Elicio Therapeutics Announces Publication of ELI-002 Updated AMPLIFY-201 Phase 1 Follow-up Data in Nature Medicine for Minimal Residual Disease (“MRD”) Positive, Adjuvant-Stage Patients
Elicio Therapeutics (NASDAQ:ELTX) announced updated Phase 1 AMPLIFY-201 follow-up data for ELI-002 published in Nature Medicine. At 19.7 months median follow-up, the study showed significant improvements in survival metrics for minimal residual disease-positive, adjuvant-stage patients.
Key findings include median overall survival increasing to 28.94 months from 16.33 months, with patients showing T cell responses above threshold experiencing a 77% reduction in death risk and 88% reduction in relapse risk. The treatment demonstrated strong efficacy with 84% of patients showing mKRAS-specific T cell responses and tumor biomarker responses.
The final disease-free survival analysis for the Phase 2 AMPLIFY-7P study in pancreatic ductal adenocarcinoma is expected in Q4 2025. The therapy was well-tolerated with no safety concerns or dose-limiting toxicities reported.
Elicio Therapeutics (NASDAQ:ELTX) ha pubblicato su Nature Medicine i dati di follow-up aggiornati della fase 1 AMPLIFY-201 per ELI-002. A 19,7 mesi di follow-up mediano, lo studio ha evidenziato miglioramenti significativi nelle misure di sopravvivenza per pazienti in fase adiuvante con malattia residua minima (MRD) positiva.
Tra i risultati principali, la sopravvivenza globale mediana è salita a 28,94 mesi rispetto a 16,33 mesi; i pazienti che hanno mostrato risposte delle cellule T superiori alla soglia hanno registrato una riduzione del 77% del rischio di morte e una riduzione dell’88% del rischio di recidiva. Il trattamento ha dimostrato forte efficacia, con l’84% dei pazienti che ha evidenziato risposte delle cellule T specifiche per mKRAS e risposte ai biomarcatori tumorali.
L’analisi finale della sopravvivenza libera da malattia per lo studio di fase 2 AMPLIFY-7P nel carcinoma duttale pancreatico è prevista per il 4° trimestre 2025. La terapia è stata ben tollerata, senza problemi di sicurezza né tossicità dose-limite segnalate.
Elicio Therapeutics (NASDAQ:ELTX) anunció datos de seguimiento actualizados de la fase 1 AMPLIFY-201 para ELI-002 publicados en Nature Medicine. Con un seguimiento mediano de 19,7 meses, el estudio mostró mejoras significativas en las medidas de supervivencia para pacientes en estadio adyuvante con enfermedad residual mínima (MRD) positiva.
Entre los hallazgos clave, la supervivencia global mediana aumentó a 28,94 meses desde 16,33 meses; los pacientes con respuestas de células T por encima del umbral experimentaron una reducción del 77% del riesgo de muerte y una reducción del 88% del riesgo de recaída. El tratamiento demostró una fuerte eficacia, con el 84% de los pacientes mostrando respuestas de células T específicas para mKRAS y respuestas en biomarcadores tumorales.
El análisis final de la supervivencia libre de enfermedad del estudio de Fase 2 AMPLIFY-7P en adenocarcinoma ductal pancreático se espera para el 4T de 2025. La terapia fue bien tolerada, sin problemas de seguridad ni toxicidades limitantes de dosis informadas.
Elicio Therapeutics (NASDAQ:ELTX)는 ELI-002에 대한 1상 AMPLIFY-201의 업데이트된 추적관찰 데이터를 Nature Medicine에 발표했습니다. 중앙 추적관찰 기간이 19.7개월일 때, 해당 연구는 최소잔류질환(MRD) 양성인 보조요법 단계 환자들의 생존 지표에서 유의미한 개선을 보였습니다.
