Elicio Therapeutics Reports ELI-002 7P Achieved Robust mKRAS-Specific T Cell Responses in 99% of Evaluable Patients in Ongoing Phase 2 AMPLIFY-7P Trial
Elicio Therapeutics (NASDAQ:ELTX) reported impressive immunogenicity data from its ongoing Phase 2 AMPLIFY-7P trial for ELI-002 7P, its investigational vaccine immunotherapy. The trial demonstrated that 99% of evaluable patients (89 of 90) generated strong mKRAS-specific T cell responses, with an average increase of 145.3x over baseline.
Key highlights include 85% of patients showing both mKRAS-specific CD4 and CD8 T cells, and 87.6% of patients demonstrating response to their specific tumor antigen. The results are consistent with previous Phase 1 trials, where T cell responses correlated with clinical activity in minimal residual disease positive (MRD+) patients. The final disease-free survival analysis is expected in Q4 2025.
Elicio Therapeutics (NASDAQ:ELTX) ha riportato dati immunogenici impressionanti dal suo attuale studio di fase 2 AMPLIFY-7P per ELI-002 7P, la sua immunoterapia vaccinale in fase di ricerca. Lo studio ha dimostrato che il 99% dei pazienti valutabili (89 su 90) ha generato robuste risposte delle cellule T mirate a mKRAS, con un aumento medio di 145,3x rispetto alla baseline.
Tra i punti chiave, l'85% dei pazienti ha mostrato sia cellule T CD4 sia CD8 specifiche per mKRAS, e l'87,6% dei pazienti ha dimostrato una risposta al proprio antigene tumorale specifico. I risultati sono coerenti con i precedenti studi di fase 1, in cui le risposte delle cellule T si correlavano all'attività clinica nei pazienti MRD+ (malattia residua minima positiva). L'analisi finale della sopravvivenza libera da malattia è prevista nel Q4 2025.
Elicio Therapeutics (NASDAQ:ELTX) informó datos inmunogénicos impresionantes de su ensayo de fase 2 AMPLIFY-7P en curso para ELI-002 7P, su inmunoterapia vacunal en investigación. El ensayo demostró que el 99% de los pacientes evaluables (89 de 90) generó respuestas fuertes de células T específicas de mKRAS, con un aumento medio de 145,3x respecto al baseline.
Entre los aspectos destacados, el 85% de los pacientes mostró células T CD4 y CD8 específicas de mKRAS, y el 87,6% de los pacientes demostró respuesta a su antígeno tumoral específico. Los resultados son consistentes con ensayos de fase 1 anteriores, donde las respuestas de células T se correlacionaron con la actividad clínica en pacientes MRD+ (enfermedad mínima residual positiva). El análisis final de la supervivencia libre de enfermedad se espera en el cuarto trimestre de 2025.
Elicio Therapeutics(나스닥:ELTX)는 진행 중인 2상 AMPLIFY-7P 시험에서 ELI-002 7P에 대한 임상 백신 면역요법의 인체 면역원성 데이터를 발표했습니다. 이 시험은 평가 가능한 환자의 99%(90명 중 89명)가 mKRAS 특이적 T 세포 반응을 강하게 생성했으며 기저선 대비 평균 145.3배 증가를 보였음을 보여주었습니다.
주요 하이라이트로는 환자의 85%가 mKRAS 특이 CD4 및 CD8 T 세포를 모두 보였고, 87.6%의 환자가 자신의 종양 항원에 반응을 보였습니다. 이 결과는 이전 1상 시험에서의 T 세포 반응이 MRD+(잔여 질환 양성) 환자에서 임상 활성성과 상관관계가 있던 점과 일치합니다. 최종 무병 생존 분석은 2025년 4분기에 발표될 예정입니다.
