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.

Positive results from phase 1 INSIGHT-003 study, using eftilagimod alpha in combination with KEYTRUDA and chemotherapy in treating first-line metastatic non-squamous NSCLC patients. Additional data from the phase 1 INSIGHT-003 study is expected in 2025, with plans to initiate a phase 3 TACTI-004 study targeting the same patient population. The global non-small cell lung cancer market size is projected to reach $36.9 billion by 2031.

Immutep: Potential Of Efti As New Standard Of Care For NSCLC Patients

On Thursday, Immutep Limited IMMP released data from the INSIGHT-003 Phase 1 trial of eftilagimod alpha (efti) in combination with Merck & Co Inc's MRK Keytruda (pembrolizumab) and chemotherapy for first-line treatment of metastatic non-squamous non-small cell lung cancer (1L NSCLC) patients.

Immutep's Lead Cancer Drug Shows Promising 2-Year Survival Data In Lung Cancer Trial

Media Release Mature data in patients with a minimum follow-up of 22 months (N=21) shows excellent results, well above historical controls and exceeding expectations: Median Overall Survival is 32.9 months, with median Progression Free Survival reaching 12.7 months, and a 24-month Overall Survival rate of 81.0% Data from all evaluable patients to date (N=40) demonstrates significant improvement of Overall Response Rate compared to historical controls Safety continues to be favourable with no new safety signals INSIGHT-003, which is nearing completion of enrolment, evaluates efti with the most widely used immunotherapy-chemo combination today in a similar population to upcoming TACTI-004 Phase III trial  SYDNEY, AUSTRALIA, Nov. 14, 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 positive data from the investigator-initiated INSIGHT-003 Phase I trial evaluating eftilagimod alpha (efti) in combination with KEYTRUDA® (pembrolizumab) and chemotherapy for first-line treatment of metastatic non-squamous non-small cell lung cancer (1L NSCLC) patients. Prof. Dr. Salah-Eddin Al-Batran of the Frankfurt Institute of Clinical Cancer Research (IKF) and project lead stated, “The strength of these mature survival results coupled with a favourable safety profile in first-line treatment of patients with non-squamous NSCLC, the vast majority of whom have negative or low PD-L1 expression, is very encouraging.

Immutep's Efti Shows Excellent Survival Data from INSIGHT-003 Trial in Non-Small Cell Lung Cancer

SYDNEY, AUSTRALIA, Oct. 29, 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, provides an update on its activities for the quarter ended 30 September 2024 (Q1 FY25).

Immutep Quarterly Activities Report Q1 FY25

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.

Immutep to Participate in the 2024 Maxim Healthcare Virtual Summit

Immutep Limited (IMMP) has shown underwhelming results in their TACTI-003 trial, raising questions about the efficacy of their lead drug, eftilagimod. Despite the disappointing data, IMMP has a strong cash position, giving them a 3-4 year runway to continue their development efforts. The company remains a speculative investment with potential, especially with upcoming results from the AIPAC-003 breast cancer study expected in 2025.

Immutep: Navigating The Bumps In The Road

SYDNEY, AUSTRALIA, Sept. 16, 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 positive efficacy and safety results from the TACTI-003 Phase IIb trial evaluating eftilagimod alpha (efti) in combination with MSD's (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) as first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma patients (1L HNSCC).

Immutep's Efti in Combination with MSD's KEYTRUDA® Leads to Positive Efficacy with Favourable Safety in First Line Head and Neck Cancer

