Indaptus Therapeutics Presents Encouraging Interim Safety Data from Phase 1 Clinical Trial of Decoy20 at the Society for Immunotherapy of Cancer (SITC) 2024 Annual Meeting
Indaptus Therapeutics has presented interim safety data from its Phase 1 clinical trial of Decoy20 at the SITC 2024 Annual Meeting. The data comes from two cohorts totaling 13 patients receiving single administration and one cohort of 6 patients receiving weekly administration. Results showed mainly mild to moderate and transient side effects with weekly intravenous administration. The pharmacokinetic analysis confirmed rapid clearance from bloodstream, supporting the company's 'pulse' approach. One patient with squamous cell carcinoma of the head and neck showed stable disease at first imaging. The trial is now enrolling patients with 6 tumor types for weekly dosing, and the company has partnered with BeiGene to test Decoy20 in combination with tislelizumab.
Indaptus Therapeutics ha presentato dati preliminari sulla sicurezza del suo studio clinico di Fase 1 relativo a Decoy20 durante l'Annual Meeting SITC 2024. I dati provengono da due coorti di 13 pazienti che hanno ricevuto una singola somministrazione e una coorte di 6 pazienti che hanno ricevuto somministrazioni settimanali. I risultati hanno mostrato principalmente effetti collaterali lievi a moderati e transitori con somministrazioni endovenose settimanali. L'analisi farmacocinetica ha confermato una rapida eliminazione dal flusso sanguigno, supportando l'approccio 'pulse' dell'azienda. Un paziente affetto da carcinoma a cellule squamose della testa e del collo ha mostrato una malattia stabile alla prima imaging. Lo studio sta ora reclutando pazienti con 6 tipi di tumore per il dosaggio settimanale, e l'azienda ha stretto una partnership con BeiGene per testare Decoy20 in combinazione con tislelizumab.
Indaptus Therapeutics ha presentado datos intermedios de seguridad de su ensayo clínico de Fase 1 sobre Decoy20 en la Reunión Anual SITC 2024. Los datos provienen de dos cohortes que suman 13 pacientes que recibieron una sola administración y una cohorte de 6 pacientes que recibieron administración semanal. Los resultados mostraron principalmente efectos secundarios leves a moderados y transitorios con administración intravenosa semanal. El análisis farmacocinético confirmó una rápida eliminación del torrente sanguíneo, apoyando el enfoque 'pulse' de la empresa. Un paciente con carcinoma de células escamosas de cabeza y cuello mostró enfermedad estable en la primera imagen. El ensayo está ahora reclutando pacientes con 6 tipos de tumores para el dosaje semanal, y la empresa ha asociado con BeiGene para probar Decoy20 en combinación con tislelizumab.
Indaptus Therapeutics는 SITC 2024 연례 회의에서 Decoy20에 대한 1상 임상 시험의 중간 안전성 데이터를 발표했습니다. 데이터는 단일 투여를 받은 13명의 환자가 포함된 2개의 집단과 주간 투여를 받은 6명의 환자가 포함된 1개의 집단에서 나왔습니다. 결과는 주간 정맥 주사에 대해 주로 경미한 정도에서 중간 정도의 일시적인 부작용을 보였습니다. 약리학적 분석 결과는 혈류에서의 빠른 제거를 확인하여 회사의 '펄스' 접근법을 지원했습니다. 두경부의 편평세포암 환자 1명이 첫 영상에서 안정적인 병변을 보였습니다. 현재 이 연구는 주간 복용을 위한 6종의 종양으로 환자를 모집하고 있으며, 회사는 BeiGene과 협력하여 tislelizumab와 함께 Decoy20을 시험하고 있습니다.
Indaptus Therapeutics a présenté des données intermédiaires de sécurité de son essai clinique de Phase 1 concernant Decoy20 lors de la Réunion Annuelle SITC 2024. Les données proviennent de deux cohortes totalisant 13 patients ayant reçu une administration unique et d'une cohorte de 6 patients ayant reçu des administrations hebdomadaires. Les résultats ont montré principalement des effets secondaires légers à modérés et transitoires avec l'administration intraveineuse hebdomadaire. L'analyse pharmacocinétique a confirmé un rapide élimination du sang, soutenant l'approche 'pulse' de l'entreprise. Un patient atteint de carcinome à cellules squameuses de la tête et du cou a montré une maladie stable lors de la première imagerie. L'essai recrute maintenant des patients avec 6 types de tumeurs pour une posologie hebdomadaire, et l'entreprise s'est associée à BeiGene pour tester Decoy20 en combinaison avec tislelizumab.
