Immutep (ASX: IMM; NASDAQ: IMMP) is progressing a focused development strategy for eftilagimod alfa (efti), centred on head and neck cancer patients with PD-L1 CPS below one and neoadjuvant soft tissue sarcoma. The two indications are supported by existing clinical data and regulatory designations, including FDA Fast Track status in head and neck cancer and Orphan Drug Designation in soft tissue sarcoma.
CEO and Executive Director Marc Voigt said Immutep’s ongoing root cause analysis of the discontinued TACTI-004 trial has examined clinical, pharmacological and manufacturing factors. The review identified unusual immune-monitoring results and structural differences in the manufactured product, with the company now moving ahead with a new 200-litre manufacturing run as part of a staged approach to efti’s development.
Preparatory regulatory, medical and operational work is underway, with Immutep planning to return efti to clinical development in the second half of 2027. The company is also progressing IMP761 in autoimmune diseases, following interim Phase I results showing favourable safety and tolerability and pharmacodynamic activity.
To hear more about Immutep’s development strategy and upcoming milestones, watch the full presentation with Marc Voigt above.
