Imugene Ltd. (IUGNF)
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FDA backs Imugene's azer-cel treatment plan - ICYMI
Imugene Ltd (ASX:IMU, OTC:IUGNF) earlier this week confirmed that the US FDA has fully supported the company's Phase 1B study data for its CAR-T cell therapy, azer-cel. The company said the regulator has validated its proposed dosing regimen, lymphodepletion schedule, and manufacturing process.
Imugene hits 82% response rate in blood cancer trial - ICYMI
Imugene Ltd (ASX:IMU, OTC:IUGNF) earlier this week reported new clinical data from its Phase 1b trial evaluating azer-cel in patients with diffuse large B-cell lymphoma (DLBCL), including those who had previously failed CAR-T therapies. The company said the trial has achieved an 82% overall response rate in the CAR-T-fail population, with every patient experiencing either a complete response or partial response.
Imugene prepares pivotal azer-cel trial with FDA - ICYMI
Imugene Ltd (ASX:IMU, OTC:IUGNF) earlier this week provided an update on its cell therapy candidate azer-cel, highlighting strong response rates and upcoming regulatory and scientific milestones. The company said azer-cel achieved an 81% response rate in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who had previously failed autologous CAR-T therapy.
Imugene activates Australian site for Phase II bowel cancer vaccine trial
Imugene Ltd (ASX:IMU, OTC:IUGNF) 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.
