# EDGAR Filing Document

**Accession Number:** 0001506184
**File Stem:** 0001193125-25-243950
**Filing Date:** 2025-10
**Character Count:** 10461
**Document Hash:** 4cc8106bbaddcdf9b9448fcd90348f48
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193125-25-243950.hdr.sgml**: 20251021

**ACCESSION NUMBER**: 0001193125-25-243950

**CONFORMED SUBMISSION TYPE**: 6-K

**PUBLIC DOCUMENT COUNT**: 4

**CONFORMED PERIOD OF REPORT**: 20251020

**FILED AS OF DATE**: 20251021

**DATE AS OF CHANGE**: 20251020

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** IMMUTEP Ltd
- **CENTRAL INDEX KEY:** 0001506184
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 000000000
- **STATE OF INCORPORATION:** C3
- **FISCAL YEAR END:** 0630

**FILING VALUES:**
- **FORM TYPE:** 6-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-35428
- **FILM NUMBER:** 251405162

**BUSINESS ADDRESS:**
- **STREET 1:** LEVEL 32, SUITE 32.07 AUSTRALIA SQUARE
- **STREET 2:** 264 GEORGE STREET
- **CITY:** SYDNEY,
- **STATE:** C3
- **ZIP:** NSW 2000
- **BUSINESS PHONE:** 612 8315 7003

**MAIL ADDRESS:**
- **STREET 1:** LEVEL 32, SUITE 32.07 AUSTRALIA SQUARE
- **STREET 2:** 264 GEORGE STREET
- **CITY:** SYDNEY,
- **STATE:** C3
- **ZIP:** NSW 2000

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Prima BioMed Ltd
- **DATE OF NAME CHANGE:** 20101119

**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** 

**Date as October 20, 2025** 

**Commission File Number 001-35428** 

## IMMUTEP LIMITED
**(Exact Name as Specified in its Charter)** 

**N/A** 

**(Translation of Registrant's Name)** 

**Level 32, 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.

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**EXHIBIT INDEX** 

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| | |
|:---|:---|
| **Exhibit** | **Description of Exhibit** |
| 99.1 | [Primary Endpoint Met in EFTISARC-NEO Phase II Evaluating Neoadjuvant Efti in Soft Tissue Sarcoma and Data Presented at ESMO Congress 2025](d62294dex991.htm) |

---

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**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.

Date: October 20, 2025

---

| | |
|:---|:---|
| IMMUTEP LIMITED | IMMUTEP LIMITED |
| By: | /s/ Marc Voigt |
| Name: | Marc Voigt |
| Title: | Chief Executive Officer |

---

## Exhibit 99.1

**Exhibit 99.1**![LOGO](g62294g1020165050929.jpg)

**Primary Endpoint Met in EFTISARC-NEO Phase II Evaluating Neoadjuvant** 

**Efti in Soft Tissue Sarcoma and Data Presented at ESMO Congress 2025** 

• Novel combination including eftilagimod alfa (efti) in neoadjuvant setting drives 51.5% tumour hyalinization/fibrosis in
patients with soft tissue sarcoma (p<0.001)

• High level of tumour hyalinization/fibrosis, achieved across multiple STS subtypes, over 3-fold greater than historical results from standard-of-care radiotherapy alone

• Data from investigator-initiated Phase II selected for Proffered Paper oral presentation

**SYDNEY, AUSTRALIA – October, 20, 2025 –** <u>Immutep Limited</u> (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a late-stage immunotherapy company targeting cancer and autoimmune diseases, today announces positive data from the EFTISARC-NEO Phase II trial were shared in a Proffered Paper oral presentation by Katarzyna Kozak, M.D., Ph.D., Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland, at the 2025 European Society of Medical Oncology (ESMO) Congress in Berlin, Germany.

The investigator-initiated Phase II study evaluating eftilagimod alfa (efti) with radiotherapy plus KEYTRUDA<sup>®</sup> (pembrolizumab) in the neoadjuvant setting for resectable soft tissue sarcoma (STS) met the primary endpoint and significantly exceeded the study's prespecified 35% tumour hyalinization/fibrosis. In the evaluable patient population (N=38), the novel combination with efti reached a median 51.5% tumour hyalinization/fibrosis (p<0.001).

This impressive outcome, over three times greater than 15% from standard-of-care radiotherapy alone based on historical data, may hold significance in terms of future outcomes as tumour hyalinization/fibrosis serves as an early surrogate endpoint correlated with enhanced overall survival and recurrence-free survival in STS patients.<sup>1,2</sup>

These promising results were achieved across multiple STS subtypes and the study proved a very good safety profile for the therapy, with only one grade ≥3 toxicity related to immunotherapy.

