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) has announced positive results from its Phase II EFTISARC-NEO trial, evaluating eftilagimod alfa (efti) in combination with radiotherapy and KEYTRUDA® for resectable soft tissue sarcoma (STS). The trial met its primary endpoint, achieving significantly higher tumor hyalinization/fibrosis rates compared to historical data. The combination therapy demonstrated 50% tumor hyalinization/fibrosis in preliminary analysis, substantially exceeding the prespecified target of 35% and historical radiotherapy-alone data of 15%.
The study, conducted at Poland's national STS reference center, completed enrollment of 40 patients in January 2025. This chemotherapy-free treatment represents a potential breakthrough for STS, an orphan disease with poor prognosis affecting approximately 13,520 new cases in the US in 2025, with an estimated 5,420 deaths.
Immutep (NASDAQ: IMMP) has announced exceptional results from its TACTI-003 Phase IIb trial, showing a median Overall Survival (OS) of 17.6 months for head and neck cancer patients with PD-L1 CPS <1. The trial evaluated eftilagimod alfa (efti) combined with KEYTRUDA® in first-line therapy for recurrent/metastatic head and neck squamous cell carcinoma.
The results significantly outperform current standard-of-care treatments, which show OS of 10.7 months for cetuximab + chemotherapy and 11.3 months for anti-PD-1 therapy + chemotherapy. The combination therapy was well-tolerated with no new safety concerns. Notably, this represents a potential breakthrough for the 20% of patients with CPS <1, who currently have no chemotherapy-free treatment options.
The company has requested an FDA meeting to discuss potential paths to approval, leveraging its Fast Track designation in 1L HNSCC.
Immutep has reached significant milestones in Q3 FY25, with the first patient dosed in their pivotal TACTI-004 Phase III lung cancer trial. This global trial will evaluate eftilagimod alfa (efti) in combination with KEYTRUDA® and chemotherapy for non-small cell lung cancer treatment, targeting 756 patients across 150+ clinical sites.
The company completed patient enrollment in two key trials: the EFTISARC-NEO Phase II trial for soft tissue sarcoma and the INSIGHT-003 Phase I trial for NSCLC treatment. Immutep maintains a strong financial position with A$146.25 million in cash, providing runway through end of CY2026.
Key financial highlights for Q3 FY25:
- R&D expenses decreased to A$13.6 million from A$16.2 million in Q2
- G&A costs were A$704k
- Staff costs remained stable at A$2.5 million
- Total operating cash outflow was A$16.26 million
Immutep (ASX: IMM; NASDAQ: IMMP), a late-stage immunotherapy company focused on cancer and autoimmune diseases, has announced its participation in three major upcoming investor conferences.
The company will attend the Jones Healthcare and Technology Innovation Conference in Las Vegas on April 9, 2025, at 4:30 pm ET, followed by the Citizens Life Sciences Conference in New York on May 8, 2025, at 1:00 pm ET. Additionally, Immutep will participate in the Jefferies Global Healthcare Conference in New York on June 4-5, 2025, with detailed presentation information to be released later on the company's website.
Immutep (NASDAQ: IMMP) has initiated its pivotal TACTI-004 Phase III trial with the first patient successfully dosed at Calvary Mater Newcastle Hospital in Australia. The trial will evaluate eftilagimod alfa, a first-in-class MHC Class II agonist, in combination with KEYTRUDA® and chemotherapy as first-line treatment for advanced or metastatic non-small cell lung cancer (NSCLC).
The global study will enroll approximately 756 patients across more than 150 clinical sites. The trial has received regulatory approvals in 16 countries, including Australia, Canada, and several European nations, with additional clearances expected soon. The 30mg subcutaneous efti dosing will be used, based on previous regulatory discussions and demonstrated efficacy.
NSCLC represents 80-85% of all lung cancer diagnoses, with less than 30% survival rate after five years. The trial results will support a potential marketing approval application in NSCLC, one of the largest oncology indications.
Immutep (NASDAQ: IMMP) has announced an upcoming poster presentation at the European Lung Cancer Congress (ELCC) 2025 in Paris, featuring their pivotal TACTI-004 Phase III trial. The trial evaluates eftilagimod alfa (efti) in combination with KEYTRUDA® and chemotherapy for first-line treatment of advanced or metastatic non-small cell lung cancer (NSCLC).
The global study will enroll approximately 750 patients across 150+ clinical sites in 25+ countries, including patients with non-squamous or squamous tumors regardless of PD-L1 expression. The poster presentation, numbered 131TiP, will be delivered by Dr. Margarita Majem on March 26, 2025, at 13:50 CET.
According to CSO Frédéric Triebel, the combination therapy could potentially transform treatment for advanced NSCLC patients, building on promising safety and efficacy data observed to date.
Immutep (ASX: IMM; NASDAQ: IMMP) reported significant progress in Q2 FY25, marking its transition to a Phase III biotech company. Key highlights include:
The company's TACTI-004 Phase III trial in first-line non-small cell lung cancer received its first regulatory approval. Mature data from INSIGHT-003 showed impressive results with 32.9-month median overall survival and 81.0% 24-month OS rate. The TACTI-003 trial in head & neck cancer demonstrated promising outcomes with 67% 12-month OS rate.
The Phase II soft tissue sarcoma trial showed a three-fold increase in tumor hyalinization compared to historical data. The company's IMP761 Phase I trial reported favorable initial safety results.
Financially, Immutep maintains a strong position with A$159.26 million in cash, cash equivalents, and term deposits, providing an expected cash reach until the end of CY2026. The quarter saw increased R&D spending of A$16.2 million, primarily due to the Phase III trial commencement.
Immutep (IMMP) has completed patient enrollment for its Phase II EFTISARC-NEO trial, reaching the target of 40 patients. The trial evaluates eftilagimod alpha (efti) in combination with radiotherapy plus KEYTRUDA® for patients with resectable soft tissue sarcoma (STS).
Preliminary data presented at the CTOS Annual Meeting in November 2024 showed promising results. Among 21 patients assessed, the triple combination achieved a median tumor hyalinization/fibrosis of 50%, representing a three-fold increase compared to the historical median of 15% from radiotherapy alone. This early surrogate endpoint is associated with improved survival for STS patients.
The treatment has demonstrated a favorable safety profile with no grade ≥3 toxicities related to efti and pembrolizumab. Further data updates are expected in 2025.
Immutep (ASX: IMM; NASDAQ: IMMP), a clinical-stage biotechnology company, announced the completion of patient enrolment for the INSIGHT-003 trial. This multi-centre Phase I trial evaluates the combination of eftilagimod alpha (efti), pembrolizumab (KEYTRUDA®), and doublet chemotherapy as a first-line treatment for advanced or metastatic non-squamous non-small cell lung cancer (1L NSCLC).
The trial has enrolled approximately 50 evaluable patients across multiple sites in Germany, led by the Frankfurt Institute of Clinical Cancer Research IKF. Initial results, reported on 14 November 2024, showed a median Overall Survival (OS) of 32.9 months and a 24-month OS rate of 81.0% in patients with a minimum follow-up of 22 months (N=21). These results compare favourably to a registrational trial showing a median OS of 22.0 months and a 24-month OS rate of 45.5% for anti-PD-1 and doublet chemotherapy in non-squamous 1L NSCLC regardless of PD-L1 expression.
Further data updates from the INSIGHT-003 trial are expected in 2025 and beyond. For more information on the trial, visit clinicaltrials.gov (NCT03252938).