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]

Core Insights - Immutep's proprietary soluble LAG-3 protein, efti, is being developed as a cancer treatment in combination with Merck's Keytruda, showing promising results in clinical trials for head and neck squamous cell carcinoma (HNSCC) [1][10]. Efficacy and Safety - The combination therapy of efti and Keytruda achieved an objective response rate (ORR) of 35.5% and a disease control rate (DCR) of 58.1% in patients with negative PD-L1 expression, significantly higher than historical controls [2][11]. - The treatment demonstrated a complete response rate of 9.7%, compared to 0% in historical controls for anti-PD-1 monotherapy [2]. - More than 50% of patients treated with the combination therapy have maintained their response for at least six months, with no new safety concerns reported [3]. Regulatory and Development Plans - Based on the positive efficacy and safety data, the company plans to engage with regulatory agencies regarding the next steps for efti [4]. - In addition to HNSCC, Immutep is exploring efti in combination with other agents for various solid tumors, including non-small cell lung cancer and metastatic breast cancer [5]. Market Position and Competitors - Merck's Keytruda continues to expand into new indications and markets, reinforcing its position in the oncology market, accounting for 47% of Merck's pharmaceutical sales in 2023 [6][14]. - Immutep currently holds a Zacks Rank 3 (Hold), while other companies in the biotech sector, such as Arcutis Biotherapeutics and Annovis Bio, have better rankings [7][15]. Stock Performance - Year to date, shares of Immutep have decreased by 3.7%, contrasting with a 2.5% decline in the industry [18].

Results Durability of Responses and Favourable Safety regulatory agencies. Efti has received FDA Fast Track designation in 1L HNSCC regardless of PD-L1 expression. The prevalence for CPS <1, CPS 1-19, and CPS >20 PD-L1 expression levels are approximately 20%, 30%, and 50% of the HNSCC patient population, respectively.3 KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About Eftilagimod Alfa (Efti) Immutep is a clinical-stage biotechnology com ...

Guide to Identifying Oversold Stocks This technical indicator is not the only factor that calls for a potential rebound for the stock. There is a fundamental indicator as well. A strong agreement among sell-side analysts covering IMMP in raising earnings estimates for the current year has led to an increase in the consensus EPS estimate by 6.7% over the last 30 days. And an upward trend in earnings estimate revisions usually translates into price appreciation in the near term. Moreover, IMMP currently has a ...

SYDNEY, AUSTRALIA, June 25, 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 diseases, today announces a License Agreement with Cardiff University granting the Company exclusive rights to develop and commercialise anti-LAG-3 small molecules. Professor Andrew Godkin of Cardiff University said: "Our collaboration with Immutep has been exciting and fruitful, res ...

Media Release SYDNEY, AUSTRALIA, June 25, 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 diseases, today announces a License Agreement with Cardiff University granting the Company exclusive rights to develop and commercialise anti-LAG-3 small molecules. A number of promising compounds that block LAG-3, an immune checkpoint known to reduce the immune system' ...