Elicio Therapeutics Announces Positive Recommendation by IDMC to Continue ELI-002 7P Randomized Phase 2 Study in Pancreatic Cancer Without Modifications to Final Analysis
Elicio Therapeutics (NASDAQ:ELTX) announced that the Independent Data Monitoring Committee (IDMC) has recommended continuing the Phase 2 AMPLIFY-7P study of ELI-002 7P for pancreatic cancer without modifications. The trial, involving 144 patients across 24 U.S. sites, evaluates ELI-002 7P's effectiveness against standard of care in improving disease-free survival (DFS) for pancreatic ductal adenocarcinoma (PDAC) patients.
The IDMC's positive recommendation suggests preliminary efficacy signals and confirms a favorable safety profile. The final DFS analysis is expected in Q4 2025. Notably, Elicio has already aligned with the FDA on key elements of the planned Phase 3 study design and maintains a cash runway extending into Q1 2026.
Elicio Therapeutics (NASDAQ:ELTX) ha annunciato che il Comitato Indipendente per il Monitoraggio dei Dati (IDMC) ha raccomandato di proseguire lo studio di Fase 2 AMPLIFY-7P su ELI-002 7P per il cancro al pancreas senza apportare modifiche. Lo studio, che coinvolge 144 pazienti in 24 centri negli Stati Uniti, valuta l'efficacia di ELI-002 7P rispetto allo standard di cura nel migliorare la sopravvivenza libera da malattia (DFS) per i pazienti con adenocarcinoma duttale pancreatico (PDAC).
La raccomandazione positiva dell'IDMC indica segnali preliminari di efficacia e conferma un profilo di sicurezza favorevole. L'analisi finale della DFS è prevista per il quarto trimestre del 2025. È importante sottolineare che Elicio ha già concordato con la FDA gli elementi chiave del disegno dello studio di Fase 3 pianificato e dispone di risorse finanziarie sufficienti fino al primo trimestre del 2026.
Elicio Therapeutics (NASDAQ:ELTX) anunció que el Comité Independiente de Monitoreo de Datos (IDMC) recomendó continuar el estudio de Fase 2 AMPLIFY-7P de ELI-002 7P para el cáncer de páncreas sin modificaciones. El ensayo, que involucra a 144 pacientes en 24 sitios de EE.UU., evalúa la efectividad de ELI-002 7P frente al tratamiento estándar para mejorar la supervivencia libre de enfermedad (DFS) en pacientes con adenocarcinoma ductal pancreático (PDAC).
La recomendación positiva del IDMC sugiere señales preliminares de eficacia y confirma un perfil de seguridad favorable. El análisis final de DFS se espera para el cuarto trimestre de 2025. Cabe destacar que Elicio ya ha acordado con la FDA los elementos clave del diseño planificado para el estudio de Fase 3 y cuenta con fondos suficientes hasta el primer trimestre de 2026.
Elicio Therapeutics (NASDAQ:ELTX)가 독립 데이터 모니터링 위원회(IDMC)로부터 췌장암 치료제 ELI-002 7P의 2상 AMPLIFY-7P 연구를 수정 없이 계속 진행하라는 권고를 받았다고 발표했습니다. 이 임상시험은 미국 내 24개 기관에서 144명의 환자를 대상으로 하며, 췌관 선암(PDAC) 환자의 무병 생존 기간(DFS) 개선을 위해 ELI-002 7P의 표준 치료 대비 효과를 평가합니다.
IDMC의 긍정적 권고는 초기 효능 신호를 시사하며 안전성 프로파일이 우수함을 확인했습니다. 최종 DFS 분석은 2025년 4분기에 예정되어 있습니다. 특히, Elicio는 이미 FDA와 3상 시험 설계의 주요 요소에 대해 합의했으며, 2026년 1분기까지의 자금 확보 상태를 유지하고 있습니다.
