IMM-101 / Immodulon - LARVOL DELTA

PRIMUS006: A Trial of Gemcitabine, Pembrolizumab and IMM-101 as First Line Treatment in Patients With Metastatic Pancreatic Cancer (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Karen Carty | N=50 ➔ 0 | Trial completion date: Dec 2027 ➔ May 2025 | Recruiting ➔ Withdrawn | Trial primary completion date: Jun 2027 ➔ May 2025

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Oncology • Pancreatic Cancer • Solid Tumor

COV-IMMUNO: Immunization With IMM-101 vs Observation for Prevention of Respiratory and Severe COVID-19 Related Infections in Cancer Patients at Increased Risk of Exposure (clinicaltrials.gov) - P3 | N=195 | Active, not recruiting | Sponsor: Canadian Cancer Trials Group | Trial completion date: Dec 2024 ➔ Jun 2025

Trial completion date • Infectious Disease • Multiple Myeloma • Novel Coronavirus Disease • Oncology

Quality of Life in Patients with Locally Advanced Pancreatic Cancer During Stereotactic Radiotherapy Combined with Heat-Killed Mycobacterium Obuense Vaccination. (PubMed, J Palliat Med) - "Setting/Participants: In total, 42 Dutch patients with LAPC were included after completion of at least four cycles of (m) leucovorin calcium (folinic acid), fluorouracil, irinotecan hydrochloride, and oxaliplatin (FOLFIRINOX). In the multivariable model, with "Global HRQoL scale" and "RCSQ total score" as outcomes, we did not find a significant change during treatment. In this prospective cohort study, we found that SBRT combined with IMM-101, in patients with LAPC, is well tolerated and does not negatively affect HRQoL, sleep quality, and pain."

HEOR • Journal • Hepatology • Oncology • Pain • Pancreatic Cancer • Solid Tumor

Stereotactic radiotherapy and IMM-101 in patients with oligometastatic pancreatic cancer following FOLFIRINOX: The MEPANC trial (ESMO 2024) - "Stereotactic beam radiotherapy combined with IMM-101 deemed to be safe and feasible in patients with oligometastatic PDAC and shows favourable preliminary progressive free survival outcomes. Additionally, immunomodulatory effects of the treatment on the peripheral blood will be analysed."

Clinical • Metastases • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

COV-IMMUNO: Immunization With IMM-101 vs Observation for Prevention of Respiratory and Severe COVID-19 Related Infections in Cancer Patients at Increased Risk of Exposure (clinicaltrials.gov) - P3 | N=195 | Active, not recruiting | Sponsor: Canadian Cancer Trials Group | Trial completion date: Apr 2024 ➔ Dec 2024

Trial completion date • Infectious Disease • Multiple Myeloma • Novel Coronavirus Disease • Oncology

PRIMUS006: A Trial of Gemcitabine, Pembrolizumab and IMM-101 as First Line Treatment in Patients With Metastatic Pancreatic Cancer (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Karen Carty

Metastases • New P2 trial • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

Precision-Panc Team Open the PRIMUS-006 Study, a Novel Combination of IMM-101, Gemcitabine and Pembrolizumab (GlobeNewswire) - "The Precision-Panc team at the University of Glasgow, with their Co-Sponsor, NHS Greater Glasgow & Clyde, today announced the opening of the Phase II PRIMUS-006 study evaluating IMM-101, a broad-spectrum immunomodulatory agent containing heat-killed, whole cell Mycobacterium obuense, in combination with gemcitabine and pembrolizumab as first-line treatment in patients with metastatic pancreatic cancer....The Phase II PRIMUS-006 study is a single-arm clinical study evaluating IMM-101, gemcitabine and pembrolizumab as first-line combination triplet therapy in patients diagnosed with metastatic pancreatic cancer who are deemed not sufficiently fit enough to tolerate treatment consisting of two or more cytotoxic agents."

Trial status • Pancreatic Cancer

Immodulon Announces Formation of New Scientific Advisory Board to Support Late-stage Clinical Development of IMM-101 (BioSpace) - "Immodulon Therapeutics Ltd...today announced the formation of a new Scientific Advisory Board comprising leading global experts in the field of clinical oncology...The new SAB consists of the following members:...Prof. Josep Tabernero, MD, PhD...Prof. Dr. Eric Van Cutsem, MD..."

Immodulon Announces Formation of New Scientific Advisory Board to Support Late-stage Clinical Development of IMM-101 (GlobeNewswire) - "Immodulon...today announced the formation of a new Scientific Advisory Board comprising leading global experts in the field of clinical oncology. The new SAB will be chaired by Prof. Dr. med. Thomas Seufferlein, Director, Department of Gastroenterology, University of Ulm, Germany, and will complement the experience of Immodulon’s new management team to support the advancement of IMM-101 into a pivotal trial for pancreatic cancer as well as broader pipeline progress."

