Indaptus Therapeutics Initiates Phase 1 Combination Study of Decoy20 with PD-1 Checkpoint Inhibitor Tislelizumab
Indaptus Therapeutics (INDP) has initiated a new expansion arm in its Phase 1b/2 clinical trial, combining Decoy20 with BeiGene's PD-1 checkpoint inhibitor, tislelizumab. The study will evaluate safety, dosing, and preliminary anti-tumor activity in advanced solid tumors.
The expansion marks a significant development in testing Decoy20's synergistic potential with checkpoint inhibitors in patients for the first time. The combination aims to address the limitations of current checkpoint inhibitor treatments, where many patients either don't respond or don't experience lasting effects.
Decoy20 is designed to activate the immune system in a way that could potentially enhance and expand the effectiveness of checkpoint inhibitors, representing a possible breakthrough in solid tumor treatment approaches.
Indaptus Therapeutics (INDP) ha avviato un nuovo braccio di espansione nel suo studio clinico di fase 1b/2, combinando Decoy20 con l'inibitore del checkpoint PD-1 di BeiGene, tislelizumab. Lo studio valuterà la sicurezza, il dosaggio e l'attività antitumorale preliminare nei tumori solidi avanzati.
L'espansione segna uno sviluppo significativo nel testare il potenziale sinergico di Decoy20 con gli inibitori del checkpoint per la prima volta nei pazienti. La combinazione mira a affrontare le limitazioni dei trattamenti attuali con inibitori del checkpoint, dove molti pazienti non rispondono o non sperimentano effetti duraturi.
Decoy20 è progettato per attivare il sistema immunitario in un modo che potrebbe potenzialmente migliorare ed espandere l'efficacia degli inibitori del checkpoint, rappresentando una possibile svolta negli approcci al trattamento dei tumori solidi.
Indaptus Therapeutics (INDP) ha iniciado un nuevo brazo de expansión en su ensayo clínico de fase 1b/2, combinando Decoy20 con el inhibidor de checkpoint PD-1 de BeiGene, tislelizumab. El estudio evaluará la seguridad, la dosificación y la actividad antitumoral preliminar en tumores sólidos avanzados.
La expansión marca un desarrollo significativo en la prueba del potencial sinérgico de Decoy20 con los inhibidores de checkpoint por primera vez en pacientes. La combinación tiene como objetivo abordar las limitaciones de los tratamientos actuales con inhibidores de checkpoint, donde muchos pacientes no responden o no experimentan efectos duraderos.
Decoy20 está diseñado para activar el sistema inmunológico de una manera que podría potencialmente aumentar y expandir la efectividad de los inhibidores de checkpoint, representando un posible avance en los enfoques de tratamiento de tumores sólidos.
Indaptus Therapeutics (INDP)는 BeiGene의 PD-1 체크포인트 억제제인 티슬리주맙(tislelizumab)과 Decoy20를 결합하여 1b/2상 임상 시험의 새로운 확장 팔을 시작했습니다. 이 연구는 진행된 고형 종양에서 안전성, 용량 및 초기 항종양 활성을 평가할 것입니다.
이번 확장은 환자에게서 체크포인트 억제제와 Decoy20의 시너지 가능성을 처음으로 테스트하는 중요한 발전을 의미합니다. 이 조합은 많은 환자가 반응하지 않거나 지속적인 효과를 경험하지 못하는 현재 체크포인트 억제제 치료의 한계를 해결하는 것을 목표로 합니다.
Decoy20은 체크포인트 억제제의 효과를 잠재적으로 강화하고 확장할 수 있는 방식으로 면역 시스템을 활성화하도록 설계되어, 고형 종양 치료 접근 방식에서의 돌파구가 될 수 있습니다.
Indaptus Therapeutics (INDP) a lancé un nouveau bras d'expansion dans son essai clinique de phase 1b/2, combinant Decoy20 avec l'inhibiteur de checkpoint PD-1 de BeiGene, le tislelizumab. L'étude évaluera la sécurité, le dosage et l'activité antitumorale préliminaire dans les tumeurs solides avancées.
Cette expansion marque un développement significatif dans l'évaluation du potentiel synergique de Decoy20 avec les inhibiteurs de checkpoint pour la première fois chez des patients. La combinaison vise à remédier aux limitations des traitements actuels avec des inhibiteurs de checkpoint, où de nombreux patients ne répondent pas ou ne ressentent pas d'effets durables.
