Immutep has announced the approval of its Investigational New Drug (IND) application by the United States Food and Drug Administration (FDA) for eftilagimod alpha (efti or IMP321).

The FDA approval of the IND allows Immutep to initiate its planned AIPAC-002 Phase I clinical study in metastatic breast cancer (MBC) patients. Immutep will commence the study, subject to the completion of other preparatory steps and pending positive results from its larger AIPAC Phase IIb study, which are expected to be reported by the end of March 2020.

"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," Immutep CEO, Marc Voigt aid. "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."

AIPAC-002 is a Phase I trial evaluating efti in combination with a taxane-based standard of care chemotherapy, called paclitaxel, in 24 patients with MBC in the US and the EU to boost the T-cell immune responses against tumours. This is the same combination therapy being investigated in Immutep’s Phase IIb AIPAC study. The trial forms part of Immutep’s strategy to expedite the possible use of efti for MBC patients in the US.

The IND application allows Immutep to ship efti across US state borders to US clinical investigators participating in the AIPAC-002 clinical study.

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