IMMUTEP Ltd (IMMP)

Immutep Limited is a late-stage biotechnology company developing novel immunotherapies related to Lymphocyte Activation Gene-3 (LAG-3) for cancer and autoimmune disease. Incorporated in Australia in 1987 as a mining company (Prima Resources), it was repositioned as a biotechnology company in 2001, acquired the French company Immutep S.A. in December 2014, and changed its name from Prima BioMed to Immutep in November 2017 to focus on its LAG-3 portfolio. The company describes itself as a pioneer in understanding and advancing LAG-3 therapeutics, and it aims to bring new treatment options to patients and maximise shareholder value.

The lead candidate is eftilagimod alfa (efti or IMP321), a soluble LAG-3Ig fusion protein and first-in-class antigen-presenting cell agonist. It activates antigen-presenting cells via MHC II molecules, driving expansion of CD8+ and CD4+ T cells, dendritic cells, NK cells and monocytes, and it can be combined with anti-PD-(L)1 therapy and/or chemotherapy. Efti trials include TACTI-004, a registrational Phase III trial in first-line non-small cell lung cancer (NSCLC) with an anti-PD-1 therapy and chemotherapy; TACTI-003, a Phase IIb trial in first-line head and neck squamous cell carcinoma with pembrolizumab; and AIPAC-003, a Phase II/III trial with paclitaxel in metastatic breast cancer. Investigator-initiated studies include INSIGHT and EFTISARC-NEO. Completed trials include TACTI-002 (NSCLC and head and neck cancer), AIPAC and TACTI-mel. The FDA has granted Fast Track designation to efti in first-line NSCLC and in first-line head and neck cancer. Other assets are IMP761, an LAG-3 agonist for autoimmune disease; IMP701 (LAG525, ieramilimab), licensed to Novartis; and IMP731, returned to Immutep by GSK in 2024. Immutep also holds an exclusive license from Cardiff University for next-generation anti-LAG-3 small molecules. Milestones and royalties may be received from Novartis and from EOC Pharma, which conducts efti trials in China.

The company's markets are cancer indications such as NSCLC, head and neck squamous cell carcinoma, metastatic breast cancer, melanoma and soft tissue sarcoma, plus autoimmune disease. Its clinical trials run across the United States, Europe and Australia. It has collaboration and supply agreements with Merck & Co. (MSD outside the US and Canada) for combination trials with KEYTRUDA (pembrolizumab).

Immutep's registered office is in Sydney, Australia, with administrative offices in Sydney, Leipzig and Berlin, and a laboratory near Paris for LAG-3 research and development. As of June 30, 2025 it had 51 employees. Internal staff handle finance, business development, intellectual property, investor relations, and oversight of manufacturing and clinical development, while outside contractors and consultants carry out much of the manufacturing and clinical trial work. The LAG-3 intellectual property was licensed from Merck Serono in 2002, with development milestones and royalties payable on efti, IMP701 and IMP731. Its agent for service of process in the United States is Immutep U.S., Inc.