HLA class II antigen modulators, LAG3 inhibitors(Lymphocyte activation gene 3 protein inhibitors), Antigen-presenting cells stimulants(Antigen-presenting cells stimulants)

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal DiseasesRespiratory Diseases+ [1]

Active Indication

Metastatic breast cancerMetastatic HER2-Negative Breast CarcinomaSoft Tissue Sarcoma+ [11]

Inactive Indication

COVID-19Hepatitis BHormone Receptor Positive Breast Adenocarcinoma+ [3]

Originator Organization

Immutep Ltd.

Active Organization

Immutep SASMerck Sharp & Dohme LLC

Immutep Ltd.

+ [2]

Inactive Organization

CYTLIMIC, Inc.Startup

Wuxi Biologics (Cayman), Inc.Immutep Australia Pty Ltd.

Drug Highest PhasePhase 2/3

First Approval Date-

RegulationFast Track (US)

Gene Sequence

Sequence Code 17007211

Source: *****

Clinical Trials associated with Eftilagimod alpha

NCT06128863 / RecruitingPhase 2IIT

Phase II, Single-arm Clinical Trial Evaluating Efficacy and Safety of Pembrolizumab in Combination With a Soluble LAG-3 Protein, Eftilagimod Alpha, and Radiotherapy in Neoadjuvant Treatment of Patients With Soft Tissue Sarcomas (EFTISARC-NEO)

This is a phase II single-arm single-stage study evaluating efficacy and safety of pembrolizumab in combination with a soluble LAG-3 protein, eftilagimod alpha (Efti) and radiotherapy in neoadjuvant treatment of patients with soft tissue sarcomas. This study will determine the pathologic response rate (defined as percentage of tumor hyalinization/fibrosis) to the combination treatment.

Start Date17 Jul 2023

Sponsor / Collaborator

Maria Sklodowska-Curie National Research Institute of Oncology

[+1]

NCT04252768 / WithdrawnPhase 1

AIPAC-002 (Active Immunotherapy PAClitaxel-002): A Multicentre, Phase Ib Study to Test a New Schedule of Eftilagimod Alpha (a Soluble LAG-3 Protein) as Adjunctive to Weekly Paclitaxel in Hormone Receptor-positive Metastatic Breast Carcinoma Patients

This is a multicentre, multinational Phase Ib study in female HR+ MBC patients not receiving Her2-targeted therapy. Treatment consists of a chemo-immunotherapy phase followed by a maintenance phase. The chemo-immunotherapy phase consists of 6 cycles of 4 weeks each. During each cycle the subject will receive 80 mg/m2 paclitaxel intravenously on Day 1, 8 and 15 and 30 mg efti subcutaneously on Day 1 and 15 in a 28-day (4-week) cycle. Efti will always be given after paclitaxel. The maintenance phase comprises 6 visits with 4 weekly intervals; during each such visit 30 mg efti is given subcutaneously as monotherapy. A total of 24 subjects will be enrolled into the study. The primary goal of the study is safety and tolerability profile of efti in combination with weekly paclitaxel both given the same day in contrast to subsequent days as in the AIPAC trial.

Start Date01 Jun 2023

Sponsor / Collaborator

Immutep SAS

NCT05747794 / RecruitingPhase 2/3

AIPAC-003 (Active Immunotherapy and PAClitaxel): A Randomized, Double-blind, Placebo-controlled Phase 3 Trial Testing Eftilagimod Alpha (Soluble LAG-3) in HER2-neg/Low Metastatic Breast Cancer Patients Receiving Paclitaxel, Following an Open-label Dose Optimization

