Biotechnology company Immutep (ASX: IMM) has received approval from the US Food and Drug Administration for an investigational new drug (IND) application relating to its lead product candidate eftilagimod alpha for the treatment of metastatic breast cancer.
The IND approval allows Immutep to initiate a planned AIPAC-002 phase I clinical study in 24 metastatic breast cancer patients across the United States and the European Union.
It will evaluate the effectiveness of eftilagimod in combination with a taxane-based standard of care chemotherapy, known as paclitaxel, to boost T-cell immune responses against tumours.
Commencement of the study is pending positive results from a larger AIPAC phase IIb study based on the same drug combination and expected to be released this month.
If the results are positive, the company will proceed with final preparations for the study and advance its discussions with regulators.
The IND approval will allow Immutep to ship eftilagimod across US state borders to clinical investigators participating in the AIPAC-002 clinical study.
Immutep chief executive officer Marc Voigt said the IND approval signifies a crucial step forward in the development of eftilagimod alpha.
“It allows us to initiate, effectively, a small bridging study called AIPAC-002 which enables us to further interact with the FDA in terms of efti in metastatic breast cancer,” he said.
“The results of our larger AIPAC trial will be reported this month and we look forward to being able to advance our discussions with regulators in order to make key strategic decisions about efti.”
Last month, Immutep reported positive interim data from an ongoing study into the effectiveness of eftilagimod on patients with lung, head and neck carcinomas in combination with Keytruda.
At the time, Immutep had recorded encouraging responses in 47% of first line non-small cell lung cancer patients and in 33% of second line head and neck squamous cell carcinoma patients.
Mr Voigt said the results were “very encouraging”.