IMM Immutep Limited

By Chris Wack

Immutep Ltd. said Tuesday that the U.S. Food and Drug Administration granted fast track designation to eftilagimod alpha IMP321 in combination with pembrolizumab for the treatment of first line non-small cell lung cancer.

Efti is the company's first-in-class soluble LAG-3 clinical stage candidate which activates antigen presenting cells to engage both the innate and adaptive immune system to target solid tumors.

The FDA's fast track designation process is designed to facilitate the development and expedite the review of drug candidates to treat serious conditions and fill an unmet medical need. Immutep will now have access to more frequent interactions with the FDA to discuss efti's development path and, if relevant criteria are met, eligibility for rolling review, accelerated approval, and priority review.

This is the second fast track designation that efti has received, following receipt of the same designation in April 2021 for efti in combination with pembrolizumab in 1st line treatment of recurrent or metastatic head and neck squamous cell carcinoma, the company said.

Immutep shares were up 9% to $1.74 in premarket trading.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

October 04, 2022 08:38 ET (12:38 GMT)

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