-- No safety or tolerability issues in open-label, safety lead-in phase evaluating the higher 90mg dose of efti in combination with weekly paclitaxel in the first 6 patients
-- Good safety profile allows for lead-in phase to be closed early and the randomized Phase II portion of study will now proceed
SYDNEY, AUSTRALIA – 06 November 2023 – Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces the open-label safety lead-in of its integrated AIPAC-003 Phase II/III trial evaluating for the very first time 90mg of eftilagimod alpha (efti) in combination with paclitaxel has been completed with no safety or tolerability issues.
Six patients with metastatic breast cancer receiving this immuno-oncology chemotherapy (IO-chemo) combination, after exhaustion of all endocrine/CDK4/6 based therapies, tolerated the therapy very well and there were no dose limiting toxicities, as confirmed by the independent Data Monitoring Committee (IDMC) appointed for the trial. The IDMC recommended proceeding to the randomised Phase II portion of the trial.
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