Decoy20 / Indaptus Therap - LARVOL DELTA

Indaptus Therapeutics…Provides Corporate Update (GlobeNewswire) - "Key Highlights: Completed the Safety Lead-In cohort, dosing six evaluable participants with the combination of Decoy20 and tislelizumab."

Trial status • Solid Tumor

Mechanisms of action of a killed, bacteria-based, multiple immune receptor agonist in development for pulsed anti-tumor immunotherapy (CICON 2025) - "One product, Decoy10, contained TLR2,4,8,9, NOD2 and STING agonist activity and exhibited reduced i.v. toxicity in mice and rabbits relative to unprocessed cells...Regressions were observed in combination with chemotherapy, a non-steroidal anti-inflammatory drug, anti-PD-1, or rituximab, were associated with induction of 18-26 plasma cytokines/chemokines, activation of innate and adaptive immune pathways in tumors, and were dependent on NK, CD4+and CD8+T cells...The results demonstrate that Decoy bacteria induce polarization, maturation, and/or activation of cellular mediators of innate and adaptive anti-tumor immune responses. Decoy20 has recently entered a US clinical Phase 1b/2 combination study with an anti-PD-1 (Tislelizumab), and first initial results will be discussed."

IO biomarker • Hematological Malignancies • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Pancreatic Cancer • Solid Tumor • CD14 • CD69 • CD8 • CD80 • CD83 • CD86 • IFNG • STING • TLR2 • TLR4

Indaptus Therapeutics...Provides Corporate Update (GlobeNewswire) - "...'A few weeks ago, we dosed the first patient in our Phase 1b/2 combination study evaluating Decoy20 with the PD-1 checkpoint inhibitor tislelizumab'....'We remain focused on disciplined execution and look forward to sharing initial combination trial data later this year'."

P1/2 data • Solid Tumor

Indaptus Therapeutics Provides Clinical Update (GlobeNewswire) - "...'We are encouraged to report a patient in our monotherapy study who previously received an anti-PD-1 therapy had a clear reduction in size of liver metastases, consistent with a Partial Response. Unfortunately, there was evidence of disease progression at the next scheduled imaging, and the patient discontinued the study'....'Of the first three evaluable patients, one patient had stable disease at the first assessment, and the other two patients had disease progression. We continue to dose additional patients and will report their results in the coming weeks'."

P1/2 data • Solid Tumor

Indaptus Therapeutics, Inc. Announces Sale of $2.3 Million in Private Placement of Convertible Notes and Warrants (GlobeNewswire) - "Indaptus intends to use the net proceeds from the offering for research and development activities including the funding of a Phase 1b/2 clinical trial as well as for working capital and general corporate purposes."

Commercial • Solid Tumor

Indaptus Therapeutics Doses First Patient in Phase 1b/2 Combination Study of Decoy20 with PD-1 Checkpoint Inhibitor Tislelizumab (GlobeNewswire) - "Indaptus Therapeutics...announces that the first patient has been dosed in the expansion arm of its Phase 1b/2 clinical trial evaluating Decoy20 in combination with BeOne’s (formerly known as Beigene) PD-1 checkpoint inhibitor, tislelizumab. This newly activated arm of the trial will assess safety, dose optimization, and early signs of anti-tumor activity in patients with advanced solid tumors, previously treated with a checkpoint inhibitor or with tumors typically unresponsive to a checkpoint inhibitor....Over 25 patients have now received weekly doses of Decoy20 at 30 million cells and the treatment has been well tolerated....Initially, patients will be enrolled sequentially onto combination treatment to closely monitor safety before expanding enrollment."

Trial status • Solid Tumor

Indaptus Therapeutics Reports First Quarter 2025 Financial Results and Provides Corporate Update (GlobeNewswire) - "Finally, to date, we have enrolled 32 patients in the weekly dosing among the two Decoy20 dose levels and decided to conclude enrollment for this arm and shift our focus to the combination treatment of Decoy20 with Tislelizumab....Additionally, we have implemented a cost-reduction plan to focus on the combination study."

Trial status • Solid Tumor

Indaptus Therapeutics Reports New Data Demonstrating Successful Broad Immune System Activation in Weekly Dosing Trial of Decoy20 (GlobeNewswire) - P1/2 | N=120 | NCT05651022 | Sponsor: Indaptus Therapeutics, Inc | "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....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."

P1 data • Solid Tumor

Indaptus Therapeutics Reports Fourth Quarter and Year-End 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "2025 Outlook: (i) The Company plans to dose the first patients in its combination study to evaluate potential synergy with BeiGene’s Tislelizumab; (ii) The Company is working to increase the number of trial sites to accelerate patient enrollment and data collection; (iii) The Company expects to provide further clinical updates throughout 2025, including data from weekly-dosing cohorts; (iv) The Company plans to provide new data on expansion of the Decoy platform and nominate a new candidate for IND enabling studies."

