Imugene manufacturing on track

Company News

Imugene (ASX:IMU), a Melbourne-based clinical stage immuno-oncology company, has updated on the manufacturing of its HER-Vaxx cancer immunotherapy product, currently initiating activity in gastric cancer.

HER-Vaxx is a B Cell peptide vaccine for the treatment of gastric cancer. The company is also developing mimotope-based immunotherapies against validated and new oncology targets.

Since announcing a re-formulation of HER-Vaxx in April last year, which showed a significant increase in cancer fighting antibody production, several batches of both the peptide antigen and the final vaccine drug substance have been manufactured by the company’s new manufacturing partner, Austrian contract manufacturer piCHEM GmbH.

Batch-to-batch variation and stability studies have been completed and, after a process of optimisation, manufacturing of the final GMP clinical batch is also complete.

The clinical grade material will be delivered in time to begin the company's Phase 1b/2 clinical trial in gastric cancer.

The entire process resulting from optimising the formulation to make it more clinically and commercially viable, manufacturing process, and the CMO sourced with manufacturing the GMP batch, has resulted in a substantial saving of over $500,000 compared to the original budget.

Imugene Chief Operating Officer, Ms Leslie Chong, said: “This is a critical milestone met in our preparation for commencing our clinical trial in patients with gastric cancer. The achievement of keeping this sophisticated manufacturing process on track and even below budget is a testament to the dedication and the relationship developed between our management team and our high quality dedicated suppliers.”