排名前五的靶点	数量

LAG3(淋巴细胞活化基因3蛋白)	2
LAG3 + MHC II(淋巴细胞活化基因3蛋白 + 主要组织相容性复合体II)	1
CD3 + HLA class I抗原 + MAGEA3(T细胞表面糖蛋白CD3复合体 + HLA class I抗原 + 黑色素瘤相关抗原3)	1

关联

项与 Immutep Ltd. 相关的药物

Eftilagimod alpha

重组人源淋巴细胞激活基因-3（hLAG-3）融合蛋白

靶点

LAG3 + MHC II

作用机制

LAG3抑制剂 [+3]

在研机构

Immutep Ltd. [+7]

原研机构

Immutep Ltd.

在研适应症

转移性乳腺癌 [+12]

非在研适应症

乙型肝炎

药物最高研发状态临床2/3期

首次获批国家/地区-

首次获批日期-

Ieramilimab

埃拉利单抗

靶点

LAG3

作用机制

LAG3抑制剂

在研机构

Novartis Pharma AG [+2]

原研机构

Immutep Ltd.

在研适应症

黑色素瘤 [+14]

非在研适应症-

药物最高研发状态临床2期

首次获批国家/地区-

首次获批日期-

HLA-A2 peptides(Immutep)

靶点

CD3 + HLA class I抗原 + MAGEA3

作用机制

CD3调节剂 [+3]

在研机构

Immutep SAS

原研机构

Immutep Ltd.

在研适应症

黑色素瘤

非在研适应症-

药物最高研发状态临床1/2期

首次获批国家/地区-

首次获批日期-

项与 Immutep Ltd. 相关的临床试验

NCT04252768 / Withdrawn临床1期

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.

开始日期2023-06-01

申办/合作机构

Immutep SAS

NCT05747794 / Recruiting临床2/3期

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.

开始日期2023-05-22

申办/合作机构

Immutep SAS

NCT04811027 / Recruiting临床2期

TACTI-003 (Two ACTive Immunotherapeutics): A Multicenter, Open Label, Randomized, Phase II Trial to Investigate a Soluble LAG-3 Fusion Protein, Eftilagimod Alpha (Efti; IMP321) in Combination With Pembrolizumab (PD-1 Antagonist) for First Line Treatment of Subjects With Unresectable Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC)

Evaluate the safety and efficacy of eftilagimod alpha in combination with pembrolizumab against pembrolizumab alone in 1st line metastatic or recurrent HNSCC with PD-L1 positive (CPS ≥1) tumors, and determine the efficacy and safety of efti plus pembrolizumab in patients with PD-L1 negative tumors.

开始日期2021-08-27

申办/合作机构

Immutep SAS

[+1]

0 项与 Immutep Ltd. 相关的专利（医药）

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项与 Immutep Ltd. 相关的文献（医药）

2010-07-23·Journal of Translational Medicine2区 · 医学

First-line chemoimmunotherapy in metastatic breast carcinoma: combination of paclitaxel and IMP321 (LAG-3Ig) enhances immune responses and antitumor activity

2区 · 医学

ArticleOA

作者: Brignone, Chrystelle ; Gutierrez, Maya ; Mefti, Fawzia ; Brain, Etienne ; Jarcau, Rosana ; Cvitkovic, Frederique ; Bousetta, Nabil ; Medioni, Jacques ; Gligorov, Joseph ; Grygar, Caroline ; Marcu, Manon ; Triebel, Frederic

BACKGROUND:

IMP321 is a recombinant soluble LAG-3Ig fusion protein that binds to MHC class II with high avidity and mediates APC and then antigen-experienced memory CD8+ T cell activation. We report clinical and biological results of a phase I/II in patients with metastatic breast carcinoma (MBC) receiving first-line paclitaxel weekly, 3 weeks out of 4.

METHODS:

MBC patients were administered one dose of IMP321 s.c. every two weeks for a total of 24 weeks (12 injections). The repeated single doses were administered the day after chemotherapy at D2 and D16 of the 28-day cycles of paclitaxel (80 mg/m2 at D1, D8 and D15, for 6 cycles). Blood samples were taken 13 days after the sixth and the twelfth IMP321 injections to determine sustained APC, NK and memory CD8 T cell responses.

