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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 September 21, 2023
Commission File Number 001-35428
IMMUTEP LIMITED
(Exact Name as Specified in its Charter)
N/A
(Translation of Registrant’s 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 |
Commercial Manufacturing of Eftilagimod Alpha at 2000L Scale Granted Authorization for Clinical Trial Use | |
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: September 21, 2023
| IMMUTEP LIMITED | ||
| By: | /s/ Marc Voigt |
|
| Name: | Marc Voigt | |
| Title: | Chief Executive Officer | |
Exhibit 99.1
ASX/Media Release
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 achieved
SYDNEY, AUSTRALIA – September 21, 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 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-g 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 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. Investors/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 Board of Immutep Limited.
Immutep Limited, Level 33, Australia Square, 264 George Street, Sydney NSW 2000, Australia
ABN: 90 009 237 889