Actuate Therapeutics Provides FDA with Updated Clinical Data Package to Support Planned Regulatory Interactions with FDA and EMA Over the Coming Months
Actuate Therapeutics (NASDAQ: ACTU) has updated its IND application with the FDA, including new clinical data from its Phase 2 trial of elraglusib in first-line metastatic pancreatic cancer treatment. The trial demonstrated statistically significant improvement in median overall survival when combining elraglusib with gemcitabine/nab-paclitaxel (GnP) versus GnP alone.
The ongoing Phase 2 study shows promising durability, with 22 patients in the combination arm remaining active for 20-42 months, compared to only 3 patients in the control arm at 21-23 months. The company plans regulatory submissions to FDA and EMA through early 2026, supported by its recent $17.25 million public offering which extends its runway through H2 2026.
Actuate Therapeutics (NASDAQ: ACTU) ha aggiornato la sua IND alla FDA, includendo nuovi dati clinici dal suo studio di fase 2 su elraglusib nel trattamento di prima linea del cancro pancreatico metastatico. Lo studio ha mostrato un miglioramento statisticamente significativo della sopravvivenza globale mediana quando elraglusib viene combinato con gemcitabina/nab-paclitaxel (GnP) rispetto a GnP da solo. Il necessario studio di fase 2 in corso mostra una durabilità promettente, con 22 pazienti nel braccio di combinazione che rimangono attivi per 20-42 mesi, rispetto a soli 3 pazienti nel braccio di controllo a 21-23 mesi. L'azienda intende presentare documenti regolatori alla FDA e all'EMA entro l'inizio del 2026, supportata dal recente offerta pubblica da 17,25 milioni di dollari che estende la sua runway fino al secondo semestre del 2026.
Actuate Therapeutics (NASDAQ: ACTU) ha actualizado su solicitud IND ante la FDA, incluyendo nuevos datos clínicos de su ensayo de fase 2 con elraglusib en el tratamiento de primera línea del cáncer pancreático metastásico. El ensayo mostró una mejora estadísticamente significativa de la supervivencia global mediana al combinar elraglusib con gemcitabina/nab-paclitaxel (GnP) frente a GnP solo. El estudio de fase 2 en curso muestra una durabilidad prometedora, con 22 pacientes en el brazo de la combinación que siguen activos durante 20-42 meses, frente a solo 3 pacientes en el brazo de control a 21-23 meses. La empresa planea presentaciones regulatorias ante la FDA y la EMA hasta principios de 2026, respaldadas por su reciente oferta pública de 17,25 millones de dólares que extiende su runway hasta la segunda mitad de 2026.
Actuate Therapeutics (NASDAQ: ACTU)가 FDA에 IND 신청서를 업데이트했으며, 엘라글루시브(elraglusib)를 1차 치료로 사용하는 전이성 췌장암의 2상 시험에서 새로운 임상 데이터를 포함합니다. 이 시험은 엘라글루시브를 글리사타빈/납-파클리탁셀(GnP)과 병용했을 때 중간 생존 기간의 통계적으로 유의미한 개선을 보였습니다. 진행 중인 2상 연구는 지속 가능성이 유망하며, 병용군의 22명이 20-42개월 동안 지속적으로 활발하고, 대조군은 21-23개월에 불과한 3명만 남아 있습니다. 회사는 2026년 초까지 FDA와 EMA에 규제 제출을 계획하고 있으며, 최근 1,725만 달러의 공모로 2026년 하반기까지 자금을 확보했습니다.
Actuate Therapeutics (NASDAQ: ACTU) a mis à jour sa demande IND auprès de la FDA, en incluant de nouvelles données cliniques tirées de son essai de phase 2 avec l’elraglusib dans le traitement de première ligne du cancer du pancréas métastatique. L’essai a montré une amélioration statistiquement significative de la survie globale médiane lorsqu’il est associé à la gemcitabine/nab-paclitaxel (GnP) par rapport à GnP seul. L’étude de phase 2 en cours montre une durabilité prometteuse, avec 22 patients dans le bras combiné restant actifs pendant 20–42 mois, contre seulement 3 patients dans le bras témoin à 21–23 mois. L’entreprise prévoit des soumissions réglementaires à la FDA et à l’EMA d’ici le début de 2026, soutenues par sa récente offre publique de 17,25 millions de dollars, qui prolonge sa runway jusqu’au second semestre 2026.
