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]

Exhibit 99.1 Immutep Limited Preliminary final report 2. Results for announcement to the market Explanation of the above information: | --- | --- | |------------------------------------|---------------------------------| | | | | | | | Name of entity: | Immutep Limited | | ABN: | 90 009 237 889 | | Reporting period: | Year ended 30 June 2024 | | Previous corresponding period: | Year ended 30 June 2023 | | --- | --- | --- | --- | --- | |------------------------------------------------------------------------- ...

SYDNEY, AUSTRALIA, Aug. 07, 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 its management will present at the following investor conferences: Canaccord Genuity 44th Annual Growth Conference Location: InterContinental Boston Hotel, Boston, MA Date: Wednesday, 14 August 2024 Time: 08:30am – 8:55am ET Baird 2024 Global Healthcare Confe ...

Entered into third and most important clinical trial collaboration and supply agreement to date with MSD to evaluate eftilagimod alfa (efti) in combination with KEYTRUDA® (pembrolizumab) and chemotherapy for first-line non-small cell lung cancer in a pivotal Phase III trial Continuing positive clinical data reported from efti: Positive results from TACTI-003 Phase IIb trial in first-line head and neck squamous cell carcinoma with efti in combination with KEYTRUDA® Encouraging efficacy and safety data from A ...

Core Insights - The FDA has provided positive feedback on the TACTI-004 Phase III trial design for evaluating efti in combination with KEYTRUDA and standard chemotherapy for first-line non-small cell lung cancer (NSCLC) [1][2][4] - The trial aims to enroll approximately 750 patients, regardless of PD-L1 expression, to address the entire first-line NSCLC market eligible for anti-PD-1 therapy [1][3][6] Regulatory Developments - The feedback from the FDA, along with previous input from the Paul-Ehrlich-Institut and the Spanish Agency for Medicines and Health Products, concludes the preparatory regulatory interactions for the trial [2] - This marks a significant advancement in developing effective treatments for both non-squamous and squamous 1L NSCLC patients [2] Trial Design - TACTI-004 will be a 1:1 randomized, double-blind, multinational, controlled clinical trial comparing efti with KEYTRUDA and chemotherapy against the standard of care [6] - The dual primary endpoints of the trial will be progression-free survival and overall survival, with a prespecified futility boundary and a pre-planned interim analysis [6] Product Information - Efti is a proprietary soluble LAG-3 protein that stimulates both innate and adaptive immunity, enhancing the immune response against cancer [7] - Efti is being evaluated for various solid tumors, including NSCLC, and has received Fast Track designation from the FDA for first-line indications in both NSCLC and head and neck squamous cell carcinoma [8] Company Overview - Immutep is a clinical-stage biotechnology company focused on developing novel LAG-3 immunotherapies for cancer and autoimmune diseases [9] - The company aims to leverage its expertise in LAG-3 to provide innovative treatment options and maximize shareholder value [9]