Immutep Limited American Depositary Shares - IMMP STOCK NEWS

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.

Immutep reports significant progress in Q1 FY25. The company received positive FDA feedback for TACTI-004 Phase III trial in first-line non-small cell lung cancer. Their TACTI-003 Phase IIb trial showed promising results with efti and KEYTRUDA® combination in head and neck cancer, achieving 35.5% objective response rate in PD-L1 negative patients. The first participant was dosed in Phase I trial of IMP761 for autoimmune diseases. Financial highlights include strong cash position of A$172.3 million as of September 2024, with expected reach until end of CY2026. The company was added to the S&P ASX300 Index, marking significant growth.

Immutep (NASDAQ: IMMP) announces upcoming presentation of new Phase IIb data from TACTI-003 trial's Cohort B at ESMO Immuno-Oncology Congress 2024. The study focuses on first-line recurrent/metastatic head and neck squamous cell carcinoma patients with negative PD-L1 expression (CPS <1), evaluating the combination of eftilagimod alpha and pembrolizumab. Dr. Martin Forster from UCL Cancer Institute will present the findings on December 12, 2024, in Geneva, Switzerland. The abstract will be available on December 5, with the complete poster released on Immutep's website after the presentation.