Actuate Therapeutics To Collaborate with Incyte Corporation and the University of Pittsburgh on Clinical Trial of Elraglusib in Combination with Retifanlimab and mFOLFIRINOX in Patients with Advanced Pancreatic Cancer
Actuate Therapeutics (NASDAQ: ACTU) has announced the initiation of a Phase 1b trial studying the combination of its drug elraglusib with Incyte's PD-1 inhibitor retifanlimab and mFOLFIRINOX as a frontline therapy for advanced pancreatic cancer. The trial, named RiLEY (NCT06896188), will be conducted at UPMC Hillman Cancer Center.
The study will initially enroll up to 12 patients with advanced pancreatic adenocarcinoma, with potential for expansion based on interim results. In a recent Phase 2 study, elraglusib combined with gemcitabine/nab-paclitaxel showed promising results, including a 37% reduction in death risk and doubled 12-month survival rate in metastatic pancreatic cancer patients.
The collaboration between Actuate, UPMC Hillman Cancer Center, and Incyte aims to explore synergistic opportunities in treatment-na茂ve patients, building on elraglusib's demonstrated immune-modulating properties.
Actuate Therapeutics (NASDAQ: ACTU) ha annunciato l'avvio di uno studio di Fase 1b che valuta la combinazione del suo farmaco elraglusib con l'inibitore PD-1 retifanlimab di Incyte e mFOLFIRINOX come terapia di prima linea per il cancro pancreatico avanzato. Lo studio, denominato RiLEY (NCT06896188), sar脿 condotto presso l'UPMC Hillman Cancer Center.
Lo studio arruoler脿 inizialmente fino a 12 pazienti con adenocarcinoma pancreatico avanzato, con possibilit脿 di espansione in base ai risultati intermedi. In un recente studio di Fase 2, la combinazione di elraglusib con gemcitabina/nab-paclitaxel ha mostrato risultati promettenti, includendo una riduzione del 37% del rischio di morte e un raddoppio del tasso di sopravvivenza a 12 mesi nei pazienti con cancro pancreatico metastatico.
La collaborazione tra Actuate, UPMC Hillman Cancer Center e Incyte mira a esplorare opportunit脿 sinergiche nei pazienti non trattati, basandosi sulle propriet脿 immunomodulanti dimostrate di elraglusib.
Actuate Therapeutics (NASDAQ: ACTU) ha anunciado el inicio de un ensayo de Fase 1b que estudia la combinaci贸n de su medicamento elraglusib con el inhibidor PD-1 retifanlimab de Incyte y mFOLFIRINOX como terapia de primera l铆nea para el c谩ncer pancre谩tico avanzado. El ensayo, llamado RiLEY (NCT06896188), se llevar谩 a cabo en el UPMC Hillman Cancer Center.
El estudio inscribir谩 inicialmente a hasta 12 pacientes con adenocarcinoma pancre谩tico avanzado, con posibilidad de expansi贸n seg煤n los resultados intermedios. En un reciente estudio de Fase 2, la combinaci贸n de elraglusib con gemcitabina/nab-paclitaxel mostr贸 resultados prometedores, incluyendo una reducci贸n del 37% en el riesgo de muerte y una duplicaci贸n de la tasa de supervivencia a 12 meses en pacientes con c谩ncer pancre谩tico metast谩sico.
La colaboraci贸n entre Actuate, UPMC Hillman Cancer Center e Incyte busca explorar oportunidades sin茅rgicas en pacientes no tratados previamente, bas谩ndose en las propiedades inmunomoduladoras demostradas de elraglusib.