Commercial • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

COV-IMMUNO: Immunization With IMM-101 vs Observation for Prevention of Respiratory and Severe COVID-19 Related Infections in Cancer Patients at Increased Risk of Exposure (clinicaltrials.gov) - P3 | N=195 | Active, not recruiting | Sponsor: Canadian Cancer Trials Group | Trial primary completion date: Oct 2023 ➔ Apr 2024

Trial primary completion date • Infectious Disease • Multiple Myeloma • Novel Coronavirus Disease • Oncology

Collagen remodeling biomarkers in patients with locally advanced pancreatic cancer treated with stereotactic body radiotherapy plus intradermal heat-killed mycobacterium obuense (IMM-101) vaccination (SITC 2023) - "In the LAPC-2 trial, patients with non-progressive locally advanced pancreatic cancer (LAPC) after treatment with FOLFIRINOX, were included...Moreover, the treatment resulted in increased levels of the C4G/C4M ratio in patients with partial response suggesting that this biomarker ratio – high T cell infiltration (C4G) relative to tumor invasion (C4M) – could reflect clinical response. If validated, this suggests that collagen remodeling biomarkers could have a predictive value in pancreatic cancer patients treated with immunomodulatory therapy such as SBRT in combination with IMM-101."

Biomarker • Clinical • Metastases • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • GZMB

COV-IMMUNO: Immunization With IMM-101 vs Observation for Prevention of Respiratory and Severe COVID-19 Related Infections in Cancer Patients at Increased Risk of Exposure (clinicaltrials.gov) - P3 | N=195 | Active, not recruiting | Sponsor: Canadian Cancer Trials Group | Trial completion date: Jun 2023 ➔ Apr 2024 | Trial primary completion date: Jun 2023 ➔ Oct 2023

Trial completion date • Trial primary completion date • Infectious Disease • Multiple Myeloma • Novel Coronavirus Disease • Oncology • Solid Tumor

Immodulon Appoints New Chair and Leadership Team to Drive Late-Stage Clinical Development of IMM-101 in Pancreatic Cancer (GlobeNewswire) - "Immodulon...announces it has elected Richard Davies as Chairman of the Board and appointed Gertjan Bartlema as Chief Executive Officer and Peter Greaney as Chief Business Officer....Their expertise will be crucial in guiding IMM-101 through late-stage clinical development and maximising its potential for patients."

Commercial • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Has the Landscape of Immunotherapy for Prostate Cancer Changed? A Systematic Review and Post Hoc Analysis. (PubMed, Am J Mens Health) - "In total, 10 types of immunotherapies were identified with Pembrolizumab (among 8 patients) followed by IMM-101 (among 6 patients) being the most commonly administered. The mean OS for all patients was 27.8 months (24 patients) with the relatively highest mean OS reported with IMM-101 (56 months) followed by tumor-infiltrating lymphocytes (30 months). This research article provides critical insights into the evolving landscape of immunotherapies being tested for PCa and addresses gaps in oncological research to advance the understanding of PCa."

Journal • Retrospective data • Review • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Baseline carcinoembryonic antigen predicts response to IMM-101 in advanced pancreatic cancer: Data analysis from a randomised, open label, phase II study (ESMO-GI 2017) - P2; "Introduction: IMAGE-1 (Immune Modulation and Gemcitabine Evaluation-1), was a randomised, open-label, phase II, first-line, proof of concept study (NCT01303172) of IMM-101 in combination with gemcitabine (GEM) in advanced pancreatic ductal adenocarcinoma (PDAC). Analysis included pre-defined variables reported as prognostic for survival in PDAC: carbohydrate antigen 19.9 (CA19.9), carcinoembryonic antigen (CEA), lactate dehydrogenase (LDH), c-reactive protein (CRP), neutrophil-lymphocyte ratio (NLR), total bilirubin, age and performance status (PS). Modeling included terms for..."

Clinical • P2 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Feasibility, safety, and efficacy of stereotactic body radiotherapy combined with intradermal heat-killed mycobacterium obuense (IMM-101) vaccination for non-progressive locally advanced pancreatic cancer, after induction chemotherapy with (modified)FOLFIRINOX - the LAPC-2 trial. (PubMed, Radiother Oncol) - "Combination treatment with IMM-101 and SBRT was safe and feasible for non-progressive locally advanced pancreatic cancer patients after (modified) FOLFIRINOX. No improvement in the progression-free survival could be demonstrated by adding IMM-101 to SBRT."