Elicio Therapeutics (NASDAQ:ELTX) a annoncé que le Comité Indépendant de Surveillance des Données (IDMC) a recommandé de poursuivre l'étude de Phase 2 AMPLIFY-7P portant sur ELI-002 7P pour le cancer du pancréas sans modifications. L'essai, impliquant 144 patients répartis sur 24 sites aux États-Unis, évalue l'efficacité d'ELI-002 7P par rapport au traitement standard pour améliorer la survie sans maladie (DFS) chez les patients atteints d'adénocarcinome canalaire pancréatique (PDAC).
La recommandation positive de l'IDMC suggère des signaux préliminaires d'efficacité et confirme un profil de sécurité favorable. L'analyse finale de la DFS est prévue pour le quatrième trimestre 2025. Il est à noter qu'Elicio a déjà convenu avec la FDA des éléments clés du design prévu pour l'étude de Phase 3 et dispose de liquidités suffisantes jusqu'au premier trimestre 2026.
Elicio Therapeutics (NASDAQ:ELTX) gab bekannt, dass das Unabhängige Datenüberwachungskomitee (IDMC) empfohlen hat, die Phase-2-Studie AMPLIFY-7P mit ELI-002 7P bei Bauchspeicheldrüsenkrebs ohne Änderungen fortzusetzen. Die Studie mit 144 Patienten an 24 Standorten in den USA bewertet die Wirksamkeit von ELI-002 7P im Vergleich zur Standardtherapie zur Verbesserung des krankheitsfreien Überlebens (DFS) bei Patienten mit duktalem Adenokarzinom der Bauchspeicheldrüse (PDAC).
Die positive Empfehlung des IDMC deutet auf erste Wirksamkeitssignale hin und bestätigt ein günstiges Sicherheitsprofil. Die endgültige DFS-Analyse wird für das vierte Quartal 2025 erwartet. Bemerkenswert ist, dass Elicio bereits mit der FDA die Schlüsselaspekte des geplanten Phase-3-Studien-Designs abgestimmt hat und über ausreichende finanzielle Mittel bis ins erste Quartal 2026 verfügt.
- Positive IDMC recommendation indicating preliminary efficacy signals
- FDA alignment already achieved on Phase 3 study design elements
- Cash runway extends into Q1 2026, beyond final DFS analysis
- Previous Phase 1 data showed promising 16.3-month median recurrence-free survival
- ELI-002 7P targets mutations present in 88% of PDAC patients
- Final DFS analysis results still pending until Q4 2025
- Company remains blinded to trial clinical efficacy outcomes
Insights
Elicio's pancreatic cancer vaccine shows promising signals at interim analysis, supporting continued development with final results expected Q4 2025.
The Independent Data Monitoring Committee's recommendation to continue Elicio's Phase 2 AMPLIFY-7P trial without modifications represents a significant positive signal for ELI-002 7P in pancreatic ductal adenocarcinoma (PDAC). This event-driven interim analysis examined both efficacy and safety data, with the IDMC confirming a favorable safety profile while detecting preliminary efficacy signals.
ELI-002 7P targets seven KRAS mutations present in 88% of PDAC patients, addressing a critical unmet need in an aggressive cancer with only 13% five-year survival. The vaccine is being tested in the adjuvant setting—after surgery and chemotherapy—where no effective treatments currently exist and patients are simply monitored for recurrence.
The trial design is methodologically sound: a 2:1 randomized study across 24 U.S. sites with 144 patients comparing the vaccine to standard observation. The subcutaneous vaccine administration protocol consists of six initial doses, followed by an observation period and four booster doses—a regimen designed to maintain immune surveillance.
Importantly, Elicio has already aligned with the FDA on key elements of their planned Phase 3 study, indicating regulatory receptiveness to their approach. Their previous Phase 1 data showed a 16.3-month median recurrence-free survival and 28.9-month median overall survival, suggesting meaningful clinical benefit.
With final disease-free survival analysis expected in Q4 2025 and cash runway extending into Q1 2026, Elicio appears well-positioned to reach their next critical milestone. While remaining appropriately blinded to efficacy outcomes, this interim success increases the probability that ELI-002 7P could become the first effective immunotherapy vaccine for pancreatic cancer.
