IMU-201 / Imugene - LARVOL DELTA

Neo-POLEM: A phase II trial of neoadjuvant PD-1 vaccine PD1-Vaxx in operable MSI high colorectal cancer (ESMO 2025) - "The rationale for targeting these hyper-/ultramutated tumours is based upon their known enrichment of neo-antigens and excellent responsiveness to current immune-oncologic agents nivolumab, pembrolizumab and ipilimumab in the early and metastatic setting. Legal entity responsible for the study University of Southampton. Funding Imugene Limited."

Clinical • IO biomarker • MSI-H • P2 data • Tumor mutational burden • Colon Cancer • Colorectal Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI • PD-1 • TMB

Imugene to showcase PD1-Vaxx colorectal cancer trial at ESMO 2025 Congress (Proactiveinvestors) - "Recruitment began in May 2025 and is now open across several Australian sites, with UK site activation under way. The single-arm Bayesian optimal design study will enrol 44 patients with operable stage II–III microsatellite-instability-high (MSI-H) or mismatch-repair-deficient (dMMR) colon cancer, who will receive three PD1-Vaxx vaccinations over six weeks before surgery."

dMMR • MSI-H • Trial status • Colorectal Cancer

Imugene activates Australian site for Phase II bowel cancer vaccine trial (Proactiveinvestors) - "Imugene Ltd...has activated its first Australian site in the Phase II Neo-POLEM trial, expanding the clinical investigation of its PD1-Vaxx immunotherapy for a difficult-to-treat form of colorectal cancer. The investigator-sponsored study trial (IST) is now recruiting patients in both Australia and the United Kingdom to assess PD1-Vaxx - a neoadjuvant B-cell vaccine designed to trigger an immune response against PD-1 - in patients with mismatch repair-deficient or microsatellite instability-high (dMMR/MSI-high) colorectal cancer."

dMMR • MSI-H • Trial status • Colorectal Cancer • Microsatellite Instability

Neo-POLEM: A Phase II Trial of Neoadjuvant PD-1 Vaccine PD1-Vaxx in Operable MSI High Colorectal Cancer (clinicaltrials.gov) - P2 | N=44 | Not yet recruiting | Sponsor: University of Southampton | Trial completion date: Jun 2028 ➔ Jan 2029 | Initiation date: Dec 2024 ➔ May 2025 | Trial primary completion date: Aug 2026 ➔ Jan 2027

Trial completion date • Trial initiation date • Trial primary completion date • Colorectal Cancer • Oncology • Solid Tumor

IMPRINTER: A Study of IMU-201 (PD1-Vaxx), a B-Cell Immunotherapy, in Adults with Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: Imugene Limited | Trial completion date: Mar 2026 ➔ May 2025 | Trial primary completion date: Feb 2026 ➔ Nov 2024

Combination therapy • Monotherapy • Trial completion date • Trial primary completion date • Large Cell Carcinoma • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-1 • PD-L1

Neo-POLEM: A Phase II Trial of Neoadjuvant PD-1 Vaccine PD1-Vaxx in Operable MSI High Colorectal Cancer (clinicaltrials.gov) - P2 | N=44 | Not yet recruiting | Sponsor: University of Southampton

New P2 trial • Colorectal Cancer • Oncology • Solid Tumor • PD-1

IMPRINTER: A Study of IMU-201 (PD1-Vaxx), a B-Cell Immunotherapy, in Adults With Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: Imugene Limited | Recruiting ➔ Active, not recruiting | N=88 ➔ 24

Combination therapy • Enrollment change • Enrollment closed • Monotherapy • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-1 • PD-L1

Imugene to open new PD1-Vaxx Phase 2 bowel cancer clinical trial in UK and Australia (Proactiveinvestors) - "Imugene Ltd...is preparing 10 clinical trial sites in Australia and the UK for a new PD1-Vaxx Phase 2 colorectal (CRC) cancer clinical trial set to begin in 2024...The company intends to enrol 44 patients across the six Australian and four UK sites, to participate in the study for about 18 months...The primary objective of the trial is to determine major pathological response rates, a measurement of tumour size, after treating with PD1-Vaxx but before surgery to remove any residual tumour – also known as neoadjuvant in operable CRC cancer patients....This trial will be conducted by the Cancer Research UK Southampton Clinical Trials Unit at the University of Southampton in collaboration with Royal Surrey Hospital NHS Foundation Trust and The Australasian Gastro-Intestinal Trials Group (AGITG)."

New P2 trial • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Imugene to be granted European patent for cancer vaccine (Proactiveinvestors) - "The European Patent Office has issued a notification of Intention to Grant a patent for the PD1-Vaxx cancer vaccine of Imugene Ltd...The clinical-stage immuno-oncology company’s PD1-Vaxx cancer vaccine is a first-in-class programmed death-1 (PD1) vaccine, currently in clinical development for non-small cell lung cancer (NSCLC)...The patent application, which encompasses the production and treatment methodology, is anticipated to be approved in late 2023 after finalising the necessary granting procedures....Upon approval, the patent will remain valid until March 28, 2038, at the latest. The European Application, designated as number 3600398..."

