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Immutep Announces Data from EFTISARC-NEO Phase II Evaluating Neoadjuvant Efti in Soft Tissue Sarcoma Accepted for Oral Presentation at CTOS 2025

MWN-AI** Summary

Immutep Limited (ASX: IMM; NASDAQ: IMMP), an immunotherapy company based in Sydney, has announced that data from its EFTISARC-NEO Phase II trial has been accepted for oral presentation at the Connective Tissue Oncology Society (CTOS) 2025 Annual Meeting, scheduled for November 12-15, 2025, in Boca Raton, Florida. This trial represents the first evaluation of eftilagimod alpha (efti) in a neoadjuvant setting—prior to surgery—combined with radiotherapy and Merck's KEYTRUDA® (pembrolizumab) for patients with soft tissue sarcoma (STS), a group of rare and challenging cancers characterized by high unmet medical need.

The oral presentation, titled "Primary endpoint and translational correlates from EFTISARC-NEO: phase II trial of neoadjuvant eftilagimod alpha (efti), pembrolizumab, and radiotherapy in patients with resectable soft tissue sarcoma," will be delivered by Dr. Pawel Sobczuk from the Maria Sklodowska-Curie National Research Institute of Oncology in Warsaw, Poland. It is set for November 13, 2025, during the session focused on Immunotherapy & Cell Therapy in Sarcoma.

In the United States alone, approximately 13,520 new cases of STS are anticipated in 2025, leading to around 5,420 deaths, highlighting the critical need for effective treatments. The EFTISARC-NEO trial is funded by a Polish government grant, underscoring the collaborative effort in the fight against this orphan disease.

Immutep continues to pioneer in immune response modulation through its exploration of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), aiming to bring innovative treatment options to patients while maximizing shareholder value. Presentation materials will be accessible on Immutep’s website following the event. For more details, interested parties can visit clinicaltrials.gov (NCT06128863).

MWN-AI** Analysis

Immutep Limited (ASX: IMM; NASDAQ: IMMP) has made a significant step in the field of oncology with the announcement that data from its EFTISARC-NEO Phase II trial has been accepted for oral presentation at the CTOS 2025 Annual Meeting. This trial evaluates eftilagimod alpha, an innovative immunotherapy, combined with pembrolizumab (KEYTRUDA®) and radiotherapy for patients with resectable soft tissue sarcoma (STS).

Soft tissue sarcoma represents a considerable unmet medical need, given its high mortality rate and the limited treatment options currently available. The latest statistical data indicates a forecast of approximately 13,520 new cases in the U.S. in 2025. The acceptance of this trial for presentation is a testament to the potential of Immutep’s therapeutic approach in addressing an orphan disease with dire prognostic implications.

Investors should closely monitor developments leading up to the presentation on November 13, 2025. Positive results from EFTISARC-NEO could enhance investor sentiment and lead to increased stock demand, particularly given the backing of the Polish government through the Polish Medical Research Agency. The presentation will detail the primary endpoints and correlates, providing crucial insights into the efficacy of the combination therapy.

Looking ahead, continued advancements in the trial and prospective regulatory approvals could significantly boost Immutep’s market position. Therefore, it may be prudent for investors to consider accumulating shares leading up to the presentation, as favorable outcomes could catalyze upward momentum in the stock price. However, potential investors should also weigh the inherent risks associated with clinical trials and regulatory processes in the biotech sector. As always, thorough due diligence and consideration of market dynamics are advisable prior to making investment decisions.

**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.

Source: GlobeNewswire
  • Data to be presented in the Immunotherapy & Cell Therapy in Sarcoma: Emerging Frontiers session at the Connective Tissue Oncology Society (CTOS) 2025 Annual Meeting

SYDNEY, AUSTRALIA, Sept. 08, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a late-stage immunotherapy company targeting cancer and autoimmune diseases, today announces an abstract for the EFTISARC-NEO Phase II investigator-initiated trial has been accepted for oral presentation at the Connective Tissue Oncology Society (CTOS) 2025 Annual Meeting taking place 12-15 November 2025, in Boca Raton, Florida.

EFTISARC-NEO is the first study to evaluate eftilagimod alpha (efti) in a neoadjuvant setting (prior to surgery) administered in combination with radiotherapy plus KEYTRUDA ® (pembrolizumab) for patients with soft tissue sarcoma (STS).

Presentation Details
Title : Primary endpoint and translational correlates from EFTISARC-NEO: phase II trial of neoadjuvant eftilagimod alpha (efti), pembrolizumab, and radiotherapy in patients with resectable soft tissue sarcoma
Session: Immunotherapy & Cell Therapy in Sarcoma: Emerging Frontiers
Presenter : Pawel Sobczuk, M.D., Ph.D., Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie National Research Institute of Oncology
Date : Thursday, 13 November 2025, 1:30 PM – 3:00 PM ET
Format : Oral Presentation

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. 1

EFTISARC-NEO is is being conducted by the Maria Sk?odowska-Curie National Research Institute of Oncology in Warsaw, Poland. The study is primarily funded with an approved grant from the Polish government awarded by the Polish Medical Research Agency program. For more information on the trial visit clinicaltrials.gov (NCT06128863).

The presentation slides will be available on the Posters & Publications section of Immutep’s website after the presentation at CTOS 2025.

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 www.immutep.com .

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

KEYTRUDA® 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; eleanor.pearson@sodali.com

U.S. Investors/Media:
Chris Basta, VP, Investor Relations and Corporate Communications
+1 (631) 318 4000; chris.basta@immutep.com


FAQ**

How does the EFTISARC-NEO trial led by Immutep Limited IMMP address the high unmet medical need in soft tissue sarcoma (STS) treatment as outlined at the CTOS 2025 session?

The EFTISARC-NEO trial by Immutep Limited aims to address the high unmet medical need in soft tissue sarcoma treatment by evaluating the efficacy and safety of its lead candidate, eftilagimod alpha, in a neoadjuvant setting, potentially enhancing patient outcomes.

What are the primary endpoints and translational correlates of the EFTISARC-NEO trial involving neoadjuvant eftilagimod alpha (efti), pembrolizumab, and radiotherapy as presented by Immutep Limited IMMP?

The primary endpoints of the EFTISARC-NEO trial include overall response rate and pathologic response rate, with translational correlates focusing on immune activation and biomarker analysis related to treatment efficacy.

Can we expect any insights on patient demographics or regional variations in STS incidence from the EFTISARC-NEO trial results highlighted by Immutep Limited IMMP at CTOS 2025?

Yes, the EFTISARC-NEO trial results presented by Immutep Limited at CTOS 2025 are expected to shed light on patient demographics and regional variations in the incidence of soft tissue sarcoma (STS).

How is Immutep Limited IMMP planning to leverage the findings from the EFTISARC-NEO trial to enhance its portfolio of immunotherapy treatments in the future?

Immutep Limited (IMMP) plans to leverage findings from the EFTISARC-NEO trial by identifying and optimizing its immunotherapy treatments to improve patient outcomes and expand indications, thereby strengthening its portfolio and market position in cancer therapies.

**MWN-AI FAQ is based on asking OpenAI questions about Immutep Limited (NASDAQ: IMMP).

Immutep Limited

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