Immutep Announces Research Collaboration with the George Washington University Cancer Center to Evaluate Neoadjuvant Efti
Immutep (NASDAQ: IMMP) has announced a new Phase II trial collaboration with the George Washington University Cancer Center to evaluate eftilagimod alfa (efti) in early-stage HR+/HER2-negative breast cancer patients. The trial will assess efti as both a monotherapy and in combination with standard chemotherapy before surgery.
The study will enroll up to 50 evaluable patients in a two-stage design, primarily funded by grants and GW Cancer Center. The trial will be led by Dr. Pavani Chalasani and aims to determine pathological complete response (pCR) in Stage I-III breast cancer patients.
Efti's unique mechanism targets antigen-presenting cells via MHC Class II, activating a broad anti-cancer immune response, including cytotoxic CD8+ T cells. The trial is registered under NCT07102940.
Immutep (NASDAQ: IMMP) ha annunciato una nuova collaborazione in fase II con il George Washington University Cancer Center per valutare l'eftilagimod alfa (efti) in pazienti con cancro al seno allo stadio iniziale HR+/HER2-negativo. Lo studio valuterà efti sia come monoterapia sia in combinazione con la chemioterapia standard prima dell'intervento chirurgico.
Lo studio prevedrà l'arruolamento di fino a 50 pazienti valutabili in un disegno a due fasi, principalmente finanziato da sovvenzioni e dal GW Cancer Center. La trial sarà guidata dalla Dott.ssa Pavani Chalasani e mira a determinare la risposta patologica completa (pCR) nei pazienti con cancro al seno dallo stadio I-III.
Il meccanismo unico di Efti punta alle cellule presentanti l'antigene tramite MHC di classe II, attivando una ampia risposta immunitaria antitumorale, inclusi i linfociti T citotossici CD8+. La sperimentazione è registrata con NCT07102940.
Immutep (NASDAQ: IMMP) ha anunciado una nueva colaboración en un estudio de fase II con el George Washington University Cancer Center para evaluar el eftilagimod alfa (efti) en pacientes con cáncer de mama en estadio temprano HR+/HER2-negativo. El ensayo evaluará efti como monoterapia y en combinación con quimioterapia estándar antes de la cirugía.
El estudio reclutará hasta 50 pacientes evaluables en un diseño de dos etapas, principalmente financiado por becas y por GW Cancer Center. El ensayo será dirigido por la Dra. Pavani Chalasani y tiene como objetivo determinar la respuesta patológica completa (pCR) en pacientes con cáncer de mama en estadio I-III.
El mecanismo único de Efti dirige a las células presentadoras de antígenos a través de MHC de clase II, activando una amplia respuesta inmunitaria antitumoral, incluyendo las células T CD8+ citotóxicas. El ensayo está registrado con NCT07102940.
Immutep (NASDAQ: IMMP)는 초기 단계 HR+/HER2 음성 유방암 환자들을 대상으로 eftilagimod alfa(efti)를 평가하기 위한 조지 워싱턴 대학교 암 센터와의 새로운 2상 연구 협력을 발표했습니다. 연구는 수술 전 표준 화학요법과의 단독 요법 및 병용 요법으로 efti를 평가합니다.
연구는 평가 가능한 최대 50명의 환자를 두 단계 설계로 모집하며, 주로 보조금과 GW 암 센터의 자금으로 지원됩니다. 연구는 Pavani Chalasani 박사가 이끌며 1~3기 유방암 환자에서 병리학적 완전 반응(pCR)을 결정하는 것을 목표로 합니다.
Efti의 고유한 작용 기전은 MHC 클래스 II를 통해 항원 제시 세포를 표적으로 삼아 광범위한 항암 면역 반응을 활성화하고, CD8+ 사이토톡sic T 세포를 포함합니다. 연구는 NCT07102940로 등록되어 있습니다.
Immutep (NASDAQ: IMMP) a annoncé une nouvelle collaboration d'essai de phase II avec le George Washington University Cancer Center afin d'évaluer l'eftilagimod alfa (efti) chez des patientes atteintes d'un cancer du sein HR+/HER2 négatif à un stade précoce. L'essai évaluera efti en monothérapie et en association avec la chimiothérapie standard avant la chirurgie.
L'étude recrutera jusqu'à 50 patientes évaluables selon un schéma en deux étapes, principalement financé par des subventions et le GW Cancer Center. L'essai sera dirigé par le docteur Pavani Chalasani et vise à déterminer la réponse pathologique complète (pCR) chez les patientes atteintes d'un cancer du sein entre les stades I et III.
Le mécanisme unique d'Efti cible les cellules présentatrices d'antigènes via le CMH de classe II, activant une réponse immunitaire anticancéreuse étendue, incluant les lymphocytes T CD8+ cytotoxiques. L'essai est enregistré sous NCT07102940.
