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Immutep Announces Positive Preliminary Topline Results from TACTI-003 Cohort B
Newsfilter· 2024-04-24 12:00
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 studyData 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" ...
Immutep Appoints Leading Research Institute to Conduct First-in-Human Phase I Study of IMP761
Newsfilter· 2024-04-18 12:00
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 diseasesCHDR will utilize its unique challenge model that enables insights into IMP761's pharmacological activity early in clinical developmentTrial expected to begin mid-CY2024 SYDNEY, AUSTRALIA, April 18, 2024 (GLOBE NEWSWIRE) -- Immutep Limited ((ASX: IMM, NASDAQ:IMMP) ("Im ...
Immutep Receives Positive Feedback from the Spanish Medicines Agency for Upcoming TACTI-004 Registrational Trial in Metastatic Non-Small Cell Lung Cancer
Newsfilter· 2024-04-17 12:00
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 ...
Immutep(IMMP) - 2024 Q2 - Quarterly Report
2024-02-29 11:08
Exhibit 99.1 IMMUTEP LIMITED ABN 90 009 237 889 Appendix 4D Half-Year Financial Report For the Half-Year Ended 31 December 2023 (previous corresponding period: half-year ended 31 December 2022) To be read in conjunction with the 30 June 2023 Annual Report. In compliance with Listing Rule 4.2A. ABN 90 009 237 889 ASX/Media Release (ASX: IMM) 28 February 2024 Appendix 4D Half-Year Financial Report Results for Announcement to the Market Current Reporting Period – Half-year Ended 31 December 2023 Previous Repor ...
Immutep(IMMP) - 2023 Q4 - Annual Report
2023-10-24 13:30
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION ...
Immutep(IMMP) - 2023 Q4 - Annual Report
2023-10-24 10:35
Immutep Announces Excellent Overall Survival Benefit in NSCLC [Introduction and Key Announcement](index=1&type=section&id=Introduction%20and%20Key%20Announcement) Immutep announced excellent TACTI-002 Phase II trial data for first-line NSCLC treatment, presented at ESMO 2023 - Immutep announced excellent new clinical data from the TACTI-002 / KEYNOTE-798 Phase II trial[2](index=2&type=chunk) - The trial evaluates eftilagimod alpha (efti) in combination with KEYTRUDA® for first-line treatment of metastatic non-small cell lung cancer (NSCLC)[2](index=2&type=chunk) - Updated TACTI-002 data, with a cut-off date of August 15, 2023, and a median follow-up of over **2 years (25.1 months)**, was presented at ESMO Congress 2023[3](index=3&type=chunk) [TACTI-002 Phase II Trial Results](index=1&type=section&id=TACTI-002%20Phase%20II%20Trial%20Results) TACTI-002 trial demonstrated excellent overall survival and promising efficacy across all PD-L1 subgroups in NSCLC patients [Overall Survival (OS) Data](index=1&type=section&id=Overall%20Survival%20(OS)%20Data) Median Overall Survival (mOS) showed strong results across PD-L1 subgroups, exceeding expectations and comparing favorably to standard-of-care | PD-L1 Expression (TPS) | Median Overall Survival (mOS) | | :--------------------- | :---------------------------- | | >1% | 35.5 months | | 1-49% | 23.4 months | | >50% | Not yet reached | - The **35.5-month mOS** in TPS ≥1% compares very favorably to standard-of-care IO, IO-IO, IO-chemo, and IO-IO-chemo therapies[5](index=5&type=chunk) [Other Efficacy Endpoints and Durability](index=1&type=section&id=Other%20Efficacy%20Endpoints%20and%20Durability) Promising Overall Response Rate (ORR), Progression Free Survival (PFS), and Duration of Response (DOR) were observed across all PD-L1 subgroups, with exceptional durability - Promising Overall Survival, Overall Response Rate, Progression Free Survival, and Duration of Response are visible across all PD-L1 subgroups (TPS <1%, ≥1%, 1-49%, and ≥50%)[4](index=4&type=chunk)[5](index=5&type=chunk) | Efficacy Endpoint (PD-L1 >1%) | Value | | :---------------------------- | :----------- | | Overall Response Rate (ORR) | 48.3% | | Median PFS (mPFS) | 11.2 months | | Median DOR (mDOR) | 24.2 months | | Median OS (mOS) | 35.5 months | | PD-L1 Expression (TPS) | 3-year OS Rate | 12-month PFS Rate | | :--------------------- | :------------- | :---------------- | | >1% | 45.6% | 46.8% | | 1-49% | 31.0% | 42.1% | | >50% | 63.6% | 55.0% | | Entire Population (N=114) | 36% (36-month OS rate) | N/A | [Differentiation and Expert Commentary](index=2&type=section&id=Differentiation%20and%20Expert%20Commentary) Efti's strong efficacy across all PD-L1 expressions, especially in low and negative patients, differentiates it from other chemo-free immuno-oncology combinations - Efti in combination with anti-PD-1 differentiates from other chemo-free immuno-oncology combinations due to strong efficacy across