Immutep (ASX: IMM) is advancing a more focused development strategy for eftilagimod alpha (efti), prioritising first-line head and neck cancer patients with CPS below one and the neoadjuvant treatment of soft tissue sarcoma. CEO and Executive Director Marc Voigt said the decision reflects existing clinical data, regulatory status and discussions with potential partners.
Both indications have regulatory support in the US, with Fast Track designation for efti in head and neck cancer and FDA Orphan Drug designation for the neoadjuvant soft tissue sarcoma setting. Voigt highlighted supportive results from the EFTISARC-NEO study, which met its primary endpoint, alongside head and neck cancer data showing a high rate of complete responses and mature overall survival of 17.5 months. He said the company sees these indications as potential candidates for registration-directed clinical development.
The strategy follows Immutep’s ongoing root cause analysis of the TACTI-004 trial. Voigt said the investigation has considered clinical, pharmacological and manufacturing factors and identified unusual immune-monitoring results as well as structural differences in the manufactured product, including in its N-glycan structure. Immutep has subsequently signed off on a new 200-litre manufacturing run, returning to a scale used repeatedly in earlier efti development.
Voigt said preparations for future clinical trials are already underway, including regulatory, medical and operational work. Immutep plans to return efti to clinical development in the second half of 2027, while also progressing IMP761 in autoimmune diseases. In the meantime, potential milestones include further soft tissue sarcoma data, regulatory developments and partnering discussions.
To hear more about Immutep’s development strategy and plans for efti and IMP761, watch the full interview with Marc Voigt .
