Immutep Completes Patient Enrolment in Randomised Phase II of AIPAC-003 Trial in Metastatic Breast Cancer
Immutep (ASX: IMM; NASDAQ: IMMP) has completed patient enrolment in the randomised Phase II portion of the AIPAC-003 clinical trial. The trial enrolled 65 metastatic breast cancer patients who have exhausted endocrine therapy including CDK4/6 inhibitors. Patients were recruited from 22 clinical sites in Europe and the United States.
The study is designed to determine the optimal biological dose of eftilagimod alpha ('efti') in combination with paclitaxel, aligning with the FDA's Project Optimus initiative. Patients were randomised 1:1 to receive either 30mg or 90mg dosing of efti. The company will provide further updates after data collection, cleaning, and analysis.
Immutep (ASX: IMM; NASDAQ: IMMP) ha completato l'arruolamento dei pazienti nella fase randomizzata II dello studio clinico AIPAC-003. Lo studio ha arruolato 65 pazienti con carcinoma mammario metastatico che hanno esaurito le terapie endocrine, inclusi gli inibitori CDK4/6. I pazienti sono stati reclutati da 22 siti clinici in Europa e negli Stati Uniti.
Lo studio è progettato per determinare il dosaggio biologico ottimale di eftilagimod alfa ('efti') in combinazione con paclitaxel, in linea con l'iniziativa Project Optimus della FDA. I pazienti sono stati randomizzati 1:1 per ricevere un dosaggio di 30mg o 90mg di efti. L'azienda fornirà ulteriori aggiornamenti dopo la raccolta, la pulizia e l'analisi dei dati.
Immutep (ASX: IMM; NASDAQ: IMMP) ha completado el reclutamiento de pacientes en la fase aleatoria II del ensayo clínico AIPAC-003. El estudio incluyó a 65 pacientes con cáncer de mama metastásico que han agotado la terapia endocrina, incluidos los inhibidores CDK4/6. Los pacientes fueron reclutados de 22 sitios clínicos en Europa y Estados Unidos.
El estudio está diseñado para determinar la dosis biológica óptima de eftilagimod alfa ('efti') en combinación con paclitaxel, alineándose con la iniciativa Project Optimus de la FDA. Los pacientes fueron aleatorizados 1:1 para recibir 30mg o 90mg de efti. La empresa proporcionará más actualizaciones después de la recopilación, limpieza y análisis de datos.
Immutep (ASX: IMM; NASDAQ: IMMP)는 AIPAC-003 임상 시험의 무작위 II상 부분에서 환자 등록을 완료했습니다. 이 시험은 내분비 요법이 고갈된 65명의 전이성 유방암 환자를 등록했습니다. 환자들은 유럽과 미국의 22개 임상 사이트에서 모집되었습니다.
이 연구는 FDA의 Project Optimus 이니셔티브에 따라 paclitaxel과 함께 eftilagimod alpha('efti')의 최적 생물학적 용량을 결정하기 위해 설계되었습니다. 환자들은 30mg 또는 90mg의 efti 용량을 받기 위해 1:1로 무작위 배정되었습니다. 회사는 데이터 수집, 정리 및 분석 후 추가 업데이트를 제공할 예정입니다.
Immutep (ASX: IMM; NASDAQ: IMMP) a terminé le recrutement des patients dans la phase randomisée II de l'essai clinique AIPAC-003. L'étude a inclus 65 patients atteints de cancer du sein métastatique ayant épuisé les thérapies endocriniennes, y compris les inhibiteurs CDK4/6. Les patients ont été recrutés à partir de 22 sites cliniques en Europe et aux États-Unis.
L'étude est conçue pour déterminer la dose biologique optimale d'eftilagimod alpha ('efti') en combinaison avec le paclitaxel, conformément à l'initiative Project Optimus de la FDA. Les patients ont été randomisés 1:1 pour recevoir soit 30mg soit 90mg d'efti. L'entreprise fournira des mises à jour supplémentaires après la collecte, le nettoyage et l'analyse des données.
