# EDGAR Filing Document

**Accession Number:** 0001506184
**File Stem:** 0001193125-26-157524
**Filing Date:** 2026-4
**Character Count:** 7091
**Document Hash:** 3caf37781b34b867b02593e2ec930d2d
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193125-26-157524.hdr.sgml**: 20260416

**ACCESSION NUMBER**: 0001193125-26-157524

**CONFORMED SUBMISSION TYPE**: 6-K

**PUBLIC DOCUMENT COUNT**: 4

**CONFORMED PERIOD OF REPORT**: 20260415

**FILED AS OF DATE**: 20260416

**DATE AS OF CHANGE**: 20260415

**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:** 26865402

**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 April 15, 2026** 

**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 | [Immutep Receives FDA Orphan Drug Designation for Eftilagimod Alfa in Soft Tissue Sarcoma](d118452dex991.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: April 15, 2026

---

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

---

## Exhibit 99.1

**Exhibit 99.1**![LOGO](g118452snap1.jpg)

**Immutep Receives FDA Orphan Drug Designation for** 

**Eftilagimod Alfa in Soft Tissue Sarcoma** 

**SYDNEY, AUSTRALIA – April 15, 2026 –** I<u>mmutep Limited</u> (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company targeting cancer and autoimmune diseases, today announces that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for eftilagimod alfa ("efti") for the treatment of Soft Tissue Sarcoma (STS), a rare cancer with significant unmet medical need.

The FDA's Orphan Drug Designation program is designed to encourage development of therapies for rare diseases affecting fewer than 200,000 people in the United States. Benefits of ODD may include regulatory support, potential tax credits, fee exemptions, and seven years of market exclusivity upon approval.

This designation recognises the potential therapeutic relevance of efti in STS, supported by encouraging clinical data from the investigator-initiated Phase II EFTISARC-NEO trial which has been evaluating efti in combination with radiotherapy and KEYTRUDA<sup>®</sup> (pembrolizumab) in the neoadjuvant setting in patients with resectable soft tissue sarcoma. In 38 evaluable patients, the study met its primary endpoint, demonstrating a median tumour hyalinization/fibrosis of 51.5%, significantly exceeding the pre-specified target of 35% and historical benchmarks of ~15% with radiotherapy alone.<sup>1</sup>

These results were observed across multiple sarcoma subtypes and were supported by translational data showing immune activation consistent with efti's mechanism of action, with a favourable safety profile and no delays to planned surgery.<sup>2</sup>

**CEO of Immutep, Marc Voigt said:** "We are pleased that the FDA has recognised the potential of efti for patients with soft tissue sarcoma, a rare and difficult to treat cancer. As previously communicated, the Company is currently undertaking a comprehensive review and analysis following the discontinuation of its Phase III TACTI-004 trial and the outcome will influence the decision regarding any potential future clinical trial with efti. The FDA's designation, based on very encouraging data from the EFTISARC-NEO trial, provides us with a potential direct step forward into a late-stage study in the neoadjuvant setting for STS."

**About Immutep** 

Immutep is a clinical-stage biotechnology company developing novel immunotherapies for cancer and autoimmune diseases*.* 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. ESMO Congress 2025 Proffered Paper presentation, "EFTISARC-NEO: A phase II study of neoadjuvant eftilagimod alpha, pembrolizumab and radiotherapy in patients with resectable soft tissue sarcoma".

![LOGO](g118452snap2.jpg)

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2. CTOS 2025 Annual Meeting Oral Presentation, "Primary endpoint and translational correlates from EFTISARC-NEO: Phase II trial of neoadjuvant eftilagimod alfa (efti), pembrolizumab and radiotherapy in patients with resectable soft tissue sarcoma".

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>

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

Matthew Beck, astr partners

Ph: +1 (917) 415-1750; <u>matthew.beck@astrpartners.com</u>

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

![LOGO](g118452snap2.jpg)