Media Release 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 AIPAC-003 Phase II/III trial with efti and paclitaxel in metastatic breast cancer presented at ESMO Breast Cancer 2024 Novel triple combination of efti with radiotherapy and KEYTRUDA well tolerated with encouraging initial efficacy data in EFTISARC-NEO Phase II trial in soft tissue sarcoma Positive regulatory feedback received from Spanish Agency for Medicines and Health Products (AEMPS) Competent Authority regarding the upcoming TACTI-004 Phase III trial Appointed Centre for Human Drug Research (CHDR) to conduct Phase I trial to evaluate IMP761, a first-in-class LAG-3 agonist antibody designed to treat autoimmune diseases Exclusive license agreement signed with Cardiff University for development of an orally available, small molecule anti-LAG-3 therapy to treat cancer A$100.2 million equity underwritten financing completed Immutep cash runway extended to the end of calendar year 2026, with a strong cash, cash equivalent and term deposit position totalling approximately A$181.8 million SYDNEY, AUSTRALIA, July 31, 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, provides an update on its activities for the quarter ended 30 June 2024 (Q4 FY24). EFTI DEVELOPMENT PROGRAM FOR CANCER TACTI-004 (KEYNOTE-PNC91) – 1L NSCLC Phase III Clinical Collaboration with MSD In June, Immutep entered into a clinical trial collaboration and supply agreement with MSD (Merck & Co., Inc., Rahway, NJ, USA), through a subsidiary, to evaluate efti in combination with MSD's anti-PD-1 therapy, KEYTRUDA and chemotherapy for a pivotal Phase III trial in first-line treatment of metastatic non-small cell lung cancer (1L NSCLC).

Immutep Quarterly Activities Report Q4 FY24

Immutep Limited achieved positive results in the phase 2b study, using efti + Keytruda for the treatment of patients with 1st-line head and neck squamous cell carcinoma; Both PD-L1 positive and negative patients. Company to meet with FDA to be in a position to initiate a phase 3 study using efti + Keytruda for the treatment of patients with 1st-line HNSCC. Merck supply collaboration agreement in place to advance phase 3 study, using efti + Keytruda + chemotherapy for the treatment of 1stline NSCLC patients.

Immutep: Positive Efti Treatment Data Leads To Late-Stage Programs

Immutep (IMMP) jumps 15% on positive results from a late-stage study evaluating its candidate, efti, in combination with Keytruda to treat first-line head and neck squamous cell carcinoma patients.

Immutep (IMMP) Up as Combo Therapy Meets Carcinoma Study Goals

Media Release Efti in combination with KEYTRUDA® (pembrolizumab) achieved a 35.5% response rate in evaluable patients (N=31), according to RECIST 1.1, among the highest recorded for a treatment approach not containing chemotherapy in patients with CPS

Immutep Reports Positive Results in First Line Head and Neck Squamous Cell Carcinoma Patients with Negative PD-L1 Expression

Company to Host Webcast on 12th July at 9am AEST (7pm ET, 11 July) SYDNEY, AUSTRALIA, July 03, 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 details for an upcoming oral presentation at the European Society for Medical Oncology (ESMO) Virtual Plenary session on July 11, 2024, featuring new clinical data in patients with negative PD-L1 expression (Cohort B) in the TACTI-003 (KEYNOTE-PNC-34) Phase IIb trial, and a webcast to discuss these clinical results. ESMO Virtual Plenaries are monthly presentations of the latest, original scientific data, including “Phase II trials which demonstrate remarkable therapeutic benefit, scientific insight or progress in an area of unmet need”.

Immutep Announces Details for Oral Presentation at ESMO Virtual Plenary Session and Webcast to Discuss Clinical Results

The heavy selling pressure might have exhausted for Prima BioMed (IMMP) as it is technically in oversold territory now. In addition to this technical measure, strong agreement among Wall Street analysts in revising earnings estimates higher indicates that the stock is ripe for a trend reversal.

Prima BioMed (IMMP) Loses -34.84% in 4 Weeks, Here's Why a Trend Reversal May be Around the Corner

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's response to fight cancer, have been identified under Immutep's collaboration with the world-leading scientists at Cardiff University.

Immutep Signs Exclusive License Agreement with Cardiff University for Next Generation Anti-LAG-3 Molecules for Cancer

Sydney, Australia, June 05, 2024 (GLOBE NEWSWIRE) -- Immutep Limited ACN 009 237 889 (ASX: IMM, NASDAQ: IMMP) (Immutep or the Company) is pleased to announce the successful completion of its institutional placement (Placement) and the institutional component (Institutional Entitlement Offer) of its 1 for 16 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 entitlement offer

SYDNEY, AUSTRALIA, June 03, 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 announced that it has entered into a clinical trial collaboration and supply agreement with MSD (Merck & Co., Inc., Rahway, NJ, USA), through a subsidiary, to evaluate eftilagimod alfa (efti) in combination with MSD's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) and chemotherapy for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in a pivotal Phase III trial.

