Immutep Limited

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IMM

AU000000IMM6

Biotechnology & Medical Research

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09/12	Immutep Shares Rise After Unit's Deal With Indian Drugmaker's Subsidiary	MT
09/12	Immutep, Dr. Reddy's Sign Licensing Deal for Cancer Drug Candidate	MT

Immutep Limited to Present New Data from AIPAC-003 Phase II at the 2025 San Antonio Breast Cancer Symposium

Published on 12/03/2025 at 02:51 am AEDT

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Immutep Limited

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Immutep Limited announces new data from the AIPAC-003 trial will be presented at the 2025 San Antonio Breast Cancer Symposium (SABCS) taking place in San Antonio, Texas, from December 9-12, 2025. The Phase II study randomised female participants (N=66) with HR+ and HER2-negative/HER2-low metastatic breast cancer (MBC) resistant to endocrine-based therapy (ET) including cyclin-dependent kinase 4/6 (CDK4/6) inhibitors or metastatic triple-negative breast cancer (mTNBC) not eligible for PD-(L)1-based therapy. Patients were randomised 1:1 to receive either 30 or 90 mg eftilagimod alfa (efti) in combination with paclitaxel to determine the optimal biological dose (OBD) consistent with the FDA?s Project Optimus initiative.

Both efti dosing levels on top of weekly paclitaxel in heavily pretreated metastatic breast cancer patients, who received a median of three prior lines of systemic therapy, led to strong objective response rates (ORR) and disease control rates (DCR) of 41.9% and 87.1% (30 mg efti) and 48.5% and 78.8% (90 mg efti), respectively, in the evaluable population (N=64). Time to onset of response (TTR) was comparable at 2.0 months (30 mg) versus 1.9 months (90 mg). Additionally, both dosing levels elicited the desired pharmacodynamic (PD) response in line with efti?s mechanism of action with substantial increases in immune activation biomarkers including absolute-lymphocyte count (ALC) and interferon-gamma (IFN-?).

Data cut-off date for efficacy results was 15 September 2025. Tolerability at 90 mg was suboptimal including dose-limiting toxicities (DLT) and a higher proportion of local injection site reactions (LISR). In line with FDA guidance/advice and as previously reported on 13 October 2025, 30 mg of efti administered subcutaneously has been defined as the OBD.

The AIPAC-003 trial has resulted in the successful completion of the FDA?s Project Optimus requirements and agreement on 30 mg as efti?s OBD carries strategic importance in ongoing and future clinical programs in oncology. This includes the global TACTI-004 (KEYNOTE-F91) Phase III trial evaluating efti in combination with MSD?s (Merck & Co. Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA (pembrolizumab), and chemotherapy as first-line treatment for advanced or metastatic non-small cell lung cancer (1L NSCLC), regardless of PD-L1 expression, which is now in the process of opening sites in the United States.

Details on the SABCS 2025 presentation are as follows: Title: Optimal biological dose of eftilagimod alpha, a soluble LAG-3 protein, in metastatic breast cancer patients receiving weekly paclitaxel in AIPAC-003. Presenter: Dr. Nuhad Ibrahim, Professor, Department of Breast Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center. Presentation number: PS1-09-16.

Abstract number: 315. Date and time: Wednesday, December 10 at 12:30-2:30 p.m. CST.

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17/10	Immutep passes enrolment milestone in cancer trial	FI
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Company Profile

Immutep Limited is an Australia-based clinical-stage biotechnology company. The Company is focused on developing Lymphocyte Activation Gene (LAG)-3 immunotherapies for cancer and autoimmune diseases. Its lead product candidate, Eftilagimod alpha (efti or IMP321), is a soluble LAG-3Ig fusion protein that is an antigen-presenting cell (APC) agonist designed to capitalize on LAG-3âs ability to drive the adaptive and innate immune systems against cancer. IMP761 is an immunosuppressive agonist antibody to LAG-3, which has the potential to address the root cause of autoimmune diseases by specifically silencing autoimmune memory T cells. Its third product candidate is LAG525, an antagonist (blocking) antibody targeting the LAG-3 molecule on T cells with potential applications in the treatment of cancer. Its fourth product candidate is IMP731 (GSK 781), a depleting (cytotoxic) antibody that is intended to destroy LAG-3 expressing activated T cells involved in autoimmunity.

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Biotechnology & Medical Research

Calendar

19/02 - Q2 2026 Earnings Release (Projected)

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