Indaptus Therapeutics hat auf dem SITC 2024 Jahrestreffen Zwischenberichte zur Sicherheit aus seiner Phase-1-Studie zu Decoy20 vorgestellt. Die Daten stammen aus zwei Kohorten mit insgesamt 13 Patienten, die eine einmalige Verabreichung erhalten haben, und einer Kohorte von 6 Patienten, die wöchentliche Verabreichungen erhalten haben. Die Ergebnisse zeigten hauptsächlich leichte bis mäßige und vorübergehende Nebenwirkungen bei wöchentlicher intravenöser Verabreichung. Die pharmakokinetische Analyse bestätigte eine schnelle Clearance aus dem Blutkreislauf und unterstützte den 'Pulse'-Ansatz des Unternehmens. Ein Patient mit Plattenepithelkarzinom des Kopfes und Halses zeigte bei der ersten Bildgebung stabile Erkrankung. Die Studie rekrutiert jetzt Patienten mit 6 Tumorarten für die wöchentliche Dosierung, und das Unternehmen hat mit BeiGene eine Partnerschaft geschlossen, um Decoy20 in Kombination mit Tislelizumab zu testen.
- Demonstrated favorable safety profile with mild to moderate side effects
- One patient showed stable disease in initial imaging
- Successfully expanded trial to include 6 tumor types
- Established partnership with BeiGene for combination therapy study
- No clear efficacy data reported beyond one case of stable disease
- Early stage trial with patient data (19 patients total)
Insights
The interim Phase 1 data for Decoy20 shows encouraging safety signals and validates key mechanistic hypotheses. The mild to moderate side effects profile and rapid clearance from bloodstream support the weekly dosing strategy. The observation of stable disease in a SCCHN patient with high PD-L1 expression is noteworthy, though preliminary.
The planned combination study with BeiGene's tislelizumab could be significant, as preclinical data suggests synergistic potential. However, with only 19 patients reported and one case of disease stabilization, more data is needed to establish efficacy. The expansion to 6 tumor types and combination therapy represents important progress for this
Data further confirms Company’s “Pulse-Prime” hypothesis
NEW YORK, Nov. 07, 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, announces compelling safety, pharmacokinetics, and biomarker data on its lead compound, Decoy20, at the Society for Immunotherapy of Cancer (SITC) 2024 annual meeting. The data derive from two cohorts (13 patients) of Decoy20 single administration and one cohort (6 patients) of Decoy20 weekly administration in the Company’s ongoing Phase 1 clinical trial. The SITC conference is being held November 6-10, 2024 in Houston, Tex.
The data presented demonstrated that Decoy20 administered intravenously once weekly mainly showed side effects that were classified as mild or moderate and transient in duration. Further, pharmacokinetic analysis confirmed that Decoy20 quickly disappeared from the bloodstream after administration, supporting the Company’s “pulse” approach. One patient in the trial who has squamous cell carcinoma of the head and neck (SCCHN) with high levels of PD-L1, which is a protein that is associated with tumor response to certain immunotherapies, had “stable disease” — meaning the cancer had not progressed or worsened — at the time of their first imaging scan.
“We continue to be encouraged by the safety profile of Decoy20 when administered weekly,” said Dr. Roger Waltzman, Chief Medical Officer. “In addition, we see a broad innate and adaptive immune response. Based upon pre-clinical data, we expect Decoy20 combined with a PD-1 inhibitor to work together effectively to control tumors.”
Jeffrey Meckler, Chief Executive Officer, commented, “We’re pleased to present our latest clinical data at SITC because it further validates our hypotheses in this Phase 1 trial. We continue to confirm our “pulse-prime” approach, while observing an acceptable safety profile. Our trial is now enrolling patients with 6 tumor types for weekly dosing. Furthermore, we recently announced that we have engaged with BeiGene to embark on a new cohort where we will combine Decoy20 with BeiGene’s PD-1 inhibitor, tislelizumab. We have great confidence in our Decoy platform's potential and are excited to continue sharing positive results and pursuing new opportunities.”
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. 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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