Core Insights - Immutep Limited has completed patient enrolment in the INSIGHT-003 trial, which is evaluating the combination of eftilagimod alpha (efti) with KEYTRUDA® and doublet chemotherapy for advanced non-squamous non-small cell lung cancer [1][7] - The Phase I trial has successfully enrolled approximately 50 evaluable patients across multiple clinical sites in Germany [2] - Initial Overall Survival results from INSIGHT-003 indicate a median Overall Survival of 32.9 months and a 24-month Overall Survival rate of 81.0%, which is significantly better than the 22.0-month median OS and 24-month OS rate of 45.5% from a registrational trial of anti-PD-1 and doublet chemotherapy [3][6] - Additional data updates from INSIGHT-003 are anticipated in 2025 and beyond [3][7] Company Overview - Immutep is a clinical-stage biotechnology company focused on developing novel LAG-3 immunotherapies for cancer and autoimmune diseases [5] - The company is recognized for its pioneering work in LAG-3 therapeutics, aiming to provide innovative treatment options and maximize shareholder value [5]

Core Insights - Immutep Limited has announced favorable initial safety data for IMP761, the world's first LAG-3 agonist, with no treatment-related adverse events reported in the first three cohorts of a Phase I study [1][2] - The study aims to assess the safety and immunosuppressive efficacy of IMP761 in healthy participants, with additional safety data and pharmacokinetic/pharmacodynamic assessments expected in the first half of CY2025 [2][3] Company Overview - Immutep is a clinical-stage biotechnology company focused on developing LAG-3 immunotherapies for cancer and autoimmune diseases, leveraging its expertise in LAG-3 to create innovative treatment options [6] - The company is conducting a Phase I trial of IMP761 at the Centre for Human Drug Research in the Netherlands, involving up to 49 participants [2] Product Details - IMP761 is designed to enhance the "brake" function of LAG-3 on T cells, aiming to restore immune system balance and address the root causes of various autoimmune diseases [1][3] - Preclinical studies have shown that IMP761 significantly decreases inflammatory cytokines and effectively suppresses antigen-specific T cell-mediated immune responses [3][5] Future Developments - The company is eager to generate more data from the ongoing study, which is crucial for derisking this promising asset in the context of autoimmune diseases [2] - Additional safety data and assessments of pharmacokinetic and pharmacodynamic relationships are anticipated in the first half of CY2025 [1][2]

Group 1 - Immutep Limited has published findings in Science Immunology that clarify how human LAG-3 binds to its main ligand MHC Class II, providing a foundation for developing blocking LAG-3 therapeutics, including its anti-LAG-3 small molecule program [1][3] - The study reveals the crystal structure of a human LAG-3/HLA-II complex, which is significant for future therapeutic developments targeting LAG-3 [1][3] - Eftilagimod alfa (efti) has been shown to preferentially bind to a subset of MHC Class II molecules on antigen-presenting cells, leading to their activation [1][3] Group 2 - The research was conducted under the supervision of Professor Jamie Rossjohn at Monash University's Biomedicine Discovery Institute, highlighting the importance of industry-academia collaborations in advancing LAG-3 research [2] - The findings contribute to a deeper understanding of the LAG-3 immune control mechanism, which is a clinically validated target of interest across various sectors [2][3] - The study emphasizes the unique action of efti as an MHC-II agonist, which preferentially binds to specific MHC-II molecules clustered in lipid raft microdomains on antigen-presenting cells [3]

Core Insights - The article highlights positive clinical results from Immutep Limited's TACTI-003 Phase IIb trial, demonstrating the efficacy of eftilagimod alpha (efti) in combination with pembrolizumab for treating difficult-to-treat head and neck cancer patients with PD-L1 CPS <1 [1][4][5] Group 1: Clinical Results - Median overall survival (OS) has not yet been reached, with a 12-month OS rate of 67%, significantly higher than historical controls [1][4] - Promising progression-free survival (PFS) of 5.8 months and strong durability with an interim median duration of response (DOR) of 9.3 months [4] - The objective response rate (ORR) is 35.5%, and the disease control rate (DCR) is 58.1%, with complete response rates increasing to 12.9% and 16.1% according to RECIST 1.1 and iRECIST, respectively [4][5] Group 2: Treatment Tolerance and Safety - The combination treatment continues to be well-tolerated, with no new safety signals reported [4][5] - This data compares favorably to historical results from anti-PD-1 therapy alone, which showed a median OS of 7.9 months and a 12-month OS rate of 39% [4] Group 3: Market Implications - The results indicate a potential new treatment option for the underserved population of head and neck cancer patients with PD-L1 expression of less than one, representing up to 20% of patients [5][6] - The company plans to continue monitoring the maturing data from TACTI-003 and engage with regulatory authorities regarding potential paths forward [6]