Patent • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

IMRPrinter: A Phase 1/1b Trial of IMU‑201 (PD1-Vaxx) as Monotherapy or in Combination with Atezolizumab +/- Chemotherapy in NSCLC (IASLC-WCLC 2023) - P1 | "IMU-201 is a B-cell peptide vaccine which stimulates polyclonal antibodies against PD-1 leading to active immunization and induction of memory B- and T-cells. This study is currently enrolling patients in Australia and US. NCT04432207"

Combination therapy • Monotherapy • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Imugene granted patent extension for PD1-Vaxx to treat non-small cell lung cancer (Small Caps) - "Clinical stage immuno-oncology company Imugene (ASX: IMU) has been granted a patent extension by the US Patent Office to protect its immunotherapeutic PD1-Vaxx for the treatment of non-small cell lung cancer. The patent is titled Human PD1 Peptide Vaccines and Uses Thereof and protects the composition of matter and method of treatment for the generation of a therapeutic antibody response against the PD1 checkpoint target. It will expire in February 2040 and includes 685 days of patent term adjustment added to the original expiry date of March 2038."

Patent • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

Imugene doses first combination patient in lung cancer clinical trial (Proactiveinvestors) - "Imugene Ltd...has dosed its first combination patient in the PD1-Vaxx and Immune Checkpoint Inhibitor lung cancer clinical trial....The objectives of the open-label, multi-centre, dose escalation/expansion, phase 1/1b study of IMU-201 (PD1-Vaxx), a B-Cell Immunotherapy as monotherapy or in combination with atezolizumab with or without chemotherapy, are to determine safety, efficacy, and optimal dose of PD1-Vaxx together with atezolizumab as therapy in ICI treatment-naïve (those yet to be exposed) NSCLC patients or ICI pre-treated patients."

Trial status • Lung Adenocarcinoma • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

IMPRINTER: A Study of IMU-201 (PD1-Vaxx), a B-Cell Immunotherapy, in Adults With Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=88 | Recruiting | Sponsor: Imugene Limited | N=22 ➔ 88 | Trial completion date: Jul 2023 ➔ Mar 2026 | Trial primary completion date: Dec 2022 ➔ Feb 2026

Combination therapy • Enrollment change • Monotherapy • Trial completion date • Trial primary completion date • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-1 • PD-L1

IMPRINTER: An open label, multicenter, dose escalation/expansion, phase 1 study of imu-201 (PD1-Vaxx), a B-cell immunotherapy as monotherapy or in combination with atezolizumab, in adults with non-small cell lung cancer (IMU.201.101). (ASCO 2022) - P1 | "IMU-201 had no observed DLT and demonstrated preliminary signs of efficacy. The study will therefore move into Phase 1b with IMU-201 being assessed in combination with atezolizumab."

Clinical • Combination therapy • Monotherapy • P1 data • Immune Modulation • Inflammation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Solid Tumor

Imugene locks in further US patent protection for PD1-VAXX (Proactiveinvestors) - "Imugene Ltd...has once again locked in international property protection for its assets. The US Patent and Trademark Office (USPTO) has given Imugene a Notice of Allowance related to its B-cell activating immunotherapy PD1-Vaxx (patent application number 16/498,929). The asset is in clinical development for non-small cell lung cancer (NSCLC). The clinical-stage immuno-oncology company’s patent titled 'Human PD1 Peptide Vaccines and Uses Thereof' protects to 2038 the composition of matter and method of treatment in cancer of Imugene’s PD1- Vaxx for the generation of a therapeutic antibody response against the programmed death-1 (PD1) checkpoint target."

Patent • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Phase 1: IMU-201 (PD1-Vaxx), a B-Cell Immunotherapy as Monotherapy or in Combination with Atezolizumab, in Adults with Non-Small Cell Lung Cancer (IASLC-WCLC 2022) - "IMU-201 had no observed DLT and demonstrated preliminary signs of efficacy. The study will therefore move into Phase 1b with IMU-201 being assessed in combination with atezolizumab."

Clinical • Combination therapy • Monotherapy • P1 data • Immune Modulation • Inflammation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Solid Tumor

[VIRTUAL] IMPRINTER: An open label, multi-center, dose escalation/expansion, phase I study of IMU-201 (PD1-Vaxx), a B-cell immunotherapy, in adults with non-small cell lung cancer (ESMO 2021) - P1 | "Values and changes in humoral and cellular immunogenicity data including IMU-201 and PD-1 specific antibodies (IgG, IgM), vaccine-specific cytokine levels, and regulatory and effector T and B cells will be evaluated. The study has completed the second dose cohort and enrollment of the third cohort is scheduled."

