- Immutep (IMM) receives “constructive feedback” from the US Food and Drug Administration (FDA) regarding its clinical development program for eftilagimod alpha (efti)
- The FDA is supporting Immutep’s view to continue exploring the development of efti in metastatic breast cancer in a new registrational trial
- Immutep says the FDA advice is based on clinical data presented by the company, including final overall survival data from its phase IIb AIPAC trial, and follows feedback received from the European Medicines Agency (EMA) last year.
- The planned new trial will be based on its phase IIb AIPAC trial but with an optimised design
- IMM shares last traded at 39 cents on March 9
Immutep (IMM) has received “constructive feedback” from the US Food and Drug Administration (FDA) regarding its clinical development program for lead product candidate, eftilagimod alpha (efti) in metastatic breast cancer (MBC).
The company said the FDA supported it continuing to explore the development of efti in MBC in a new registrational trial.
The FDA advice was based on clinical data presented by Immutep, including final overall survival data from its phase IIb AIPAC trial and follows feedback received from the European Medicines Agency (EMA) last year.
Immutep’s planned new registrational trial, AIPAC-003, will be based on its completed AIPAC trial but with an optimised design and a focus on patients who are most likely to benefit from the treatment.
As the new trial is intended to take place across multiple countries, additional regulatory interactions are continuing, including with the FDA and EMA.
“As we have noted previously, many of these patients do not respond well to conventional immune checkpoint inhibitors and so it is important that we continue to advance efti, with its unique mechanism of action, with a carefully designed trial,” Immutep CSO and CMO Dr Frederic Triebel said.
Immutep is a biotechnology company working on the development of immunotherapeutic products for the treatment of cancer and autoimmune disease.
IMM shares last traded at 39 cents on March 9.