주요 결과로는 전체 생존중앙값이 16.33개월에서 28.94개월로 증가했으며, 기준치 이상의 T세포 반응을 보인 환자들은 사망 위험이 77% 감소하고 재발 위험이 88% 감소했습니다. 치료는 높은 효능을 나타냈으며, 84%의 환자에서 mKRAS 특이 T세포 반응 및 종양 바이오마커 반응이 확인되었습니다.
췌장 관상선암(ductal adenocarcinoma) 대상의 2상 AMPLIFY-7P 연구에 대한 최종 무재발생존 분석은 2025년 4분기에 예정되어 있습니다. 치료는 내약성이 양호했으며 보고된 안전성 우려나 용량 제한 독성은 없었습니다.
Elicio Therapeutics (NASDAQ:ELTX) a publié des données de suivi actualisées de la phase 1 AMPLIFY‑201 pour ELI‑002, parues dans Nature Medicine. À 19,7 mois de suivi médian, l’étude a montré des améliorations significatives des indicateurs de survie chez des patients en phase adjuvante positifs pour une maladie résiduelle minimale (MRD).
Les résultats clés incluent une survie globale médiane passant à 28,94 mois contre 16,33 mois ; les patients présentant des réponses T au‑dessus du seuil ont observé une réduction de 77% du risque de décès et une réduction de 88% du risque de récidive. Le traitement a démontré une forte efficacité, 84% des patients ayant présenté des réponses T spécifiques à mKRAS et des réponses des biomarqueurs tumoraux.
L’analyse finale de la survie sans maladie de l’étude de phase 2 AMPLIFY‑7P dans l’adénocarcinome canalaire du pancréas est attendue au 4e trimestre 2025. La thérapie a été bien tolérée, sans problèmes de sécurité ni toxicités limitantes de dose rapportés.
Elicio Therapeutics (NASDAQ:ELTX) hat aktualisierte Follow-up-Daten der Phase‑1‑Studie AMPLIFY‑201 für ELI‑002 veröffentlicht, die in Nature Medicine erschienen sind. Bei einer medianen Nachbeobachtungszeit von 19,7 Monaten zeigte die Studie deutliche Verbesserungen der Überlebenskennzahlen bei Patienten im adjuvanten Stadium mit minimaler Resterkrankung (MRD) positiv.
Wesentliche Befunde sind, dass das mediane Gesamtüberleben auf 28,94 Monate gegenüber 16,33 Monaten anstieg; Patienten mit T‑Zell‑Antworten über dem Schwellenwert hatten ein um 77% reduziertes Sterberisiko und ein um 88% reduziertes Rezidivrisiko. Die Behandlung zeigte starke Wirksamkeit, wobei 84% der Patienten mKRAS‑spezifische T‑Zell‑Antworten und Tumor‑Biomarker‑Ansprechen zeigten.
Die abschließende Analyse des krankheitsfreien Überlebens der Phase‑2‑Studie AMPLIFY‑7P beim duktalen Adenokarzinom des Pankreas wird für das 4. Quartal 2025 erwartet. Die Therapie wurde gut vertragen; es wurden keine Sicherheitsbedenken oder dosisbegrenzenden Toxizitäten berichtet.
- 84% of patients (21/25) showed mKRAS-specific T cell responses and tumor biomarker responses
- 77% reduction in death risk and 88% reduction in relapse risk for above-threshold T cell responders
- Median overall survival increased significantly to 28.94 months from 16.33 months
- Complete biomarker clearance observed in 24% of patients (6/25)
- No safety concerns or dose-limiting toxicities reported
- Antigen-spreading observed in 67% of patients, indicating broader immune response
- 8 of 8 patients with below-threshold T cell responses had confirmed radiographic progression
- 7 of 8 below-threshold T cell responders died
- Patients with below-threshold responses showed shorter median survival of 15.98 months
Insights
ELI-002 vaccine shows powerful survival benefit in pancreatic cancer patients with minimal residual disease, correlating with strong T-cell responses.
Elicio's updated Phase 1 data for their ELI-002 cancer vaccine represents a potentially significant breakthrough for pancreatic cancer treatment. With extended follow-up of 19.7 months, patients who mounted strong T-cell responses showed 77% reduction in death risk and 88% reduction in relapse risk - extraordinary margins in a disease with historically poor outcomes.