Immutep (ASX: IMM; NASDAQ: IMMP) hat die Patientenrekrutierung im randomisierten Phase-II-Teil der klinischen Studie AIPAC-003 abgeschlossen. In die Studie wurden 65 Patienten mit metastasiertem Brustkrebs aufgenommen, die alle Möglichkeiten der endokrinen Therapie, einschließlich der CDK4/6-Inhibitoren, erschöpft haben. Die Patienten wurden aus 22 klinischen Standorten in Europa und den Vereinigten Staaten rekrutiert.
Die Studie ist darauf ausgelegt, die optimale biologisch wirksame Dosis von eftilagimod alpha ('efti') in Kombination mit Paclitaxel zu bestimmen, im Einklang mit der Initiative Project Optimus der FDA. Die Patienten wurden im Verhältnis 1:1 randomisiert, um entweder 30mg oder 90mg efti zu erhalten. Das Unternehmen wird nach der Datensammlung, -bereinigung und -analyse weitere Updates bereitstellen.
- Completed patient enrolment for Phase II of AIPAC-003 trial
- Study aligns with FDA's Project Optimus initiative
- Trial conducted across 22 clinical sites in Europe and the US
- None.
Insights
The completion of patient enrollment in the randomized Phase II portion of the AIPAC-003 trial is a significant milestone for Immutep. This study focuses on metastatic breast cancer patients who have exhausted endocrine therapy options, including CDK4/6 inhibitors. The trial's design, comparing
The trial's scope, involving 65 patients across 22 clinical sites in Europe and the US, provides a robust sample for evaluating efti's efficacy. This LAG-3 immunotherapy approach could potentially offer a new treatment option for patients with alternatives. However, it's important to note that while enrollment completion is positive, the true value lies in the upcoming data analysis.
Investors should monitor for future updates on data collection and analysis, as these results will be critical in determining efti's potential market impact and Immutep's future prospects in the competitive oncology field.
From a financial perspective, the completion of patient enrollment in this Phase II trial is a positive development for Immutep (NASDAQ: IMMP). It signifies progress in their clinical pipeline, which is important for biotech companies with a
However, it's important to note that the real value driver will be the trial results. Positive data could significantly boost Immutep's market valuation and potentially attract partnership opportunities or additional funding. Conversely, negative results could have a substantial adverse impact.
Investors should consider the company's cash position and burn rate, as clinical trials are expensive. The timeline for data analysis and potential regulatory submissions will be critical in assessing the company's financial needs and strategic options going forward. While this news is encouraging, it's prudent to await the trial results before making significant investment decisions.
Media Release
SYDNEY, AUSTRALIA, Oct. 03, 2024 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces patient enrolment has been completed in the randomised Phase II portion of the AIPAC-003 (Active Immunotherapy and PAClitaxel) clinical trial.
The Phase II enrolled 65 metastatic hormone receptor positive (HR+), HER2-negative/low or triple-negative breast cancer patients who exhausted endocrine therapy including cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. Patients across 22 clinical sites in Europe and the United States have been randomised 1:1 to receive either 30mg or 90mg dosing of eftilagimod alpha (“efti”) in combination with paclitaxel to determine the optimal biological dose consistent with the FDA’s Project Optimus initiative.
Further updates will be provided after data collection, data cleaning, and analysis. For more information on the trial, please visit clinicaltrials.gov (NCT05747794).
About Immutep
Immutep is a clinical-stage biotechnology company developing novel LAG-3 immunotherapy for cancer and autoimmune disease. We are pioneers in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and our diversified product portfolio harnesses its unique 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:
Catherine Strong, Sodali & Co.
+61 (0)406 759 268; catherine.strong@sodali.com
U.S. Media:
Chris Basta, VP, Investor Relations and Corporate Communications
+1 (631) 318 4000; chris.basta@immutep.com
FAQ
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