Actuate Announces Upcoming Presentation on Initial Data on Elraglusib in Combination with FOLFIRINOX at the AACR Special Conference on Advances in Pancreatic Cancer Research
Actuate Therapeutics (NASDAQ: ACTU) announced promising data from a Phase 2 trial combining FOLFIRINOX with elraglusib and losartan for untreated metastatic pancreatic adenocarcinoma at the AACR Special Conference. The study highlights elraglusib's potential in overcoming FOLFIRINOX-induced chemoresistance through EMT downregulation.
Key findings include:
- Early evidence of increased clinical activity in the combination therapy
- Deep, durable responses observed in 3/6 patients with extensive liver metastases
- Promising safety profile and initial evidence of clinical activity
The ongoing trial (NCT05077800) will enroll up to 70 treatment-naïve patients, with primary objectives of determining safety, tolerability, and progression-free survival. Actuate supplies elraglusib, while the Lustgarten Foundation provides funding support.
Actuate Therapeutics (NASDAQ: ACTU) ha annunciato dati promettenti da uno studio di fase 2 che combina FOLFIRINOX con elraglusib e losartan per adenocarcinoma pancreatico metastatico non trattato durante la Conferenza Speciale AACR. Lo studio evidenzia il potenziale di elraglusib nel superare la chemioresistenza indotta da FOLFIRINOX attraverso la downregolazione dell'EMT.
I principali risultati includono:
- Prime evidenze di un'attività clinica aumentata nella terapia combinata
- Risposte profonde e durature osservate in 3/6 pazienti con metastasi epatiche estese
- Profilo di sicurezza promettente e prime evidenze iniziali di attività clinica
Lo studio in corso (NCT05077800) arruolerà fino a 70 pazienti naïve al trattamento, con obiettivi primari di determinare sicurezza, tollerabilità e sopravvivenza libera da progressione. Actuate fornisce elraglusib, mentre la Fondazione Lustgarten offre supporto finanziario.
Actuate Therapeutics (NASDAQ: ACTU) anunció datos prometedores de un ensayo de fase 2 que combina FOLFIRINOX con elraglusib y losartán para adenocarcinoma pancreático metastásico no tratado durante la Conferencia Especial de la AACR. El estudio destaca el potencial de elraglusib para superar la quimiorresistencia inducida por FOLFIRINOX a través de la regulación a la baja de EMT.
Los hallazgos clave incluyen:
- Primeras evidencias de actividad clínica aumentada en la terapia combinada
- Respuestas profundas y duraderas observadas en 3/6 pacientes con metástasis hepáticas extensas
- Perfil de seguridad prometedor y evidencias iniciales de actividad clínica
El ensayo en curso (NCT05077800) reclutará hasta 70 pacientes naïve al tratamiento, con objetivos primarios de determinar la seguridad, tolerabilidad y supervivencia libre de progresión. Actuate suministra elraglusib, mientras que la Fundación Lustgarten proporciona apoyo financiero.
Actuate Therapeutics (NASDAQ: ACTU)는 AACR 특별 회의에서 FOLFIRINOX와 elraglusib, losartan을 병합한 2상 시험의 유망한 데이터를 발표했습니다. 이 연구는 FOLFIRINOX에 의해 유도된 화학 저항성을 극복하는 데 있어 elraglusib의 잠재력을 강조합니다.
주요 발견은 다음과 같습니다:
- 병합 요법에서 증가된 임상 활동에 대한 초기 증거
- 광범위한 간 전이가 있는 6명 중 3명에서 관찰된 깊고 지속적인 반응
- 유망한 안전성 프로필과 초기 임상 활동의 증거
계속 진행 중인 시험(NCT05077800)은 치료에 나선 적이 없는 최대 70명의 환자를 등록할 예정이며, 주요 목표는 안전성, 내약성 및 무진행 생존을 확인하는 것입니다. Actuate는 elraglusib를 공급하며, Lustgarten 재단은 자금 지원을 제공합니다.
Actuate Therapeutics (NASDAQ: ACTU) a annoncé des données prometteuses d'un essai de phase 2 combinant FOLFIRINOX avec elraglusib et losartan pour l'adénocarcinome pancréatique métastatique non traité lors de la Conférence Spéciale AACR. L'étude met en lumière le potentiel d'elraglusib à surmonter la chimiothérapie résistance induite par FOLFIRINOX grâce à la régulation à la baisse de l'EMT.
Les principales conclusions comprennent :
- Premières preuves d'une activité clinique accrue dans la thérapie combinée
- Réponses profondes et durables observées chez 3/6 patients avec métastases hépatiques étendues
- Profil de sécurité prometteur et premières preuves d'activité clinique
L'essai en cours (NCT05077800) recrutera jusqu'à 70 patients naïfs de traitement, avec pour objectifs principaux de déterminer la sécurité, la tolérabilité et la survie sans progression. Actuate fournit elraglusib, tandis que la Fondation Lustgarten soutient financièrement.
