Key points
- Future development of efti will focus on head and neck squamous cell carcinoma (HNSCC) and soft tissue sarcoma (STS).
- A new manufacturing run of efti at 200 L scale has been initiated.
- Clinical trials are planned to start in the second half of 2027.
Full summary
Immutep Limited has outlined a focused development strategy for eftilagimod alfa (efti), its novel immunotherapy. The company plans to concentrate on head and neck squamous cell carcinoma (HNSCC) in patients with negative PD-L1 expression and the neoadjuvant setting of soft tissue sarcoma (STS). This decision follows a root cause analysis of the early discontinuation of the TACTI-004 study, which identified differences between efti manufactured at 200 L and 2,000 L scales. A new manufacturing run at 200 L scale has been initiated. The development focus aligns with prior interactions with the FDA, including Orphan Drug Designation for STS and Fast Track designation for HNSCC. Preparations for the next clinical trials have commenced, with a target study start in the second half of 2027, subject to regulatory interactions and other factors.