- Business
- Immutep Limited Immutep Limited is an Australia-based late clinical-stage biotechnology company that develops novel Lymphocyte Activation Gene-3 (LAG-3) related immunotherapies for cancer and autoimmune diseases. The company offers a diversified portfolio of proprietary therapeutics, including its lead candidate eftilagimod alfa (efti or IMP321), a soluble LAG-3Ig fusion protein and antigen-presenting cell agonist for oncology indications such as first-line non-small cell lung cancer (TACTI-004 and INSIGHT-003 trials), first-line head and neck squamous cell carcinoma (TACTI-003), metastatic urothelial cancer (INSIGHT-005), soft tissue sarcoma (EFTISARC-NEO), and breast cancer (AIPAC-003 and EOC 202); IMP761, an agonist LAG-3 antibody for autoimmune diseases; IMP731, a depleting LAG-3 antibody for ulcerative colitis and psoriasis; and out-licensed LAG-3 candidates in combination therapies for solid tumors, blood cancers, triple-negative breast cancer, and melanoma. Immutep was founded in 1999 stemming from the discovery of LAG-3 by its Chief Scientific Officer Dr. Frédéric Triebel and maintains headquarters in Sydney, New South Wales, with global operations encompassing clinical trials across Australia, Europe, and the United States; it retains worldwide rights to its key assets excluding mainland China, Hong Kong S.A.R., Macao S.A.R., and Taiwan for efti, where rights are licensed to EOC Pharma for potential milestone and royalty payments. In recent developments, Immutep met the primary endpoint in the EFTISARC-NEO Phase II trial evaluating neoadjuvant efti in soft tissue sarcoma, with data presented at ESMO Congress 2025 and highlighted in an oral presentation at CTOS 2025; completed FDA Project Optimus requirements confirming 30mg efti as the optimal biological dose for its oncology pipeline; received positive FDA feedback on late-stage development of efti in head and neck cancer for patients with CPS <1; announced an update advancing the TACTI-004 (KEYNOTE-F91) Phase III trial in first-line NSCLC; and entered a research collaboration with the George Washington University Cancer Center to evaluate neoadjuvant efti. The company maintains strategic clinical trial collaborations and supply agreements with MSD (Merck & Co., Inc.) for KEYTRUDA combinations, Merck KGaA for BAVENCIO, and Novartis for multiple out-licensed programs where Novartis funds development and Immutep receives milestones and royalties; additional partnerships include EOC Pharma and investigator-initiated trials by institutions such as the Institute of Clinical Cancer Research IKF and Maria Skłodowska-Curie National Research Institute of Oncology.