UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
Dated May 26, 2023
Commission File Number 001-35428
IMMUTEP LIMITED
(Exact Name as Specified in its Charter)
N/A
(Translation of Registrants Name)
Level 33, Australia Square
264 George Street, Sydney
NSW 2000, Australia
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes ☐ No ☒
If Yes is marked, indicated below the file number assigned to the registrant in connection with Rule 12g3-2(b): Not applicable.
EXHIBIT INDEX
Exhibit |
Description of Exhibit | |
99.1 |
Immutep Announces Publication of Abstracts for ASCO 2023 Annual Meeting |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Dated: May 26, 2023
IMMUTEP LIMITED | ||
By: | /s/ Marc Voigt | |
Name: | Marc Voigt | |
Title: | Chief Executive Officer |
Exhibit 99.1
ASX/Media Release
Immutep Announces Publication of Abstracts for ASCO 2023 Annual Meeting
| 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 26 May 2023 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 Oncologys (ASCO) Annual Meetings official website. A Trial in Progress abstract for the Phase II/III AIPAC-003 trial has also been published.
The TACTI-002 poster will contain more mature (longer follow up) and final data that is not part of the abstract and will be available on the Posters & Publication section of Immuteps website after its presentation at ASCO. Abstracts are available at ASCO.org.
TACTI-002 Abstract
Title: Final results from TACTI-002 Part C: A Phase II study of eftilagimod alpha (soluble LAG-3 protein) and pembrolizumab in patients with metastatic 2nd line head and neck squamous cell carcinoma unselected for PD-L1
Poster Session: Head and Neck Cancer
Date and Time: 5 June 2023, 2:15PM-5:15PM EDT
Presenter: Dr. Bernard Doger, START Madrid-FJD, Fundación Jiménez Díaz University Hospital, Madrid, Spain
Abstract #: 6029
AIPAC-003 Abstract
Title: AIPAC-003: 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.
Poster Session: Breast Cancer Local/Regional/Adjuvant
Date and Time: 4 June 2023, 9:00AM-12:00PM EDT
Presenter: Dr. Nuhad K. Ibrahim, Professor, Department of Breast Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX
Abstract #: TPS1120
About Eftilagimod Alpha (Efti)
Efti is Immuteps 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-g and CXCL10 that further boost the immune systems 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 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, 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
This announcement was authorised for release by the CEO of Immutep Limited.
Immutep Limited, Level 33, Australia Square, 264 George Street, Sydney NSW 2000, Australia
ABN: 90 009 237 889