- Cohort 1 patients exhibited a significant immune response consistent with the mechanism of action
- Safety Review Committee approved continuation to the next cohort of patients
Four patients were enrolled and evaluable in this cohort. Overall, patients experienced symptoms or adverse events (AEs) that were short-lived and consistent with the mechanism of action of Decoy20. These symptoms included temperature elevation, nausea and chills. Additional transient effects included changes in heart rate and blood pressure.
“The safety profile exhibited among the first cohort of patients in our Phase 1 dose ranging study was consistent with the Decoy20 mechanism of action. We expect the enrollment of the next cohort will bring us closer to determination of the recommended phase 2 dose for the multi-dosing part of the trial. We are pleased that the safety and immune activation data support continued dosing,” said
Three of the patients in the first cohort have completed the 28-day safety review period with two of the patients having also completed post-study tumor re-staging. One clinically relevant dose limiting toxicity of grade 3 bradycardia occurred and was reversible in under 30 minutes following a bolus of normal saline; grade 3 malaise in the same patient resolved overnight. Two patients experienced a grade 3 AST increase which resolved within 1 day. Other Adverse Events including chills, fatigue, vomiting, and fever were of grade 1-2 severity, resolved quickly, and were to be expected following exposure to the TLR4 agonist lipopolysaccharide (LPS), which is a major active ingredient of Decoy20 and a facilitator of innate and adaptive immune responses.
Evidence of immune activation was observed, based on transient expression of multiple plasma cytokines and chemokines associated with activation of innate and adaptive immune pathways, including several not expected with LPS exposure. “The presence of multiple, additional immune activating molecules in Decoy20 appears to have stimulated production of potential anti-tumor cytokines and chemokines beyond what would be expected for LPS alone, without significantly altering the safety profile,” said Dr.
The Company continues to analyze the data generated. Further, the Company anticipates that the data from the dose finding studies will guide the selection for the Recommended Phase 2 dose for subsequent multi-dosing and combination studies, which are planned for 2024.
About
Forward-Looking Statements
This press release contains forward-looking statements with 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 the timing and design of Phase 1 clinical trial of Decoy20, including the timing of the enrollment of the second cohort of patients; the anticipated effects of our product candidates, including Decoy20; the expectation that the data generated from the dose finding studies will guide the selection for the Recommended Phase 2 dose for subsequent multi-dosing and combination studies; and the expected timing of subsequent studies. 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
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