Immutep Stock Price, News & Analysis

Immutep (ASX:IMM; NASDAQ:IMMP) reports strong operational progress in the registrational TACTI-004 (KEYNOTE-F91) Phase III trial of eftilagimod alfa (efti) with KEYTRUDA and chemotherapy for first-line advanced/metastatic NSCLC.

Key facts: 289 patients enrolled (≈38% of 756 target), >120 activated clinical sites, 27 countries with full regulatory approvals, futility analysis on track for Q1 CY2026, and expected completion of enrolment in Q3 CY2026. Licensing interest noted with a deal for emerging markets with Dr Reddy's.

Immutep (ASX: IMM; NASDAQ: IMMP) and Dr. Reddy’s entered an exclusive licensing and collaboration for eftilagimod alfa (efti) in all countries outside North America, Europe, Japan, and Greater China, announced 8 December 2025. Immutep will receive an upfront payment of USD 20 million, is eligible for up to USD 349.5 million in regulatory and commercial milestones, and will receive double-digit royalties on sales in the licensed markets. Immutep retains rights in key markets (North America, Europe, Japan), holds global manufacturing rights, and will supply product to Dr. Reddy’s as efti advances in a registrational Phase III NSCLC trial (TACTI-004/KEYNOTE-F91).

Immutep (NASDAQ: IMMP) will present Phase II AIPAC-003 data at SABCS 2025 showing the immunotherapy-chemotherapy combination of eftilagimod alfa (efti) plus paclitaxel produced strong responses and immune activation in heavily pretreated metastatic breast cancer patients.

In the evaluable population (N=64) ORR/DCR were 41.9%/87.1% (30 mg) and 48.5%/78.8% (90 mg); time to response was ~2.0 months. FDA Project Optimus requirements were satisfied and 30 mg was selected as efti’s optimal biological dose (OBD) after tolerability issues at 90 mg.

Immutep (NASDAQ: IMMP) reported positive Phase II EFTISARC-NEO results presented at CTOS 2025 for neoadjuvant eftilagimod alfa (efti) with radiotherapy + pembrolizumab in resectable soft tissue sarcoma.

In the evaluable population (N=38) the combination reached a median 51.5% tumor hyalinization/fibrosis (p<0.001), meeting the study primary endpoint across ten STS subtypes including myxofibrosarcoma and undifferentiated pleomorphic sarcoma. Early translational data (n=20) showed statistically significant increases in peripheral biomarkers: CXCL9 2.5x, CXCL10 1.8x, IL-23 2.2x, IFN-γ 2.5x, with IFN-γ increases correlating with pathologic response. Disease-free and overall survival data remain immature and will be reported later.

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.