

However, investors should remain cautious due to the inherent risks in drug development, including potential safety concerns that might arise in further phases and regulatory hurdles. Financially, this achievement can be seen as a positive step forward, reinforcing the company’s innovative potential and strategic direction.

Oncology Doctor

As an Oncology Doctor, it is impressive to see the leap that Indaptus Therapeutics is making with Decoy20. The therapy's approach of activating both the innate and adaptive immune systems is a considerable advancement over existing cancer treatments that often target fewer pathways. The use of attenuated Gram-negative bacteria to induce a broad immune response is particularly innovative.

The primary focus on safety in this phase is crucial, given that immune system activation without causing excessive toxicity is a significant challenge in cancer immunotherapy. The preliminary results showing systemic administration without intolerable adverse events are encouraging. Additionally, the broad activation of tumor-fighting cytokines and chemokines holds promise for efficacy across multiple cancer types, which could drastically improve treatment outcomes for patients with poor prognosis and limited treatment options.

For patients and oncologists alike, the prospect of a new, effective treatment for advanced solid tumors is highly anticipated. However, it is essential to await further clinical data to confirm these early positive results. If successful, Decoy20 could revolutionize the treatment landscape for several hard-to-treat cancers.

• First-in-human trial confirms “Pulse-Prime” hypothesis targeting stimulation of innate and adaptive immune systems
• Investigational package of broad immune agonists derived from Gram-negative bacteria which induces dozens of cytokines/chemokines that are quickly cleared from the body
• Identification of tolerable single dose in Phase 1a, recommended for multi-dosing, will be presented at ASCO
  

NEW YORK, May 22, 2024 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc, (Nasdaq: INDP), a clinical stage biotechnology company dedicated to pioneering innovative cancer and viral infection treatments, today announced the successful advancement of its Phase 1 trial for Decoy20, an investigational novel package of broad immune agonists for cancer immunotherapy that has first-in-class potential across a diverse range of cancers including liver, pancreatic, colorectal and non-small cell lung.

Following review by a Safety Review Committee (SRC) of the company’s initial clinical data, which will be presented at the annual meeting of the American Society of Clinical Oncology (ASCO), the Company has successfully dosed the first patient in the multi-dose portion of the trial with Decoy20. The primary goal of this stage of the trial is to determine the safety of Decoy20 when administered multiple times to the same patient, and to begin to examine efficacy across multiple types of cancer.

“Current immunotherapies usually target a few immune system pathways and have low cure rates in advanced cancers. Indaptus is investigating an incredibly exciting and differentiated approach to fighting cancerous tumors that deviates from a focus on targeted therapies in the field,” said Roger Waltzman, MD, Chief Medical Officer of Indaptus. “The advancement of this trial is a significant milestone that builds on strong evidence that Decoy20 successfully and broadly activates potent tumor-fighting cytokines and chemokines in both the innate and adaptive immune systems, and was administered systemically without intolerable adverse events.”

Decoy20 is composed of attenuated and killed, intact, non-pathogenic Gram-negative bacteria which are designed to act as a “decoy,” tricking the body into activating a broad antitumor response from both its innate and adaptive immune systems. In preclinical studies, the treatment has been shown to activate specialized immune receptors called TLRs, that facilitate a potent defense against tumors, without inducing excessive toxicity. The product candidate is designed to induce a strong and broad pulse of immune activation, followed by rapid clearance from the body.

“There is significant unmet medical need for people living with advanced solid tumors and we are thrilled with the successful completion of the first patient of the multi-dose part of our Phase 1 clinical trial with Decoy20 and potential to offer a disruptive, first-in-class innovation, with the successful initiation of the multi-dosing part of our Phase 1 clinical trial with Decoy20,” said Jeffrey Meckler, CEO of Indaptus. “As part of our commitment to delivering innovative therapies to patients in need, we look forward to advancing this research that has the potential to treat patients who have limited options today.”

The company intends to progress Decoy20 into combination studies with a checkpoint inhibitor, due to the observation of tumor eradications by the Decoy platform in combination with checkpoint therapy in pre-clinical studies.

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, 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; 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 Decoy20?

Decoy20 is an immuno-oncology therapy developed by Indaptus Therapeutics, targeting advanced solid tumors by activating both the innate and adaptive immune systems.

What are the key findings of Indaptus Therapeutics' trial for Decoy20?

The first patient has been successfully dosed in the multi-dose phase, and the single-dose phase identified a tolerable dose, with results to be presented at the ASCO meeting.

What types of cancer is Decoy20 targeting?

Decoy20 targets a diverse range of cancers including liver, pancreatic, colorectal, and non-small cell lung cancers.

What is the significance of Decoy20's immune system activation?

Decoy20 aims to activate both innate and adaptive immune systems, providing a broad and potent antitumor response.

What are the next steps for Decoy20 in clinical trials?

Indaptus plans to progress Decoy20 into combination studies with checkpoint inhibitors, based on preclinical results showing tumor eradication.

When and where will the initial clinical data of Decoy20 be presented?

The initial clinical data from the single-dose phase of Decoy20 will be presented at the annual meeting of the American Society of Clinical Oncology (ASCO).