RESULTS:

Thirty MBC patients received IMP321 in three cohorts (doses: 0.25, 1.25 and 6.25 mg). IMP321 induced both a sustained increase in the number and activation of APC (monocytes and dendritic cells) and an increase in the percentage of NK and long-lived cytotoxic effector-memory CD8 T cells. Clinical benefit was observed for 90% of patients with only 3 progressors at 6 months. Also, the objective tumor response rate of 50% compared favorably to the 25% rate reported in the historical control group.

CONCLUSIONS:

The absence of toxicity and the demonstration of activity strongly support the future development of this agent for clinical use in combined first-line regimens.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00349934.

2009-10-01·Clinical Cancer Research1区 · 医学

A Phase I Pharmacokinetic and Biological Correlative Study of IMP321, a Novel MHC Class II Agonist, in Patients with Advanced Renal Cell Carcinoma

1区 · 医学

Article

作者: Brignone, Chrystelle ; Escudier, Bernard ; Grygar, Caroline ; Marcu, Manon ; Triebel, Frederic

PURPOSE:

To evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IMP321, a recombinant soluble LAG-3Ig fusion protein which agonizes MHC class II-driven dendritic cell activation.

EXPERIMENTAL DESIGN:

Patients with advanced renal cell carcinoma were treated with escalating doses of IMP321 s.c. Blood samples were assayed to determine plasma pharmacokinetic parameters, detect human anti-IMP321 antibody formation, and determine long-lived CD8 T cell responses.

RESULTS:

Twenty-one advanced renal cell carcinoma patients received 119 injections of IMP321 at doses ranging from 0.050 to 30 mg/injection s.c. biweekly for 6 injections. No clinically significant adverse events were observed. Good systemic exposure to the product was obtained following s.c. injections of doses above 6 mg. IMP321 induced both sustained CD8 T-cell activation and an increase in the percentage of long-lived effector-memory CD8 T cells in all patients at doses above 6 mg. Tumor growth was reduced and progression-free survival was better in those patients receiving higher doses (>6 mg) of IMP321: 7 of 8 evaluable patients treated at the higher doses experienced stable disease at 3 months compared with only 3 of 11 in the lower dose group (P = 0.015).

CONCLUSION:

The absence of toxicity and the demonstration of activity at doses above 6 mg warrant further disease-directed studies of IMP321 in combined regimens (e.g., chemoimmunotherapy).

2007-06-11·Vaccine3区 · 医学

IMP321 (sLAG-3) safety and T cell response potentiation using an influenza vaccine as a model antigen: a single-blind phase I study

3区 · 医学

Article

作者: Brignone, Chrystelle ; Grygar, Caroline ; Marcu, Manon ; Perrin, Gaelle ; Triebel, Frederic

sLAG-3 (IMP321), a natural high affinity ligand for MHC class II, was tested for safety, tolerability and its ability to increase Th-1-type T cell responses to a commercial trivalent split influenza vaccine (Agrippal) in a phase I single-blinded, randomized, controlled clinical trial. Twenty healthy volunteers were first injected with increasing doses of IMP321 alone (safety for first-in-man use). Then 40 volunteers were recruited into 4 consecutive cohorts of 10 subjects, who were randomly assigned to receive the flu vaccine plus 3, 10, 30 or 100 microg IMP321 or the flu vaccine plus saline control. All vaccine formulations were found to be generally well tolerated with similar frequency and intensity of adverse reaction in groups receiving IMP321 as in controls. Post-vaccination humoral immune responses, as determined 29 and 57 days later by assay of hemagglutinin inhibition activity were similar for both IMP321 and control groups. In contrast, the addition of 10, 30 or 100 microg IMP321 to the flu vaccine resulted in higher levels of Th1-type (IFN-gamma, TNF-alpha or IL-2) flu-specific CD4 T cells in PBMC recovered at D29 and D57 and tested in a short-term ex vivo restimulation assay (6-colour FACS analysis after intra-cellular staining of cytokines). In summary, IMP321 as an adjuvant to a model antigen (Agrippal) was well-tolerated and may enhance T cell response vaccine immunogenicity.