P1/2 data • Pipeline update • Trial status • Colorectal Cancer • Hepatocellular Cancer • Microsatellite Instability • Non Small Cell Lung Cancer • Pancreatic Cancer • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

Indaptus Therapeutics Initiates Phase 1 Combination Study of Decoy20 with PD-1 Checkpoint Inhibitor Tislelizumab (GlobeNewswire) - "Indaptus Therapeutics, Inc...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....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."

Trial status • Solid Tumor

Key recent highlights (GlobeNewswire) - "Successfully advanced Phase 1 study of Decoy20 in advanced solid tumors, with weekly dosing now underway following a positive Safety Review Committee assessment. Achieved key milestone with more than 20 patients enrolled in the weekly dosing cohort among the two Decoy20 dose levels, further supporting the clinical evaluation of Decoy20’s safety and activity. Additionally, early signs of potential benefit emerge with some patients with Stable Disease."

Trial status • Solid Tumor

Indaptus Therapeutics’ Chief Scientific Officer Dr. Michael Newman to Present at the 10th Annual Innate Killer Summit (GlobeNewswire) - "Dr. Newman will deliver a scientific presentation on Tuesday, March 4, 2025, titled, 'Employing Attenuated & Killed Gram-Negative Bacteria to Induce NK-Mediated Anti-Tumor Immunity.' In this presentation, Dr. Newman will discuss: The science behind Indaptus’ Decoy platform, a multi-immune receptor agonist designed to trigger broad innate and adaptive immune activation against tumors. How the Company’s 'Pulse-Prime' approach supports safe and effective anti-tumor activity in pre-clinical models, including the role of Natural Killer (NK) cells. Clinical data from Indaptus’ ongoing Phase 1 trial evaluating Decoy20 in advanced solid tumors."

P1 data • Preclinical • Colorectal Cancer • Hepatocellular Cancer • Microsatellite Instability • Non Small Cell Lung Cancer • Pancreatic Adenocarcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

Indaptus Therapeutics Receives Approval from Health Canada to Expand Clinical Trial of Decoy20 (GlobeNewswire) - "Indaptus Therapeutics, Inc...today announced the Company has received Clinical Trial Authorization from Health Canada to initiate its clinical trial for its lead asset, Decoy20. This approval will allow the Company to expand its ongoing U.S. clinical trial, INDP-D101, to Canadian sites, broadening patient recruitment and enhancing its clinical research program. The trial will enroll patients in Canada under the current protocol, which involves weekly dosing of Decoy20. Indaptus also plans to submit an amendment to Health Canada to incorporate its upcoming combination trial, which pairs Decoy20 with Beigene’s PD-1 checkpoint inhibitor, tislelizumab."

New trial • Trial status • Solid Tumor

INDP-D101: Study of DECOY20 with or Without Tislelizumab in Patients with Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=120 | Recruiting | Sponsor: Indaptus Therapeutics, Inc | Phase classification: P1 ➔ P1/2

Phase classification • Colorectal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Lung Adenocarcinoma • Lung Cancer • Microsatellite Instability • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

Indaptus Therapeutics Provides Year-End Review and Outlook for 2025 (GlobeNewswire) - "The Company currently anticipates that it will achieve the following milestones in the first half of 2025: The Company plans to open an amendment to its clinical trial to include a combination cohort evaluating Decoy20 in conjunction with the PD-1 checkpoint inhibitor, tislelizumab; the Company intends to increase the number of participating clinical sites beyond the eight active locations at the end of last year, enabling broader patient enrollment; The Company plans to provide an update on the patients treated in the higher dose expansion cohort; The Company aims to start dosing the first patients in the combination cohort"

Trial status • Solid Tumor

Invention and characterization of a systemically administered, attenuated and killed bacteria-based multiple immune receptor agonist for anti-tumor immunotherapy. (PubMed, Front Immunol) - "Decoy10 and a closely related product, Decoy20, produced single agent anti-tumor activity or combination-mediated durable regression of established subcutaneous, metastatic or orthotopic colorectal, hepatocellular (HCC), pancreatic, and non-Hodgkin's lymphoma (NHL) tumors in mice, with induction of both innate and adaptive immunological memory (syngeneic and human tumor xenograft models). Decoy bacteria combination-mediated regressions were observed with a low-dose, oral non-steroidal anti-inflammatory drug (NSAID), anti-PD-1 checkpoint therapy, low-dose cyclophosphamide (LDC), and/or a targeted antibody (rituximab). Efficient tumor eradication was associated with plasma expression of 15-23 cytokines and chemokines, broad induction of cytokine, chemokine, innate and adaptive immune pathway genes in tumors, cold to hot tumor inflammation signature transition, and required NK, CD4+ and CD8+ T cells, collectively demonstrating a role for both innate and adaptive immune..."

IO biomarker • Journal • Hematological Malignancies • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD4 • CD8 • STING • TLR2 • TLR4

Preliminary results of a phase 1 study of Decoy20, an intravenous, killed, multiple immune receptor agonist bacterial product in patients with advanced solid tumors (SITC 2024) - P1 | "Decoy20 produced pre-clinical single-agent and combination-mediated anti-tumor activity including innate/adaptive immune-mediated eradication of established tumors, involving combination with anti-PD-1, indomethacin, rituximab or cyclophosphamide. A combination is planned. Ethics Approval This study was approved by the following institutions' Ethics Boards: WIRB/Copernicus covering Atlantic, Hoag, Emory and Karmanos with approval number 20223025; USC approval number HS-22-00497."

