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 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 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.
| Capital Markets Industry | Financials Sector | James G. Silk CEO | OTC PINK Exchange | AU000000IMU9 ISIN |
| US Country | 80 Employees | - Last Dividend | 2 Jul 2025 Last Split | - IPO Date |
Imugene Limited is a pioneering clinical stage immuno-oncology company based in Sydney, Australia, established in 1986. The company focuses on developing a diverse array of immunotherapies designed to activate the immune system of cancer patients for the eradication of tumors. Imugene's commitment to innovation in cancer treatment is demonstrated through its collaboration with Arovella Therapeutics Ltd and a research partnership with RenovoRx, Inc. These collaborations aim to enhance the efficacy of treating and accessing difficult-to-treat tumors through advanced oncolytic virus therapy and integrated cell therapy platforms.
A leading product of Imugene, HER-Vaxx, targets HER2-positive cancers, including gastric and breast cancers, by stimulating a polyclonal antibody response against HER2/neu receptors. Currently undergoing a phase 2 study for gastric cancer, HER-Vaxx represents a significant advancement in targeted cancer immunotherapy, offering hope for patients with these aggressive forms of cancer.
Another innovative product in Imugene's portfolio, the PD1-Vaxx vaccine, is designed to block PD-1 signalling, thereby inducing the body to produce polyclonal antibodies. This mechanism is crucial for enhancing the immune system's capability to fight cancer. PD1-Vaxx is currently in a phase I trial, showcasing Imugene's dedication to expanding its range of cancer immunotherapies.
Imugene is also developing CF33, a multifaceted oncolytic virus derived from various genomic sequences of vaccinia virus strains. This approach aims to generate a potent virus capable of effectively targeting and eliminating cancer cells. The innovative nature of CF33 highlights Imugene's commitment to exploring diverse therapeutic strategies to combat cancer.