Indaptus Therapeutics to Present Positive Pharmacodynamic (PD) Immune and Pharmacokinetic (PK) Results with Patients from First Cohort of Ongoing Phase 1 Study of Decoy20 at Cancer Immunotherapy Meeting
Poster to be presented at 38th Annual Meeting of the Society for Immunotherapy of Cancer on November 4, 2023
NEW YORK, Oct. 31, 2023 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP) announces it will be presenting interim data from the first cohort of four patients in the Phase 1 INDP-D101 trial of its lead compound, Decoy20. The interim data, released today in abstract form, demonstrated that as of August 31, 2023, each of the first cohort participants experienced transient activation of biomarkers associated with innate and/or adaptive immune responses, and generally expected transient adverse events, both associated with predicted rapid clearance of Decoy20. The data in full will be presented in a poster at the Society for Immunotherapy of Cancer (SITC) on November 4. The conference will be held from November 1-5, 2023 in San Diego.
Michael J. Newman, Ph.D., Indaptus’ Founder and Chief Scientific Officer noted, “Even in this early study, Decoy20 is exceeding our expectations from the perspective that we are seeing activation of the immune system, based on transient expression of multiple plasma cytokines and chemokines, with expected transient adverse events. These results, in conjunction with the desired and observed rapid clearance of Decoy20 from the blood, are highly supportive of our “Pulse-Prime” hypothesis for the Decoy20 mechanism of action.”
Roger Waltzman, M.D., Indaptus’ Chief Medical Officer, added, “We are encouraged by the tolerability of Decoy20 and the notable evidence for broad immune biomarker activation at this early stage. At one month following the single dose of Decoy20, all four of the first cohort patients had stable disease. We are following these patients as well as working on enrolling the second cohort, which utilizes a lower dose. This lower dose is based on the pharmacodynamic results seen with the first cohort and plans to optimize Decoy20 for both weekly dosing and combination approaches.”
The abstract/poster is titled, “Preliminary results of an in progress, first-in-human Phase 1 study of Decoy20, an intravenous, killed, multiple immune receptor agonist bacterial product in patients with advanced solid tumors.” First cohort patients received a single dose of 7x107 killed Decoy20 bacteria via a one-hour IV infusion. As of August 31, 2023, treatment-related adverse events, potentially expected based upon prior clinical studies with purified lipopolysaccharide, have included, among other events, changes in hemodynamic parameters, transaminase elevations, and lymphopenia; all resolved with or without treatment within 30 minutes to 3 days. The Company believes the short half-life of Decoy20 observed in blood coupled with the marked, but transient, induction of multiple cytokines and chemokines over approximately 24 hours supports the PK “pulse” and PD “prime” hypothesis for the Decoy20 immune-oncology strategy.
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 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 timing of the enrollment of the second cohort of patients in the Phase 1 trial, 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; and upcoming events and presentations. 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 June 30, 2023 filed with the SEC on August 14, 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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