Actuate Therapeutics (NASDAQ: ACTU)電� 鞛愳偓鞚� 鞎诫 elraglusib瓿� Incyte鞚� PD-1 鞏奠牅鞝� retifanlimab, 攴鸽Μ瓿� mFOLFIRINOX毳� 氤戩毄頃橃棳 歆勴枆靹� 旆岇灔鞎� 1彀� 旃橂鞝滊 鞐瓣惮頃橂姅 1b靸� 鞛勳儊鞁滍棙鞚� 鞁滌瀾頄堧嫟瓿� 氚滍憸頄堨姷雼堧嫟. 鞚� 鞛勳儊鞁滍棙鞚� RiLEY (NCT06896188)霛茧姅 鞚措鞙茧 UPMC Hillman Cancer Center鞐愳劀 歆勴枆霅╇媹雼�.
氤� 鞐瓣惮電� 齑堦赴鞐愲姅 歆勴枆靹� 旆岇灔靹犾晹 頇橃瀽 斓滊寑 12氇�鞚� 霌彪頃橂┌, 欷戧皠 瓴瓣臣鞐� 霐半澕 頇曥灔 臧�電レ劚鞚� 鞛堨姷雼堧嫟. 斓滉芳 2靸� 鞐瓣惮鞐愳劀 elraglusib瓿� gemcitabine/nab-paclitaxel 氤戩毄鞚� 鞝勳澊靹� 旆岇灔鞎� 頇橃瀽鞐愳劀 靷 鞙勴棙 37% 臧愳唽鞕� 12臧滌洈 靸濎〈鞙� 2氚� 歃濌皜霛茧姅 鞙犽頃� 瓴瓣臣毳� 氤挫榾鞀惦媹雼�.
Actuate, UPMC Hillman Cancer Center, Incyte 臧勳潣 順戨牓鞚� elraglusib鞚� 氅挫棴 臁办爤 韸轨劚鞚� 氚旐儠鞙茧 旃橂 瓴巾棙鞚� 鞐嗠姅 頇橃瀽鞐愳劀 鞁滊剤歆� 須臣毳� 韮愱惮頃橂姅 瓴冹潉 氇╉憸搿� 頃╇媹雼�.
Actuate Therapeutics (NASDAQ : ACTU) a annonc茅 le lancement d'un essai de phase 1b 茅tudiant la combinaison de son m茅dicament elraglusib avec l'inhibiteur PD-1 retifanlimab d'Incyte et le mFOLFIRINOX en traitement de premi猫re ligne pour le cancer du pancr茅as avanc茅. L'essai, nomm茅 RiLEY (NCT06896188), sera men茅 au UPMC Hillman Cancer Center.
L'茅tude recrutera initialement jusqu'脿 12 patients atteints d'ad茅nocarcinome pancr茅atique avanc茅, avec une possibilit茅 d'extension selon les r茅sultats interm茅diaires. Dans une r茅cente 茅tude de phase 2, la combinaison d'elraglusib avec gemcitabine/nab-paclitaxel a montr茅 des r茅sultats prometteurs, incluant une r茅duction de 37 % du risque de d茅c猫s et un doublement du taux de survie 脿 12 mois chez les patients atteints d'un cancer du pancr茅as m茅tastatique.
La collaboration entre Actuate, l'UPMC Hillman Cancer Center et Incyte vise 脿 explorer des opportunit茅s synergiques chez des patients non trait茅s, en s'appuyant sur les propri茅t茅s immunomodulatrices d茅montr茅es d'elraglusib.
Actuate Therapeutics (NASDAQ: ACTU) hat den Beginn einer Phase-1b-Studie bekannt gegeben, die die Kombination seines Medikaments elraglusib mit dem PD-1-Inhibitor Retifanlimab von Incyte und mFOLFIRINOX als Erstlinientherapie bei fortgeschrittenem Bauchspeicheldr眉senkrebs untersucht. Die Studie mit dem Namen RiLEY (NCT06896188) wird am UPMC Hillman Cancer Center durchgef眉hrt.
Die Studie wird zun盲chst bis zu 12 Patienten mit fortgeschrittenem Pankreasadenokarzinom einschlie脽en, mit der M枚glichkeit einer Erweiterung basierend auf Zwischenergebnissen. In einer k眉rzlich durchgef眉hrten Phase-2-Studie zeigte die Kombination von elraglusib mit Gemcitabin/nab-Paclitaxel vielversprechende Ergebnisse, darunter eine 37%ige Reduktion des Sterberisikos und eine Verdopplung der 12-Monats-脺berlebensrate bei Patienten mit metastasiertem Bauchspeicheldr眉senkrebs.
