Indaptus Therapeutics Announces Positive Results from Second Cohort of Phase 1 Trial; Company Initiates Multi-Dose Cohort
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Insights
The transition from single-dose to multi-dose cohorts in a Phase 1 clinical trial is a critical step in oncology drug development, especially for a novel therapeutic like Decoy20. This progression underscores the importance of safety in early-stage trials and sets the stage for subsequent efficacy assessments. From an oncological perspective, the broad immune response observed is encouraging, as it suggests potential for a systemic anti-tumor effect. However, it's imperative to remain cautious until more comprehensive data are available, particularly from the multi-dose cohort.
Multi-dosing could amplify the therapeutic effects seen in preclinical models, but it could also introduce new safety concerns. As such, the long-term implications for patients will depend on a delicate balance between efficacy and tolerability. The ability of Decoy20 to induce significant anti-tumor activity across multiple tumor types, as suggested by preclinical studies, could represent a breakthrough if these results translate to humans.
The recommendation by the Safety Review Committee to proceed with multi-dosing is a pivotal moment for Indaptus Therapeutics. This decision is likely based on robust safety data, which is a positive indicator for investors tracking the development of new oncology treatments. The potential for Decoy20 to be administered in multiple doses could have a significant impact on the treatment landscape if efficacy is proven in later-stage trials.
It's important to note that the transition to multi-dosing also implies a higher level of complexity in trial design and monitoring. The forthcoming data publication at a scientific conference will be a key event for stakeholders, as it will provide deeper insights into Decoy20's safety profile and immune response metrics. These data points will be critical for assessing the drug's potential market value and competitive advantage.
Indaptus Therapeutics' announcement regarding the advancement of Decoy20 into multi-dosing trials could be a significant value driver for the company's stock (Nasdaq: INDP). The positive safety outcomes and the initiation of patient screening for multi-dosing cohorts suggest that the company is moving forward as planned, which is likely to be well-received by investors. The potential for Decoy20 to address multiple types of cancer expands the drug's market opportunity, which could have a substantial impact on the company's future revenue streams.
However, investors should consider the inherent risks associated with clinical trials, including the possibility of encountering safety issues in later stages or failing to demonstrate sufficient efficacy. The long-term financial implications will hinge on clinical results, regulatory approvals and the ability to successfully commercialize the drug. As such, close monitoring of upcoming trial results and management's execution on clinical development milestones will be crucial.
• Positive data following completion of second cohort of Phase 1 trial of Decoy 20 leads independent Safety Review Committee to recommend initiating multi-dosing cohort
• Single dose cohort data expected to be published at a scientific conference in 2024
NEW YORK, March 04, 2024 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc, (Nasdaq: INDP), a clinical stage biotechnology company dedicated to pioneering innovative cancer and viral infection treatments, announces positive results from the second cohort of its Phase 1 INDP-D101 trial. Patients continue to exhibit a broad immune response similar to the first cohort. The preliminary results of this study were reviewed by the Company and an independent Safety Review Committee. Based on this review, it was recommended that the Company continue the trial and enroll patients for multiple doses of its lead therapeutic candidate, Decoy20. The company has immediately started screening potential patients.
Jeffrey Meckler, Indaptus’ Chief Executive Officer, commented, “We have now confirmed the safety requirements necessary to advance our Phase 1 trial of Decoy20 to multi-dosing. The ability to do so is based on positive safety outcomes in the single dose regimen as well as the anti-cancer activity we observed from multi-dosing in our pre-clinical models.”
The primary goal of the next stage of the trial is to determine the safety of Decoy20 when administered multiple times to the same patient, and to begin to examine the efficacy across multiple types of cancer. In animal models, Decoy20 was shown to be safe in several multiple dosing schedules.
“The advancement to multi-dosing is our opportunity to potentially demonstrate what we saw in our preclinical models, namely, that multiple doses given consistently over time produce systemic immune responses that promote significant anti-tumor activity across multiple tumor types,” stated Dr. Michael Newman, Indaptus’ Founder and Chief Scientific Officer.
Dr. Roger Waltzman, Indaptus’ Chief Medical Officer, added, "While our Phase 1 trial is designed for safety and tolerability, it also provides our first opportunity to demonstrate the potential of our therapy in humans. We look forward to seeing how patients in this cohort tolerate and respond to Decoy20, which will also be instructive as we progress toward Phase 2.”
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 and our expectations regarding the recommended Phase 2 doses for subsequent multi-dosing and combination studies and related timing; 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 September 30, 2023 filed with the SEC on November 6, 2023, our most recent Annual Report on Form 10-K filed with the SEC on March 17, 2023, 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.
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