Immutep Limited, a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune disease, announces it has completed all the necessary competent authority steps with the US Food and Drug Administration (FDA) and has received IRB approval to commence its phase IIb TACTI-003 trial in the United States. Patient recruitment for the TACTI-003 trial is expected to begin within this quarter.

TACTI-003 will evaluate the Company’s lead product candidate, eftilagimod alpha (“efti” or “IMP321”), in combination with MSD’s KEYTRUDA(R) (pembrolizumab) as a first line therapy in approximately 154 patients with Head and Neck Squamous Cell Carcinoma (HNSCC). It is a randomized, controlled clinical study that will take place across Australia, Europe and the United States of America in up to 35 clinical sites.

Immutep was granted Fast Track designation for efti to treat 1st line HNSCC patients by the US FDA in early April 2021.

Pending approval by the European and Australian competent authorities and ethics committees, Immutep expects to broaden its recruitment sites into these regions.

Commenting on the start of the TACTI-003 trial, Immutep CSO and CMO Frédéric Triebel said: “We are delighted to start our new TACTI-003 trial in first line HNSCC patients to evaluate efti in combination with pembrolizumab vs pembrolizumab monotherapy. Results we reported from this therapeutic combination earlier in June at ASCO in the second line setting were robust, with sustained and durable responses. We look forward to deepening these results with a larger group of 1 st line HNSCC patients in TACTI-003.”