Immutep Stock Price, News & Analysis

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.

Immutep announced positive data from EFTISARC-NEO, a Phase II trial evaluating eftilagimod alpha (efti) combined with radiotherapy and KEYTRUDA® in soft tissue sarcoma (STS) patients. The preliminary analysis of 21 patients showed the triple combination achieved a three-fold increase in tumor hyalinization/fibrosis (median 50%) compared to standard radiotherapy's historical 15%. 71.4% of patients achieved pathologic response (≥35% hyalinization/fibrosis) and 9.5% achieved complete pathologic response. The treatment demonstrated safety with no grade ≥3 toxicities related to efti and pembrolizumab. The study aims to enroll 40 patients by Q1 2025.