Actuate Therapeutics (NASDAQ: ACTU) hat seinen IND-Antrag bei der FDA aktualisiert und neue klinische Daten aus seiner Phase-2-Studie mit Elraglusib in der Erstlinienbehandlung von metastasierendem Bauchspeicheldrüsenkrebs einbezogen. Die Studie zeigte eine statistisch signifikante Verbesserung der medianen Gesamtüberlebenszeit, wenn Elraglusib mit Gemcitabin/Nab-Paclitaxel (GnP) kombiniert wurde im Vergleich zu GnP allein. Die laufende Phase-2-Studie zeigt eine vielversprechende Haltbarkeit, wobei 22 Patienten im Kombinationsarm aktiv bleiben und zwar über 20–42 Monate, verglichen mit nur 3 Patienten im Kontrollarm nach 21–23 Monaten. Das Unternehmen plant regulatorische Einreichungen bei FDA und EMA bis Anfang 2026, unterstützt durch die jüngste öffentliche Emission über 17,25 Mio. USD, die seine Laufzeit bis zur zweiten Hälfte 2026 verlängert.
Actuate Therapeutics (NASDAQ: ACTU) قامت بتحديث طلب IND لديها لدى الـ FDA، بما في ذلك بيانات سريرية جديدة من تجربة المرحلة 2 لـ elraglusib في العلاج من الخط الأول لسرطان البنكرياس المتقدم. أظهر الاختبار تحسناً دالاً إحصائياً في البقاء على قيد الحياة الإجمالي الوسيط عند دمج elraglusib مع gemcitabine/nab-paclitaxel (GnP) مقارنة بـ GnP وحده. الدراسة الجارية في المرحلة 2 تُظهر ثباتاً واعداً، مع 22 مريضاً في ذراع الدمج لا يزالون نشطين لمدة 20-42 شهراً، مقابل 3 مرضى فقط في ذراع التحكم عند 21-23 شهراً. تخطط الشركة لتقديم تقارير تنظيمية إلى FDA وEMA حتى بداية 2026، مدعومة بإطلاقها الأخير لـ طرح عام بقيمة 17.25 مليون دولار الذي يمد سقف التمويل حتى النصف الثاني من 2026.
Actuate Therapeutics (NASDAQ: ACTU) 已向FDA更新其IND申请，新增来自其阶段2试验的临床数据，针对
- None.
- Recent public offering may cause dilution for existing shareholders
- Regulatory approval pathway still uncertain pending FDA and EMA interactions
Insights
Elraglusib shows statistically significant survival benefits in metastatic pancreatic cancer with compelling durability data, positioning it as a potential backbone therapy.
The updated clinical data package for elraglusib represents a significant milestone in pancreatic cancer treatment development. The Phase 2 trial (Actuate-1801 Part 3B) demonstrated statistically significant improvement in median overall survival when combining elraglusib with gemcitabine/nab-paclitaxel (GnP) versus GnP alone - the current standard of care in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC).
What's particularly compelling is the durability signal: 22 patients in the combination arm remain in active treatment or follow-up with time-on-study ranging from 20-42 months, while only 3 control arm patients remain in follow-up with substantially shorter durations (21-23 months). In pancreatic cancer, where median survival typically ranges from 8-11 months with standard therapies, this represents a potentially meaningful advancement.
The mechanistic rationale involving GSK-3β inhibition is scientifically sound. By targeting this kinase, elraglusib may address multiple cancer-promoting pathways simultaneously, potentially explaining its efficacy across different combination regimens including both chemotherapy (GnP, FOLFIRINOX) and immunotherapy (retifanlimab). The company's exploration of combinations with RAS inhibitors is particularly intriguing given the high prevalence of KRAS mutations in pancreatic cancer.
The
- Elraglusib represents a potential back bone therapy in pancreatic cancer with three ongoing trials in combination with current standards of care and novel immunotherapies
- Recent financing provides extended runway through key anticipated regulatory inflection points
- Additional nonclinical studies are ongoing combining elraglusib with RAS inhibitors based on potential synergies and complimentary mechanisms of action
CHICAGO and FORT WORTH, Texas, Sept. 22, 2025 (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), today announced a corporate update on the regulatory path for elraglusib in pancreatic cancer and anticipated milestones enabled by the recent
Actuate has amended its investigational new drug (IND) application with updated clinical data from its international randomized Phase 2 trial in first-line treatment of metastatic pancreatic cancer (Actuate-1801 Part 3B), which showed a statistically significant improvement in median overall survival with the combination arm of elraglusib plus gemcitabine/nab-paclitaxel (GnP) versus GnP alone. These data are intended to support planned regulatory submissions with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) beginning later this year and continuing into early 2026.
The 1801-3B Phase 2 study is currently ongoing, with 22 patients in the elraglusib plus GnP arm either in active treatment or survival follow-up, ranging from 20 to 42 months in time on study, while only 3 patients remain in survival follow-up in the GnP arm, with time on study ranging from 21 to 23 months.
These compelling results of elraglusib in combination with GnP, combined with early data demonstrating significant and durable long term responses in patients with highly metastatic disease treated with the combination of elraglusib/FOLFIRINOX/losartan in the ongoing clinical trial in patients with mPDAC led by Havard/MGH, plus the new clinical collaboration with Incyte and UPMC Hillman Cancer Center in patients with advanced pancreatic cancer using the combination of modified FOLFIRINOX and Incyte’s anti-PD-1 retifanlimab, further strengthen the case for elraglusib as a back-bone therapy that can be combined with different regimens used to treat this highly aggressive and deadly disease.
