Immutep Stock Price, News & Analysis

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.

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.