The goal of this clinical trial is to compare the safety and efficacy of eftilagimod alpha (efti) in combination with paclitaxel standard of care chemotherapy in participants with metastatic breast cancer.
The main questions it aims to answer are:
* What is the optimal biological dose (OBD) of efti in combination with weekly paclitaxel chemotherapy?
* Can efti combined with weekly paclitaxel chemotherapy prolong overall survival in participants with metastatic breast cancer if compared to weekly paclitaxel chemotherapy alone?
In the first component of the trial (phase 2, lead-in) researchers will compare two groups (different dose levels of efti in combination with standard chemotherapy) to see if the treatment is safe and well tolerated and evaluate which is the optimal biological dose. In the second component of the trial (phase 3) researchers will assess if the treatment of metastatic breast cancer with the optimal biological dose of efti in combination with paclitaxel is superior compared to chemotherapy alone (placebo-controlled).
The treatment concept of each trial component consists of a chemo-immunotherapy phase followed by an immunotherapy phase. In the first phase participants will be treated with efti plus paclitaxel chemotherapy or placebo plus paclitaxel chemotherapy. After completion of the chemotherapy per standard of care, participants will be treated with the study agent alone.

Start Date22 May 2023

Sponsor / Collaborator

Immutep SAS

100 Clinical Results associated with Eftilagimod alpha

100 Translational Medicine associated with Eftilagimod alpha

100 Patents (Medical) associated with Eftilagimod alpha

Literatures (Medical) associated with Eftilagimod alpha

01 Nov 2024·JTO clinical and research reports

Eftilagimod Alpha (a Soluble LAG-3 Protein) Combined With Pembrolizumab in Second-Line Metastatic NSCLC Refractory to Anti–Programmed Cell Death Protein 1/Programmed Death-Ligand 1-Based Therapy: Final Results from a Phase 2 Study

Article

Author: Roxburgh, Patricia ; Krebs, Matthew G. ; Majem, Margarita ; Clay, Tim ; Mueller, Christian ; Andres, B. ; Doger, Bernard ; Krebs, Matthew G ; Triebel, F. ; Doger, B. ; Forster, Martin ; Triebel, Frédéric ; Majem, M. ; Forster, M. ; Iams, W. ; Clay, T. ; Bajaj, P. ; Iams, Wade ; Perera, Suvini ; Peguero, J. ; Mueller, C. ; Bajaj, Pawan ; Barba, Andres ; Krebs, M.G. ; Roxburgh, P. ; Perera, S. ; Peguero, Julio

Introduction:

Eftilagimod alpha (efti), a soluble lymphocyte activation gene-3 protein, triggers antigen-presenting cell and T-cell (CD4⁺ and CD8⁺) activation and helps overcome resistance to programmed cell death protein 1 or programmed cell death-ligand 1 (PD-(L)1) inhibitors. We assessed efti plus pembrolizumab in second-line anti-PD-(L)1-refractory metastatic patients with NSCLC.

Methods:

After confirmed progression on anti-PD-(L)1-based first-line therapy, patients received efti (30 mg subcutaneously every 2 weeks for eight 3-week cycles and then every 3 weeks for up to 54 weeks) plus pembrolizumab (200 mg intravenously every 3 weeks for up to 105 weeks). The primary endpoint was the objective response rate by modified Response Evaluation Criteria in Solid Tumors version 1.1 for immune-based therapies. Secondary endpoints included disease control rate, progression-free survival, overall survival (OS), and tolerability. Exploratory endpoints included tumor growth kinetics and predefined subgroup analyses. Programmed cell death-ligand 1 tumor proportion score was assessed centrally.

Results:

Thirty-six patients were enrolled from April 2019 to August 2021 using Simon's two-stage design. Most patients (81.8%) had low or negative (<50%) PD-(L)1 tumor proportion score. First-line therapy was anti-PD-(L)1-based for all patients, combined with chemotherapy for 66.7%. The confirmed objective response and disease control rates were 8.3% and 33.3%. The median progression-free survival was 2.1 months and the median OS was 9.9 months. Patients exhibiting high PD-(L)1 expression or acquired resistance to PD-(L)1 inhibitors revealed superior response and survival outcomes, and OS was closely correlated with disease control. No treatment-emergent adverse event led to permanent discontinuation of study treatment.

Conclusions:

Efti plus pembrolizumab was well-tolerated and revealed signs of antitumor activity in patients with NSCLC resistant to PD-(L)1 inhibitors, warranting further investigation. Trial registration number: NCT03625323.