130

项与 Immutep Ltd. 相关的新闻（医药）

2023-09-21

·GlobeNewswire-Health Care

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

Comparability of Drug Substance and Drug Product manufactured at 2,000L scale achievedMedia Release SYDNEY, AUSTRALIA, Sept. 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 the regulatory authorization of eftilagimod alpha (“efti”) manufactured at commercial 2,000L scale for use in clinical trials across multiple European countries including Germany, Belgium, Denmark, and the United Kingdom. After successfully scaling up the manufacturing process of efti to commercial scale at WuXi Biologics, the process-related changes were presented in a substantial amendment of the Investigational Medicinal Product Dossier (IMPD). Overall comparability of the first 2,000L and the previous 200L scale clinical stage manufacturing process was achieved. Immutep plans to introduce efti manufactured by the 2,000L scale process into current and future clinical trials. Marc Voigt, CEO of Immutep, said: “With late-stage clinical development underway for our first-in-class soluble LAG-3 protein and MHC Class II agonist in non-small cell lung cancer, head and neck cancer, and metastatic breast cancer, commercial scale manufacturing of efti for use in clinical trials is a significant achievement and brings us closer to realizing efti’s potential to help cancer patients worldwide”. About Eftilagimod Alpha (Efti)Efti is Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (major histocompatibility complex) Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-ƴ and CXCL10 that further boost the immune system’s ability to fight cancer. Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track Designation in 1st line HNSCC and in 1st line NSCLC from the United States Food and Drug Administration (FDA). 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, Citadel-MAGNUS+61 (0)406 759 268; cstrong@citadelmagnus.com U.S. Investors/Media:Chris Basta, VP, Investor Relations and Corporate Communications+1 (631) 318 4000; chris.basta@immutep.com

免疫疗法快速通道临床研究临床申请

2023-09-05

·GlobeNewswire-Health Care

Immutep to Participate in September Investor Conferences

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: The 18th Annual Citi Biopharma Conference in Boston, MA on Thursday, September 7.Bell Potter Emerging Ideas Leaders Conference on Tuesday, September 12. Presentation at 3:30 p.m. AEST.Baird 2023 Global Healthcare Conference in New York City, NY on Tuesday, September 12. Fireside chat at 3:45 p.m. ET.E&P Small Caps Conference on Wednesday, September 13. Presentation 3:50 p.m. AEST.2023 Cantor Global Healthcare Conference in New York City, NY on Tuesday, September 26. Panel presentation at 2:45 p.m. ET. Further information about upcoming conferences and events that management will be attending is available at the Events page within the Investors & Media section of Immutep’s website. 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, Citadel-MAGNUS+61 (0)406 759 268; cstrong@citadelmagnus.com U.S. Media:Chris Basta, VP, Investor Relations and Corporate Communications+1 (631) 318 4000; chris.basta@immutep.com

免疫疗法

2023-09-05

·BioSpace

Immutep to Participate in September 2023 Investor Conferences

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: The 18th Annual Citi Biopharma Conference in Boston, MA on Thursday, September 7. Bell Potter Emerging Ideas Leaders Conference on Tuesday, September 12. Presentation at 3:30 p.m. AEST. Baird 2023 Global Healthcare Conference in New York City, NY on Tuesday, September 12. Fireside chat at 3:45 p.m. ET. E&P Small Caps Conference on Wednesday, September 13. Presentation 3:50 p.m. AEST. 2023 Cantor Global Healthcare Conference in New York City, NY on Tuesday, September 26. Panel presentation at 2:45 p.m. ET. Further information about upcoming conferences and events that management will be attending is available at the Events page within the Investors & Media section of Immutep’s website. 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 . Australian Investors/Media: Catherine Strong, Citadel-MAGNUS +61 (0)406 759 268; cstrong@citadelmagnus.com U.S. Media: Chris Basta, VP, Investor Relations and Corporate Communications +1 (631) 318 4000; chris.basta@immutep.com

免疫疗法

管线布局

2023年10月04日管线快照

管线布局中药物为当前组织机构及其子机构作为药物机构进行统计，早期临床1期并入临床1期，临床1/2期并入临床2期，临床2/3期并入临床3期

临床前

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药物(靶点)	适应症	全球最高研发状态

重组人源淋巴细胞激活基因-3（hLAG-3）融合蛋白 ( LAG3 + MHC II )	转移性乳腺癌更多	临床3期
HLA-A2 peptides(Immutep) ( CD3 + HLA class I抗原 + MAGEA3 )	黑色素瘤更多	临床2期
埃拉利单抗 ( LAG3 )	前列腺癌更多	临床2期
IMP-761 ( LAG3 )	多发性硬化症更多	临床前
IMP-361 ( HPV E7 )	乳头状瘤病毒感染更多	无进展