Indaptus Therapeutics’ Pioneering Research on Novel Immunotherapy Approach Published in Peer-Reviewed Frontiers in Immunology
Indaptus Therapeutics (NASDAQ: INDP) announced the publication of groundbreaking research in Frontiers in Immunology, detailing their novel Decoy platform and Decoy20 immunotherapy candidate. The research demonstrates how their technology activates multiple immune pathways using attenuated, killed bacteria to fight cancer.
Preclinical studies showed Decoy20's effectiveness against various cancers, including colorectal, pancreatic, hepatocellular cancers, and lymphomas, both as a single agent and in combination with other therapies. The platform's unique 'pulse-prime' approach enables broad immune system activation while reducing toxicity compared to traditional immunotherapies. The company is currently conducting Phase 1 clinical trials for Decoy20 in advanced solid tumors and plans to combine it with BeiGene's tislelizumab.
Indaptus Therapeutics (NASDAQ: INDP) ha annunciato la pubblicazione di una ricerca innovativa su Frontiers in Immunology, che descrive la loro nuova piattaforma Decoy e il candidato immunoterapico Decoy20. La ricerca dimostra come la loro tecnologia attivi molteplici vie immunitarie utilizzando batteri attenuati e uccisi per combattere il cancro.
Gli studi preclinici hanno mostrato l'efficacia di Decoy20 contro vari tipi di cancro, tra cui il cancro colorettale, pancreatico, epatocellulare e i linfomi, sia come agente singolo che in combinazione con altre terapie. L'approccio unico 'pulse-prime' della piattaforma consente una vasta attivazione del sistema immunitario riducendo al contempo la tossicità rispetto alle immunoterapie tradizionali. L'azienda sta attualmente conducendo trial clinici di Fase 1 per Decoy20 in tumori solidi avanzati e prevede di combinarlo con il tislelizumab di BeiGene.
Indaptus Therapeutics (NASDAQ: INDP) anunció la publicación de una investigación innovadora en Frontiers in Immunology, detallando su nueva plataforma Decoy y el candidato a inmunoterapia Decoy20. La investigación demuestra cómo su tecnología activa múltiples vías inmunitarias utilizando bacterias atenuadas y muertas para combatir el cáncer.
Los estudios preclínicos mostraron la efectividad de Decoy20 contra varios tipos de cáncer, incluidos el colorrectal, pancreático, hepatocelular y linfomas, tanto como agente único como en combinación con otras terapias. El enfoque único 'pulse-prime' de la plataforma permite una amplia activación del sistema inmunológico mientras reduce la toxicidad en comparación con las inmunoterapias tradicionales. La empresa está llevando a cabo ensayos clínicos de Fase 1 para Decoy20 en tumores sólidos avanzados y planea combinarlo con el tislelizumab de BeiGene.
Indaptus Therapeutics (NASDAQ: INDP)는 Frontiers in Immunology에 혁신적인 연구 결과를 발표했으며, 그들의 새로운 Decoy 플랫폼과 면역치료 후보인 Decoy20에 대해 자세히 설명했습니다. 이 연구는 그들의 기술이 어떻게 약화된 죽은 박테리아를 사용하여 암과 싸우기 위해 다양한 면역 경로를 활성화하는지를 보여줍니다.
전임상 연구는 Decoy20이 대장암, 췌장암, 간세포암 및 림프종을 포함한 여러 암에 대해 단독 요법으로 또는 다른 치료법과의 병용으로 효과적임을 보여주었습니다. 이 플랫폼의 독특한 'pulse-prime' 접근법은 전통적인 면역요법에 비해 독성을 줄이면서 광범위한 면역 시스템 활성화를 가능하게 합니다. 회사는 현재 진행 중인 고형 종양에 대한 Decoy20의 임상 1상을 수행하고 있으며, BeiGene의 tislelizumab과 병용할 계획입니다.
Indaptus Therapeutics (NASDAQ: INDP) a annoncé la publication d'une recherche révolutionnaire dans Frontiers in Immunology, détaillant leur nouvelle plateforme Decoy et le candidat à l'immunothérapie Decoy20. La recherche démontre comment leur technologie active plusieurs voies immunitaires en utilisant des bactéries atténuées et tuées pour lutter contre le cancer.
Les études précliniques ont montré l'efficacité de Decoy20 contre plusieurs cancers, y compris le cancer colorectal, pancréatique, hépatocellulaire et les lymphomes, à la fois en tant qu'agent unique et en combinaison avec d'autres thérapies. L'approche unique 'pulse-prime' de la plateforme permet une large activation du système immunitaire tout en réduisant la toxicité par rapport aux immunothérapies traditionnelles. La société mène actuellement des essais cliniques de phase 1 pour Decoy20 dans des tumeurs solides avancées et prévoit de le combiner avec le tislelizumab de BeiGene.
Indaptus Therapeutics (NASDAQ: INDP) gab die Veröffentlichung bahnbrechender Forschung in Frontiers in Immunology bekannt, die ihre neuartige Decoy-Plattform und den Immuntherapiekandidaten Decoy20 beschreibt. Die Forschung zeigt, wie ihre Technologie mehrere Immunwege aktiviert, indem sie abgeschwächte, abgetötete Bakterien zur Bekämpfung von Krebs einsetzt.
Präklinische Studien zeigten die Wirksamkeit von Decoy20 gegen verschiedene Krebsarten, darunter kolorektale, pankreatische, hepatozelluläre Krebserkrankungen und Lymphome, sowohl als Einzeltherapie als auch in Kombination mit anderen Therapien. Der einzigartige 'pulse-prime'-Ansatz der Plattform ermöglicht eine breite Aktivierung des Immunsystems und verringert gleichzeitig die Toxizität im Vergleich zu herkömmlichen Immuntherapien. Das Unternehmen führt derzeit klinische Phase-1-Studien für Decoy20 bei fortgeschrittenen soliden Tumoren durch und plant, es mit dem Tislelizumab von BeiGene zu kombinieren.
- Successful publication in peer-reviewed Frontiers in Immunology validates scientific approach
- Preclinical data shows efficacy against multiple cancer types
- Platform demonstrates potential for both standalone and combination therapy applications
- Strategic partnership with BeiGene for combination therapy trials
- Currently advancing in Phase 1 clinical trials
- Still in early clinical stage with unproven human efficacy
- Results to preclinical data only
Insights
The publication of Decoy20's preclinical research in a peer-reviewed journal represents a significant scientific validation of Indaptus' novel immunotherapy platform. The data reveals three key competitive advantages:
- Multi-receptor targeting capability that activates both innate and adaptive immunity
- Demonstrated efficacy across multiple tumor types including hard-to-treat cancers like pancreatic and colorectal
- A potentially safer toxicity profile through controlled immune activation
The platform's ability to combine with four different drug classes (NSAIDs, checkpoint inhibitors, low-dose chemo and targeted antibodies) suggests broad therapeutic potential. The upcoming BeiGene collaboration trial combining Decoy20 with tislelizumab will be a important test of the platform's clinical value. However, investors should note that despite promising preclinical data, clinical success is not guaranteed and Phase 1 results will be critical.
Preclinical data demonstrates Decoy platform single agent anti-tumor activity and combination-mediated tumor eradication with NSAID, anti-PD1 checkpoint therapy, low dose chemotherapy (LDC) and/or targeted antibody therapy
NEW YORK, Nov. 11, 2024 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus” or the “Company”), a clinical stage biotechnology company dedicated to pioneering innovative cancer and viral infection treatments, announced today that Dr. Michael Newman, Founder and Chief Scientific Officer, has published his groundbreaking research in the peer-reviewed journal, Frontiers in Immunology. The article, titled "Invention and Characterization of a Systemically Administered, Attenuated and Killed Bacteria-Based Multiple Immune Receptor Agonist for Antitumor Immunotherapy," presents the Company’s innovative approach to activating both the innate and adaptive sides of the immune system to treat cancer. The paper is being published as part of a Research Topic on The Vital Role of Innate Immunity in Cancer Immunotherapy.