03 Sep 2024·CLINICAL CANCER RESEARCH

Eftilagimod Alpha (Soluble LAG3 Protein) Combined with Pembrolizumab as Second-Line Therapy for Patients with Metastatic Head and Neck Squamous Cell Carcinoma

Article

Author: Patel, Grisma ; Pousa, Antonio L. ; Roxburgh, Patricia ; Bajaj, Pawan ; Brignone, Chrystelle ; Mueller, Christian ; Doger, Bernard ; Krebs, Matthew ; Forster, Martin ; Triebel, Frederic ; Peguero, Julio ; Brana, Irene ; Carcereny, Enric

Abstract:

Purpose::

Eftilagimod alpha (efti), a soluble LAG3 protein, activates antigen-presenting cells (APC) and downstream T cells. TACTI-002 (part C) evaluated whether combining efti with pembrolizumab led to strong antitumor responses in patients with second-line recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) while demonstrating good tolerability.

Patients and Methods::

In this multinational phase II trial using Simon’s two-stage design, patients who were PD-L(1)-naïve with R/M HNSCC who had failed first-line platinum-based therapy, unselected for PD-L1, received intravenous pembrolizumab (200 mg, once every 2 weeks) combined with subcutaneous efti (30 mg once every 2 weeks for 24 weeks and once every 3 weeks thereafter). The primary endpoint was objective response rate per RECIST 1.1 modified for immune-based therapy by investigator assessment. Additional endpoints included duration of response, progression-free survival, overall survival, and tolerability. Pharmacodynamic effects (absolute lymphocyte count) and Th1 cytokine biomarkers (IFNγ/CXCL10)] were evaluated in liquid biopsies.

Results::

Between March 2019 and January 2021, 39 patients were enrolled; 37 were evaluated for response. All patients received prior chemotherapy, and 40.5% were pretreated with cetuximab; 53.1% of patients had PD-L1 combined positive score <20. With a median follow-up of 38.8 months, the objective response rate was 29.7%, including 13.5% complete responders. The median duration of response was not reached. Rapid and sustained absolute lymphocyte count increase was observed in patients who had an objective response. Th1 biomarkers increased sustainably after first treatment. No unexpected safety signals were observed.

Conclusions::

Efti plus pembrolizumab was safe and showed encouraging antitumor activity and pharmacodynamic effects in patients with second-line head and neck squamous cell carcinoma (HNSCC), thus supporting further evaluation of this combination in earlier treatment lines.

01 Feb 2024·Clinical cancer research : an official journal of the American Association for Cancer Research

Paclitaxel plus Eftilagimod Alpha, a Soluble LAG-3 Protein, in Metastatic, HR+ Breast Cancer: Results from AIPAC, a Randomized, Placebo Controlled Phase IIb Trial

Article

Author: Perjesi, Luca ; Dalenc, Florence ; Pápai, Zsuzsanna ; Brignone, Chrystelle ; Duhoux, Francois P. ; Armstrong, Anne ; Marme, Frederik ; Kuemmel, Sherko ; Jager, Agnes ; Dirix, Luc ; Cuypere, Eveline ; Triebel, Frederic ; Schröder, Carolina P. ; Wildiers, Hans ; Mueller, Christian ; Vuylsteke, Peter ; Menke-van der Houven van Oordt, Catharina Willemien ; Chan, Steve ; Huober, Jens ; Brain, Etienne

Abstract:

Purpose::

Eftilagimod alpha (efti), a soluble lymphocyte activation gene (LAG-3) protein and MHC class II agonist, enhances innate and adaptive immunity. Active Immunotherapy PAClitaxel (AIPAC) evaluated safety and efficacy of efti plus paclitaxel in patients with predominantly endocrine-resistant, hormone receptor–positive, HER2-negative metastatic breast cancer (ET-resistant HR+ HER2− MBC).

Patients and Methods::

Women with HR+ HER2– MBC were randomized 1:1 to weekly intravenous paclitaxel (80 mg/m2) and subcutaneous efti (30 mg) or placebo every 2 weeks for six 4-week cycles, then monthly subcutaneous efti (30 mg) or placebo maintenance. Primary endpoint was progression-free survival (PFS) by blinded independent central review. Secondary endpoints included overall survival (OS), safety/tolerability, pharmacokinetics/pharmacodynamics, and quality of life. Exploratory endpoints included cellular biomarkers.