Clinical • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Imugene showcases new PD1-Vaxx data at World Conference on Lung Cancer (Proactiveinvestors) - P1 | N=22 | NCT04432207 | Sponsor: Imugene Limited | "Imugene Ltd...has presented findings from its PD1-Vaxx trial in non-small cell lung cancer patients at the International Association for the Study of Lung Cancer’s annual conference...Exploratory biomarker data indicates that IMU-201 is immunogenic and stimulates a sustained, antibody response. Importantly, by week six, antibodies to IMU-201 were generated and sustained at high titres during treatment with 100 micrograms of PD1-Vaxx. There was also a dose-dependent increase in antibody production in patients receiving the 100-microgram dose."

P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Imugene invited to present new PD1-Vaxx findings at prestigious lung cancer conference (Proactiveinvestors) - "Imugene Ltd...has been given the distinction of presenting at the IASLC 2022 World Conference on Lung Cancer (WCLC 2022) taking place in-person and online from August 6-9, 2022, in Vienna, Austria. At the conference, the clinical stage immuno-oncology company, will present new data from non-small cell lung cancer patients in the Phase I IMPRINTER trial. The company will present its findings on August 7, 2022, between 5:00 pm and 7:00 pm CEST..."

P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Imugene Announces Publication Of PD1-Vaxx Abstract At ASCO 2022 (Kalkine Media) - "Imugene Limited...to announce results from its Phase 1 PD1-Vaxx IMPRINTER trial in adults with non-small cell lung cancer has been published today in an abstract at the American Society of Clinical Oncology’s (ASCO) 2022 Annual Meeting."

P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology

A Study of IMU-201 (PD1-Vaxx), a B-Cell Immunotherapy, in Adults With Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1; N=22; Recruiting; Sponsor: Imugene Limited; Trial completion date: Dec 2021 ➔ Jul 2023; Trial primary completion date: Dec 2021 ➔ Dec 2022

Clinical • Trial completion date • Trial primary completion date • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Imugene welcomes phase-1 trial dosing schedule for third monotherapy cohort of immunotherapy PD1-Vaxx (Proactiveinvestors) - "Imugene Limited...has welcomed the dosing schedule for the third monotherapy cohort of its phase-1 trial of the immunotherapy PD1-Vaxx on three patients. Barring any unforeseen clinical observations, the optimal biological dose of 100µg is expected to be ratified at the next Cohort Review Committee (CRC), poised for the first week of October...The first-in-human, phase-1, multi-centre, dose-escalation study of PD1-Vaxx is recruiting patients with non-small cell lung cancer."

Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Imugene (ASX:IMU) to proceed to final dose cohort for lung cancer treatment (Finance News Network) - P1, N=22; NCT04432207; Sponsor: Imugene Limited; "$620-million cancer treatment provider Imugene...has announced that an independent team of researchers have certified that lung cancer drug PD1-Vaxx is safe for human use at 50 micrograms...This means the company can now advance the Phase I clinical trial of the immunotherapy candidate to the full and final dosage of 100 micrograms. The tests recorded promising signs of the product’s efficacy, as PD1-Vaxx halted the tumour spread for 3 patients and fully regressed the cancer in one patient...Imugene has also received the green light from the US Institutional Review Board to commence the Phase I clinical trial of the product at the renowned Mayo Clinic in Phoenix, Arizona."

P1 data • Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Imugene doses first patient in cohort-2 in phase-I clinical trial of PD1-Vaxx (Proactiveinvestors) - “Imugene Ltd…has notched up a key milestone with dosing of the first patient in cohort-2 in the phase-I clinical trial of its checkpoint immunotherapy candidate, PD1-Vaxx. The first patient in the mid-dose (50µg) cohort-2 was dosed at the Hackensack University Medical Center in New Jersey, USA, and the first-in-human, Phase-I multi-centre dose escalation study of PD1-Vaxx is recruiting patients with non-small cell lung cancer.”

Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Imugene receives approval for phase I clinical trial of new checkpoint immunotherapy candidate PD1-VAX (Proactiveinvestors) - “Imugene Limited…has received Cohort Review Committee (CRC) approval for the Phase I clinical trial of its checkpoint immunotherapy candidate, PD1-Vaxx and will proceed to the second dose cohort. The CRC unanimously agreed that PD1-Vaxx is safe with no dose-limiting toxicities (DLTs) and no serious adverse reactions observed after CRC review of all safety and tolerability data for the first 3 patients dosed with the lowest dose of PD1-Vaxx (10mcg) as monotherapy. After the completion of the review meeting, the CRC advised Imugene to proceed with opening the second PD1-Vaxx Phase 1 cohort at the 50mcg mid-dose level.”

Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology