Indaptus Therapeutics Reports New Data Demonstrating Successful Broad Immune System Activation in Weekly Dosing Trial of Decoy20
Indaptus Therapeutics (NASDAQ: INDP) has reported new data from the weekly dosing cohort of its Phase 1 trial of Decoy20, showing successful broad immune system activation. The trial has enrolled over 20 patients, with the 30 million cell dose demonstrating general tolerability and a favorable safety profile.
Key findings reveal that Decoy20 treatment triggers:
- Short-term increases in immune system biomarkers (cytokines and chemokines)
- Broad blood-based immune cell trafficking
- Transient weekly fluctuations in innate and adaptive immune cell levels
Some patients have shown stable disease in early clinical observations. The company has initiated a new Phase 1b/2 trial arm combining Decoy20 with BeiGene's PD-1 checkpoint inhibitor, tislelizumab, focusing on safety, dose optimization, and preliminary anti-tumor activity.
Indaptus Therapeutics (NASDAQ: INDP) ha riportato nuovi dati dal gruppo di dosaggio settimanale del suo studio di Fase 1 su Decoy20, mostrando un'attivazione generale del sistema immunitario. Lo studio ha arruolato oltre 20 pazienti, con il dosaggio di 30 milioni di cellule che dimostra una generale tollerabilità e un profilo di sicurezza favorevole.
I risultati chiave rivelano che il trattamento con Decoy20 attiva:
- Aumenti a breve termine nei biomarcatori del sistema immunitario (citochine e chemiochine)
- Un ampio traffico di cellule immunitarie nel sangue
- Fluttuazioni settimanali transitorie nei livelli delle cellule immunitarie innate e adattive
Alcuni pazienti hanno mostrato una malattia stabile nelle prime osservazioni cliniche. L'azienda ha avviato un nuovo braccio di studio di Fase 1b/2 combinando Decoy20 con l'inibitore del checkpoint PD-1 di BeiGene, tislelizumab, concentrandosi su sicurezza, ottimizzazione del dosaggio e attività antitumorale preliminare.
Indaptus Therapeutics (NASDAQ: INDP) ha reportado nuevos datos del grupo de dosificación semanal de su ensayo de Fase 1 de Decoy20, mostrando una activación general exitosa del sistema inmunológico. El ensayo ha inscrito a más de 20 pacientes, con la dosis de 30 millones de células demostrando una tolerabilidad general y un perfil de seguridad favorable.
Los hallazgos clave revelan que el tratamiento con Decoy20 desencadena:
- Aumentos a corto plazo en los biomarcadores del sistema inmunológico (citoquinas y quimiocinas)
- Tráfico amplio de células inmunitarias en sangre
- Fluctuaciones semanales transitorias en los niveles de células inmunitarias innatas y adaptativas
Algunos pacientes han mostrado enfermedad estable en las primeras observaciones clínicas. La compañía ha iniciado un nuevo brazo de ensayo de Fase 1b/2 combinando Decoy20 con el inhibidor de checkpoint PD-1 de BeiGene, tislelizumab, centrándose en la seguridad, la optimización de dosis y la actividad antitumoral preliminar.
Indaptus Therapeutics (NASDAQ: INDP)는 Decoy20의 1상 시험 주간 투여 집단에서 새로운 데이터를 보고하며 면역 시스템의 성공적인 광범위한 활성화를 보여주었습니다. 이 시험에는 20명 이상의 환자가 등록되었으며, 3천만 세포 용량이 일반적인 내약성과 유리한 안전성 프로필을 나타냈습니다.
주요 발견은 Decoy20 치료가 유도하는:
- 면역 시스템 바이오마커(사이토카인 및 케모카인)의 단기 증가
- 광범위한 혈액 기반 면역 세포 이동
- 선천적 및 적응적 면역 세포 수준의 일시적인 주간 변동
일부 환자는 초기 임상 관찰에서 안정적인 질병을 보였습니다. 회사는 Decoy20을 BeiGene의 PD-1 체크포인트 억제제인 티슬리주맙과 결합한 새로운 1b/2상 시험 팔을 시작하여 안전성, 용량 최적화 및 초기 항종양 활성을 중점적으로 조사하고 있습니다.
Indaptus Therapeutics (NASDAQ: INDP) a rapporté de nouvelles données provenant du groupe de dosage hebdomadaire de son essai de phase 1 sur Decoy20, montrant une activation réussie et large du système immunitaire. L'essai a inclus plus de 20 patients, avec une dose de 30 millions de cellules montrant une tolérance générale et un profil de sécurité favorable.
Les résultats clés révèlent que le traitement par Decoy20 déclenche:
- des augmentations à court terme des biomarqueurs du système immunitaire (cytokines et chimiokines)
- un large trafic de cellules immunitaires dans le sang
- des fluctuations hebdomadaires transitoires dans les niveaux de cellules immunitaires innées et adaptatives
Certains patients ont montré une maladie stable lors des premières observations cliniques. L'entreprise a lancé un nouveau bras d'essai de phase 1b/2 combinant Decoy20 avec l'inhibiteur de point de contrôle PD-1 de BeiGene, tislelizumab, en se concentrant sur la sécurité, l'optimisation de la dose et l'activité antitumorale préliminaire.
Indaptus Therapeutics (NASDAQ: INDP) hat neue Daten aus der wöchentlichen Dosierungsgruppe seiner Phase-1-Studie zu Decoy20 veröffentlicht, die eine erfolgreiche breite Aktivierung des Immunsystems zeigen. In der Studie wurden über 20 Patienten eingeschlossen, wobei die Dosis von 30 Millionen Zellen eine allgemeine Verträglichkeit und ein günstiges Sicherheitsprofil aufweist.
Wichtige Ergebnisse zeigen, dass die Behandlung mit Decoy20:
- kurzfristige Erhöhungen von Biomarkern des Immunsystems (Zytokine und Chemokine) auslöst
- einen breiten Blutfluss von Immunzellen ermöglicht
- vorübergehende wöchentliche Schwankungen der Ebenen von angeborenen und adaptiven Immunzellen aufweist
Einige Patienten zeigten in frühen klinischen Beobachtungen eine stabile Erkrankung. Das Unternehmen hat einen neuen Arm der Phase 1b/2-Studie initiiert, der Decoy20 mit dem PD-1-Checkpoint-Inhibitor von BeiGene, Tislelizumab, kombiniert und sich auf Sicherheit, Dosisoptimierung und vorläufige antitumorale Aktivität konzentriert.
- Favorable safety profile and tolerability demonstrated at 30 million cell dose
- Some patients showing stable disease in early clinical observations
- Successful activation of immune system biomarkers and cell trafficking
- Expansion into combination therapy trial with checkpoint inhibitor
- No concrete efficacy data or tumor response rates reported yet
- Effects on immune cells described as 'transient'
Insights
Indaptus Therapeutics' latest clinical data represents measurable progress for its lead cancer immunotherapy candidate, Decoy20. The reported data from over 20 patients in the weekly dosing cohort shows three critical elements: favorable safety, desired pharmacodynamic effects (immune activation), and early signs of clinical activity with some patients achieving stable disease.
What makes this data meaningful is the consistent immune activation observed with weekly dosing - the reported immune cell trafficking indicates Decoy20 is working as designed, continuously mobilizing immune cells with each administration. For early cancer immunotherapies, establishing this biological activity without significant safety concerns represents an important de-risking event.
The initiation of a combination trial with BeiGene's checkpoint inhibitor demonstrates strategic progression toward potential synergistic effects. Modern cancer immunotherapy increasingly relies on combination approaches, and Decoy20's mechanism targeting both innate and adaptive immunity positions it as a potentially complementary therapy.
However, investors should recognize this remains early-stage data. "Stable disease" represents cancer that isn't growing but isn't shrinking either - a modest clinical benefit. The
Key findings support weekly induction of immune cell trafficking by Decoy20, a critical factor in effective cancer immunotherapy
NEW YORK, March 20, 2025 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP), a clinical-stage biotechnology company dedicated to developing novel treatments for cancer and viral infections, today provided an update on key pharmacodynamic findings from the weekly dosing cohort of its ongoing Phase 1 trial of Decoy20.
As announced in last week’s earnings release, the Company has now enrolled more than 20 patients in the weekly dosing cohort, marking a key milestone in the trial. Initial data indicate that Decoy20 at the 30 million cell dose was generally well-tolerated, with a favorable safety profile and promising early signs of clinical benefit, including some patients demonstrating stable disease. Additionally, Decoy20 triggered short-term increases in multiple key immune system biomarkers (cytokines and chemokines), which play a crucial role in activating the body’s natural defenses against cancer.
Today, Indaptus is reporting further insights showing that weekly Decoy20 treatment also leads to broad, blood-based immune cell trafficking. This immune cell movement, which includes transient weekly increases and decreases in the levels of major innate and adaptive immune cell types in the blood, is an important pharmacodynamic marker, indicating that immune cells are actively mobilizing from bone marrow and/or trafficking to tissues.
Michael Newman, Founder and Chief Scientific Officer of Indaptus, commented, “Immune cell movement – or trafficking to and from tissues, tumors and bone marrow – is critical for successful anti-tumor therapy. In our weekly dosing cohort, we have observed transient but broad movement of key immune cells that is consistent with the chemokine induction we previously reported. These findings further validate Decoy20’s ability to modulate the immune system in a controlled and potentially meaningful way. We are encouraged by the consistency of these pharmacodynamic effects with each week of Decoy20 dosing and look forward to continuing to assess their impact on potential tumor response.”
Decoy20 is designed to activate both the innate and adaptive sides of the immune system, with the goal of potentially enhancing the effectiveness of existing cancer treatments, including checkpoint inhibitors. The Company previously announced that it has initiated a new arm of its Phase 1b/2 clinical trial evaluating Decoy20 in combination with BeiGene’s PD-1 checkpoint inhibitor, tislelizumab, which will focus on safety, dose optimization, and preliminary anti-tumor activity.
Indaptus remains committed to advancing innovative therapies that harness the body’s immune system to fight cancer and will continue to share updates as new data emerges.
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.
For more information, visit www.indaptusrx.com
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 and our Phase 1b/2 of the combination study and the anticipated effects of our product candidates, including Decoy20. 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 most recent Annual Report on Form 10-K filed with the SEC on March 13, 2025, 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.
Contact: investors@indaptusrx.com
Investor Relations Contact:
CORE IR
Louie Toma
louie@coreir.com
FAQ
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