Results::

114 patients received efti and 112 patients received placebo. Median age was 60 years (91.6% visceral disease, 84.1% ET-resistant, 44.2% with previous CDK4/6 inhibitor treatment). Median PFS at 7.3 months was similar for efti and placebo. Median OS was not significantly improved for efti (20.4 vs. 17.5 months; HR, 0.88; P = 0.197) but became significant for predefined exploratory subgroups. EORTC QLQC30-B23 global health status was sustained for efti but deteriorated for placebo. Efti increased absolute lymphocyte, monocyte and secondary target cell (CD4, CD8) counts, plasma IFNγ and CXCL10 levels.

Conclusions::

Although the primary endpoint, PFS, was not met, AIPAC confirmed expected pharmacodynamic effects and demonstrated excellent safety profile for efti. OS was not significantly improved globally (2.9-month difference), but was significantly improved in exploratory biomarker subgroups, warranting further studies to clarify efti's role in patients with ET-resistant HER2− MBC.

137

News (Medical) associated with Eftilagimod alpha

29 Oct 2024

·www.globenewswire.com

Immutep Quarterly Activities Report Q1 FY25

Positive feedback received from US FDA regarding the planned TACTI-004 Phase III in first-line non-small cell lung cancer successfully concluding regulatory preparations for the trial designEfti in combination with MSD’s KEYTRUDA® reports positive efficacy and favourable safety in first-line head and neck cancer in TACTI-003 Phase IIb trialFirst participant successfully dosed in the first-in-human Phase I trial of IMP761, a novel LAG-3 agonist antibody designed to treat autoimmune diseasesImmutep added to the S&P ASX300 Index, recognising its considerable growth and enhancing market visibilityImmutep has a strong aggregate cash, cash equivalent and term deposit position of A$172.3 million as at 30 September 2024 with an expected cash reach to the end of CY2026. 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). EFTI DEVELOPMENT PROGRAM FOR CANCER TACTI-004 (KEYNOTE-PNC91) – 1L NSCLC Phase III Clinical Collaboration with MSD In July, Immutep received positive feedback from the US Food and Drug Administration (FDA) regarding its planned TACTI-004 Phase III trial of eftilagimod alfa (efti) in combination with KEYTRUDA® (pembrolizumab), MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, and histology-based platinum doublet chemotherapy for the treatment of first-line metastatic non-small cell lung cancer (1L NSCLC), regardless of PD-L1 expression. The FDA feedback builds on previously received guidance from the Paul-Ehrlich-Institut and the Spanish Agency for Medicines and Health Products, successfully concluding the preparatory regulatory interactions for the design of this registrational trial. The study will enrol ~750 patients regardless of PD-L1 expression in order to address the entire 1L NSCLC market eligible for anti-PD-1 therapy. TACTI-003 (KEYNOTE-C34) – Phase IIb clinical trial in 1L HNSCCTACTI-003 is evaluating efti 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 patients (1L HNSCC). The randomized Cohort A portion of the study is evaluating efti in combination with KEYTRUDA as compared to KEYTRUDA monotherapy in patients with PD-L1 positive (Combined Positive Score [CPS] ≥1) tumours, whereas Cohort B is evaluating efti in combination with KEYTRUDA in patients with PD-L1 negative tumours (CPS <1). In July, Immutep reported updated positive efficacy and safety results from Cohort B of the TACTI-003 Phase IIb trial at an ESMO Virtual Plenary session. In patients with negative PD-L1 expression (CPS <1) in Cohort B, efti in combination with KEYTRUDA® achieved a 35.5% objective response rate (ORR). This is among the highest recorded for a treatment approach not containing chemotherapy in patients with CPS <1. The immuno-oncology combination with efti also attained a high complete response rate of 9.7%, which compares favourably to a historical control of 0% from anti-PD-1 monotherapy in 1L HNSCC patients with a CPS <1. Additionally, durability of responses was tracking well. In September, further data was reported from Cohort A of the TACTI-003 trial in a late-breaking abstract and prestigious Proffered Paper oral presentation at ESMO Congress 2024. At ESMO, late-breaking abstracts are generally reserved for high-quality, new research findings from randomised phase II or phase III trials with implications for clinical practice or understanding of disease processes. Proffered Papers are oral presentations of original data of superior quality, followed by expert discussion and perspectives. In patients with PD-L1 positive tumours (CPS ≥1), efti in combination with KEYTRUDA outperformance was largest in CPS ≥20 with 31.0% ORR (34.5% ORR including a partial response recorded after data cut-off date) versus 18.5% ORR for KEYTRUDA monotherapy. Efti in combination with KEYTRUDA led to a high durability of response of 17.5 months in patients with CPS ≥1 and the combination continues to have favourable safety profile. Additionally, a statistically significant increase in absolute lymphocyte count, measured as an exploratory biomarker, was seen in the efti with KEYTRUDA arm indicating an effective efti-induced immune response in this randomised setting. Immutep will continue to follow the maturing data from TACTI-003, with the most relevant endpoint of Overall Survival expected in 2025 and engage with regulatory authorities regarding potential paths forward. TACTI-002 (KEYNOTE-PN798) – Phase II clinical trial in 1L NSCLCImmutep continues to follow patients with first-line non-small cell lung cancer (1L NSCLC), in Part A of the TACTI-002 trial, where excellent median Overall Survival (mOS) rates were seen across all levels of PD-L1 expression. Immutep has previously reported final data from the other parts of the TACTI-002 trial. AIPAC-003 – Integrated Phase