The IND approval will enable the company to ship eftilagimod across US state borders to clinical investigators participating in the AIPAC-002 clinical study
Immutep receives FDA approval for efti cancer drug. Credit: luvqs/Pixabay.
Biotechnology firm Immutep has received second investigational new drug (IND) approval from the US Food and Drug Administration (FDA) for eftilagimod alpha (efti or IMP321), which is designed to treat metastatic breast cancer (MBC).
The IND approval enables Immutep to begin a planned AIPAC-002 phase I clinical study in 24 metastatic breast cancer patients across the US and the European Union.
The trial will assess the effectiveness of efti in combination with paclitaxel, a taxane-based conventional chemotherapy treatment, to boost T-cell immune responses against tumours.
Pending positive results from a larger AIPAC phase IIb study based on the same drug combination, the start of the study is expected to be to be reported this month.
AIPAC-002 to expedite the possible use of efti for patients in US
According to Immutep, AIPAC-002 will accelerate the possible use of efti for patients in the US.
The IND approval will enable the company to ship eftilagimod across US state borders to clinical investigators participating in the AIPAC-002 clinical study.
Immutep CEO Marc Voigt said: “Receiving our second IND approval for efti from the FDA is a crucial step forward for Immutep. The IND allows us to initiate, effectively, a small bridging study called AIPAC-002 that enables us to further interact with the FDA in terms of efti in metastatic breast cancer.
“The results of our larger AIPAC trial will be reported this month. If they are positive, we will proceed with the final preparations and more importantly, will advance our discussions with regulators in order to make key strategic decisions about efti.”
Immutep is involved in the development of LAG-3 related immunotherapeutic products for the treatment of cancer and autoimmune disease.