Clinical • IO biomarker • Late-breaking abstract • Metastases • P1 data • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor • CD40LG • CSF2 • IFNG • IL2 • STING • TLR4 • TNFA

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 (GlobeNewswire) - P1 | N=120 | NCT05651022 | Sponsor: Indaptus Therapeutics, Inc | "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 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'...at the time of their first imaging scan."

P1 data • Squamous Cell Carcinoma of Head and Neck

Indaptus Therapeutics Announces Clinical Supply Agreement with BeiGene to Evaluate Novel Cancer Treatment Combinations (GlobeNewswire) - "Indaptus Therapeutics, Inc...today announced a clinical supply agreement with BeiGene. Building on Indaptus’ preclinical observation that Decoy20, when combined with a PD-1 inhibitor, induced complete cancer regressions and immunological memory in animal models, Indaptus plans to advance human clinical evaluation of the combination of BeiGene's anti-PD-1 antibody, tislelizumab, with Indaptus’ Decoy20, a novel treatment designed to induce a broad immune response to fight cancer....As part of the agreement, BeiGene will provide Indaptus with access to its PD-1 inhibitor as well as technical expertise in order to accelerate the first clinical trial combining the two investigational drugs....Indaptus will seek approval from the FDA to initiate a combination trial, which is anticipated to begin in 2025."

Commercial • New trial • Oncology

Indaptus Therapeutics Initiates Unrestricted Enrollment of Patients on Decoy20 Weekly Dosing Based on Encouraging Safety Data (GlobeNewswire) - "Indaptus Therapeutics, Inc...provides an update regarding key clinical advancements in its Phase 1 trial of lead drug candidate Decoy20. The Safety Review Committee examined weekly administration data at the lower Decoy20 dose and cleared unrestricted enrollment of patients at this dose. The safety profile observed to date remains aligned with Decoy20’s expected mechanism of action."

Enrollment status • Oncology • Solid Tumor

INDP-D101: DECOY20 Study in Patients with Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=120 | Recruiting | Sponsor: Indaptus Therapeutics, Inc | Trial completion date: Apr 2025 ➔ Sep 2027 | Trial primary completion date: Mar 2025 ➔ Jun 2027

Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Indaptus Therapeutics Reports Encouraging New Safety Data for Decoy20 Clinical Program; Company Expands Enrollment of Patients on Weekly Dosing at Two Different Doses (GlobeNewswire) - "The independent Safety Review Committee overseeing the Company’s Phase 1 clinical trial convened in August to review the safety data at the higher Decoy20 dose with single dose administration and the safety data at the lower Decoy20 dose with weekly administration. The encouraging data has led to the decision to: Continue dosing additional patients at the lower Decoy20 dose on a weekly schedule; Initiate dosing patients at the higher Decoy20 dose on a weekly schedule."

DSMB • Trial status • Oncology • Solid Tumor

Indaptus Therapeutics Reports Second Quarter 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "Advancing clinical trial from single to weekly doses of Decoy20, the company completed one month of weekly dosing in three patients at the 3-x 10^7 Decoy20 dose; Completed a single dose cohort at the higher dose of 7 x 10^7 Decoy20 and intend to initiate weekly dosing later this year."

Trial status • Oncology • Solid Tumor

Indaptus Therapeutics to Present Positive Data on Lead Product Candidate, Decoy20, at STING & TLR-Targeted Therapies Summit (GlobeNewswire) - "Indaptus Therapeutics, Inc...will present additional data on the Company’s lead product candidate, Decoy20, at the 5th Annual STING & TLR-Targeted Therapies Summit in San Diego on June 19-20, 2024. Dr. Newman has also been named chair of the Summit....It will highlight how the Company’s pre-clinical data and, in particular, its 'Pulse-Prime' hypothesis, are being further validated by its initial Decoy20 clinical data."

Clinical data • Preclinical • Oncology

Preliminary results of a phase 1 study of Decoy20, an intravenous, killed, multiple immune receptor agonist bacterial product in patients with advanced solid tumors. (ASCO 2024) - P1 | "Decoy20 produced pre-clinical single-agent and combination-mediated anti-tumor activity (colon, liver, pancreas, lymphoma), including innate/adaptive immune-mediated eradication of established tumors, involving combination with anti-PD-1, indomethacin, or cyclophosphamide. Decoy20 generated transient AEs expected for LPS exposure. Broad systemic immune activation and preliminary evidence of stable disease were observed with only one infusion of Decoy20. These observations and PK data support our pulse-prime hypothesis and continued Decoy20 trial enrollment as a multi-dosed monotherapy and planned combinations."

Clinical • IO biomarker • Metastases • P1 data • Cardiovascular • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Hematological Malignancies • Lymphoma • Oncology • Pancreatic Cancer • Solid Tumor • CD40LG • IFNG • IL2 • STING • TNFA