Elicio Therapeutics (NASDAQ:ELTX) a publié des données immunogènes impressionnantes issues de son essai de phase 2 AMPLIFY-7P en cours pour ELI-002 7P, son immunothérapie vaccinale expérimentale. L’essai a démontré que 99% des patients évaluables (89 sur 90) ont généré de fortes réponses des T cells spécifiques à mKRAS, avec une augmentation moyenne de 145,3x par rapport à la ligne de base.
Les points forts incluent que 85% des patients ont montré à la fois des T CD4 et CD8 spécifiques à mKRAS, et que 87,6% des patients ont démontré une réponse à leur antigène tumoral spécifique. Les résultats sont cohérents avec les essais de phase 1 précédents, où les réponses des T cells corrélaient avec l’activité clinique chez les patients MRD+ (maladie résiduelle minimale positive). L’analyse finale de la survie sans maladie est attendue au Q4 2025.
Elicio Therapeutics (NASDAQ:ELTX) meldete beeindruckende Immunogenitätsdaten aus seiner laufenden Phase-2-Studie AMPLIFY-7P für ELI-002 7P, seine erfahrungsbasierte Impfstoff-Immuntherapie. Die Studie zeigte, dass 99% der auswertbaren Patienten (89 von 90) starke mKRAS-spezifische T-Zell-Antworten erzeugten, mit einem durchschnittlichen Anstieg von 145,3x gegenüber dem Ausgangswert.
Zu den Kernpunkten gehört, dass 85% der Patienten sowohl mKRAS-spezifische CD4- als auch CD8-T-Zellen aufwiesen, und 87,6% der Patienten eine Reaktion auf ihr spezifisches Tumorantigen zeigten. Die Ergebnisse stimmen mit früheren Phase-1-Studien überein, in denen T-Zell-Antworten mit klinischer Aktivität bei MRD+‑Patienten korrelierten. Die abschließende Analyse des krankheitsfreien Überlebens wird voraussichtlich im Q4 2025 erfolgen.
Elicio Therapeutics (NASDAQ:ELTX) أصدرت بيانات مناعية مثيرة من تجربتها في المرحلة الثانية AMPLIFY-7P الجارية لـ ELI-002 7P، وهو لقاح مناعي-علاجي تجريبي. أظهرت التجربة أن 99% من المرضى القابلين للتقييم (89 من 90) طوروا استجابات قوية لخلايا T المحددة بـ mKRAS، مع زيادة متوسطة قدرها 145.3× عن خط الأساس.
من أبرز النقاط أن 85% من المرضى أظهروا خلايا T CD4 وCD8 محددة لـ mKRAS معاً، وأن 87.6% من المرضى أظهروا استجابة لمولدهم الورمي المحدد. تتوافق النتائج مع تجارب المرحلة 1 السابقة، حيث ارتبطت استجابات T بالنشاط السريري لدى مرضى MRD+ (المَرَض المتبقي الإيجابي minimal residual). التحليل النهائي للبقاء خالياً من المرض متوقع في الربع الرابع من 2025.
Elicio Therapeutics（纳斯达克股票代码：ELTX） 宣布来自正在进行的2期AMPLIFY-7P研究的令人印象深刻的免疫原性数据，针对其研究性疫苗免疫治疗 ELI-002 7P。该试验显示，99%的可评估患者（90例中89例）产生了针对mKRAS的强烈T细胞反应，基线值的平均增幅为 145.3倍。
关键亮点包括，85%的患者同时呈现mKRAS特异性CD4和CD8 T细胞，87.6%的患者对其特异性肿瘤抗原有反应。结果与早期1期试验一致，在MRD+（微量残留阳性）患者中，T细胞反应与临床活性相关。最终的无病生存分析预计在 2025年第四季度公布。
- Exceptional response rate with 99% of patients (89 of 90) showing mKRAS-specific T cell responses
- Strong average T cell response of 145.3x increase over baseline, significantly higher than Phase 1 results (71.1x)
- 85% of patients demonstrated both CD4 and CD8 T cell responses, indicating robust immune activation
- 87.6% of patients showed response to their specific tumor antigen
- Independent Data Monitoring Committee recommended trial continuation, suggesting preliminary efficacy signals
- Final clinical efficacy outcomes remain blinded
- Correlation between T cell responses and antitumor response still unknown in Phase 2 trial
Insights
ELI-002 7P shows remarkably consistent 99% T-cell response rate in Phase 2 trial, suggesting strong potential efficacy for KRAS-mutated cancers.