Die Zusammenarbeit zwischen Actuate, dem UPMC Hillman Cancer Center und Incyte zielt darauf ab, synergetische M枚glichkeiten bei unbehandelten Patienten zu erforschen, basierend auf den nachgewiesenen immunmodulierenden Eigenschaften von elraglusib.
- Previous Phase 2 study showed 37% reduction in death risk with elraglusib combination therapy
- Demonstrated doubled 12-month survival rate in previous metastatic pancreatic cancer trial
- Initial data from separate Phase 2 trial showed deep, durable responses in patients with extensive liver metastases
- Early-stage Phase 1b trial requiring further validation of safety and efficacy
- Small initial patient enrollment of only 12 patients
Insights
Actuate's new triple-combination trial for pancreatic cancer builds on promising survival data, potentially expanding treatment options for this deadly disease.
This Phase 1b trial represents a strategic extension of Actuate's clinical program for elraglusib in pancreatic cancer. The study will evaluate elraglusib combined with Incyte's PD-1 inhibitor (retifanlimab) and modified FOLFIRINOX chemotherapy as frontline therapy for advanced pancreatic adenocarcinoma.
What makes this approach particularly notable is its multi-mechanistic rationale. Elraglusib inhibits GSK-3尾, which has demonstrated immune-modulating effects including stimulating NK/T-cell functions, enhancing antigen presentation, and reducing immunosuppressive cells in the tumor microenvironment. The prior Phase 2 data mentioned showed elraglusib plus chemotherapy produced a 37% reduction in death risk and doubled the 12-month survival rate in metastatic pancreatic cancer patients.
Pancreatic cancer has been notoriously resistant to immunotherapy approaches alone. This triple combination represents a sophisticated attempt to overcome this resistance by simultaneously targeting multiple aspects of tumor biology: direct cytotoxicity (mFOLFIRINOX), immune checkpoint inhibition (retifanlimab), and immune microenvironment modulation (elraglusib).
The trial's design 鈥� starting with up to 12 patients and expanding based on interim efficacy 鈥� allows for rapid assessment and potential acceleration if promising signals emerge. The involvement of UPMC Hillman Cancer Center provides access to substantial clinical expertise in pancreatic cancer treatment.
This builds on another ongoing trial combining elraglusib with FOLFIRINOX and losartan, which has already shown deep, durable responses in patients with extensive liver metastases 鈥� typically a population with dismal prognosis. The company's multi-trial strategy creates multiple potential paths to demonstrate clinical utility.
- Clinical Trial Study to be Conducted at UPMC Hillman Cancer to Evaluate Novel Combination as Frontline Therapy
CHICAGO and FORT WORTH, Texas, Aug. 06, 2025 (GLOBE NEWSWIRE) -- Actuate Therapeutics, Inc. (NASDAQ: ACTU) (鈥淎ctuate鈥� or the 鈥淐ompany鈥�), 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-3尾), today announced the initiation of the Phase 1b trial of elraglusib in combination with Incyte鈥檚 PD-1 inhibitor, retifanlimab, and modified FOLFIRINOX (mFOLFIRINOX) as frontline therapy in advanced pancreatic adenocarcinoma. The trial is being conducted in collaboration with UPMC Hillman Cancer Center and Incyte Corporation.
The Investigator-Initiated Phase 1b open-label, single-arm RiLEY () trial, led by Anwaar Saeed, MD, Associate Professor of Medicine, and Chief of the Gastrointestinal Medical Oncology at UPMC Hillman Cancer Center, will initially enroll up to 12 patients with advanced pancreatic adenocarcinoma with an expansion plan based on interim efficacy results. The primary objective of the trial is to determine the recommended phase 2 dose (RP2D) for the combination regimen, while the secondary objectives include evaluation of overall response rate (ORR), disease control rate (DCR), median progression-free survival (mPFS), overall survival (OS), and assessment of safety and tolerability.
