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 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.

Immutep Granted United States Patent for IMP761, a First-in-Class Agonist Antibody Targeting LAG-3

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SYDNEY, AUSTRALIA, June 07, 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 Marc Voigt, CEO of Immutep, will be presenting at the Jefferies Healthcare Conference being held on June 7-9, 2023 in New York City, NY.

Immutep to Participate at the Jefferies Healthcare Conference

Media Release Efti plus pembrolizumab led to deep, durable responses, regardless of PD-L1 expression levels, and median Duration of Response not reached despite median follow up of 39 months in TACTI-002 Phase II Promising efficacy in patients with a PD-L1 Combined Positive Score (CPS) of ≥1 with median Overall Survival of 12.6 months, a 12-month Overall Survival rate of 52.0%, and a response rate of 38.5% Patients with a PD-L1 CPS ≥20 achieved a median Overall Survival of 15.5 months, a 12-month Overall Survival rate of 66.7%, and a response rate of 60.0% One long-lasting complete response occurred in a patient with negative PD-L1 expression or CPS

Immutep Reports Final Positive Data in 2nd Line Head and Neck Squamous Cell Carcinoma at ASCO 2023 Annual Meeting

Sydney, Australia, June 02, 2023 (GLOBE NEWSWIRE) -- Immutep Limited, an Australian company (ASX: IMM) (Nasdaq: IMMP) (Immutep or the Company), is pleased to announce the successful completion of an institutional placement (Placement) and the institutional component (Institutional Entitlement Offer) of its 1 for 7.6 pro rata accelerated non-renounceable entitlement offer (Entitlement Offer and, together with the Placement, the Offer) of new fully paid ordinary shares in Immutep (New Shares).

Immutep Successfully Completes Institutional Placement and Institutional Component of its Entitlement Offer

Media Release Appointment of Charles River Laboratories ("Charles River") to run Immutep's preclinical toxicology study evaluating the safety and toxicity of IMP761 Forms a key step prior to first-in-human trials for this first-in-class LAG-3 agonist antibody designed to treat the underlying cause of multiple autoimmune diseases Charles River is a highly respected, global provider of drug discovery and non-clinical development solutions operating more than 110 sites across more than 20 countries SYDNEY, AUSTRALIA, May 29, 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 entered into an agreement with Charles River under which Charles River will conduct a GLP toxicology study for IMP761, Immutep's proprietary preclinical candidate for autoimmune diseases. IMP761 is a first-in-class LAG-3 agonist antibody that aims to address the underlying cause of many autoimmune diseases, namely the overactivation of self-antigen-specific memory T cells expressing LAG-3.

Immutep Selects Charles River Laboratories for IMP761's GLP Toxicology Study

Media Release New data published from Part C of TACTI-002 Phase II Trial evaluating eftilagimod alpha plus pembrolizumab in metastatic 2nd line head and neck squamous cell carcinoma Deep, durable responses seen across all PD-L1 subgroups with a 13.5% Complete Response rate and median Duration of Response not yet reached (minimum follow-up of 17 months) In the overall patient population, regardless of PD-L1 expression, a strong response rate of 29.7% and 12-month overall survival rate of 46.0% were achieved In patients with a PD-L1 Combined Positive Score of ≥20, a very promising response rate of 60% and 12-month overall survival rate of 66.7% were achieved Treatment was safe and well tolerated with no new safety signals More mature and final data will be presented during the poster session at ASCO 2023 SYDNEY, AUSTRALIA, May 26, 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 data from Part C of its TACTI-002 Phase II trial has been published in an abstract available on the 2023 American Society of Clinical Oncology's (ASCO) Annual Meeting's official website. A Trial in Progress abstract for the Phase II/III AIPAC-003 trial has also been published.

Immutep Announces Publication of Abstracts for ASCO 2023 Annual Meeting

Immutep (IMMP) shares surge on encouraging initial data from a triple combination therapy study, INSIGHT-003, for non-small cell lung cancer.