Decoy20 est conçu pour activer le système immunitaire d'une manière qui pourrait potentiellement améliorer et élargir l'efficacité des inhibiteurs de checkpoint, représentant une possible percée dans les approches de traitement des tumeurs solides.
Indaptus Therapeutics (INDP) hat einen neuen Erweiterungsarm in seiner klinischen Studie der Phase 1b/2 gestartet, der Decoy20 mit dem PD-1-Checkpoint-Inhibitor von BeiGene, Tislelizumab, kombiniert. Die Studie wird Sicherheit, Dosierung und vorläufige antitumorale Aktivität bei fortgeschrittenen soliden Tumoren bewerten.
Die Erweiterung stellt eine bedeutende Entwicklung dar, da sie das synergetische Potenzial von Decoy20 mit Checkpoint-Inhibitoren erstmals bei Patienten testet. Die Kombination zielt darauf ab, die Einschränkungen der aktuellen Behandlungen mit Checkpoint-Inhibitoren zu adressieren, bei denen viele Patienten entweder nicht ansprechen oder keine dauerhaften Effekte erleben.
Decoy20 wurde entwickelt, um das Immunsystem auf eine Weise zu aktivieren, die potenziell die Wirksamkeit von Checkpoint-Inhibitoren verbessern und erweitern könnte, was einen möglichen Durchbruch in den Ansätzen zur Behandlung solider Tumoren darstellt.
- First-time testing of Decoy20's synergistic potential with checkpoint inhibitors in human patients
- Expansion of Phase 1b/2 trial indicates development progress
- Potential to enhance effectiveness of existing checkpoint inhibitor treatments
- Early-stage trial focused only on safety and tolerability, not efficacy
- No proven clinical benefits yet in human patients
- Success of the combination therapy remains theoretical based on preclinical data
New trial arm to evaluate safety, dosing and preliminary anti-tumor activity in advanced solid tumors
NEW YORK, March 18, 2025 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP), a clinical-stage biotechnology company dedicated to developing novel treatments for cancer and viral infections, today announced that it has advanced to a new expansion arm of its Phase 1b/2 clinical trial of Decoy20. This expansion will evaluate the combination of Decoy20 with BeiGene’s PD-1 checkpoint inhibitor, tislelizumab, with a focus on safety, dose optimization, and early signs of anti-tumor activity.
Jeffrey Meckler, CEO of Indaptus, commented, “This marks a pivotal step forward for Indaptus and our Decoy platform. Preclinical research has consistently shown that Decoy20 works synergistically with a checkpoint inhibitor, and we now have the opportunity to test that in patients for the first time. While this initial phase will focus on safety and tolerability, we are laying the groundwork for what could be a game-changing approach to treating solid tumors. This combination trial is not just a milestone – it’s an opportunity to showcase our platform’s versatility and move one step closer to improving patient outcomes.”
Checkpoint inhibitors such as tislelizumab have improved outcomes in a variety of cancers but many patients still do not respond or ultimately do not experience a long-lasting effect. Decoy20 is engineered to activate the immune system in a manner that is theorized to significantly enhance and broaden the effectiveness of checkpoint inhibitors.
About the Combination Trial
- Initial participants will first receive one week of Decoy20 monotherapy intravenously before starting the combination treatment with Decoy20 + tislelizumab.
- The first few patients in the combination phase will be enrolled sequentially to monitor safety.
- After review by the trial’s Safety Review Committee, unrestricted enrollment will begin.
- Participants will receive both treatments for up to one year, or until disease progression, unacceptable toxicity, or withdrawal from the study.
About PD-1 Inhibitors
PD-1 inhibitors work by blocking the PD-1 (programmed death-1) receptor on T cells, preventing cancer cells from evading the immune system and restoring the body’s ability to fight cancer. Combining checkpoint inhibitors with immune system activators like Decoy20 could provide a more powerful and sustained anti-tumor response.
Indaptus is committed to advancing innovative therapies that harness the immune system to fight cancer. With the launch of this combination trial, the Company is taking a major step towards realizing the full potential of its Decoy platform.
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
What is the purpose of Indaptus Therapeutics' new Phase 1b/2 trial expansion for Decoy20?
How does Decoy20 potentially enhance checkpoint inhibitor effectiveness?
What clinical phase is INDP's Decoy20 combination therapy currently in?
What problem does INDP's Decoy20-tislelizumab combination aim to solve?