- The AMPLIFY-7P study of ELI-002 7P successfully passes event-driven interim analysis for efficacy, futility, and safety by the IDMC
- The Company views the IDMC’s positive recommendation as an indication that ELI-002 7P has shown preliminary signals of efficacy
- Final disease-free survival analysis is anticipated to occur in Q4 2025
- Elicio previously reached alignment with the FDA on key elements of the planned pivotal Phase 3 study design
- The Company’s current cash runway extends into Q1 2026, past the anticipated final DFS analysis
BOSTON, Aug. 05, 2025 (GLOBE NEWSWIRE) -- Elicio Therapeutics, Inc. (Nasdaq: ELTX, “Elicio” or the “Company”), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, today announced that following the Independent Data Monitoring Committee’s (“IDMC”) pre-specified interim review of the unblinded safety and efficacy data in the Company’s Phase 2 AMPLIFY-7P study in mutant KRAS (“mKRAS”)-driven pancreatic ductal adenocarcinoma (“PDAC”), the IDMC recommended that the trial continue to the final analysis without modifications. In addition, the IDMC confirmed the favorable safety profile of ELI-002 7P to date.
“We are encouraged by the IDMC’s recommendation to support the continuation of the AMPLIFY-7P trial as planned, as we believe it indicates that ELI-002 7P has shown preliminary signals of efficacy. We look forward to the final disease-free survival (“DFS”) analysis anticipated to occur in the fourth quarter of 2025 and continue to believe that ELI-002 7P has the potential, based on the compelling data generated to date, to offer a new solution to patients facing PDAC in the adjuvant setting,” said Robert Connelly, Chief Executive Officer of Elicio. “Importantly, we previously reached alignment with the U.S. Food and Drug Administration (“FDA”) on the key elements of the planned pivotal Phase 3 study design, and, upon final DFS analysis, plan to request an End-of-Phase 2 meeting with the FDA to finalize the regulatory strategy for the ELI-002 Phase 3 study.”
The AMPLIFY-7P trial is a 2:1 randomized, open-label, multicenter clinical trial that enrolled 144 patients at 24 U.S. sites to evaluate the effectiveness and safety of ELI-002 7P monotherapy compared to standard of care (“SOC”) (observation) to improve DFS in patients with PDAC in the adjuvant setting post local therapy, following surgery, chemotherapy, with or without radiation. Currently, the SOC in this setting is to conduct serial imaging scans to monitor closely for cancer progression. ELI-002 7P treatment consists of six doses, followed by an observation period of eight weeks, and followed with four additional booster doses.
PDAC is an aggressive cancer with a five-year survival rate of
The Company remains blinded to the trial clinical efficacy outcomes.
Elicio Therapeutics, Inc. (Nasdaq: ELTX) is a clinical-stage biotechnology company advancing novel immunotherapies for the treatment of high-prevalence cancers, including mKRAS-positive pancreatic and colorectal cancers. Elicio intends to build on recent clinical successes in the personalized cancer vaccine space to develop effective, off-the-shelf vaccines. Elicio’s Amphiphile (“AMP”) technology aims to enhance the education, activation and amplification of cancer-specific T cells relative to conventional vaccination strategies, with the goal of promoting durable cancer immunosurveillance in patients. Elicio’s ELI-002 lead program is an off-the-shelf vaccine candidate targeting the most common KRAS mutations, which drive approximately
About ELI-002
Elicio’s lead product candidate, ELI-002, is a structurally novel investigational AMP cancer vaccine that targets cancers that are driven by mutations in the KRAS-gene—a prevalent driver of many human cancers. ELI-002 is comprised of two powerful components that are built with Elicio’s AMP technology consisting of AMP-modified mutant KRAS peptide antigens and ELI-004, an AMP-modified CpG oligodeoxynucleotide adjuvant that is available as an off-the-shelf subcutaneous administration.