This publication describes the invention and pre-clinical characterization of the Decoy platform, including Decoy20, a novel clinical stage immunotherapy candidate. Decoy20 leverages attenuated, killed and stabilized bacteria to activate multiple immune pathways with a weekly pulse, aimed at creating a comprehensive immune response against tumors. By priming or activating both the innate and adaptive immune systems, Decoy20 has demonstrated the potential to enhance immune responses to effectively fight various types of cancer, including colorectal, pancreatic, hepatocellular cancers and lymphomas. Dr. Newman’s study highlights Decoy20’s potential advantages over traditional treatments, such as chemotherapy, as well as its potential to significantly enhance the efficacy of current, single-target immunotherapy, because it triggers a broad yet controlled activation of the immune system while reducing toxicity often seen with other cancer immunotherapies.
Dr. Newman commented, “It is incredibly rewarding to have our work recognized in such a prestigious publication. I am honored to share years of scientific research with the broader scientific community, contributing a deeper understanding of our ‘pulse-prime’ approach to enhancing both innate and adaptive immune activation. We believe this methodology, represents a significant step toward more effective cancer immunotherapy.”
Jeffrey Meckler, CEO of Indaptus Therapeutics, commented, "We are pleased to share Dr. Newman's valuable contribution to immunotherapy research, which aligns with Indaptus’ mission to redefine cancer treatment. This publication not only strengthens the science behind Decoy20, but also showcases the transformative potential of our Decoy platform to address some of the most challenging cancers. Our recently announced agreement with BeiGene will allow us to further explore these promising findings by combining our Decoy20 with their anti PD-1 checkpoint inhibitor, tislelizumab. We are excited to advance this work and bring new hope to patients in need."
Key Highlights from the Research:
- Multi-Pathway Immune Activation: Unlike traditional immunotherapies that focus on a single immune pathway, Decoy20 engages multiple immune receptors, including Toll-like, NOD-like, and STING receptors, to initiate a broader and more durable immune response.
- Encouraging Preclinical Data: Decoy20 has produced efficacy in preclinical studies across a variety of tumor types and in combination with four different classes of existing drugs, demonstrating both innate and adaptive immune activation that led to tumor regression and immunological memory.
- Reduced Toxicity Profile: By using a rapidly cleared, bacteria-based delivery package and significantly lowering but leaving a small amount of immune activating LPS-endotoxin activity, Decoy20 is designed to produce a broad, but transient or pulsed activation of innate and adaptive immune pathways, minimizing toxicity and enabling safe systemic administration - a longstanding challenge with novel cancer immunotherapies.
Dr. Newman, added, “Being published in Frontiers in Immunology is an important milestone that reinforces the promise of our Decoy platform to potentially redefine immunotherapy. We’re encouraged by our preclinical and clinical findings, and we look forward to continuing to advance Decoy20 in clinical trials, where we hope to see its unique immune-activating properties translate into meaningful patient outcomes.”
As Indaptus moves forward with clinical development, this publication underscores the company’s commitment to advancing innovative science to meet the urgent need for more effective and tolerable cancer treatments. Indaptus is currently enrolling patients in its Phase 1 clinical trial of Decoy20, targeting a range of advanced solid tumors, and plans to roll out its trial combining Decoy20 with BeiGene’s tislelizumab next year.
For more information, please visit the full publication here:
https://www.frontiersin.org/journals/immunology/articles/10.3389/fimmu.2024.1462221/full
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 candidate, with associated “cold” to “hot” tumor inflammation signature transition. The Decoy platform has also been shown to induce activation, polarization or maturation of human macrophages, dendritic, NK, NKT, CD4 T and CD8 T cells in vitro. 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 candidate. Indaptus’ Decoy product candidates have also produced meaningful 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 clinical supply agreement with BeiGene; our plans to advance clinical evaluation of the combination of BeiGene's anti-PD-1 antibody, tislelizumab, with Decoy20; our plans to seek FDA approval and to initiate a combination trial; 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 June 30, 2024 filed with the SEC on August 12, 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.
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FAQ
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