Immutep Has Successful Type C Meeting With FDA

By Chris Wack

Immutep Ltd. said Friday it had a successful Type C meeting with the U.S. Food and Drug Administration regarding late-stage clinical development plans for its first-in-class soluble LAG-3 protein, eftilagimod alpha, in conjunction with standard-of-care chemotherapy for the treatment of metastatic breast cancer.

The company said it and the FDA have agreed to an integrated Phase II/III trial design that will help inform a Biologics License Application.

Patients in the trial will receive efti and paclitaxel on the same day and treatment will continue until disease progression. The patient population also has been expanded to include triple-negative breast cancer, an aggressive form of breast cancer with limited treatment options.

Subject to regulatory and ethic committee feedback, the Phase II portion of the trial is expected to begin during the first quarter of 2023. In addition to the biologically active 30mg dosing for efti, the company and the FDA have agreed to test 90mg efti dosing in combination with paclitaxel. The trial design has a safety lead in of six to 12 patients, given the higher 90mg dosing of efti, followed by 58 patients for the randomized Phase II portion of the trial.

Immutep shares were up 6% to $2 in premarket trading.

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

(END) Dow Jones Newswires

December 23, 2022 08:25 ET (13:25 GMT)

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