II/III trial in MBCSubsequent to quarter end, Immutep completed patient enrolment in the randomised Phase II portion of the AIPAC-003 trial in October. The Phase II portion enrolled 65 metastatic hormone receptor positive (HR+), HER2-negative/low or triple-negative breast cancer patients who had exhausted endocrine therapy including cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. The patients have been enrolled across 22 clinical sites in Europe and the United States and have been randomised 1:1 to receive either 30mg or 90mg dosing of efti in combination with paclitaxel to determine the optimal biological dose of efti consistent with the FDA’s Project Optimus initiative. Further updates will be provided after data collection, data cleaning and analysis. INSIGHT-003 – Phase I in non-squamous 1L NSCLCThe investigator-initiated INSIGHT-003 trial continued to enrol patients throughout the quarter and they have been safely dosed across six sites in Germany. Further updates from the trial are anticipated in Q 4 CY2024. INSIGHT-005 – Phase I trial in Urothelial CarcinomaThe INSIGHT-005 trial is evaluating efti and the anti-PD-L1 therapy BAVENCIO® (avelumab) in up to 30 patients with metastatic urothelial cancer. The study is jointly funded with Merck KGaA, Darmstadt, Germany. EFTISARC-NEO – Phase II Trial in Soft Tissue SarcomaNew data from the EFTISARC-NEO Phase II investigator-initiated trial of efti in combination with radiotherapy plus KEYTRUDA® (pembrolizumab) for patients with soft tissue sarcoma (STS) will be presented on 14 November at the Connective Tissue Oncology Society (CTOS) 2024 Annual Meeting taking place in San Diego, California. IMP761 DEVELOPMENT PROGRAM FOR AUTOIMMUNE DISEASEIn August, Immutep successfully dosed the first participant in the first-in human Phase I trial of IMP761 after receiving regulatory clearance from the ethics and competent authority in the Netherlands to initiate the study. Safety data from this first-in-human study is anticipated by the end of the calendar year 2024, with pharmacokinetics and pharmacodynamics data in first half CY2025. IMP761 is a first-in-class agonist LAG-3 antibody designed to restore balance to the immune system by enhancing the “brake” function of LAG-3 to silence dysregulated self-antigen-specific memory T cells that cause many autoimmune diseases. INTELLECTUAL PROPERTY During the quarter, Immutep was granted seven new patents for efti, IMP761 and LAG525 (ieramilimab) in various territories. Two patents were granted for efti in combination with a PD-1 pathway inhibitor in South Korea and Brazil and one patent was granted in Mexico for a binding assay for determining MHC Class II binding activity. The assay is used in the characterisation of efti in GMP-grade manufacturing. New patents were also granted for IMP761 in India and Israel. For LAG525, which is exclusively licensed to Novartis by Immutep, two new patents were granted in Australia and Taiwan. CORPORATE & FINANCIAL SUMMARY Immutep enters the ASX300Following the September quarterly review of the S&P Dow Jones Indices, Immutep was added to the S&P/ASX 300 index. Joining the ASX300 recognises the Company's considerable growth over the years, enhances its market visibility and supports investor confidence. Cash Flow SummaryDuring the quarter, Immutep continued to advance its clinical trial programs for efti and preclinical program for IMP761 to create value for shareholders. The Company is well funded with a strong cash and cash equivalent balance as at 30 September 2024 of approximately A$120.3 million. In addition to this cash balance, Immutep has an A$52.0 million bank term deposit, which has been recognised as a short-term investment due to the maturity date of 5-12 months. This aggregate position of A$172.3 million as at 30 September 2024 gives Immutep an expected cash reach to the end of CY2026. Cash receipts from customers in Q1 FY25 were $20k. During the quarter, Immutep received a €2,194,918 (~A$3,602,362) research and development (R&D) tax incentive payment in cash from the French Government under its Crédit d’Impôt Recherche scheme and $549k from the Australian government R&D tax rebate. The net cash used in G&A activities in the quarter was $961k, compared to $1.9 million in Q4 FY24. Payments to Related Parties comprises Non-Executive Directors’ fees and Executive Directors’ remuneration of $576 k. The net cash used in R&D activities during the quarter was $9.5 million, compared to $3.8 million to Q4 FY24. The increase is mainly due to the increased level of clinical trial activities. Payment for staff costs was $2.8 million in the quarter compared to $2.0 million in Q4 FY24. Total net cash outflows used in operating activities in the quarter were $8.6 million compared to $7.4 million in Q4 FY24. For the cash flow used in investing activities, the company invested $32.4 million in bank term deposits with maturity between 5 and 6 months which has been recognised as a short-term investment. Net cash outflow from financing activities for the quarter was approximately $373 k including $254k for the payment of capital raising cost. About ImmutepImmutep is a clinical-stage biotechnology company developing novel LAG-3 immunotherapy for cancer and autoimmune disease. We are pioneers in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and our diversified product portfolio harnesses its unique ability to stimulate or suppress the immune response. Immutep is dedicated to leveraging its expertise to bring innovative treatment options to patients in need and to maximise value for shareholders. For more information, please visit www.immutep.com. Australian Investors/Media:Catherine Strong, Sodali & Co+61 (0)406 759 268; catherine.strong@sodali.com U.S. Investors/Media:Chris Basta, VP, Investor Relations and Corporate Communications+1 (631) 318 4000; chris.basta@immutep.com

