Immutep Stock Price, News & Analysis

Immutep Limited (NASDAQ: IMMP, ASX: IMM) is a late-stage biotechnology company developing novel immunotherapies for cancer and autoimmune disease. The company focuses on therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), an immune checkpoint that can either stimulate or suppress the immune response. Immutep describes itself as a pioneer in the understanding and advancement of LAG-3–related therapeutics, with a diversified product portfolio that harnesses LAG-3’s ability to modulate the immune system.

Immutep’s research and development activities centre on two main areas: oncology and autoimmune diseases. In oncology, its lead product candidate is eftilagimod alfa (efti), a first-in-class soluble LAG-3 protein and MHC Class II agonist designed to activate antigen-presenting cells (APCs) such as dendritic cells and monocytes. By stimulating APCs through MHC Class II ligands, efti engages both the adaptive and innate immune system to initiate a broad anti-cancer immune response, including priming and activating cytotoxic T cells and generating co-stimulatory signals and cytokines that support anti-tumour activity. Efti is being evaluated across multiple solid tumours, including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), soft tissue sarcoma, and breast cancer.

A key program for efti is TACTI-004 (KEYNOTE-F91), a global, randomised, double-blind, controlled Phase III trial in first-line advanced or metastatic NSCLC. The study evaluates efti in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA (pembrolizumab) and chemotherapy, compared against pembrolizumab plus chemotherapy and placebo. The trial is designed to enrol approximately 756 patients with non-squamous or squamous tumours regardless of PD-L1 expression at more than 150 clinical sites in over 25 countries, with dual primary endpoints of progression-free survival and overall survival. Immutep has reported that enrolment is progressing globally and that futility analysis and other key milestones are planned as the trial advances.

Beyond TACTI-004, efti is under evaluation in several other clinical settings. Investigator-initiated and company-sponsored studies include trials in head and neck cancer, where Immutep has reported encouraging data in first-line HNSCC patients with PD-L1 expression below 1 (CPS <1), and soft tissue sarcoma (STS), where the EFTISARC-NEO Phase II trial combines neoadjuvant efti with radiotherapy and KEYTRUDA in resectable STS. In EFTISARC-NEO, Immutep has announced that the trial met its primary endpoint, with a median tumour hyalinization/fibrosis of 51.5% in the evaluable population, significantly exceeding the study’s prespecified target and historical data for radiotherapy alone. Early translational data from this trial show statistically significant increases in cytokines and chemokines such as CXCL9, CXCL10, IL-23 and interferon-gamma (IFN-γ), consistent with efti’s mode of action.

In metastatic breast cancer, Immutep is conducting the AIPAC-003 Phase II study, which randomised patients with hormone receptor–positive, HER2-negative/HER2-low or triple-negative metastatic breast cancer to receive either 30 mg or 90 mg efti in combination with paclitaxel. The trial was designed to determine the optimal biological dose in line with the US Food and Drug Administration’s (FDA) Project Optimus initiative. Immutep has reported that both dosing levels led to strong objective response and disease control rates and that both doses elicited pharmacodynamic responses in line with efti’s mechanism of action, including increases in immune activation biomarkers such as absolute lymphocyte count and IFN-γ. Based on efficacy, safety and pharmacodynamic data, 30 mg efti administered subcutaneously has been defined as the optimal biological dose for oncology programs.

Immutep has also highlighted data from the INSIGHT-003 Phase I investigator-initiated trial in first-line non-squamous NSCLC, where efti is combined with KEYTRUDA and doublet chemotherapy. The company reports strong objective response and disease control rates across all PD-L1 expression levels, with particularly notable outcomes in patients with low or no PD-L1 expression (tumour proportion score <50%), a large patient segment where PD-(L)1 inhibitors alone typically perform less well. These findings support the rationale for the registrational TACTI-004 Phase III trial using the same immunotherapy/chemotherapy combination.

In addition to oncology, Immutep is advancing IMP761, a first-in-class immunosuppressive LAG-3 agonist antibody for autoimmune diseases. IMP761 is designed to enhance the “brake” function of LAG-3 to silence dysregulated self-antigen-specific memory T cells that drive autoimmune pathology and to restore balance to the immune system. The company is conducting a placebo-controlled, double-blind first-in-human Phase I study in healthy participants. Immutep has announced that the single-ascending dose portion of this study has successfully completed multiple dosing levels (including 2.5 and 7 mg/kg) with a favourable safety profile and dose-dependent immunosuppressive effects. Evidence includes significant, long-lasting inhibition of T cell–mediated intradermal reactions to a strong foreign antigen, and the company notes that these data provide proof-of-concept for IMP761’s potential to address the root cause of autoimmune diseases by specifically silencing autoimmune memory T cells at disease sites.