ELI-002 2P (2-peptide formulation) has been studied in the Phase 1 (AMPLIFY-201) trial in patients with high relapse risk mKRAS-driven solid tumors, following surgery and chemotherapy (NCT04853017). ELI-002 7P (7-peptide formulation) is currently being studied in a Phase 1/2 (AMPLIFY-7P) trial in patients with mKRAS-driven pancreatic cancer (NCT05726864). The ELI-002 7P formulation is designed to provide immune response coverage against seven of the most common KRAS mutations present in
About the Amphiphile Platform
Elicio’s proprietary AMP platform delivers investigational immunotherapeutics directly to the “brain center” of the immune system – the lymph nodes. Elicio believes this site-specific delivery of disease-specific antigens, adjuvants and other immunomodulators may efficiently educate, activate and amplify critical immune cells, potentially resulting in induction and persistence of potent adaptive immunity required to treat many diseases. In preclinical models, Elicio observed lymph node-specific engagement driving therapeutic immune responses of increased magnitude, function and durability. Elicio believes its AMP lymph node-targeted approach will produce superior clinical benefits compared to immunotherapies that do not engage the lymph nodes based on preclinical studies.
Elicio’s AMP platform, originally developed at the Massachusetts Institute of Technology, has broad potential in the cancer space to advance a number of development initiatives through internal activities, in-licensing arrangements or development collaborations and partnerships.
The AMP platform has been shown to deliver immunotherapeutics directly to the lymph nodes by latching on to the protein albumin, found in the local injection site, as it travels to lymphatic tissue.
Cautionary Note on Forward-Looking Statements
Certain statements contained in this communication regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, known as the PSLRA. These include statements regarding the sufficiency of Elicio’s existing cash and cash equivalents to support operations into the first quarter of 2026, beyond the anticipated AMPLIFY-7P Phase 2 final DFS analysis expected in the fourth quarter of 2025; Elicio’s planned clinical programs, including the timing and outcome of planned clinical trials; the timing of the expected final DFS analysis of the Phase 2 AMPLIFY-7P clinical trial anticipated in the fourth quarter of 2025; the potential efficacy of Elicio’s product candidates, including ELI-002 7P; the potential of Elicio’s product candidates, including ELI-002, to offer a new solution to patients facing PDAC in the adjuvant setting; Elicio’s plan to request an End-of-Phase 2 meeting with the FDA to finalize the regulatory strategy for the ELI-002 Phase 3 study and the potential outcome of such meeting, if granted; the potential for future expansion of ELI-002 to other indications, including in combination regimens for PDAC and colorectal cancer; the potential benefits and effectiveness of off-the-shelf vaccine approaches; and other statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Elicio undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by law. We use words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions of the PSLRA. Such forward-looking statements are based on our expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including, but not limited to, Elicio’s financial condition, including its anticipated cash runway, and ability to obtain the funding necessary to advance the development of ELI-002 and any other future product candidates, and Elicio’s ability to continue as a going concern; Elicio’s plans to develop and commercialize its product candidates, including ELI-002; the timing of initiation of Elicio’s planned clinical trials; the timing of the availability of data from Elicio’s clinical trials, including the final DFS analysis from the Phase 2 AMPLIFY-7P trial expected in the fourth quarter of 2025; the timing of any planned investigational new drug application or new drug application; Elicio’s plans to research, develop and commercialize its current and future product candidates; and Elicio’s estimates regarding future revenue, expenses, capital requirements and need for additional financing.
New factors emerge from time to time, and it is not possible for us to predict all such factors, nor can we assess the impact of each such factor on the 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. These risks are more fully discussed under the heading “Risk Factors” in Elicio’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 31, 2025, and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC filed with the SEC on May 13, 2025, as updated by subsequent reports and other documents filed from time to time with the SEC. Forward-looking statements included in this release are based on information available to Elicio as of the date of this release. Elicio does not undertake any obligation to update such forward-looking statements to reflect events or circumstances after the date of this release, except to the extent required by law.
Investor Relations Contact
Brian Ritchie
LifeSci Advisors
(212) 915-2578
britchie@lifesciadvisors.com
FAQ
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