Immutep secures FDA approval for new trial

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Immutep (ASX:IMM) has announced the US FDA has approved a new Investigational New Drug (IND) application for the company's eftilagimod alpha (efti).

Immutep is working on the development of novel immunotherapy treatments for cancer and autoimmune diseases.

The new FDA approved IND allows the company to initiate its planned AIPAC-002 Phase 1 clinical study in metastatic breast cancer (MBC) patients. Immutep said it will commence the study subject to the completion of other preparatory steps and pending positive results from its larger AIPAC Phase 2b study. These are expected to be reported by the end of March 2020.

According to CEO Marc Voigt, “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.”

AIPAC-002 is a Phase 1 trial evaluating efti in combination with a taxane-based standard of care chemotherapy, 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.