Core Insights - Immutep Limited released promising data from the INSIGHT-003 Phase 1 trial of eftilagimod alpha in combination with Keytruda and chemotherapy for first-line treatment of metastatic non-squamous non-small cell lung cancer patients [1][2] Group 1: Survival Data - The trial showed a median Overall Survival (OS) of 32.9 months and a median Progression-Free Survival (PFS) of 12.7 months with a 24-month OS rate of 81.0% [1] - This data significantly outperforms historical controls, which reported a median OS of 22.0 months and a median PFS of 9.0 months [2] Group 2: Overall Response Rate (ORR) - The trial demonstrated a significant improvement in Overall Response Rate (ORR) across all levels of PD-L1 expression, with an ORR of 75.0% for high PD-L1, 58.8% for low PD-L1, and 47.4% for negative PD-L1 [3] - In the overall patient population, the trial achieved a 55.0% ORR and an 87.5% Disease Control Rate (DCR) [3] Group 3: Patient Demographics and Future Updates - The trial is biased towards low and negative PD-L1 patients, who typically show less response to anti-PD-1 therapy, with a 52.8% ORR and 86.1% DCR in this subgroup [3] - INSIGHT-003 is nearing completion of patient enrollment, with additional data updates expected in 2025 and beyond [4] Group 4: Market Reaction - Following the announcement, Immutep's stock rose by 9.6%, reaching $2.05 [4]

Core Insights - Immutep Limited announced positive results from the INSIGHT-003 Phase I trial, showing significant improvements in overall survival and progression-free survival for patients with metastatic non-squamous non-small cell lung cancer (NSCLC) treated with eftilagimod alpha (efti) in combination with KEYTRUDA® and chemotherapy [1][4]. Survival Data - Median Overall Survival (OS) is reported at 32.9 months, with a Median Progression-Free Survival (PFS) of 12.7 months, and a 24-month OS rate of 81.0% [3][4]. - These results significantly outperform historical controls, which reported a median OS of 22.0 months and a median PFS of 9.0 months for similar patient populations [3][4]. Response Rates - The Overall Response Rate (ORR) for all evaluable patients (N=40) shows a significant improvement compared to historical controls, with specific rates as follows: - 75.0% ORR in patients with high PD-L1 expression (TPS >50%) compared to 62.1% in historical controls - 58.8% ORR in patients with low PD-L1 expression (TPS 1-49%) compared to 49.2% - 47.4% ORR in patients with negative PD-L1 expression (TPS <1%) compared to 32.3% [5][6]. Safety Profile - The safety profile of efti in combination with pembrolizumab and chemotherapy remains favorable, with no new safety signals reported [7]. Future Developments - The INSIGHT-003 trial is nearing completion of patient enrollment, with additional data updates expected in 2025 and beyond [8][9]. - The upcoming TACTI-004 Phase III trial will further evaluate the efficacy of this combination therapy, focusing on PFS and OS as dual primary endpoints [2][4]. Company Overview - Immutep is a clinical-stage biotechnology company focused on developing novel LAG-3 immunotherapies for cancer and autoimmune diseases, aiming to provide innovative treatment options and maximize shareholder value [10].

Positive feedback received from US FDA regarding the planned TACTI-004 Phase III in first-line nonsmall cell lung cancer successfully concluding regulatory preparations for the trial design Efti in combination with MSD's KEYTRUDA® reports positive efficacy and favourable safety in firstline head and neck cancer in TACTI-003 Phase IIb trial First participant successfully dosed in the first-in-human Phase I trial of IMP761, a novel LAG-3 agonist antibody designed to treat autoimmune diseases Immutep added to ...

Table of Contents IMMP Nasdaq Global Market UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to OR ☐ SHELL COMPANY R ...

Media Release SYDNEY, AUSTRALIA, Oct. 10, 2024 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces Marc Voigt, CEO of Immutep, will participate in a fireside chat at the Maxim Healthcare Virtual Summit on Wednesday, October 16, 2024 at 9:30 am ET. The fireside chat will be live on M-Vest. Click here to reserve your seat. About Immutep Immutep ...

Core Insights - Immutep Limited announced positive efficacy and safety results from the TACTI-003 Phase IIb trial, evaluating eftilagimod alpha (efti) in combination with KEYTRUDA for treating recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) [1][3][9] Efficacy Results - Efti combined with KEYTRUDA achieved an overall response rate (ORR) of 32.8% (34.5% including one partial response after data cut-off) in patients with any PD-L1 expression (CPS ≥1), compared to 26.7% for KEYTRUDA alone [4][5] - The combination showed the highest efficacy in patients with high PD-L1 expression (CPS ≥20), with an ORR of 31.0% versus 18.5% for KEYTRUDA alone, and a complete response rate of 6.9% compared to 3.7% [4][5] Duration of Response - The median duration of response (DOR) for the Efti and KEYTRUDA combination was 17.5 months, slightly higher than the 17.1 months for KEYTRUDA alone, indicating favorable durability compared to historical data of ~6 to ~7 months for other anti-PD-1 combinations [5][6] Biological Activity - A statistically significant increase in absolute lymphocyte count (ALC) was observed in the Efti and KEYTRUDA arm, indicating efti's biological activity and effective immune response [5][6][7] Safety Profile - The combination therapy maintained a favorable safety profile, with a discontinuation rate from treatment-emergent adverse events of 4.3% for Efti and KEYTRUDA, similar to 4.4% for KEYTRUDA alone [6][7] - No new safety signals were observed, and the safety profile remained comparable to KEYTRUDA monotherapy, aside from expected injection site reactions [6][7] Future Directions - Immutep plans to continue monitoring the TACTI-003 trial data, with overall survival results expected in 2025, and will engage with regulatory authorities regarding potential paths forward [1][8][9]