all levels of PD-L1 expression, especially in PD-L1 low (1-49%) and PD-L1 negative (<1%) patients[8](index=8&type=chunk) - Efti enables deep, durable responses for patients regardless of PD-L1 expression with a favourable safety profile in line with anti-PD-1 monotherapy[8](index=8&type=chunk) - Immutep plans to launch a Phase III trial next year based on the strength of the data[8](index=8&type=chunk) [Conference Call and Webcast Details](index=3&type=section&id=Conference%20Call%20and%20Webcast%20Details) Immutep will host a conference call and webcast to discuss ESMO 2023 clinical data and future clinical development plans for efti in first-line NSCLC - Immutep will host a conference call and webcast to discuss ESMO 2023 clinical data and future clinical development plans for efti in 1st line NSCLC[10](index=10&type=chunk) - The event will feature CEO Marc Voigt, CSO Dr Frederic Triebel, CMO Dr Florian Vogl, and SVP Strategic Development Christian Mueller[10](index=10&type=chunk) - The webcast will be held on Monday, October 23rd, at **8 AM AEDT** (Sunday, October 22nd, at **5 PM ET**)[15](index=15&type=chunk) [About Eftilagimod Alpha (Efti)](index=3&type=section&id=About%20Eftilagimod%20Alpha%20(Efti)) Eftilagimod Alpha (Efti) is Immutep's proprietary soluble LAG-3 protein and MHC Class II agonist, stimulating innate and adaptive immunity for cancer treatment - Efti is Immutep's proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for cancer treatment[12](index=12&type=chunk) - It acts as a first-in-class antigen presenting cell (APC) activator, leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes[12](index=12&type=chunk) - Efti has received FDA Fast Track Designation in 1st line HNSCC and in 1st line NSCLC[13](index=13&type=chunk) [About Immutep](index=3&type=section&id=About%20Immutep) Immutep is a clinical-stage biotechnology company specializing in novel LAG-3 immunotherapies for cancer and autoimmune diseases - Immutep is a clinical-stage biotechnology company developing novel LAG-3 immunotherapy for cancer and autoimmune disease[14](index=14&type=chunk) - The company is a pioneer in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3)[14](index=14&type=chunk) [Additional Information and Contacts](index=3&type=section&id=Additional%20Information%20and%20Contacts) This section provides background on lung cancer, trademark information for KEYTRUDA®, and contact details for investors and media - Non-small cell lung cancer (NSCLC) accounts for approximately **80-85%** of all lung cancers, impacting an estimated **1.87 million people annually**, and is the highest cause of death among all cancers[11](index=11&type=chunk) - KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC[11](index=11&type=chunk) - Contact information is provided for Australian Investors/Media (Catherine Strong) and U.S. Investors/Media (Chris Basta)[15](index=15&type=chunk)[16](index=16&type=chunk)
Immutep(IMMP) - 2023 Q2 - Quarterly Report
2023-02-25 01:59
Exhibit 99.1 IMMUTEP LIMITED ABN 90 009 237 889 Appendix 4D Half-Year Financial Report For the Half-Year Ended 31 December 2022 (previous corresponding period: half-year ended 31 December 2021) To be read in conjunction with the 30 June 2022 Annual Report. In compliance with Listing Rule 4.2A. ABN 90 009 237 889 ASX/Media Release (ASX: IMM) 24 February 2023 Appendix 4D Half-Year Financial Report Results for Announcement to the Market Current Reporting Period – Half-year Ended 31 December 2022 Previous Repor ...
Immutep(IMMP) - 2022 Q4 - Annual Report
2022-10-31 10:06
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of event requiring this shell company report Commission file number 001-35428 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended June 30, 20 ...
Immutep (IMMP) presents at Non-Small Cell Lung Cancer (NSCLC) Drug Development Summit - Slideshow
2022-09-29 18:37
| --- | --- | |-------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | | | | | A Soluble LAG-3 Protein (Eftilagimod Alpha) with an Anti-PD-1 Antibody (Pembrolizumab): Results of a Phase II Study in NSCLC Frédéric Triebel MD, PhD Non-Small Cell Cancer Drug Development Summit | | | Boston, September 22 nd 2022 | Notice: Forward Looking Statements 2 T ...
Immutep (IMMP) presents TACTI-002 data at ASCO 2022 - Slideshow
2022-06-10 17:02
| --- | --- | --- | |-------|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | | | | | | | | | | | | | | | for | Global Webcast Slides TACTI-002 data presented at ASCO 2022 | | | Webcast Details | | | | Date & Time: | 5.00 pm CDT (Chicago) Monday 6 June 2022/ | | | Speakers: | 8.00 am AEST (Sydney) Tuesday 7 June 2022 Immutep CEO Marc Voigt, CMO/C ...