The mechanism driving these results appears robust. ELI-002 induced both CD4+ and CD8+ T-cell responses specific to mutant KRAS in 84% of patients, with complete biomarker clearance in 24%. The vaccine's lymph-node-targeting Amphiphile platform efficiently educates T-cells against the KRAS mutations that drive approximately 25% of all solid tumors.
Particularly compelling is the evidence of antigen spreading in 67% of patients, where the immune response expanded beyond the vaccine targets to recognize additional tumor-specific neoantigens. This phenomenon typically signifies a more comprehensive anti-tumor response and potentially more durable remissions.
The median overall survival increased from 16.33 to 28.94 months - remarkable for pancreatic cancer patients with residual disease. For context, standard-of-care adjuvant chemotherapy typically yields median survival around 20-24 months in similar populations. Importantly, patients exceeding the T-cell response threshold haven't yet reached median overall survival or relapse-free survival endpoints, suggesting potentially durable benefit.
The clean safety profile - no dose-limiting toxicities or Grade 3+ treatment-related adverse events - distinguishes this approach from chemotherapy or checkpoint inhibitors. The upcoming Phase 2 AMPLIFY-7P study's final disease-free survival analysis in Q4 2025 will be pivotal in confirming these promising signals in a larger, randomized trial.
- At extended median follow-up of 19.7 months, median overall survival (“OS”) increased from 16.33 to 28.94 months
- Clinical efficacy correlated with the magnitude of T cell responses specific to mutant-KRAS (“mKRAS”) induced by ELI-002
77% reduction in the risk of death and88% reduction in the risk of relapse, associated with T cell responses above the threshold for anti-tumor efficacy- ELI-002 induced both CD4+ and CD8+ mKRAS-specific T cell responses in most patients, and evidence of antigen-spreading to patient-specific neoantigens not included in ELI-002 was observed
- Final event-driven disease-free survival (“DFS”) analysis for the randomized Phase 2 AMPLIFY-7P study evaluating ELI-002 7P monotherapy in pancreatic ductal adenocarcinoma (“PDAC”) is anticipated in Q4 2025
BOSTON, Aug. 12, 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 the publication of follow-up data from the Phase 1 AMPLIFY-201 study evaluating ELI-002 in the peer-reviewed scientific journal, Nature Medicine. The article, entitled, “Lymph-node-targeted, mKRAS-specific amphiphile vaccine in pancreatic and colorectal cancer: Phase 1 AMPLIFY-201 trial final results,” highlights that with extended follow-up, more than two-thirds of participants (17 of 25) whose T cell responses exceeded the antitumor efficacy threshold experienced a significantly reduced risk for relapse or death.
“This publication, combined with the early promising clinical data we’ve generated to date, further strengthens our belief that our Amphiphile (“AMP”) platform represents a potentially transformative approach in the treatment of mKRAS-driven tumors,” commented Robert Connelly, Chief Executive Officer of Elicio.
Chris Haqq, MD, Ph.D., Chief Medical Officer of Elicio, added, “The updated Phase 1 AMPLIFY-201 data further demonstrate that the AMP platform has the potential to provide durable benefit to PDAC patients in the adjuvant setting. These promising results together with the recent positive recommendation from the Independent Data Monitoring Committee that the randomized ongoing Phase 2 AMPLIFY-7P study should continue without modification to final DFS analysis, represent critical advancements for our promising lead program.”
Key Findings:
- 25 adjuvant-stage patients with solid tumors (20 PDAC, 5 colorectal) were enrolled for treatment based on positive for minimal residual mKRAS disease after locoregional treatment, with data reported through September 24, 2024.