Immutep’s development strategy involves both internal clinical programs and collaborations. The company has entered into a strategic collaboration and exclusive licensing agreement with Dr. Reddy’s Laboratories for the development and commercialisation of efti in all countries outside North America, Europe, Japan and Greater China. Under this agreement, Immutep retains global manufacturing rights and supplies efti to Dr. Reddy’s in the licensed markets, while keeping full rights in key pharmaceutical markets such as North America, Europe and Japan. Immutep has described this collaboration as providing upfront and potential milestone payments, as well as royalties on commercial sales, while allowing the company to participate in the future commercial upside of efti in the licensed territories.

Regulatory interactions are an important part of Immutep’s story. The company has reported Fast Track designation from the FDA for efti in first-line HNSCC and first-line NSCLC. It has also announced successful completion of FDA Project Optimus requirements and agreement with the agency on 30 mg as the optimal biological dose for efti in oncology, which Immutep describes as a strategic milestone and a building block toward potential future Biological License Application filings. In head and neck cancer, Immutep has received positive feedback from the FDA regarding future late-stage development of efti in first-line HNSCC patients with PD-L1 expression below 1, including potential paths toward accelerated approval.

From a corporate and operational perspective, Immutep reports that it conducts research and development through subsidiaries, including activities in France that qualify for the French government’s Crédit d’Impôt Recherche (CIR) tax incentive. The company has disclosed receipt of R&D tax incentive payments from the French government and notes that it also qualifies for cash rebates from the Australian Federal Government’s R&D tax incentive program for eligible activities in Australia. These funds are used to support ongoing and planned global clinical development of efti and IMP761.

Immutep’s securities are listed on both the Australian Securities Exchange (ASX: IMM) and the Nasdaq market in the United States (NASDAQ: IMMP). Through its focus on LAG-3 biology, late-stage clinical programs, regulatory designations and collaborations, the company positions itself as a biotechnology issuer in the professional, scientific and technical services sector with an emphasis on research and development in biotechnology and immunotherapy.

Business model and focus

According to its public communications, Immutep’s business model is built around discovering, developing and advancing LAG-3–related immunotherapies through clinical trials, regulatory interactions and partnering. The company’s oncology programs aim to develop efti as a combination partner with existing treatments such as anti-PD-1 therapies, chemotherapy and radiotherapy, while its autoimmune program seeks to validate IMP761 as a novel approach to silencing pathogenic T cells. Licensing agreements, such as the collaboration with Dr. Reddy’s, and government R&D incentives complement its clinical development activities.

Key programs and indications

• Eftilagimod alfa (efti): MHC Class II agonist and soluble LAG-3 protein under evaluation in NSCLC (including the pivotal TACTI-004 Phase III trial), HNSCC, soft tissue sarcoma, metastatic breast cancer and other solid tumours.
• TACTI-004 (KEYNOTE-F91): Global Phase III trial in first-line advanced/metastatic NSCLC combining efti with KEYTRUDA and chemotherapy, with progression-free survival and overall survival as dual primary endpoints.
• INSIGHT-003: Phase I investigator-initiated trial in first-line non-squamous NSCLC evaluating efti with KEYTRUDA and chemotherapy, with reported strong response rates across PD-L1 expression levels.
• AIPAC-003: Phase II trial in metastatic breast cancer evaluating 30 mg versus 90 mg efti plus paclitaxel to establish the optimal biological dose; both doses have shown objective responses and immune activation.
• EFTISARC-NEO: Phase II investigator-initiated trial in resectable soft tissue sarcoma using neoadjuvant efti with radiotherapy and KEYTRUDA, which met its primary endpoint with high tumour hyalinization/fibrosis and demonstrated immune activation biomarkers.
• IMP761: First-in-class LAG-3 agonist antibody in Phase I development for autoimmune diseases, with dose-dependent immunosuppressive effects and a favourable safety profile reported in healthy participants.

Regulatory and scientific positioning

Immutep emphasises that LAG-3 is a promising therapeutic target in both oncology and autoimmune disease. The company cites scientific literature indicating the relevance of LAG-3 in conditions such as rheumatoid arthritis, type 1 diabetes and multiple sclerosis, and notes that IMP761 is designed to target dysregulated self-antigen-specific memory T cells at disease sites. In oncology, efti’s mechanism of activating antigen-presenting cells and bridging adaptive and innate immunity underpins its use in combination with PD-1 inhibitors like KEYTRUDA. Fast Track designations, completion of Project Optimus requirements and supportive FDA feedback in specific indications are presented by Immutep as validation of its approach.

Use of capital and R&D incentives

Immutep reports that it uses cash, cash equivalents and term deposits, together with tax incentives and collaboration payments, to fund its research and development programs. The company has disclosed strong cash and investment balances and notes that it exercises prudent cash management while advancing multiple clinical trials. R&D tax incentives from France and Australia, as well as potential milestone and royalty payments from collaborations, are positioned as important components of its funding mix for ongoing and planned studies of efti and IMP761.

Frequently asked questions about Immutep Limited

The following FAQs address common questions investors and observers may have about Immutep based on its public disclosures.