“We are confident that our recently completed financing provides sufficient capital to support our corporate initiatives into the second half of 2026, and well through our upcoming anticipated interactions with the FDA and EMA. We have already updated the clinical data package on file with the FDA, and during the remainder of this year and into the first quarter of 2026, we expect to gain clarity on elraglusib’s regulatory path forward for the first-line treatment of metastatic PDAC,” said Daniel Schmitt, President & Chief Executive Officer of Actuate. “The survival benefit we’ve observed with elraglusib to date is compelling, and both its mechanism of action and safety profile support combination with chemotherapy, immunotherapy and potentially RAS inhibitors, increasing elraglusib’s potential as a backbone therapy, specifically in pancreatic cancers, where clinicians have limited options to extend and improve the lives of patients.”
About Actuate-1801 Part 3β Study
The Actuate-1801 Part 3β study (NCT03678883) is a randomized, controlled Phase 2 trial of elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) versus GnP alone in first-line metastatic pancreatic adenocarcinoma (mPDAC). The trial enrolled 286 mPDAC patients with no prior systemic treatment for metastatic disease, who were randomized 2:1 to the elraglusib treatment arm (elraglusib + GnP) or the control arm (GnP alone). Elraglusib is administered at a dose of 9.3 mg/kg by IV infusion on Day 1 of each week of a 28-day cycle.
In the Phase 2 study, elraglusib in combination with GnP met its primary endpoint, showing a significant increase in median overall survival, a
Inhibition of GSK-3β may inhibit pancreatic tumor growth and improve survival through several complimentary mechanisms that include enhancement of chemotherapy activity, regulation of anti-tumor immunity, and regulation of tumor gene expression, leading to alterations in tumor metabolism and Epithelial-to-Mesenchymal Transition (EMT).
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, 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 through the inhibition of nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) and DNA Damage Response (DDR). Elraglusib may also mediate anti-tumor immunity through the regulation of multiple immune checkpoints and immune cell function.
For additional information, please visit the Company’s website at http://www.actuatetherapeutics.com or follow us on LinkedIn, X and Facebook.
Forward-Looking Statements
This press release contains forward-looking statements about us, including our and other parties’ clinical trials and development plans, and our industry. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” or the negative of these terms or other comparable terminology are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. All statements, other than statements related to present facts or current conditions or of historical facts, contained in this press release are forward-looking statements. Accordingly, these statements involve estimates, assumptions, substantial risks and uncertainties which could cause actual results to differ materially from those expressed in them, including but not limited to that preliminary and unpublished data may be subject to change and further interpretation following the availability of more data or following a more comprehensive review of the data and should not be relied upon as a final analysis; clinical and preclinical drug development involves a lengthy and expensive process with uncertain timelines and outcomes, results of prior preclinical studies, early clinical trials and sub-group studies are not necessarily predictive of future results and may not correlate with improved responses, and elraglusib may not achieve positive clinical results or favorable preclinical results or receive regulatory approval on a timely basis, if at all; that we may not successfully enroll additional patients or establish or advance plans for further development, including through conversations with the FDA or EMA and the standards such bodies may impose for such development; that elraglusib could be associated with side effects, adverse events or other properties or safety risks, which could delay or preclude regulatory approval, cause us to suspend or discontinue clinical trials or result in other negative consequences; our reliance on third parties to conduct our non-clinical studies and our clinical trials; our reliance on third-party licensors and ability to preserve and protect our intellectual property rights; that we face significant competition from other biotechnology and pharmaceutical companies; our ability to fund development activities, including because our financial condition raises substantial doubt as to our ability to continue as a going concern and we require additional capital to finance our operations beyond the second quarter of fiscal year 2026, and a failure to obtain this necessary capital in the near term on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our development programs, commercialization efforts or other operations. In addition, any forward-looking statements are qualified in their entirety by reference to the factors discussed under the heading “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 13, 2025, and our Quarterly Reports on Form 10-Q, and other filings with the SEC. Because the risk factors referred to above could cause actual results or outcomes to differ materially from those expressed in any forward-looking statements made by us or on our behalf, you should not place undue reliance on any forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made. New factors emerge from time to time, and it is not possible for us to predict which factors will arise. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Unless legally required, we do not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events.
Investor Contact
Mike Moyer
Managing Director
LifeSci Advisors, LLC
mmoyer@lifesciadvisors.com
Media Contact
Ignacio Guerrero-Ros, Ph.D., or David Schull
Russo Partners, LLC
Ignacio.guerrero-ros@russopartnersllc.com
David.schull@russopartnersllc.com
(858) 717-2310 or (646) 942-5604
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