Immutep (IMMP) Up on Initial Data From Lung Cancer Study

Media Release SYDNEY, AUSTRALIA, May 25, 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 at a European clinical site for its integrated Phase II/III AIPAC-003 trial in metastatic breast cancer. AIPAC-003 is evaluating eftilagimod alpha (“efti”), Immutep's soluble LAG-3 protein and first-in-class MHC Class II agonist, in combination with standard-of-care paclitaxel for the treatment of metastatic HER2-neg/low breast cancer and triple-negative breast cancer.

Immutep Doses First Patient in AIPAC-003 Phase II/III Trial for Metastatic Breast Cancer

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Media Release Efti plus standard-of-care anti-PD-1 therapy and doublet chemotherapy in 1st line non-small cell lung cancer is well tolerated and continues to show promising initial signals of efficacy Triple combination therapy has achieved a 67% response rate and 91% disease control rate in metastatic 1st line non-small cell lung cancer patients (N=21) despite 81% of patients having low or negative PD-L1 expression SYDNEY, AUSTRALIA, May 24, 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 encouraging clinical data in 1st line non-small cell lung cancer from INSIGHT-003, an investigator-initiated Phase I trial conducted by the Frankfurt Institute of Clinical Cancer Research IKF. INSIGHT-003 is the first study evaluating eftilagimod alpha (“efti”), a soluble LAG-3 protein and MHC Class II agonist, in conjunction with standard-of-care anti-PD-1 therapy and doublet chemotherapy (carboplatin/pemetrexed).

Immutep Announces Promising New Clinical Data from Triple Combination Therapy in INSIGHT-003 Trial

A mid-stage study data shows that Immutep's (IMMP) lead candidate as a combination therapy in first-line NSCLC achieved better-than-expected overall survival results.

Immutep (IMMP) Surges 65% on Upbeat Lung Cancer Study Data

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Media Release Immuno-oncology combination of eftilagimod alpha (efti) and the leading anti-PD-1 therapy generates meaningful long-term survival in non-small cell lung cancer patients in Phase II TACTI-002 trial Initial median Overall Survival of 25 months in non-small cell lung cancer patients with > 1% PD-L1 expression, a key area of focus for future development of efti Result is above reported rates of anti-PD-1 monotherapy and various immune checkpoint inhibitor combinations with and without chemotherapy Based on compelling initial results, the Data Monitoring Committee recommends extending overall survival follow-up collection to show mature 3-year and potentially 5-year rates More mature Overall Survival data and additional efficacy and safety results to be presented at a major medical conference in H2 CY2023 SYDNEY, AUSTRALIA, May 17, 2023 (GLOBE NEWSWIRE) -- Immutep Li m ited (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 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) achieved robust initial Overall Survival (OS) in 1st line non-small cell lung cancer (1L NSCLC) patients in the Phase II TACTI-002 trial. This immuno-oncology (IO) investigational combination, without the use of chemotherapy, led to excellent initial survival results in the overall intent-to-treat (ITT) 1L NSCLC patient population (N=114), regardless of PD-L1 expression status.

Immutep's Efti in Combination with Pembrolizumab Achieves Excellent Initial Overall Survival Benefit in 1st Line Non-Small Cell Lung Cancer

Media Release SYDNEY, AUSTRALIA, May 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 it has received positive feedback from the US Food and Drug Administration (FDA), regarding the Company's late-stage clinical development plans for its first-in-class soluble LAG-3 protein and MHC Class II agonist, eftilagimod alpha (“efti”), for the treatment of 1st line non-small cell lung cancer (NSCLC). The FDA is supportive of a registrational trial to evaluate efti in combination with an anti-PD-1 therapy based on the encouraging data from the Phase II TACTI-002, Part A (N=114) in 1st line NSCLC patients, no matter their level of PD-L1 expression, presente d in a late-breaking oral abstract presentation at the 37th Annual Society of Immunotherapy of Cancer (SITC) Meeting in November 2022.