Immutep (NASDAQ: IMMP) hat eine neue Phase-II-Studienkooperation mit dem George Washington University Cancer Center bekannt gegeben, um Eftilagimod Alfa (efti) bei Patientinnen mit HR+/HER2-negativem Brustkrebs im Frühstadium zu evaluieren. Die Studie bewertet efti sowohl als Monotherapie als auch in Kombination mit Standardchemotherapie vor der Operation.
Die Studie wird bis zu 50 bewertbare Patienten in einem zweistufigen Design einschreiben, hauptsächlich finanziert durch Zuschüsse und das GW Cancer Center. Die Studie wird von Dr. Pavani Chalasani geleitet und zielt darauf ab, die pathologische komplette Ansprechrate (pCR) bei Patientinnen mit Brustkrebs der Stadien I–III zu bestimmen.
Der einzigartige Mechanismus von Efti zielt auf Antigen-präsentierende Zellen über MHC Klasse II ab und aktiviert eine breite antitumorale Immunantwort, einschließlich zytotoxischer CD8+ T-Zellen. Die Studie ist unter NCT07102940 registriert.
Immutep (NASDAQ: IMMP) أعلنت عن تعاون جديد في تجربة المرحلة الثانية مع George Washington University Cancer Center لتقييم eftilagimod alfa (efti) لدى مرضى سرطان الثدي في مراحله المبكرة HR+/HER2- إيجابي النسبة. ستقيّم الدراسة efti كعلاج أحادي وفي تركيبة مع العلاج الكيميائي القياسي قبل الجراحة.
ستشمل الدراسة حتى 50 مريضاً يمكن تقييمهم وفق تصميم ذي مرحلتين، ممول بشكل رئيسي من المنح ومركز GW للسرطان. ستقود الدراسة الدكتورة بافاني تشالاستاني وتهدف إلى تحديد الاستجابة المرضية الكلية (pCR) لدى مرضى سرطان الثدي من المرحلة I إلى III.
آلية Efti الفريدة تستهدف خلايا تقديم المستضد عبر MHC من النوع II، وتفعّل استجابة مناعية مضادة للسرطان شاملة، بما في ذلك الخلايا التائية CD8+ السامة. الدراسة مسجلة تحت NCT07102940.
Immutep (NASDAQ: IMMP) 宣布与 George Washington University Cancer Center 合作开展新的 II 期试验，以评估 eftilagimod alfa（efti）在早期 HR+/HER2 阴性乳腺癌患者中的应用。该试验将评估 efti 作为单药治疗以及与标准化疗在手术前的联合治疗。
该研究将以两阶段设计招募 最多 50 例可评估患者，主要由资助与 GW Cancer Center 提供资金。试验将由 Pavani Chalasani 博士领导，目标是在 I-III 期乳腺癌患者中确定病理完全缓解（pCR）。
Efti 的独特机制通过 MHC II 向抗原呈递细胞发起信号，激活广泛的抗癌免疫反应，包括细胞毒性 CD8+ T 细胞。该试验注册号为 NCT07102940。
- None.
- Early-stage trial with no guaranteed success
- Limited to 50 patients in initial study
- Results and potential approval timeline not specified
Insights
Immutep expands efti testing to early-stage breast cancer through GW partnership, potentially unlocking value through neoadjuvant treatment approach.
This research collaboration represents a strategic expansion of eftilagimod alfa's (efti) clinical development into the neoadjuvant setting for early-stage HR+/HER2-negative breast cancer. The investigator-initiated Phase II trial will evaluate efti both as monotherapy and in combination with standard chemotherapy before surgery in up to 50 evaluable patients.
What makes this particularly notable is the approach of targeting earlier-stage disease where patients typically have stronger immune systems compared to those with metastatic cancer. This creates a potentially optimal environment for efti's mechanism of action – activating antigen-presenting cells via MHC Class II to generate a broad anti-cancer immune response.
The trial's primary endpoint of pathologic complete response (pCR) is clinically meaningful as it correlates with improved long-term outcomes in breast cancer. If successful, this could position efti as a valuable neoadjuvant immunotherapy option in a setting where few immunotherapy approaches have demonstrated significant benefit.
From a business perspective, this collaboration is financially efficient for Immutep, as it's primarily funded by GW Cancer Center and grants, with Immutep providing the drug, technical support, and limited funding within its existing budget. This approach allows the company to expand its clinical pipeline while managing costs effectively.
The leadership of Dr. Pavani Chalasani, who has prior clinical experience with efti from the AIPAC-003 study, provides valuable continuity and expertise to this new investigation. This collaboration reflects growing academic interest in efti's potential, which could accelerate its clinical development across multiple indications.
- 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-ƴ 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
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