Phase 2Clinical ResultPhase 1ImmunotherapyPhase 3

28 Oct 2024

·www.globenewswire.com

Immutep to Present New Phase IIb Data in PD-L1 Negative (CPS <1) Head and Neck Cancer at ESMO Immuno-Oncology 2024

Media Release SYDNEY, AUSTRALIA, Oct. 28, 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 will present new data from Cohort B of the TACTI-003 Phase IIb trial in first line recurrent/metastatic head and neck squamous cell carcinoma patients with negative PD-L1 expression (CPS <1) at the European Society for Medical Oncology Immuno-Oncology (ESMO I-O) Congress 2024 taking place 11-13 December in Geneva, Switzerland. Presentation details: Title:TACTI-003 Cohort B: Eftilagimod Alpha (Soluble LAG-3) and Pembrolizumab in First-Line Recurrent or Metastatic Head & Neck Squamous Cell Carcinoma with CPS <1Presenter:Martin Forster, M.D., Ph.D., University College London (UCL) Cancer Institute and UCL Hospital NHS Foundation, London, UKPresentation Number: 152PDate and Time:Thursday, 12 December 2024 at 12:30 – 13:30PM CET Abstracts will be made available on the ESMO I-O website on 5 December 2024 at 00:05 CET. The poster containing new data, not in the abstract, will be available on the Posters & Publications section of Immutep’s website after its presentation on 12 December 2024. About Immutep Immutep is a clinical-stage biotechnology company developing novel LAG-3 immunotherapy for cancer and autoimmune disease. We are pioneers in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and our diversified product portfolio harnesses its unique ability to stimulate or suppress the immune response. Immutep is dedicated to leveraging its expertise to bring innovative treatment options to patients in need and to maximise value for shareholders. For more information, please visit www.immutep.com. Australian Investors/Media:Catherine Strong, Sodali & Co+61 (0)406 759 268; catherine.strong@sodali.com U.S. Media:Chris Basta, VP, Investor Relations and Corporate Communications+1 (631) 318 4000; chris.basta@immutep.com

