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.
Overview of Immutep Ltd
Immutep Ltd is a globally active biotechnology company committed to advancing immunotherapy for both cancer and autoimmune diseases. Leveraging its expertise in immuno-oncology and innovative LAG-3 technology, the company has positioned itself as a specialized entity in personalized bio-therapeutic products. With dual listings on the Australian Stock Exchange and Nasdaq, Immutep demonstrates a robust international presence and a solid foundation in research and development.
Core Technology and Therapeutic Approach
The hallmark of Immutep’s approach is its focus on the LAG-3 immune control mechanism, a critical regulator of the T cell immune response. By modulating this pathway, Immutep aims to enhance the body’s natural ability to fight cancer and potentially address autoimmune conditions. This technology underpins the company’s strategic pipeline and sets a high standard for clinical precision and targeted therapy development.
Product Pipeline and Clinical Development
Immutep’s product portfolio is centered around its most advanced candidate, IMP321, which functions as a T cell immunostimulatory factor. This therapy is designed for integration into cancer chemoimmunotherapy protocols and has achieved significant clinical milestones in early phase trials. In addition to IMP321, the company is developing IMP701, a blocking anti-LAG-3 antibody candidate in early clinical evaluation, and CVac, a personalized immunocellular strategy under investigation for epithelial cancers. These development efforts illustrate a diverse and forward-looking approach that integrates both innovation and strategic collaboration.
Global Operations and Strategic Collaborations
Operating primarily from Australia, Immutep extends its influence across global markets, supported by strong regulatory compliance and research proficiency. Strategic partnerships with large pharmaceutical firms reinforce its pipeline development, enabling access to advanced clinical platforms and shared expertise. The company’s qualification for significant research tax incentives in both Europe and Australia underscores its commitment to high-caliber R&D and validates the commercial and scientific merits of its initiatives.
Industry Position and Business Model
Within the competitive landscape of biotechnology, Immutep differentiates itself by combining deep scientific expertise with a focused therapeutic strategy. Its business model hinges on collaborative partnerships, clinical innovation, and a targeted approach to harnessing LAG-3 mediated immune modulation. Investors and industry observers appreciate the rigorous clinical frameworks employed by the company, which underpin its potential to offer novel therapeutic modalities in the area of cancer treatment and beyond.
Research and Development Excellence
Immutep’s strategic emphasis on research and development is reflected in its participation in international R&D incentive programs. These initiatives not only provide substantial financial support for its clinical trials but also affirm the company’s adherence to high industry standards and scientific integrity. This relentless focus on innovation is at the core of Immutep’s operational ethos, ensuring that its immunotherapeutic solutions are developed in a rigorous and transparent environment.
Conclusion
In summary, Immutep Ltd stands as a key player in the biotechnology industry, with a specific focus on immunotherapy modalities for cancer and autoimmune diseases. Its reliance on advanced LAG-3 technology, comprehensive product pipeline, and robust global partnerships collectively fortify its standing in the competitive landscape. The company’s commitment to R&D excellence and transparent clinical strategies provides a rich source of insight for those seeking to understand a pioneering approach in modern biotechnology.
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).
Immutep (NASDAQ: IMMP) has reported positive initial safety data from its Phase I trial of IMP761, the world's first LAG-3 agonist antibody. Through the first three of five single ascending dose cohorts in healthy participants, no treatment-related adverse events have been observed. The placebo-controlled, double-blind study is being conducted at the Centre for Human Drug Research in Leiden, Netherlands, involving up to 49 participants.
IMP761 is designed to treat autoimmune diseases by enhancing LAG-3's 'brake' function on T cells to restore immune system balance. Additional safety data and pharmacokinetic/pharmacodynamic relationships assessment are expected in the first half of 2025. The drug shows potential for treating conditions like rheumatoid arthritis, Type 1 diabetes, and multiple sclerosis.
Immutep (NASDAQ: IMMP) and Monash University have published groundbreaking research in Science Immunology, revealing the first crystal structure of a human LAG-3/HLA-II complex. The study details how human lymphocyte activation gene 3 (LAG-3) binds to its main ligand MHC Class II, providing important insights for developing blocking LAG-3 therapeutics.
The research supports eftilagimod alfa's (efti) mechanism of action through preferential binding to MHC Class II molecules on antigen-presenting cells. The findings, conducted under Professor Jamie Rossjohn at Monash University's Biomedicine Discovery Institute, demonstrate how LAG-3 engages two HLA-II molecules with a distinct 38° offset angle, advancing understanding of the LAG-3 immune control mechanism.
Immutep (NASDAQ: IMMP) has announced promising clinical results from Cohort B of the TACTI-003 Phase IIb trial, evaluating eftilagimod alpha (efti) combined with KEYTRUDA® in head and neck cancer patients. The study shows significant improvements in patients with PD-L1 CPS <1 expression, including:
- Median overall survival (OS) not yet reached with 67% 12-month OS rate
- Progression-free survival of 5.8 months
- 35.5% objective response rate
- Complete response rate of 12.9% (RECIST 1.1) and 16.1% (iRECIST)
- Median duration of response of 9.3 months
These results significantly outperform historical controls of anti-PD-1 therapy alone, which showed 7.9-month median OS and 39% 12-month OS rate. The treatment continues to be well-tolerated with no new safety signals.
Immutep (NASDAQ: IMMP) has initiated the pivotal TACTI-004 Phase III clinical trial for first-line metastatic non-small cell lung cancer treatment. The trial received regulatory approval from Australia's Therapeutic Goods Administration, marking the company's advancement to Phase III status.
The global study will evaluate eftilagimod alfa in combination with KEYTRUDA® and chemotherapy against KEYTRUDA with chemotherapy and placebo. The trial will involve approximately 750 patients across 150+ clinical sites in 25+ countries. The randomized, double-blind study features dual primary endpoints of progression-free survival and overall survival. First patient enrollment is expected in Q1 2025.
Immutep (NASDAQ: IMMP) reports positive data from INSIGHT-003 Phase I trial evaluating eftilagimod alpha (efti) combined with KEYTRUDA and chemotherapy for first-line treatment of metastatic non-squamous non-small cell lung cancer. Mature data shows median Overall Survival of 32.9 months, median Progression Free Survival of 12.7 months, and 24-month Overall Survival rate of 81.0%.
The trial demonstrated significant improvement in Overall Response Rate across all PD-L1 expression levels compared to historical controls, achieving 55.0% ORR and 87.5% Disease Control Rate. Safety profile remains favorable with no new safety signals.
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