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 ...

Results delivered in prestigious Proffered Paper oral presentation at ESMO Congress 2024 In patients with any PD-L1 expression (CPS ≥1), efti in combination with KEYTRUDA outperformance is largest in CPS ≥20 with 31.0% ORR (34.5% ORR including partial response after data cut-off) versus 18.5% ORR for KEYTRUDA Efti in combination with KEYTRUDA led to a high durability of response of 17.5 months in patients with any PD-L1 expression and combination continues to have favourable safety profile Statistically sig ...