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Shares of Indaptus Therapeutics, Inc. (Nasdaq: INDP) closed at $2.30 on Monday, May 20, 2024. Indaptus is a company with the ability to harness both the body’s innate and adaptive immune responses, believes that they are uniquely positioned to revolutionize the treatment of cancer and certain infectious diseases. 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 products 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 products 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.
On May 8, Indaptus announced financial results for the first quarter ended March 31, 2024, and provided a corporate update (click here). Company is scheduled to present a poster at American Society of Clinical Oncology (ASCO) Annual Meeting on June 1, 2024 highlighting initial results from its Phase 1 clinical trial of Decoy20.
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Jeffrey Meckler, CEO, Indaptus Therapuetics, Inc. (NASDAQ: INDP)
Jeffrey Meckler, Chief Executive Officer of Indaptus, commented, “We continue to make steady progress in our clinical development plans and are receiving regular validation for results reported to date, both through a presentation in April at the American Association for Cancer Research (AACR) annual meeting, and the acceptance of further data to be presented in a poster at the American Society of Clinical Oncology (ASCO) annual meeting, which is considered among the top annual oncology conferences. We are encouraged by the results we have reported, along with the early results we are seeing as we advance our trial, and believe they are indicative of the potential for Decoy20, and indeed our platform as a whole. We look forward to reporting more about our progress as it develops.”
On April 11, Indaptus announced it was proud to unveil its poster at the 2024 Annual Meeting of the American Association for Cancer Research (AACR) in San Diego on Wednesday, April 10th. The poster details mechanism of action data that demonstrates the Company’s Decoy platform successfully induces, matures or activates multiple immune cell types involved in anti-tumor responses. The latest findings significantly enhance the Company’s understanding of its “Decoy” platform technology, which uses killed, non-pathogenic bacteria engineered to activate the immune system to attack tumors. The study highlights the platform’s effectiveness in engaging key innate and adaptive immune cells, including, natural killer cells, natural killer T cells, dendritic cells, CD4+, and CD8+ T cells. In some settings, the platform also produced additive or synergistic activity in combination with IL-2, an approved cancer drug. Additionally, the data reveal that the Decoy platform may not only boost the immune system’s ability to recognize and kill tumor cells, but potentially also overcome a mechanism that suppresses the immune response. The results suggest that the Company’s Decoy bacteria can both directly and indirectly prime the immune system to more effectively fight cancer.
Dr. Michael Newman, Indaptus’ Founder, Chief Scientific Officer, and lead author, commented, “The new data are consistent with our preclinical animal tumor model studies and provide evidence for our hypothesis that patented Decoy bacteria can activate a wide range of innate and adaptive human immune cells involved in fighting tumors. This aligns with what we’ve observed in our ongoing Phase 1 clinical trial of Decoy20 – broad immune activation, as evidenced by transiently increased levels of many key cytokines and chemokines following single dose administration. These findings bolster our confidence in Decoy20’s potential as a multifaceted immunotherapy.”
On March 4, 2024, Indaptus Therapeutics announced 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. 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 AACR: Driving Progress Against Cancer
What’s the Indaptus Timeline?
Dr. Roger Waltzman, Chief Medical Officer, shares the Indaptus journey with #Decoy20.
Indaptus Science & Pipeline
Novel Insights. Novel Therapies.
Historically, we know that tumor regression has been observed in the presence of bacterial infection. Indaptus knows that bacteria contain immune system danger signals, called pathogen-associated molecular patterns (PAMPs), that collectively can activate all of the cellular components of our innate and adaptive immune pathways. PAMPs are recognized by receptors, such as Toll-like (TLR), NOD, STING and RIG-I, that are found on and involved in activation of many different innate and adaptive immune cells.
The Indaptus platform is based on the hypothesis that highly efficient anti-tumor immunotherapy will require safe activation of both innate and adaptive cellular immunity in both tumors and immune organs, and that this might be achieved with a multi-targeted package of bacterial PAMPs, in the form of attenuated and killed, intact but non-pathogenic bacteria delivered intravenously. While current therapies are increasingly becoming more and more personalized and costly, we are advancing an approach designed to be widely accessible, with broad anti-tumor and anti-viral activity not dependent on the targeting of specific tumor or viral antigens.
Learn more about Indaptus’ science and pipeline by clicking here.
Indaptus Publications and Presentations
April 5-10, 2024 – AACR Poster Presentation
November 1-5, 2023 – Society for Immunotherapy of Cancer (SITC)
May 9-11, 2023 – 4th STING & TLR Targeting Therapies Summit
- Pre-Clinical Anti-HBV Activity with a Passively Targeted, Multi-TLR, NOD and STING Agonist
- Breaking the Toxicity Barrier: Tumor Eradication in Pre-Clinical Models by Systemic Administration of a Multi-TLR, NOD and STING Agonist
April 2023 – AACR Poster Presentation
- A systemically administered killed bacteria-based immune receptor agonist for pulsed anti-tumor immunotherapy
April 25-27, 2022 – Chronic HBV Drug Development
- Driving Pre-Clinical Anti-HBV Activity With a Novel Multi-TLR Agonist Therapeutic Vaccine
STING & TLR-Targeted Therapies Summit 2022
- Eradication of Established Tumors with Induction of Innate & Adaptive Immunological Memory in Multiple Preclinical Models with Systemically Administered Decoy Bacteria, a Multi-TLR Agonist Therapeutic Vaccine
May 25-27, 2021 – STING & TLR-Targeting Therapies Summit – Virtual Presentation
- Combination Systemic Therapy with a Multiple TLR Agonist Safely Eradicates Established Tumors with Induction of Innate and Adaptive Immunological Memory
2018 Meeting of CRI-CIMT-EATI-AACR – Poster Presentation
- Development and pre-clinical efficacy characterization of a systemically administered multiple Toll-like receptor (TLR) agonist for anti-tumor immunotherapy
LEARN MORE ABOUT INDAPTUS NOW….
Indaptus CEO, Jeffrey Meckler presented in an open Q&A on Tribe Public’s Webinar titledposter at American Society of Clinical Oncology (ASCO) Annual Meeting on June 1, 2024, “Fully Engaging The Human Immune System To Cure Disease” on Wednesday, March 20, 2024. You can now watch the event video at the Tribe Public YouTube Channel at this link.
On June 3rd, Indaptus CEO, Jeffrey Meckler will present at a Tribe Public CEO Presentation and Q&A Dinner Event on Monday, June 3 at 6:30pm CT in Nashville, TN.
Please visit Tribe Public website www.tribepublic.com in order to join the company sponsored event.