Phase 2Immunotherapy

04 Oct 2024

·www.globenewswire.com

Immutep Completes Patient Enrolment in Randomised Phase II of AIPAC-003 Trial in Metastatic Breast Cancer

Oct. 03, 2024 -- 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 patient enrolment has been completed in the randomised Phase II portion of the AIPAC-003 (Active Immunotherapy and PAClitaxel) clinical trial. The Phase II enrolled 65 metastatic hormone receptor positive (HR+), HER2-negative/low or triple-negative breast cancer patients who exhausted endocrine therapy including cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. Patients across 22 clinical sites in Europe and the United States have been randomised 1:1 to receive either 30mg or 90mg dosing of eftilagimod alpha (“efti”) in combination with paclitaxel to determine the optimal biological dose consistent with the FDA’s Project Optimus initiative. Further updates will be provided after data collection, data cleaning, and analysis. For more information on the trial, please visit clinicaltrials.gov (NCT05747794). Immutep is a clinical-stage biotechnology company developing novel LAG-3 immunotherapy for cancer and autoimmune disease. We are pioneers in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and our diversified product portfolio harnesses its unique ability to stimulate or suppress the immune response. Immutep is dedicated to leveraging its expertise to bring innovative treatment options to patients in need and to maximise value for shareholders. For more information, please visit www.immutep.com. The content above comes from the network. if any infringement, please contact us to modify.

