Immutep Stock Price, News & Analysis

Immutep (NASDAQ: IMMP) announced that data from its EFTISARC-NEO Phase II trial has been accepted for oral presentation at the CTOS 2025 Annual Meeting. The groundbreaking study evaluates eftilagimod alpha (efti) in combination with radiotherapy and KEYTRUDA® for soft tissue sarcoma (STS) patients in a neoadjuvant setting.

The presentation will be delivered by Dr. Pawel Sobczuk on November 13, 2025, focusing on the primary endpoint and translational correlates from the trial. This research addresses a significant unmet medical need, as STS affects approximately 13,520 new patients in the US annually, with an estimated 5,420 deaths in 2025.

The study is being conducted at the Maria Skłodowska-Curie National Research Institute of Oncology in Warsaw, Poland, with primary funding from the Polish government.

Immutep (NASDAQ: IMMP) has received positive FDA feedback regarding the clinical development of eftilagimod alfa (efti) for first-line treatment of head and neck cancer patients with PD-L1 expression below 1 (CPS <1). The feedback follows encouraging data from the TACTI-003 Phase IIb trial evaluating efti in combination with KEYTRUDA®.

The FDA has outlined two potential development paths: a randomized registrational trial against standard-of-care therapy or a smaller single-arm study (70-90 patients) followed by a confirmatory randomized study. This development aligns with FDA's Project FrontRunner initiative, targeting earlier clinical settings in cancer treatment.

The company notes that up to 20% of first-line HNSCC patients have CPS <1, representing a significant unmet medical need, as current treatment options for these patients all include chemotherapy.

Immutep (NASDAQ: IMMP) reported significant progress in Q4 FY25 across multiple clinical trials. The company's pivotal TACTI-004 Phase III trial in first-line non-small cell lung cancer is advancing with 78 sites across 23 countries. Notable achievements include a 60.8% response rate in the INSIGHT-003 trial combining efti with KEYTRUDA® and chemotherapy in 1L NSCLC.

Key highlights include a 17.6-month median Overall Survival in head and neck cancer patients, successful primary endpoint achievement in the EFTISARC-NEO Phase II trial for soft tissue sarcoma, and positive initial data from IMP761's Phase I autoimmune trial. The company maintains a strong financial position with A$129.69 million in cash, providing runway through end of 2026.

Immutep (NASDAQ: IMMP) announces an upcoming poster presentation of its pivotal TACTI-004 Phase III trial at the 2025 World Conference on Lung Cancer in Barcelona. The trial evaluates eftilagimod alfa (efti) in combination with KEYTRUDA® and chemotherapy as first-line therapy for advanced non-small cell lung cancer.

The global study will enroll approximately 750 patients across 150 clinical sites in over 25 countries, including patients with all PD-L1 expression levels. The presentation, scheduled for September 9, 2025, will showcase the trial design and overview, which aims to potentially change the treatment paradigm for NSCLC patients.

Immutep (NASDAQ: IMMP) announced the acceptance of three abstracts for presentation at the European Society for Medical Oncology (ESMO) Congress 2025 in Berlin. The presentations will showcase clinical trials of their first-in-class MHC Class II agonist, eftilagimod alfa (efti).

The presentations include a Proffered Paper oral presentation on the EFTISARC-NEO Phase II trial in soft tissue sarcoma, a poster presentation on the INSIGHT-003 Phase I trial in first-line non-small cell lung cancer (NSCLC), and a Trials in Progress ePoster on the pivotal TACTI-004 Phase III trial in first-line NSCLC. The abstracts will be available on October 13, 2025.

Immutep (NASDAQ: IMMP) reported positive initial efficacy data from its Phase I study of IMP761, a first-in-class LAG-3 agonist antibody for autoimmune diseases. The placebo-controlled, double-blind study demonstrated significant T cell suppression with 80% inhibition at 0.9 mg/kg dosing level and showed a favorable safety profile with no treatment-related adverse events. The company is proceeding with higher single ascending dose levels of 2.5, 7, and 14 mg/kg. IMP761 is designed to treat autoimmune diseases like rheumatoid arthritis, Type 1 diabetes, and multiple sclerosis by enhancing LAG-3's brake function to silence dysregulated self-antigen-specific memory T cells. The trial is being conducted at CHDR in Leiden, Netherlands, with additional data expected in the second half of 2025.

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 reported impressive results from its INSIGHT-003 trial evaluating eftilagimod alpha (efti) in combination with KEYTRUDA® and chemotherapy for first-line non-small cell lung cancer (NSCLC). The treatment achieved a 60.8% overall response rate and 90.2% disease control rate across all PD-L1 expression levels. Notably, ~92% of evaluable patients had PD-L1 TPS <50%, including 43% with PD-L1 below 1%. The combination showed significant improvements compared to historical controls, particularly in patients with lower PD-L1 expression: 75.0% vs 62.1% in high PD-L1, 64.0% vs 49.2% in low PD-L1, and 54.5% vs 32.3% in negative PD-L1 expression. The safety profile remains favorable with no new safety signals. Additional data updates are expected at a medical conference later in 2025.

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.