Journal • Metastases • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

COV-IMMUNO: Immunization With IMM-101 vs Observation for Prevention of Respiratory and Severe COVID-19 Related Infections in Cancer Patients at Increased Risk of Exposure (clinicaltrials.gov) - P3 | N=195 | Active, not recruiting | Sponsor: Canadian Cancer Trials Group | Trial primary completion date: Dec 2022 ➔ Jun 2023

Trial primary completion date • Infectious Disease • Multiple Myeloma • Novel Coronavirus Disease • Oncology • Solid Tumor

Immunomodulatory Effects of Stereotactic Body Radiotherapy and Vaccination with Heat-Killed Mycobacterium Obuense (IMM-101) in Patients with Locally Advanced Pancreatic Cancer. (PubMed, Cancers (Basel)) - "Combination therapy with SBRT and a heat-killed mycobacterium vaccine was safe and had an immune-stimulatory effect."

IO biomarker • Journal • Gastrointestinal Cancer • Hepatology • Immune Modulation • Inflammation • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CD14 • HAVCR2 • ICOS • ITGAM • LAG3 • PD-1

A phase II study to evaluate the safety and efficacy of IMM-101 in combination with checkpoint inhibitors in patients with advanced melanoma: Final results of the IMM-101-015 trial. (ASCO 2022) - P2 | "The clinical studies with IMM-101 have shown promising efficacy signals in pancreatic cancer when combined with gemcitabine and in melanoma as adjunctive or single agent...Pts in cohort B had the option to change to ipilimumab and IMM-101 if their disease continued to progress... IMM-101 in combination with nivolumab is safe and shows encouraging antitumor activity in treatment-naive patients with advanced melanoma."

Checkpoint inhibition • Clinical • Combination therapy • IO biomarker • P2 data • Dermatology • Endocrine Disorders • Fatigue • Gastrointestinal Cancer • Hepatology • Melanoma • Oncology • Pancreatic Cancer • Pruritus • Solid Tumor • BRAF • CD4 • CD8 • PD-L1

A novel phase I/IIa open-label study of IMM-101 in combination with selected standard of care regimens in patients with metastatic cancer or unresectable cancer at study entry. (ASCO 2017) - P1/2; "The MODULATE study will initially recruit patients in the UK and France with US sites added in Q4 2017."

Combination therapy • P1/2 data • Biosimilar • Breast Cancer • Melanoma • Oncology • Solid Tumor

COV-IMMUNO: Immunization With IMM-101 vs Observation for Prevention of Respiratory and Severe COVID-19 Related Infections in Cancer Patients at Increased Risk of Exposure (clinicaltrials.gov) - P3 | N=195 | Active, not recruiting | Sponsor: Canadian Cancer Trials Group | Trial completion date: Dec 2022 ➔ Jun 2023 | Trial primary completion date: Jul 2022 ➔ Dec 2022

Trial completion date • Trial primary completion date • Infectious Disease • Multiple Myeloma • Novel Coronavirus Disease • Oncology • Solid Tumor

A Study of IMM-101 in Combination With Checkpoint Inhibitor Therapy in Advanced Melanoma (clinicaltrials.gov) - P2 | N=16 | Completed | Sponsor: Immodulon Therapeutics Ltd | Active, not recruiting ➔ Completed | N=26 ➔ 16 | Trial completion date: Jul 2021 ➔ Dec 2021 | Trial primary completion date: Jul 2021 ➔ Dec 2021

Checkpoint inhibition • Combination therapy • Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor • BRAF

COV-IMMUNO: Immunization With IMM-101 vs Observation for Prevention of Respiratory and Severe COVID-19 Related Infections in Cancer Patients at Increased Risk of Exposure (clinicaltrials.gov) - P3 | N=195 | Active, not recruiting | Sponsor: Canadian Cancer Trials Group | Trial completion date: Mar 2022 ➔ Dec 2022 | Trial primary completion date: Dec 2021 ➔ Jul 2022

Trial completion date • Trial primary completion date • Infectious Disease • Multiple Myeloma • Novel Coronavirus Disease • Oncology • Solid Tumor

ANTONIO: Atezolizumab With/Without IMM-101 in Patients With MSI-h/MMR-D Stage III Colorectal Cancer Ineligible for Oxaliplatin (clinicaltrials.gov) - P2; N=120; Recruiting; Sponsor: AIO-Studien-gGmbH; Not yet recruiting ➔ Recruiting

Enrollment open • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Immune Modulation • Inflammation • Oncology • Solid Tumor • MSI

Stereotactic Body Radiotherapy (SBRT) and IMM-101 (Heat-Killed Mycobacterium Obuense) Combination Therapy in Locally Advanced Pancreatic Cancer Patients (IHPBA 2022) - No abstract available

Clinical • Combination therapy • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor