Welcome to our dedicated page for Immutep news (Ticker: IMMP), a resource for investors and traders seeking the latest updates and insights on Immutep stock.
Immutep Limited (IMMP) news covers a late-stage biotechnology company focused on Lymphocyte Activation Gene-3 (LAG-3)–related immunotherapies for cancer and autoimmune disease. The company regularly reports clinical, regulatory and corporate developments across its diversified LAG-3 portfolio, led by the MHC Class II agonist eftilagimod alfa (efti) and the LAG-3 agonist antibody IMP761.
On this page, readers can follow updates on Immutep’s major oncology programs, including the global TACTI-004 (KEYNOTE-F91) Phase III trial in first-line non-small cell lung cancer, as well as Phase II and investigator-initiated studies in head and neck squamous cell carcinoma, soft tissue sarcoma and metastatic breast cancer. News items highlight trial milestones such as patient enrolment progress, primary endpoint readouts, translational biomarker data and presentations at international conferences like the European Society for Medical Oncology (ESMO), the World Conference on Lung Cancer and the San Antonio Breast Cancer Symposium.
For autoimmune disease, Immutep publishes updates on the Phase I program for IMP761, a first-in-class LAG-3 agonist antibody designed to silence dysregulated self-antigen-specific memory T cells. News coverage includes safety, pharmacodynamic findings and proof-of-concept data from the ongoing first-in-human study.
Investors can also track regulatory interactions, such as Fast Track designations, FDA feedback on late-stage development strategies and completion of Project Optimus requirements, alongside business developments like the strategic collaboration and exclusive licensing agreement with Dr. Reddy’s Laboratories for efti in selected global markets. Corporate news, including R&D tax incentives from French and Australian government programs and quarterly activity reports, provides additional context on funding and operational progress.
Bookmark this page to monitor Immutep’s latest announcements, clinical data disclosures and SEC Form 6-K filings that shape the outlook for IMMP and its LAG-3–focused pipeline.
Immutep (NASDAQ: IMMP) reported successful completion of the single ascending dose (SAD) portion of its first‑in‑human Phase I study of IMP761, a LAG‑3 agonist for autoimmune diseases, with dosing up to 14 mg/kg and no dose‑limiting toxicities observed.
The multiple ascending dose (MAD) portion is ongoing, with MAD completion expected in Q3 2026. According to the company, IMP761 produced a durable immunosuppressive effect in an intradermal antigen challenge after a single administration. Phase I data will be presented at EULAR on 4 June 2026.
Immutep (NASDAQ: IMMP) announced on March 13, 2026 that an Independent Data Monitoring Committee recommended discontinuing the TACTI-004 Phase III study in first-line non-small cell lung cancer after a planned interim futility analysis.
Enrollment will be halted, the study will be wound down with patient follow-up and site close-out, and Immutep says it is reviewing the data and next steps. The company now expects its cash runway to extend well beyond its prior guidance of Q2 CY2027 and will provide an updated outlook after operational assessments.
Immutep (NASDAQ: IMMP) announced it has reached 50% enrolment in the registrational TACTI-004 (KEYNOTE-F91) Phase III trial for first-line advanced/metastatic non-small cell lung cancer. The trial has enrolled 378 patients, with >140 activated clinical sites across 27 countries.
Immutep says the futility analysis remains on track for Q1 CY2026 and patient enrolment completion is expected in Q3 CY2026.
Immutep (NASDAQ: IMMP / ASX: IMM) reported Q2 FY26 operational and clinical progress, highlighted by a strategic collaboration with Dr. Reddy’s for efti outside North America, Europe, Japan and Greater China, with an upfront ~A$30.2M and up to ~A$528.4M in milestones plus royalties.
Key clinical milestones: TACTI-004 Phase III enrolment progressing (289 patients, ~38% of target), EFTISARC-NEO met its primary endpoint, INSIGHT-003 showed strong 1L NSCLC responses, IMP761 Phase I dosing advanced, four patents granted, and pro-forma cash of ~A$129.3M extending runway into Q2 CY2027.
Immutep (NASDAQ: IMMP / ASX: IMM) reported a positive Phase I update for IMP761, a first-in-class LAG-3 agonist antibody for autoimmune diseases.
The single-ascending dose portion completed 2.5 mg/kg and 7 mg/kg cohorts with a favourable safety profile and no treatment-related adverse reactions beyond mild intensity. Dose-dependent immunosuppression was observed with significant, durable inhibition of three T-cell-mediated intradermal reactions at days 2, 9 and 23. The company said a PK/PD relationship was established between 1 and 7 mg/kg.
The trial will continue as planned and additional updates, including a possible presentation at a major medical conference, are anticipated in 1H CY2026.
Immutep (ASX:IMM; NASDAQ:IMMP) reports strong operational progress in the registrational TACTI-004 (KEYNOTE-F91) Phase III trial of eftilagimod alfa (efti) with KEYTRUDA and chemotherapy for first-line advanced/metastatic NSCLC.
Key facts: 289 patients enrolled (≈38% of 756 target), >120 activated clinical sites, 27 countries with full regulatory approvals, futility analysis on track for Q1 CY2026, and expected completion of enrolment in Q3 CY2026. Licensing interest noted with a deal for emerging markets with Dr Reddy's.
Immutep (ASX: IMM; NASDAQ: IMMP) and Dr. Reddy’s entered an exclusive licensing and collaboration for eftilagimod alfa (efti) in all countries outside North America, Europe, Japan, and Greater China, announced 8 December 2025. Immutep will receive an upfront payment of USD 20 million, is eligible for up to USD 349.5 million in regulatory and commercial milestones, and will receive double-digit royalties on sales in the licensed markets. Immutep retains rights in key markets (North America, Europe, Japan), holds global manufacturing rights, and will supply product to Dr. Reddy’s as efti advances in a registrational Phase III NSCLC trial (TACTI-004/KEYNOTE-F91).
Immutep (NASDAQ: IMMP) will present Phase II AIPAC-003 data at SABCS 2025 showing the immunotherapy-chemotherapy combination of eftilagimod alfa (efti) plus paclitaxel produced strong responses and immune activation in heavily pretreated metastatic breast cancer patients.
In the evaluable population (N=64) ORR/DCR were 41.9%/87.1% (30 mg) and 48.5%/78.8% (90 mg); time to response was ~2.0 months. FDA Project Optimus requirements were satisfied and 30 mg was selected as efti’s optimal biological dose (OBD) after tolerability issues at 90 mg.
Immutep (NASDAQ: IMMP) reported positive Phase II EFTISARC-NEO results presented at CTOS 2025 for neoadjuvant eftilagimod alfa (efti) with radiotherapy + pembrolizumab in resectable soft tissue sarcoma.
In the evaluable population (N=38) the combination reached a median 51.5% tumor hyalinization/fibrosis (p<0.001), meeting the study primary endpoint across ten STS subtypes including myxofibrosarcoma and undifferentiated pleomorphic sarcoma. Early translational data (n=20) showed statistically significant increases in peripheral biomarkers: CXCL9 2.5x, CXCL10 1.8x, IL-23 2.2x, IFN-γ 2.5x, with IFN-γ increases correlating with pathologic response. Disease-free and overall survival data remain immature and will be reported later.
Immutep (NASDAQ: IMMP / ASX: IMM) received a €2,588,954 (≈ A$4,567,769) cash R&D tax incentive from the French Government under the Crédit d’Impôt Recherche (CIR).
The payment reimburses up to 30% of eligible R&D expenditure and covers activities by subsidiary Immutep S.A.S. in France for the 2024 calendar year. Immutep also remains eligible for Australian Federal Government R&D cash rebates for eligible Australian R&D spend.
The company said the funds will be used to support ongoing and planned global clinical development of eftilagimod alfa and IMP761.