Immutep Ltd

Immutep Ltd. is a clinical stage biotechnology company, which engages in the development of LAG-3 related immunotherapeutic products for cancer and autoimmune diseases. Its products include eftilagimod alpha (IMP321), IMP761, leramilimab (IMP701), and GSK‘781 (IMP731). The company was founded on May 21, 1987 and is headquartered in Sydney, Australia.

Media Release SYDNEY, AUSTRALIA, Dec. 21, 2023 (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 constructive feedback has been received from the Paul-Ehrlich-Institut (“PEI”), a German regulatory authority and part of the Committee for Medicinal Products for Human Use (CHMP), regarding the planned TACTI-004 Phase III trial of eftilagimod alpha (“efti”) for first line treatment of metastatic non-small cell lung cancer (NSCLC). The PEI is supportive of Immutep moving into a registrational trial in first line NSCLC and evaluating efti in combination with an anti-PD-1 therapy in a chemotherapy-free regimen or as a triple combination approach that includes chemotherapy.

Immutep Receives Constructive Regulatory Feedback on TACTI-004 Registrational Trial in Metastatic Non-Small Cell Lung Cancer

Media Release SYDNEY, AUSTRALIA, Dec. 07, 2023 (GLOBE NEWSWIRE) --  Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep“ or “the Company”), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune diseases, is pleased to announce it has received a €1,595,475 (~ A$2,628,354 ) research and development (R&D) tax incentive payment in cash from the French Government under its Crédit d'Impôt Recherche scheme (CIR). The “Crédit d'Impôt Recherche” (CIR), meaning “Research Tax Credit”, is a French government tax incentive by which French companies conducting research and development activities in Europe can be reimbursed 30% of their eligible expenditure.

Immutep Receives A$2.6 million R&D Tax Incentive from French Government

SYDNEY, AUSTRALIA, Nov. 22, 2023 (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 that the INSIGHT-003 trial has been expanded to four sites across Germany including the University Clinic of Ruhr Universität Bochum and the Lung Clinic Cologne-Merheim. This site expansion will support faster enrolment in this cost-efficient, investigator-initiated study evaluating eftilagimod alpha (efti) in combination with the anti-PD-1 therapy KEYTRUDA® (pembrolizumab) and doublet chemotherapy for first line treatment of non-squamous non-small cell lung cancer (NSCLC).

Immutep Announces Site Expansion for INSIGHT-003 Phase I Trial

Media Release A total of 171 head and neck squamous cell carcinoma (HNSCC) patients enrolled in randomised, multicentre Phase IIb trial evaluating efti in combination with pembrolizumab Efti has FDA Fast Track designation for first-line treatment of HNSCC SYDNEY, AUSTRALIA, Nov. 09, 2023 (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 the completion of patient enrollment in the TACTI-003 (KEYNOTE-PNC-34) Phase IIb trial evaluating eftilagimod alpha (efti), its proprietary soluble LAG-3 protein and MHC Class II agonist, in combination with MSD's anti-PD-1 therapy KEYTRUDA® (pembrolizumab) as first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The Phase IIb trial enrolled 171 patients at over 30 centres across the United States, Europe, and Australia to evaluate the safety and efficacy of efti in combination with pembrolizumab in patients with PD-L1 positive (Combined Positive Score [CPS] ≥1) tumors (Cohort A) and in patients with PD-L1 negative tumors (Cohort B).

Immutep Completes Enrollment in TACTI-003 Phase IIb Trial of Efti and KEYTRUDA® in First Line Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma

Media Release No safety or tolerability issues in open-label, safety lead-in phase evaluating the higher 90mg dose of efti in combination with weekly paclitaxel in the first 6 patients Good safety profile allows for lead-in phase to be closed early and the randomized Phase II portion of study will now proceed SYDNEY, AUSTRALIA, Nov. 06, 2023 (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 the open-label safety lead-in of its integrated AIPAC-003 Phase II/III trial evaluating for the very first time 90mg of eftilagimod alpha (efti) in combination with paclitaxel has been completed with no safety or tolerability issues. Six patients with metastatic breast cancer receiving this immuno-oncology chemotherapy (IO-chemo) combination, after exhaustion of all endocrine/CDK4/6 based therapies, tolerated the therapy very well and there were no dose limiting toxicities, as confirmed by the independent Data Monitoring Committee (IDMC) appointed for the trial.

