Immutep Announces Research Collaboration with the George Washington University Cancer Center to Evaluate Neoadjuvant Efti
MWN-AI** Summary
Immutep Limited, an immunotherapy company, has announced a significant research collaboration with The George Washington University Cancer Center. This partnership will kick off an investigator-initiated Phase II trial to evaluate the neoadjuvant use of eftilagimod alfa (efti) in patients with early-stage HR+/HER2-negative breast cancer. The trial will explore efti both as a standalone treatment and in conjunction with standard chemotherapy prior to surgical intervention.
The study aims to enroll up to 50 patients and will primarily be financed through grants from GW Cancer Center, while Immutep will supply efti at no cost and provide some technical support. Under the leadership of Dr. Pavani Chalasani, the trial seeks to assess the drug's potential to improve pathologic complete response (pCR) rates—a critical endpoint, especially since efti has previously shown promise in metastatic settings.
Dr. Chalasani expressed optimism that administering efti at this earlier stage, where patients typically have stronger immune systems, can lead to enhanced disease-free survival rates. Efti operates by targeting antigen-presenting cells and unleashing a powerful anti-cancer immune response, which includes activating cytotoxic T cells and other immune components.
Immutep’s CEO, Marc Voigt, underscored the importance of academic collaboration in evaluating efti’s potential in tackling cancers with significant unmet needs. With the goal of establishing neoadjuvant therapies, this trial not only strengthens the clinical pipeline for efti but also represents an effort to revolutionize cancer treatment with innovative immunotherapy approaches.
For more information on the trial, interested parties can refer to clinicaltrials.gov (NCT07102940). This collaboration reflects the ongoing commitment of Immutep to advance its portfolio of LAG-3-related therapies for cancer and autoimmune diseases.
MWN-AI** Analysis
Immutep Limited (ASX: IMM; NASDAQ: IMMP) has announced an exciting collaboration with the George Washington University Cancer Center to initiate a Phase II trial evaluating its proprietary immunotherapy, eftilagimod alfa (efti), in early-stage HR+/HER2-negative breast cancer patients. As the trial aims to assess the effectiveness of efti as a neoadjuvant treatment both alone and in combination with chemotherapy, its potential to drive substantial clinical benefits could enhance Immutep's position in a competitive market.
Investors should consider several key aspects of this development. First, efti's mechanism—activating a broad anti-cancer immune response through the stimulation of various immune cells—has shown promise in previous studies, raising expectations for improved pathological complete response rates. Enhanced immune activation, particularly in earlier stages of cancer, might lead to better long-term outcomes, thereby creating a compelling narrative for the company's future prospects.
The funding structure of the trial largely relies on grants and support from GW Cancer Center, minimizing financial risk for Immutep. This strategic approach enables the company to advance its clinical pipeline while maintaining fiscal discipline, a crucial consideration for investors during economic uncertainties.
Moreover, efti's favorable safety profile and its potential compatibility with existing treatments could expand its applicability, appealing to a wider patient population. The recent Fast Track designation from the FDA further underscores its promise, suggesting a regulatory pathway that could expedite commercialization.
Given the high unmet need in oncology, particularly for innovative neoadjuvant treatments, Immutep's research initiative could lead to substantial gains. Investors may want to watch market reactions closely, as positive results from this trial could catalyze significant appreciation in Immutep's stock and reinforce its role as a leader in the immunotherapy landscape.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
- GW Cancer Center to initiate Phase II trial evaluating neoadjuvant efti as monotherapy and in combination with chemotherapy prior to surgery in HR+/HER2-neg breast cancer patients
- Second investigator-initiated trial to evaluate efti in earlier stage disease where its unique activation of a broad anti-cancer immune response may drive optimal benefit and high pathologic response rates
SYDNEY, AUSTRALIA, Sept. 22, 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 the initiation of an investigator-initiated Phase II trial evaluating neoadjuvant eftilagimod alfa (efti) administered subcutaneously as monotherapy and then in combination with standard-of-care chemotherapy prior to surgery in patients with early-stage HR+/HER2-negative breast cancer.
The study will treat up to 50 evaluable patients in a two-stage design and will be primarily funded by grants and The George Washington (GW) University Cancer Center. Immutep will provide efti at no cost, technical support, and limited funding that falls within its existing budget. The trial will be led by Principal Investigator, Pavani Chalasani, MD, MPH, Division Director of Hematology and Medical Oncology at the GW Cancer Center and a leader of the GW Cancer Center Breast Cancer clinical research team.
Dr. Chalasani stated , “Given my clinical experience with efti in the AIPAC-003 study coupled with promising data from additional trials evaluating efti in metastatic breast cancer settings, we look forward to evaluating this unique immunotherapy at earlier stage disease in patients with HR+/HER2 -ve breast cancer. As a novel neoadjuvant immunotherapy option, efti’s powerful and safe activation of a broad anti-cancer immune response in combination with chemotherapy may lead to high rates of pathologic complete responses, the primary endpoint of this study. Additionally, we are hopeful that efti’s immune activation in these patients with early stage cancer who have stronger immune systems may lead to improved disease free survival.”
Efti’s targeting and unique activation of powerful antigen-presenting cells via MHC Class II leads to a broad anti-cancer immune response. This includes the activation and proliferation of cytotoxic CD8+ T cells that can be armed in vivo with chemotherapy-induced tumour antigens, as well as numerous other immune cells and cytokines enhancing the immune system’s ability to fight cancer. This novel immunotherapy has yielded encouraging clinical results in metastatic disease and earlier stage disease in its initial trial as a neoadjuvant treatment in soft tissue sarcoma.
Immutep CEO, Marc Voigt added , “We are thankful for the interest and investment by academia in the United States and elsewhere to evaluate the promise of efti at earlier-stage disease. This trial helps us cost-efficiently expand our clinical pipeline for neoadjuvant efti in areas of high unmet need. Our belief is this novel immune system activator can play a meaningful role in metastatic settings and in the ongoing expansion of immunotherapy into neoadjuvant settings to fight cancer.”
The goal of this multi-center study led by the GW Cancer Center is to determine pathological complete response (pCR) after neoadjuvant efti treatment and neoadjuvant chemotherapy (NAC). This is a single-arm interventional trial in patients with early-stage HR+/HER2 -ve breast cancer (Stage I-III) who are eligible for NAC. Enrolled patients will be treated with efti monotherapy for three weeks and then start NAC in combination with efti. For more information, visit clinicaltrials.gov ( NCT07102940 ).
About Eftilagimod Alfa (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-? 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 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 www.immutep.com .
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 will the Phase II trial led by GW Cancer Center assess the efficacy of neoadjuvant efti in combination with chemotherapy compared to historical data for HR+/HER2-negative breast cancer patients, and what role does Immutep Limited IMMP play in this study?
Can you elaborate on the expected challenges and potential benefits of implementing a two-stage design for the trial funded by GW Cancer Center and grants, especially in terms of patient enrollment and data analysis for Immutep Limited IMMP?
What specific biomarkers or immunological parameters will be monitored during the trial to evaluate the immune response induced by efti, and how does Immutep Limited IMMP plan to integrate these findings into future clinical applications?
Given Dr. Chalasani's previous experience with efti, how do you foresee the treatment protocols evolving during this trial, and what implications might that have for the long-term strategy of Immutep Limited IMMP in the breast cancer therapeutic landscape?
**MWN-AI FAQ is based on asking OpenAI questions about Immutep Limited (NASDAQ: IMMP).
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