
Immutep contracts new manufacturing batch following study failure
- Immutep found structural differences between small-scale and large-scale batches of its cancer therapy.
- Shares rose following the announcement of a return to 200-litre manufacturing runs.
- Development will concentrate on head and neck cancer along with soft tissue sarcoma.
Immutep (ASX:IMM) has contracted a new 200-litre manufacturing run of eftilagimod alfa following the early discontinuation of its TACTI-004 clinical study.
An ongoing root cause analysis revealed structural differences between drug batches produced at the 2,000-litre scale used in TACTI-004 and earlier 200-litre batches.
The company stated that trial execution or clinical factors do not explain the unexpected trial outcome.
Immutep CEO Marc Voigt said, "Based on the totality of evidence generated with efti, we believe there is a scientifically and clinically justified path to continue its development."
Future clinical development will focus on head and neck squamous cell carcinoma and soft tissue sarcoma, with the next trials targeted to start in late 2027.
Following the announcement, the Immutep share price was up at $0.048.
The biotechnology firm develops novel immunotherapies using its lead drug candidate, eftilagimod alfa, for targeted cancer treatments.
Immutep previously completed 10 clinical manufacturing batches at the 200-litre scale for Phase 1 and Phase 2 clinical trials.