Immutep Receives Positive Feedback from FDA on Late-Stage Clinical Development of Eftilagimod Alpha in Non-Small Cell Lung Cancer

Media Release SYDNEY, AUSTRALIA, May 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 its management will present and be available for 1-on-1 meetings at the JMP Securities Life Sciences Conference, on Tuesday, May 16th, 2023. Presentation details: The JMP Securities Life Sciences Conference Location: New York Hilton Midtown, 1335 Avenue of the AmericasDate: Tuesday, May 16thPresentation time: 3:00PM ET About Immutep Immutep is a clinical stage biotechnology company developing novel LAG-3 immunotherapy for cancer and autoimmune disease.

Immutep to Participate in the JMP Securities Life Sciences Conference

Media Release Webinar to take place on Tuesday, May 9, 2023, at 11:30 AM ET SYDNEY, AUSTRALIA, May 02, 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 announces a Key Opinion Leader (KOL) event will be hosted by Ladenburg Thalmann & Co, Inc., on Tuesday, May 9, 2023, from 11:30 AM – 1:00 PM ET. The “Deep Dive into Efti Development in NSCLC and HNSCC Landscapes” discussion will be led by Ladenburg Thalmann biotech analyst Ahu Demir, Ph.D.

Immutep Announces KOL Event Focused on Eftilagimod Alpha in Non-Small Cell Lung Cancer and Head & Neck Squamous Cell Carcinoma

Media Release Investigator-initiated study jointly funded with Merck KGaA, Darmstadt, Germany, will evaluate dual immuno-oncology (IO) combination of eftilagimod alpha and BAVENCIO® in metastatic urothelial cancer Trial builds on strategy to cost-efficiently increase target indications for IO-IO combination approaches utilizing eftilagimod alpha in areas of high unmet need SYDNEY, AUSTRALIA, May 01, 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 announces it has received regulatory approval from the Paul-Ehrlich-Institut (“PEI”), German Federal Institute for Vaccines and Biomedicines, to initiate INSIGHT-005, an investigator-initiated, open-label Phase I trial evaluating the safety and efficacy of eftilagimod alpha (“efti”) in combination with BAVENCIO® (avelumab) in up to 30 patients with metastatic urothelial carcinoma. Urothelial carcinoma is the most common type of bladder cancer.

Immutep Receives Approval to Initiate INSIGHT-005 Trial Evaluating Eftilagimod Alpha and Anti-PD-L1 Therapy BAVENCIO®

Media Release Initiation of integrated Phase II/III AIPAC-003 trial evaluating eftilagimod alpha (efti) and paclitaxel in HER2-neg/low metastatic breast cancer and triple-negative breast cancer Positive final data reported from patients with 2nd line non-small cell lung cancer refractory to anti-PD-(L)1 therapies, including Overall Survival rate of 39% at 21 months Randomised TACTI-003 Phase IIb trial has reached 75% enrolment subsequent to quarter end and top line results anticipated in H2 of CY2023 Expansion of INSIGHT-003 evaluating triple combination of efti, pembrolizumab and chemotherapy post encouraging initial safety and efficacy in 1st line non-small cell lung cancer Solid cash position of A$55.2 million, with cash runway to the end of FY2024 (June 2024) Since period end Lis Boyce appointed as Non-Executive Director and Florian D. Vogl, M.D.

Immutep Quarterly Activities Report

Media Release Final results from Part C of the Phase II TACTI-002 trial in 2nd line head and neck squamous cell carcinoma patients to be presented SYDNEY, AUSTRALIA, April 26, 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 two abstracts have been selected for poster presentation at the upcoming 2023 American Society of Clinical Oncology's (ASCO) Annual Meeting, taking place in-person and online from 2-6 June 2023 in Chicago, Illinois (United States). New, final data from Part C of the Phase II TACTI-002 trial evaluating the investigational dual immuno-oncology combination of eftilagimod alpha and pembrolizumab in 2nd line head and neck squamous cell carcinoma patients unselected for PD-L1 expression will be presented.

Immutep Announces Presentation of New TACTI-002 Data at the 2023 ASCO Annual Meeting

Media Release SYDNEY, AUSTRALIA, April 26, 2023 (GLOBE NEWSWIRE) --  Immutep Limited (ASX: IMM; NASDAQ: IMMP), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune diseases, today announces that Florian D. Vogl, M.D.

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