Actuate Therapeutics (NASDAQ: ACTU) hat vielversprechende Daten aus einer Phase-2-Studie bekannt gegeben, in der FOLFIRINOX mit elraglusib und losartan bei unbehandeltem metastasierenden Bauchspeicheldrüsenadenokarzinom während der AACR-Sonderkonferenz kombiniert wurde. Die Studie hebt das Potenzial von elraglusib hervor, die durch FOLFIRINOX induzierte Chemoresistenz durch die Herunterregulierung von EMT zu überwinden.
Wichtige Ergebnisse umfassen:
- Frühe Hinweise auf erhöhte klinische Aktivität in der Kombinationstherapie
- Tiefe, anhaltende Reaktionen bei 3 von 6 Patienten mit ausgedehnten Lebermetastasen beobachtet
- Vielversprechendes Sicherheitsprofil und erste Hinweise auf klinische Aktivität
Die laufende Studie (NCT05077800) wird bis zu 70 behandlungsnaive Patienten einschließen, mit dem Hauptziel, Sicherheit, Verträglichkeit und progressionsfreie Überlebensraten zu bestimmen. Actuate stellt elraglusib bereit, während die Lustgarten-Stiftung finanzielle Unterstützung bietet.
- None.
- None.
- Preclinical Study Highlight the Potential of Elraglusib in Overcoming FOLFIRINOX-induced Chemoresistance Through Downregulation of Epithelial to Mesenchymal Transition (EMT)
- Initial Data Demonstrates Early Evidence of Increased Clinical Activity of Combining FOLFIRINOX with Elraglusib and Losartan in Patients with Untreated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
- Deep, Durable Responses Observed in 3/6 patients with Extensive Liver Metastases
CHICAGO and FORT WORTH, Texas, Sept. 16, 2024 (GLOBE NEWSWIRE) -- Actuate Therapeutics, Inc. (NASDAQ: ACTU) (“Actuate” or the “Company”), a clinical-stage biopharmaceutical company, focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3 beta (GSK-3β), announced data from the safety cohort of an ongoing Phase 2 trial of FOLFIRINOX in combination with elraglusib and losartan for untreated metastatic pancreatic adenocarcinoma at the American Association for Cancer Research (AACR) Special Conference on Advances in Pancreatic Cancer Research taking place on September 15-18, 2024, in Boston, Massachusetts.
“We are encouraged by the data presentation at this year’s AACR’s Special Conference underscoring elraglusib’s potential in addressing critical challenges in pancreatic cancer treatment,” said Daniel Schmitt, President & Chief Executive Officer of Actuate. “These initial findings provide early clinical evidence that elraglusib may overcome a key chemoresistance mechanism associated with FOLFIRINOX thus enhancing the effectiveness of the combination therapy.”
The Phase 2 trial (NCT05077800) is an open-label, multi-arm, non-comparator study of FOLFIRINOX in combination with elraglusib and losartan for the treatment of adult patients with untreated metastatic pancreatic adenocarcinoma. The primary objectives of the trial are to determine the safety, tolerability, and progression-free survival of the combination therapy. The trial will enroll up to 70 treatment-naïve metastatic pancreatic adenocarcinoma patients. Actuate Therapeutics supports this trial by supplying the study drug, elraglusib. The Lustgarten Foundation is providing funding support for this study through a research grant.
“We are excited by the promising safety profile and initial evidence of clinical activity demonstrated by the combination of FOLFIRINOX, elraglusib and losartan in this study,” said Colin Weekes, MD, Ph.D., Director of Medical Oncology Research for Pancreatic Cancer, Massachusetts General Hospital, and the study’s Principal Investigator. “The synergy observed with these drugs suggests that this combination could offer a novel and effective therapeutic strategy for patients with metastatic pancreatic cancer.”
Poster presentation details Abstract: C073
Title: “FOLFIRINOX with Glycogen Synthase Kinase-3 Beta (GSK-3β) Inhibitor Elraglusib and Transforming Growth Factor- β (TGFβ) Inhibitor Losartan in Untreated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC): Interim analysis of safety cohort.”
Presenting Author: Priyadarshini Pathak, MD, Medical Oncologist, Massachusetts General Hospital
Session date: Tuesday, September 17, 6:45-9 p.m. ET
Location: Westin Copley Place
The abstract is available online and the poster will be available on Actuate’s website after the AACR Meeting.
About Actuate Therapeutics, Inc.
Actuate is a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers. Actuate’s lead investigational drug product, elraglusib (a novel GSK-3β inhibitor), targets molecular pathways in cancer that are involved in promoting tumor growth and resistance to conventional cancer drugs such as chemotherapy including several DDR pathways. Elraglusib is designed to act as a mediator of anti-tumor immunity through the inhibition of NF-kB and regulates multiple immune checkpoints and immune cell function. For additional information, please visit the Company’s website at http://www.actuatetherapeutics.com.
About Massachusetts General Hospital
Massachusetts General Hospital, founded in 1811, is the original and largest teaching hospital of Harvard Medical School. The Mass General Research Institute conducts the largest hospital-based research program in the nation, with annual research operations of more than
Forward-Looking Statements
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Investor Contact
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Managing Director
LifeSci Advisors, LLC
mmoyer@lifesciadvisors.com
FAQ
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