Immutep Announces Completion of the Safety Lead-In and Opening of the Randomized Phase II of the AIPAC-003 Phase II/III Trial in Metastatic Breast Cancer

Media Release Statistically significant increases of Th1 biomarkers (IFN-gamma, CXCL-10), circulating immune cells (lymphocytes), and RNA levels of immune activating genes were observed and linked to improved clinical outcomes Early increase in absolute lymphocyte count is correlated with the positive Overall Survival results in non-small cell lung cancer patients recently reported at ESMO 2023, and is a potential on-treatment biomarker for clinical benefit Similar immune response biomarkers in the blood were seen in the double-blind, randomized AIPAC Phase IIb trial, which combined efti solely with chemotherapy and did not include any anti-PD-1 therapy SYDNEY, AUSTRALIA, Nov. 03, 2023 (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 new biomarker data from the TACTI-002/KEYNOTE-798 Phase II trial evaluating eftilagimod alpha (“efti”), a soluble LAG-3 protein and first-in-class MHC Class II agonist administered subcutaneously, in combination with MSD's (Merck & Co., Inc., Rahway, NJ., USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) as first-line treatment for patients with previously untreated unresectable or metastatic non-small cell lung cancer (NSCLC).

Immutep Announces New Biomarker Data from TACTI-002 Phase II in First Line Non-Small Cell Lung Cancer

SYDNEY, AUSTRALIA, Nov. 02, 2023 (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 participate in the following upcoming investor events in November:

Immutep to Participate in November Investor Events

Media Release Excellent survival benefit in 1st line non-small cell lung cancer (1L NSCLC) in TACTI-002 trial: median Overall Survival of 35.5 months (TPS ≥1% patients) providing additional 12-18 months survival compared to historical data, reported post period Late-stage & registrational trial progress: 1st line head & neck squamous cell carcinoma (1L HNSCC) - Phase IIb TACTI-003 trial recruitment progressing and expected to be complete in November 2023 1L NSCLC - Preparations ongoing to commence Phase III TACTI-004 registrational trial in CY2024 Metastatic breast cancer (MBC) - Patient recruitment ongoing for Phase II/III AIPAC-003 trial, first safety data from the open-label safety lead-in portion expected to be reported in Q4 CY2023 Strong Overall Response Rate in INSIGHT-003 of 71.4%, plus encouraging response rate of 70.6% for low or negative PD-L1 expressors in NSCLC comparing favourably to historical data, reported post period Efti trial expansion: First patient enrolled in EFTISARC-NEO Phase II trial in soft tissue sarcoma Well financed: Strong cash position of $110.1m, with cash runway to early CY2026 SYDNEY, AUSTRALIA, Oct. 31, 2023 (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, provides an update on the ongoing development of its product candidates, eftilagimod alpha (efti) and IMP761 for the quarter ended 30 September 2023 (Q1 FY24). EFTI DEVELOPMENT PROGRAM FOR CANCER In August 2023, Immutep received positive scientific advice from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for the continued development of efti.

Immutep Quarterly Activities Report Q1 FY24

Media Release (Code: ASX: IMM; NASDAQ: IMMP) SYDNEY, AUSTRALIA, Oct. 25, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or the “Company”), is pleased to announce that it has received a A$1,134,882 cash rebate from the Australian Federal Government's R&D tax incentive program. The cash rebate provided in respect of expenditure incurred on eligible R&D activities conducted in the 2022 fiscal year, mainly related to the Company's TACTI-002 and TACTI-003 clinical study using its lead compound eftilagimod alpha (“efti” or “IMP321”), conducted in Australia.

Immutep receives ~A$1.13 million R&D Tax Incentive

Media Release Promising efficacy and tolerability reported from efti plus anti-PD-1 therapy and doublet chemotherapy as first line therapy in metastatic non-squamous non-small cell lung cancer continues Strong 71.4% Overall Response Rate, 90.5% Disease Control Rate, 10.1-month median Progression Free Survival (PFS), and median Overall Survival (OS) that has not been reached, despite 81% of patients having low or negative PD-L1 expression In the difficult-to-treat PD-L1 TPS

Immutep Reports Promising Clinical Data from INSIGHT-003 Trial at ESMO Congress 2023

Media Release Median Overall Survival reaches 35.5 months in first-line treatment of metastatic non-small cell lung cancer patients expressing PD-L1 (TPS > 1%), 23.4 months in patients with low PD-L1 expression (TPS  1-49%), and has not been reached in patients with high PD-L1 expression (TPS > 50%), exceeding expectations Promising Overall Survival, Overall Response Rate, Progression Free Survival, and Duration of Response visible across all PD-L1 subgroups (TPS 1%, 1-49%, and > 50%, respectively Immutep to host webcast to discuss ESMO 2023 clinical data on Monday, October 23rd, at 8AM AEDT (Sunday, October 22nd, at 5PM ET) SYDNEY, AUSTRALIA, Oct. 23, 2023 (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 excellent new clinical data from the TACTI-002 / KEYNOTE-798 Phase II trial evaluating eftilagimod alpha (“efti”), a soluble LAG-3 protein and first-in-class MHC Class II agonist, in combination with MSD's (Merck & Co., Inc., Rahway, NJ., USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) as first-line treatment for patients with previously untreated unresectable or metastatic non-small cell lung cancer (NSCLC).