- Direct ex vivo mKRAS-specific T cell responses were observed in 21/25 patients (
84% ), including both CD4+ and CD8+ T cell responses in71% of patients, and 6/6 patients (100% ) treated at the recommended Phase 2 dose (“RPD2”); the induction of both CD4+ and CD8+ T cells correlated with overall tumor biomarker response (p<0.0035). - Tumor biomarker responses were observed in 21/25 patients (
84% ), with complete biomarker clearance observed in 6/25 patients, as determined by tumor-informed circulating tumor DNA analysis (24% ; 3 PDAC, 3 colorectal). - At 19.7 months median follow-up (compared to 8.5 months previously), the median relapse-free survival (“RFS”) was 16.33 months, and the median OS was 28.94 months for the 25-patient cohort.
- Efficacy correlated with ELI-002-induced mKRAS-specific T cell response (≥ versus < threshold: 9.17-fold over baseline; threshold defined through receiver-operating curve analysis):
- Median tumor biomarker reduction was
55.2% compared to36.7% in above versus below threshold T cell responders, respectively (p<0.0024). - 11/17 patients with T cell response above threshold remained free from radiographic progression while 8/8 patients with below threshold T cell responses had confirm radiographic progression (7/8 had died); Relative Risk of Progression or Death in below threshold T cell responders was 2.96.
- Median RFS was not reached compared to 3.02 months in above versus below threshold T cell responders, respectively (HR 0.12,
95% CI 0.02 to 0.62, p=0.0002); patients with greater than threshold T cell response had an88% reduction in the risk of progression or death. - Median OS was not reached compared to 15.98 months in above versus below threshold T cell responders, respectively (HR 0.23,
95% CI 0.06 to 0.85, p=0.0099); patients with greater than threshold T cell response had an77% reduction in the risk of death.
- Median tumor biomarker reduction was
- Antigen-spreading, a process where the immune system, initially targeting the mKRAS antigens in ELI-002, expands its response to recognize additional antigens in the patient’s tumor leading to a broader and more effective anti-tumor response, was observed in
67% of patients, with increased T cells reactive to personalized, tumor neoantigens absent from ELI-002; overall, increased T cell responses were observed in 13/52 (25% ) of evaluated tumor neoantigens. - ELI-002 was well tolerated, with no safety concerns identified, and no dose-limiting toxicities or ≥ Grade 3 treatment-related adverse events were observed.
| Pant, et al. Nature Medicine. 2024 | Wainberg, et al. Nature Medicine. 2025 | |
| DCO | 6 Sept 2023 | 24 Sept 2024 |
| Median Follow-up | 8.5 months | 19.7 months |
| Median RFS (n=25) | 16.33 months | 16.33 months |
| Median OS (n=25) | 16.33 months | 28.94 months |
| mKRAS T Cell Response Threshold | 12.75x (median) | 9.17x (ROC-defined) |
| Patients ≥ mKRAS T Cell Response Threshold | 13/25 | 17/25 |
| mKRAS T Cell Response Correlation to: | ||
| Tumor Biomarker Response | P=0.0014 | P=0.0024 |
| RFS | HR 0.14, P=0.0167 | HR 0.12, P=0.0002 |
| OS | NR | HR 0.23, P=0.0099 |
DCO: Data cut-off; RFS: Relapse-free survival; OS: Overall survival; ROC: Receiver-operating curve; NR: Not reported
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 Elicio’s planned clinical programs, including the timing and outcome of planned clinical trials; the timing of the expected event-driven final DFS analysis of the Phase 2 AMPLIFY-7P clinical trial; the potential of Elicio’s product candidates and platform, including the potential transformational approach Elicio’s AMP platform could represent in the treatment of mKRAS-driven tumors; the potential impact of the AMP Platform and ELI-002 in PDAC, including the potential for Elicio’s AMP platform to provide durable benefit for PDAC patients in the adjuvant setting; the potential for future expansion of ELI-002 to other indications, including mKRAS positive lung cancer and other mKRAS positive cancers; 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 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 event-driven final DFS analysis from the Phase 2 AMPLIFY-7P trial anticipated 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, our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 13, 2025, and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, filed with the SEC on August 7, 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
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