ImmunotherapyClinical Result

100 Deals associated with Eftilagimod alpha

External Link

KEGG	Wiki	ATC	Drug Bank
-	Eftilagimod alpha	-	DB16150

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic breast cancer	Phase 3	US	Immutep SAS	22 May 2023
Metastatic breast cancer	Phase 3	BE	Immutep SAS	22 May 2023
Metastatic breast cancer	Phase 3	GE	Immutep SAS	22 May 2023
Metastatic breast cancer	Phase 3	MD	Immutep SAS	22 May 2023
Metastatic breast cancer	Phase 3	ES	Immutep SAS	22 May 2023
Metastatic HER2-Negative Breast Carcinoma	Phase 3	US	Immutep SAS	22 May 2023
Metastatic HER2-Negative Breast Carcinoma	Phase 3	BE	Immutep SAS	22 May 2023
Metastatic HER2-Negative Breast Carcinoma	Phase 3	GE	Immutep SAS	22 May 2023
Metastatic HER2-Negative Breast Carcinoma	Phase 3	MD	Immutep SAS	22 May 2023
Metastatic HER2-Negative Breast Carcinoma	Phase 3	ES	Immutep SAS	22 May 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04811027 (TACTI-003, ESMO2024) Manual	Phase 2	Head and Neck Neoplasms First line PD-L1 Expression (CPS >= 1)	118	Eftilagimod Alpha + pembrolizumab	imcbauuaer(gcmmvaktel) = wbsqrtinfv egllnmwsib (yrjqwagtaf ) View more	Positive	15 Sep 2024
NCT04811027 (TACTI-003, ESMO2024) Manual	Phase 2		118	Pembrolizumab	imcbauuaer(gcmmvaktel) = exylhbchlv egllnmwsib (yrjqwagtaf ) View more	Positive	15 Sep 2024
NCT04811027 (TACTI-003, Company_Website) Manual	Phase 2	Squamous Cell Carcinoma of Head and Neck First line	138	Eftilagimod alfa (Efti) + KEYTRUDA (PD-L1 Expression (CPS >20))	vudtuqjipv(kselupeghf) = hwgbkxhzkg rgcoarcgdd (xbvqtstaxd ) View more	Positive	27 Jun 2024
NCT04811027 (TACTI-003, Company_Website) Manual	Phase 2	Squamous Cell Carcinoma of Head and Neck First line	138	Eftilagimod alfa (Efti) + KEYTRUDA (PD-L1 Expression (CPS 1-19))	vudtuqjipv(kselupeghf) = ceywarzecj rgcoarcgdd (xbvqtstaxd )	Positive	27 Jun 2024
NCT05747794 (AIPAC-003, ESMO_BC2024) Manual	Phase 2/3	Metastatic breast cancer HER2 Negative \| Hormone Receptor Positive	6	eftilagimod alpha+paclitaxel	ngaqwmwfgf(ydyziemowz) = none sgzgvletya (wjcpwycbsq ) View more	Positive	16 May 2024
NCT05747794 (AIPAC-003, Biospace) Manual	Phase 2/3	Metastatic breast cancer	6	Eftilagimod alpha 90 mg s.c.	akvmalyrye(eooufyqryi) = None ropgzcbshr (tlgqufdxgd ) View more	Positive	15 May 2024
NCT06128863 (EFTISARC-NEO, Corporate Publications) Manual	Phase 2	Soft Tissue Sarcoma Neoadjuvant	6	eftilagimod alpha+pembrolizumab+radiotherapy	pbdgdrglcq(gzkqbvfebs) = hsnmgsxxbe qweyfulmtc (kfqevvxklg )	Positive	02 May 2024
NCT04811027 (TACTI-003 \| KEYNOTE-PNC-34, Biospace) Manual	Phase 2	Squamous Cell Carcinoma of Head and Neck First line PD-L1 Negative	26	Eftilagimod alpha + KEYTRUDA	xxtxjgdssk(romvdnguwi) = iiqvxsynjc rwerhmgdqr (radpvyzekp ) View more	Positive	24 Apr 2024
NCT05747794 (AIPAC-003, GlobeNewswire) Manual	Phase 2/3	Metastatic breast cancer	6	Eftilagimod alpha+paclitaxel	xbhciyofkj(lprbfqdxta) = ahyerdemfk svmmulygrc (xtjfattimn ) View more	Positive	05 Mar 2024
NCT03252938 (INSIGHT 003, ESMO2023) Manual	Phase 1	Non-Small Cell Lung Cancer First line	21	Eftilagimod alpha + carboplatin + pemetrexed + pembrolizumab	zyexvjjecg(vcmfbyezkf) = utoggficxa aqvrbmnmbx (zirjeoqtbk ) View more	Positive	23 Oct 2023
NCT03625323 (TACTI-002, ESMO2023) Manual	Phase 2	Non-Small Cell Lung Cancer First line	114	Eftilagimod alpha+pembrolizumab	gdyaqxrosp(trqkytjgqk) = yfbbncepig qizaahpxks (axcdzbkbzp, 31.3 - 50.0) View more	Positive	21 Oct 2023
NCT03625323 (TACTI-002, ESMO2023) Manual	Phase 2	Non-Small Cell Lung Cancer First line	114	Eftilagimod alpha+pembrolizumab (PD-L1 TPS (N=90) ≥1%)	gdyaqxrosp(trqkytjgqk) = hrodoaevip qizaahpxks (axcdzbkbzp, 35.0 - 61.8) View more	Positive	21 Oct 2023
NCT03625323 (TACTI-002, ASCO2023) Manual	Phase 2	Squamous Cell Carcinoma of Head and Neck Second line	37	eftilagimod alpha+pembrolizumab (Overall (ITT))	dsysctvhva(xawtnncavo) = zfaifdvltk ibjtsqmhnt (seklzblocu ) View more	Positive	31 May 2023
NCT03625323 (TACTI-002, ASCO2023) Manual	Phase 2	Squamous Cell Carcinoma of Head and Neck Second line	37	eftilagimod alpha+pembrolizumab (PD-L1 CPS ≥20)	dsysctvhva(xawtnncavo) = dmgegzmeii ibjtsqmhnt (seklzblocu ) View more	Positive	31 May 2023

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