Immutep's Efti in Combination with KEYTRUDA® Generates Excellent Overall Survival Benefit in Patients with Metastatic Non-Small Cell Lung Cancer

Media Release New updated data from TACTI-002, including more mature Overall Survival data, will be presented during the Mini Oral session on Saturday, October 21st, at 9:05 CEST Immutep to host webcast to discuss ESMO 2023 clinical data on Monday, October 23rd, at 8AM AEDT (Sunday, October 22nd, at 5PM ET) SYDNEY, AUSTRALIA, Oct. 16, 2023 (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 the publication of abstracts with data from the TACTI-002 and INSIGHT-003 trials in 1st line non-small cell lung cancer (1L NSCLC) at the 2023 European Society for Medical Oncology (ESMO) Congress. TACTI-002 is a Phase II trial evaluating the chemotherapy-free combination of eftilagimod alpha (“efti”) and KEYTRUDA® (pembrolizumab), MSD's (Merck & Co., Rahway, NJ, USA) anti-PD-1 therapy, in 1L NSCLC.

Immutep Announces Publication of Abstracts at ESMO Congress 2023

Media Release SYDNEY, AUSTRALIA, Oct. 03, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a clinical-stage biotechnology company developing novel immunotherapies for cancer and autoimmune disease, today announces an abstract has been accepted for poster presentation at the Society for Immunotherapy of Cancer (SITC) Annual Meeting 2023, taking place in San Diego, California and virtually from 1 to 5 November 2023. Presentation Details Title: Biomarker results from the 1st line non-small cell lung cancer cohort of TACTI-002: pharmacodynamic effects of combining eftilagimod alpha (soluble LAG-3) and pembrolizumab Abstract Number: 595 Date and Time: Friday, 3 November, 9:00 AM-7:00 PM PT Location : Exhibit Halls A and B1, San Diego Convention Centre The abstract will be available on the SITC website as of October 31, 2023, and the poster will be available on the Posters & Publications section of Immutep's website following the presentation.

Immutep Announces Abstract Accepted for Presentation at the Society for Immunotherapy of Cancer (SITC) 2023 Annual Meeting

Comparability of Drug Substance and Drug Product manufactured at 2,000L scale achieved Comparability of Drug Substance and Drug Product manufactured at 2,000L scale achieved

Commercial Manufacturing of Eftilagimod Alpha at 2000L Scale Granted Authorization for Clinical Trial Use

SYDNEY, AUSTRALIA, Sept. 05, 2023 (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 participate in the following upcoming investor conferences in September:

Immutep to Participate in September Investor Conferences

Immutep Limited is a small cap biotech focusing on the development of eftilagimod alpha, a novel molecule that activates MHC class II molecules to enhance the immune response. The company is conducting late-stage trials in head and neck cancer, non-small cell lung cancer, and metastatic breast cancer. Immutep has sufficient cash to support its clinical efforts and is a tentative buy, but there is a risk that the add-on therapy may not show significant benefits in randomized trials.

Immutep: Nipping At The Heels Of LAG3.Is It Impressive Enough?

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Baird, the investment bank, has initiated coverage on Immutep Ltd (ASX:IMM) (IMMP), a clinical-stage biotechnology company, with an "outperform" rating and a price target of $7 - a significant premium to the current share price of $2.11. Immutep is at the forefront of developing therapies related to LAG-3, a protein involved in regulating the immune system.

Immutep price target suggests stock has much further to go

Media Release SYDNEY, AUSTRALIA, Aug. 01, 2023 (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 it has received positive scientific advice from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the continued development of eftilagimod alpha (efti), the Company's soluble LAG-3 protein and first-in-class MHC Class II agonist. In May 2023, Immutep requested scientific advice from the EMA regarding future development of efti, and in particular whether further toxicity studies would be required before the Company could seek marketing authorisation for efti in Europe.