**Dr. Katarzyna Kozak, said:** "The novel combination with neoadjuvant efti has significantly exceeded the originally established target for the trial's primary endpoint in resectable soft tissue sarcoma. These outcomes achieved in a diverse population of multiple STS subtypes further substantiate the hypothesis that efti's unique stimulation of antigen-presenting cells, resulting in a robust adaptive and innate immune response, contributes to modifying the immunosuppressed tumour microenvironment and achieving notable anti-cancer efficacy in soft tissue sarcomas. We hope these findings can help pave a path to a new therapeutic option for the substantial unmet medical need in this challenging indication."

**Marc Voigt, CEO of Immutep, noted:** "We sincerely thank the principal investigators leading this study, as well as the patients and their families for taking part in this important trial. There is a significant unmet medical need for novel therapies in STS that have the potential to provide better outcomes for patients than the current standard of care radiotherapy."

![LOGO](g62294g1020165051023.jpg)

**Immutep Limited**, Level 32, Australia Square, 264 George Street, Sydney NSW 2000, Australia; ABN: 90 009 237 889

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STS is an orphan disease with high unmet medical need and a poor prognosis for patients. The incidence of STS varies in different regions globally. In the United States, the number of new STS cases in 2025 is estimated to be ~13,520 with ~5,420 deaths, according to the American Cancer Society.<sup>3</sup>

The EFTISARC-NEO study has been primarily funded with a grant from the Polish government awarded by the Polish Medical Research Agency program. For more information on EFTISARC-NEO, visit clinicaltrials.gov (NCT06128863).

The presentation slides can be found on the Posters & Publications page of Immutep's website.

**About Eftilagimod Alfa (Efti)** 

Efti is a novel immunotherapy that directly activates antigen-presenting cells or APCs (e.g. dendritic cells, monocytes) via the MHC Class II pathway to fight cancer. As an MHC Class II agonist, its activation of APCs engages the adaptive and innate immune system to initiate a broad anti-cancer immune response. This includes priming and activating cytotoxic T cells as well as generating important co-stimulatory signals & cytokines that further boost the immune system's ability to combat cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC) in a pivotal Phase III trial called TACTI-004 (KEYNOTE-F91), as well as head and neck squamous cell carcinoma (HNSCC), soft tissue sarcoma, and breast cancer. Its favourable safety profile enables various combinations like with anti-PD-[L]1 immunotherapy, radiotherapy, and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).

**About Immutep** 

Immutep is a late-stage biotechnology company developing novel immunotherapies for cancer and autoimmune disease*.* The Company is a pioneer in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and its diversified product portfolio harnesses LAG-3's 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 <u>www.immutep.com</u>.

*1.* *Schaefer IM et al. Histologic Appearance After Preoperative Radiation Therapy for Soft Tissue Sarcoma: Assessment of the European Organization for Research and Treatment of Cancer-Soft Tissue and Bone Sarcoma Group Response Score. Int J Radiat Oncol Biol Phys. 2017 Jun 1;98(2):375-383. doi: 10.1016/j.ijrobp.2017.02.087. Epub 2017 Feb 24. PMID: 28463157.* 

*2.* *Rao SR et al. Extent of tumor fibrosis/hyalinization and infarction following neoadjuvant radiation therapy is associated with improved survival in patients with soft-tissue sarcoma. Cancer Med. 2022 Jan;11(1):194-206. doi: 10.1002/cam4.4428. Epub 2021 Nov 27. PMID: 34837341; PMCID: PMC8704179.* 

*3.* *American Cancer Society statistics: https://www.cancer.org/cancer/types/soft-tissue-sarcoma/about/key-statistics.html* 

*KEYTRUDA<sup>®</sup> is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.* 

**Australian Investors/Media:** 

Eleanor Pearson, Sodali & Co.

+61 2 9066 4071; <u>eleanor.pearson@sodali.com</u>

![LOGO](g62294g1020165051023.jpg)

**Immutep Limited**, Level 32, Australia Square, 264 George Street, Sydney NSW 2000, Australia; ABN: 90 009 237 889

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**U.S. Investors/Media:** 

Chris Basta, VP, Investor Relations and Corporate Communications

+1 (631) 318 4000; <u>chris.basta@immutep.com</u>

This announcement was authorised for release by the CEO of Immutep Limited.

![LOGO](g62294g1020165051023.jpg)

**Immutep Limited**, Level 32, Australia Square, 264 George Street, Sydney NSW 2000, Australia; ABN: 90 009 237 889