Immutep Announces Clinical Collaboration with MSD to Evaluate Efti in Combination with KEYTRUDA® (pembrolizumab) in Pivotal Phase III Trial

Media Release Confirmed complete response in a patient with metastatic breast cancer refractory to several lines of therapy achieved during combination treatment with 90mg efti and paclitaxel Ongoing complete response has been maintained since the patient started treatment with efti monotherapy Efti + paclitaxel combination continues to be well tolerated with a favourable safety profile First-ever 90mg dosing leads to higher maximum concentration of efti, as well as pharmacologically active level up to 96 hours after administration Data from randomized Phase II portion of study expected in CY2024 SYDNEY, AUSTRALIA, May 15, 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 encouraging efficacy, safety, and pharmacodynamic data from the safety lead-in of the AIPAC-003 Phase II/III trial presented at the European Society for Medical Oncology (ESMO) Breast Cancer 2024 Congress. This lead-in represents the first ever 90mg dosing of eftilagimod alpha (“efti”), a soluble LAG-3 protein and MHC Class II agonist, given in combination with weekly paclitaxel.

Immutep Presents Data from Safety Lead-in Phase of AIPAC-003 at ESMO Breast 2024

Media Release Novel triple combination of efti with radiotherapy and anti-PD-1 therapy is well tolerated and has led to encouraging initial efficacy data in EFTISARC-NEO Phase II trial Four of six patients treated have very good, near-complete pathologic responses (primary endpoint of study) that are rarely observed with standard therapies Soft tissue sarcoma is a hard-to-treat orphan disease with poor prognosis & high unmet medical need Additional data from EFTISARC-NEO planned for a medical conference in H2 CY2024 SYDNEY, AUSTRALIA, May 02, 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 initial encouraging data from EFTISARC-NEO, a Phase II investigator-initiated trial of eftilagimod alpha (efti) in combination with radiotherapy, a standard-of-care treatment, plus KEYTRUDA® (pembrolizumab) for patients with soft tissue sarcoma (STS). The EFTISARC-NEO study is the first to evaluate efti in a neoadjuvant setting, which takes place before intended surgery, and the first to combine efti with radiotherapy.

Positive Initial Clinical Data Reported from Immutep's Efti Combined with Radiotherapy and Checkpoint Inhibitor from Phase II Trial in Soft Tissue Sarcoma

Immutep Limited is focused on developing novel treatments targeting LAG3, an immune checkpoint, for various tumor types. The company's pipeline includes eftilagimod, which has shown promising response rates in thoracic malignancies. Immutep should have sufficient funding for 9–10 quarters of research and has demonstrated promising early signals of efficacy and safety.

Immutep: Realizing The Expected Catalysts, With More To Come

Media Release First clinical data from the safety lead-in of AIPAC-003 in metastatic breast cancer shows 90mg dosing of efti safe and well tolerated: 50% overall response rate, including one patient reporting a complete response (complete disappearance of all lesions), and a 100% disease control rate Subsequent to quarter end announced a positive preliminary response rate of 26.9% in first line metastatic head and neck squamous cell carcinoma patients with negative PD-L1 expression Preclinical studies of IMP761 progressing to clinical trials mid-CY2024 Anne Anderson joins as independent non-executive director on Immutep's Board SYDNEY, AUSTRALIA, April 29, 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, provides an update on the ongoing development of its product candidates, eftilagimod alpha (efti) and IMP761 for the quarter ended 31 March 2024 (Q3 FY24). EFTI DEVELOPMENT PROGRAM FOR CANCER TACTI-002 (KEYNOTE-PN798) – Phase II clinical trial in 1L NSCLC The TACTI-002 trial is ongoing with Immutep continuing to follow patients with 1L NSCLC (Part A) where, encouragingly, a median Overall Survival has not yet been reached in patients with high PD-L1 expression (TPS ≥50%).