Immutep Receives Positive Scientific Advice from European Medicines Agency

Media Release Late-stage & registrational trial progress: TACTI-004 Phase III - Positive feedback received from US FDA for planned registrational trial in 1st line non-small cell lung cancer (1L NSCLC) TACTI-003 Phase IIb – Randomised study in 1st line head & neck squamous cell carcinoma (1L HNSCC) has reached ~91% patient recruitment and top-line results expected in H2 of CY2023 AIPAC-003 Phase II/III - First patient dosed in metastatic breast cancer trial Positive efti lagimod alpha ( efti ) clinical results in TACTI-002 and INSIGHT-003 trials : TACTI-002 Phase II evaluating efti + KEYTRUDA® (pembrolizumab) led to excellent initial Overall Survival (OS) benefit of 25 months in 1L NSCLC patients with > 1% PD-L1 TPS; more mature data in H2 of CY2023 Final results in 2L HNSCC from TACTI-002 presented at ASCO 2023 showed promising response rates, overall survival, and durable responses including a Complete Response in patient with negative PD-L1 INSIGHT-003 Phase I evaluating efti + KEYTRUDA® + doublet chemo achieved 67% response rate and 91% disease control rate in 1L NSCLC, despite 81% of patients having low or negative PD-L1 expression Efti trial expansion: INSIGHT-005 - Regulatory approval to commence the investigator-initiated trial in urothelial carcinoma EFTISARC-NEO - Investigator-initiated trial commenced in soft tissue sarcoma Well financed: Strong cash position of $123.4m, following A$80m capital raise for registrational and late-stage trials of efti and potentially a first-in-human trial for IMP761; extends cash runway to early CY2026 SYDNEY, AUSTRALIA, July 31, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune diseases, provides an update on the ongoing development of its product candidates, eftilagimod alpha (efti) and IMP761 for its fiscal fourth quarter ended 30 June 2023 (Q4 FY23). EFTI DEVELOPMENT PROGRAM FOR CANCER TACTI-002 (KEYNOTE-PN798) Phase II clinical trial evaluating efti + KEYTRUDA® (pembrolizumab) : 1st line N on- S mall C ell L ung C ancer (1L NSCLC) Meaningful long-term survival was reported in from Immutep's TACTI-002 (Two A CTive Immunotherapies) trial in May.

Immutep Quarterly Activities Report Q4 FY23

Media Release Mini O ral presentation will include data from TACTI-002 Phase II trial evaluating chemotherapy-free IO combination of efti plus KEYTRUDA® ( pembrolizumab ) Two additional posters on investigator-initiated trials evaluating efti will also be presented SYDNEY, AUSTRALIA, July 31, 2023 (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 that data from its TACTI-002 Phase II trial evaluating the chemo-free combination of eftilagimod alpha (“efti”) and KEYTRUDA® (pembrolizumab), MSD's (Merck & Co., Rahway, NJ, USA) anti-PD-1 therapy, in 1st line non-small cell lung cancer (1L NSCLC) has been accepted for a Mini Oral presentation at the 2023 European Society for Medical Oncology (ESMO) Congress that will be held in Madrid, Spain from 20-24 October 2023. The presentation will include more mature overall survival data, following on from the data announced on 17 May 2023.

Immutep to Present Overall Survival Data in 1st Line Non-Small Cell Lung Cancer Accepted for Oral Presentation at ESMO Congress 2023

Media Release SYDNEY, AUSTRALIA, July 28, 2023 (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 the first patient has been enrolled and safely dosed in EFTISARC-NEO, the Phase II investigator-initiated trial of eftilagimod alpha (efti), a soluble LAG-3 protein and MHC Class II agonist, in combination with radiotherapy and the anti-PD-1 therapy KEYTRUDA® (pembrolizumab) for patients with soft tissue sarcoma. This chemo-free trial is the first to evaluate efti in a neoadjuvant setting.

First Patient Dosed in Chemotherapy-Free Triple Combination Phase II Trial Targeting Soft Tissue Sarcoma

Media Release SYDNEY, AUSTRALIA, June 27, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announced the grant of a new patent (number 11,684,654) entitled “Combined Preparations for the Treatment of Cancer or Infection” by the United States Patent Office. This United States patent was filed as a second divisional application and follows the grant of the United States parent patent and first divisional patent announced in December 2020 and March 2021, respectively.

Immutep Secures Third United States Patent for Eftilagimod Alpha in Combination with a PD-1 Pathway Inhibitor

Media Release SYDNEY, AUSTRALIA, June 27, 2023 (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 the successful completion of an A$80 million capital raise to support its late-stage and expanding clinical development pipeline. With this new capital, Immutep believes it is fully funded for its current and expanded clinical program through to Q1 CY2026 with a pro-forma cash balance of A$135.2 million (US$90.6 million).1 Dr. Russell Howard, Chairman of Immutep, said, “These funds will help us further our mission to unlock the power of the immune system to fight cancer and autoimmune disease, including advancing eftilagimod alpha into a new registrational Phase III trial in lung cancer, and supporting its late-stage trials in head and neck cancer and metastatic and triple negative breast cancer, to final data and Phase II read-outs, respectively.

Immutep Completes A$80 Million Capital Raise

Media Release SYDNEY, AUSTRALIA, June 20, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announced the grant of a new patent (number 11,680,104) by the United States Patent Office. The granted claims are composition-of-matter type claims covering Immutep's pre-clinical immunosuppressive product candidate IMP761, a first-in-class agonist LAG-3 antibody designed to target the root cause of autoimmune diseases by directly silencing self-antigen-specific effector T cells.

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