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- Immutep (IMM) enrols and doses its first patient at its European clinical site for its integrated Phase II/III AIPAC-003 trial
- The trial aims to evaluate the effectiveness of Immutep’s drug candidate, eftilagimod alpha (efti), in combination with paclitaxel for the treatment of two aggressive forms of metastatic breast cancer
- The company has set up 17 sites across Europe and the US, where patients will receive same-day administration of efti and paclitaxel, until disease progression occurs
- Based on the results obtained from the Phase II section, IMM plans to proceed with potential regulatory actions and initiate a Phase III trial to test overall survival
- IMM shares are up 4.23 per cent, trading at 37 cents at 10:30 am AEST
Immutep (IMM) has enrolled and dosed its first patient at a clinical site in Europe for its integrated Phase II/III AIPAC-003 trial.
The trial aims to evaluate the effectiveness of Immutep’s drug candidate, eftilagimod alpha (efti), in combination with paclitaxel for the treatment of two aggressive forms of metastatic breast cancer: HER2-negative/low breast cancer and triple-negative breast cancer.
The company has set up 17 sites across Europe and the US, where patients will receive same-day administration of efti and paclitaxel, until disease progression occurs.
AIPAC-003 includes an open-label lead-in of up to 12 patients, who will dosed with 90 milligrams of efti, followed by a randomised phase II section.
Phase II will test 58 patients with administered dosages of 30mg or 90mg of efti to determine the optimal biological dose in combination with paclitaxel.
Based on the results obtained from the phase II section, IMM plans to proceed with potential regulatory actions and initiate a phase III trial.
The phase III trial will be randomised, double-blind, and placebo-controlled, focusing on assessing the overall survival of patients.
Immutep CSO Professor Frédéric Triebel said the company’s previous trial, AIPAC, demonstrated encouraging efficiency and safety results as well as survival improvements ranging from 4.2 to 19.6 months.
“Our aim is to improve clinical outcomes, focusing on a robust primary
endpoint later in phase III, overall survival, for patients with standard-of-care chemotherapy,” Professor Triebel said.
“We look forward to seeing how 90miligrams efti dosing, along with same-day
administration of efti plus paclitaxel until disease progression, may build upon these prior results.”
Efti, is also being evaluated for the treatment of other solid tumors, including non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (HNSCC).
The company has previously secured fast-track designation for efti from the US Food and Drug Administration (FDA) for first-line treatment in HNSCC and NSCLC.
IMM shares are up 4.23 per cent, trading at 37 cents at 10:30 am AEST.