Immutep Quarterly Activities Report Q3 FY24

Media Release Data from efti in combination with KEYTRUDA® in first line head and neck squamous cell carcinoma patients who do not express PD-L1 (TACTI-003, Cohort B) shows a preliminary 26.9% response rate, the primary endpoint of the study Data collection, cleaning, and analysis continues and additional data from TACTI-003 (Cohorts A & B), including complete response rate, will be released in H1 CY2024 SYDNEY, AUSTRALIA, April 24, 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 preliminary topline results from Cohort B of the TACTI-003 (KEYNOTE-PNC-34) Phase IIb trial evaluating eftilagimod alpha (efti) in combination with MSD's anti-PD-1 therapy KEYTRUDA® (pembrolizumab) as first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma patients (1L HNSCC) with negative PD-L1 expression. The investigational immuno-oncology combination utilizing Immutep's MHC Class II agonist and MSD's PD-1 therapy demonstrates an overall response rate (ORR) of 26.9% and disease control rate (DCR) of 57.7% in 26 patients whose tumours do not express PD-L1 (Combined Positive Score [CPS]

Immutep Announces Positive Preliminary Topline Results from TACTI-003 Cohort B

Media Release Centre for Human Drug Research (CHDR) will conduct Phase I trial to evaluate IMP761, a first-in-class LAG-3 agonist antibody designed to restore balance to the immune system and address the underlying cause of autoimmune diseases CHDR will utilize its unique challenge model that enables insights into IMP761's pharmacological activity early in clinical development Trial expected to begin mid-CY2024 SYDNEY, AUSTRALIA, April 18, 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 it has entered into an agreement with the Centre for Human Drug Research (CHDR), a world-class institute in Leiden, the Netherlands specializing in cutting-edge early-stage clinical drug research, to perform a first-in-human clinical study of IMP761. This proprietary LAG-3 agonist antibody has been designed to restore balance to the immune system and address the underlying cause of many autoimmune diseases.

Immutep Appoints Leading Research Institute to Conduct First-in-Human Phase I Study of IMP761

SYDNEY, AUSTRALIA, April 17, 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 it has received positive feedback from the Spanish Agency for Medicines and Health Products (AEMPS) Competent Authority regarding the Company's upcoming TACTI-004 Phase III trial of eftilagimod alpha (“efti”) for first line treatment of metastatic non-small cell lung cancer (1L NSCLC).

Immutep Receives Positive Feedback from the Spanish Medicines Agency for Upcoming TACTI-004 Registrational Trial in Metastatic Non-Small Cell Lung Cancer

SYDNEY, AUSTRALIA, March 05, 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 safety and initial efficacy data from the first ever 90mg dosing of eftilagimod alpha (efti) in combination with weekly paclitaxel in patients from the safety lead-in (N=6) of the AIPAC-003 Phase II/III trial.

Immutep Announces First Clinical Data from 90mg Dosing of Efti

Media Release Excellent clinical data reported from TACTI-002 Phase II trial, including median Overall Survival of 35.5 months in first line non-small cell lung cancer (1L NSCLC) patients expressing PD-L1 (TPS ≥1%) Promising efficacy and tolerability data reported from INSIGHT-003 Phase I trial, including a strong Overall Response Rate of 71.4% in 1L NSCLC patients Late-stage & registrational trial progress: 1L NSCLC: constructive regulatory feedback received for registrational TACTI-004 Phase III trial First line head and neck squamous cell carcinoma: enrolment completed for TACTI-003 Phase IIb trial, and first data expected in H1 CY2024 Metastatic breast cancer: safety lead-in portion of AIPAC-003 Phase II/III trial completed early, with no safety or tolerability issues reported enabling the randomized portion of trial to commence Preclinical studies of IMP761, the world's first LAG-3 agonist to treat the underlying cause of autoimmune diseases, continued. The Company is planning to begin first-in-human trials by mid-CY2024.

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