鈥淲e are very excited to launch this study of elraglusib combined with retifanlimab and mFOLFIRINOX as a potentially synergistic, immune-modulatory approach for patients with advanced pancreatic cancer,鈥� said Anwaar Saeed, MD, study principal investigator. 鈥淲hile the first generation of immune checkpoint (PD-1, PDL-1, CTLA-4) inhibitors, including retifanlimab, has been transformative by targeting key immune pathways and restoring anti-cancer effector cells activity, this study explores complementary mechanisms - particularly those evoked by elraglusib - that may modulate additional checkpoints and work synergistically with existing inhibitors to deepen and broaden anti-tumor responses. A growing body of preclinical and clinical data suggests that elraglusib can stimulate NK/T-cell anticancer effector functions, enhance antigen presentation, and reduce myeloid-derived suppressor cells in the tumor. These effects have been observed in the context of emerging clinical activity in metastatic pancreatic cancer.鈥�
In a recent Phase 2 study, elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) in first-line metastatic pancreatic adenocarcinoma (mPDAC) , showing a significant increase in median overall survival, a
鈥淲e believe the combination of elraglusib with retifanlimab and mFOLFIRINOX represents a novel and mechanistically compelling strategy to address unmet needs in advanced pancreatic adenocarcinoma,鈥� said Daniel Schmitt, President & Chief Executive Officer of Actuate. 鈥淭he collaboration with UPMC Hillman Cancer Center and Incyte enables us to explore new synergistic opportunities for patients who have not yet received systemic therapy and builds on the momentum of our ongoing clinical programs. The study further allows us to assess ways to optimize elraglusib鈥檚 potential through a complementary multi-agent approach designed to enhance both efficacy and durability of response.鈥澛犅�
In addition, elraglusib is being studied in a separate investigator initiated Phase 2 (NCT05077800) trial in combination with FOLFIRINOX and losartan in treatment-na茂ve mPDAC patients. Initial data from this Phase 2 trial, which were presented at the American Association for Cancer Research (鈥淎ACR鈥�) Special Conference on Advances in Pancreatic Cancer Research last September, showed patients with extensive liver metastases experienced deep, durable responses to the novel combination treatment. Additional results from that study are expected in 2026.
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鈥檚 lead investigational drug, elraglusib (a novel GSK-3尾聽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鈥檚 website at http://www.actuatetherapeutics.com.
Forward-Looking Statements
This press release contains forward-looking statements about us, including our and other parties鈥� clinical trials and development plans, and our industry. The words 鈥渁nticipate,鈥� 鈥渂elieve,鈥� 鈥渃ontinue,鈥� 鈥渃ould,鈥� 鈥渆stimate,鈥� 鈥渆xpect,鈥� 鈥渋ntend,鈥� 鈥渕ay,鈥� 鈥渕ight,鈥� 鈥渙ngoing,鈥� 鈥減lan,鈥� 鈥減otential,鈥� 鈥減redict,鈥� 鈥減roject,鈥� 鈥渟hould,鈥� 鈥渢arget,鈥� 鈥渨ill,鈥� 鈥渨ould,鈥� 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 2025, 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 鈥淚tem 1A. Risk Factors鈥� 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 Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 15, 2025, 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
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LifeSci Advisors, LLC
[email protected]
Media Contact
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Russo Partners, LLC
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FAQ
What is the purpose of Actuate Therapeutics' new Phase 1b RiLEY trial for pancreatic cancer?
What were the results of elraglusib's previous Phase 2 study in pancreatic cancer?
How many patients will be enrolled in ACTU's RiLEY trial?
What is elraglusib's mechanism of action in cancer treatment?
When will additional results from Actuate's separate Phase 2 pancreatic cancer trial be available?
