Immutep Stock Price, News & Analysis

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.

Immutep (NASDAQ: IMMP / ASX: IMM) reported Q1 FY26 progress on clinical programs and finances on 29 Oct 2025. Key oncology highlights: the pivotal TACTI-004 Phase III in 1L NSCLC now has >170 patients enrolled (trial randomises ~756), >100 sites open across 24 countries and a futility analysis on track for Q1 CY2026. FDA gave constructive feedback on late‑stage development of efti in 1L HNSCC CPS<1, including registrational or single‑arm paths (≈70–90 patients).

Other updates: INSIGHT‑003 and EFTISARC‑NEO data presented at ESMO 2025, new investigator‑initiated neoadjuvant breast trial, IMP761 Phase I data due Q4 CY2025, four new patents granted, and CMO appointment effective 1 Jul 2025. Cash and term deposits total A$109.85M, supporting operations into end of CY2026.

Immutep (NASDAQ: IMMP) announced positive Phase II EFTISARC-NEO data presented at ESMO 2025 showing the neoadjuvant combination of eftilagimod alfa (efti) with radiotherapy and pembrolizumab met its primary endpoint.

In the evaluable population (N=38) the combination produced a median 51.5% tumour hyalinization/fibrosis (p<0.001), exceeding the prespecified 35% target and more than threefold higher than a 15% historical radiotherapy benchmark; results were seen across multiple STS subtypes and safety showed only one grade ≥3 immunotherapy-related toxicity.

Immutep (NASDAQ: IMMP) reported two posters at ESMO Congress 2025 highlighting clinical activity of eftilagimod alfa (efti) combined with KEYTRUDA and chemotherapy in first-line non-small cell lung cancer (1L NSCLC).

In the investigator-led INSIGHT-003 trial (cut-off 01 Sep 2025, 51 evaluable patients) the combo achieved a 61.7% ORR in patients with TPS <50% versus a 40.8% historical control, with overall ORR by PD-L1: No PD-L1 54.5%, Low 68.0%, High 75.0%; DCRs were 86.4%, 92.0% and 100% respectively. A Trial-in-Progress ePoster described the registrational TACTI-004 Phase III planned to enroll ~756 patients at >150 sites across >25 countries.

Immutep (NASDAQ: IMMP) announced the FDA has confirmed completion of Project Optimus requirements and agreed that 30mg is the optimal biological dose for eftilagimod alfa (efti).

The dosing agreement is described as a major de-risking step for efti’s oncology programs and a building block toward potential future BLA filings.

Immutep said the global TACTI-004 (KEYNOTE-F91) Phase III registrational trial in first-line advanced/metastatic NSCLC (efti + pembrolizumab + chemotherapy) is now in the process of opening clinical sites in the United States.

Immutep (NASDAQ: IMMP) announced that its registrational Phase III TACTI-004 (KEYNOTE-F91) trial in first-line advanced/metastatic non-small cell lung cancer has enrolled and randomised over 170 patients, exceeding the threshold required to trigger a futility analysis. The study now has more than 100 active sites across 24 countries. An independent data monitoring committee will assess futility using predefined criteria and a minimum 12-week follow-up, with the futility analysis on track for completion in Q1 CY2026. The announcement cites supportive prior data from TACTI-002 and INSIGHT-003 (combined >165 patients) reporting enhanced responses, PFS, and improved overall survival with efti plus pembrolizumab.

Immutep (NASDAQ: IMMP) has announced a new Phase II trial collaboration with the George Washington University Cancer Center to evaluate eftilagimod alfa (efti) in early-stage HR+/HER2-negative breast cancer patients. The trial will assess efti as both a monotherapy and in combination with standard chemotherapy before surgery.

The study will enroll up to 50 evaluable patients in a two-stage design, primarily funded by grants and GW Cancer Center. The trial will be led by Dr. Pavani Chalasani and aims to determine pathological complete response (pCR) in Stage I-III breast cancer patients.

Efti's unique mechanism targets antigen-presenting cells via MHC Class II, activating a broad anti-cancer immune response, including cytotoxic CD8+ T cells. The trial is registered under NCT07102940.

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.