The immunogenicity data from Elicio's Phase 2 AMPLIFY-7P trial represents a remarkably strong and consistent signal that deserves attention. A 99% T cell response rate (89 of 90 patients) is extraordinarily high for cancer immunotherapy trials, where response heterogeneity is typically a major challenge. The average 145.3x increase in mKRAS-specific T cells over baseline significantly exceeds the 9.5x threshold that correlated with clinical activity in their Phase 1 trials, with 80% of patients surpassing this threshold.
What's particularly compelling is the quality of the T cell responses. The presence of both CD4+ and CD8+ T cells in 85% of patients indicates a coordinated immune response involving both helper and cytotoxic T cells – precisely the comprehensive activation pattern needed for effective anti-tumor immunity. Additionally, 67.4% of patients showed responses to all seven mKRAS antigens included in the vaccine, and 87.6% responded to their specific tumor antigen, suggesting the vaccine is successfully targeting relevant mutations.
The consistency between Phase 1 and Phase 2 results is encouraging, as immunotherapy candidates often see diminished efficacy in larger trials. The recommendation by the Independent Data Monitoring Committee to continue without modifications strongly suggests the therapy is demonstrating preliminary efficacy signals while maintaining an acceptable safety profile. For KRAS-mutated cancers, which have been notoriously difficult to target therapeutically, these immunogenicity results represent a potentially significant advancement in addressing these challenging molecular drivers of cancer.
The Phase 2 AMPLIFY-7P trial data demonstrates exceptional consistency in generating mKRAS-specific T cell responses across nearly all treated patients. The 99% response rate with robust 145.3x average increase over baseline represents a level of immunological engagement rarely seen in cancer vaccine trials. Critically, 80% of patients exceeded the 9.5x increase threshold that previously correlated with clinical activity in Phase 1.
The expansion of the trial to include MRD-negative patients is strategically significant. While the previous Phase 1 trials focused only on MRD-positive patients (those with detectable disease after standard therapy), this Phase 2 trial includes patients without detectable disease. This broadens the potential therapeutic window and commercial opportunity, potentially positioning ELI-002 7P as both a treatment for residual disease and a preventative measure against recurrence in high-risk patients.
The IDMC recommendation to proceed without modifications following their interim review is particularly meaningful. These committees typically have predetermined stopping boundaries for both futility and overwhelming efficacy. Their recommendation suggests the trial is tracking toward its primary endpoint without safety concerns that would necessitate protocol changes. While Elicio remains appropriately blinded to efficacy outcomes, this independent assessment provides external validation of the therapy's potential. The anticipated disease-free survival analysis in Q4 2025 will be crucial, as it will reveal whether these impressive immunological responses translate to the clinical outcome that matters most - preventing cancer recurrence.
- ELI-002 induced mKRAS-specific T cell responses in
99% of evaluable patients (89 of 90) who were treated with the investigational vaccine immunotherapy - Robust mKRAS-specific T cell responses were observed with an average of 145.3x increase over baseline (median 44.3x; range 2.13-1310x), consistent with prior ELI-002 Phase 1 trial results
- T cell responses included both mKRAS-specific CD4 and CD8 T cells in
85% of patients
BOSTON, Sept. 17, 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 immunogenicity testing data showing that approximately
Robert Connelly, Chief Executive Officer of Elicio, commented, “We are extremely encouraged by the T cell immunogenicity data from the ongoing Phase 2 ELI-002 7P trial. The robust T cell responses observed are highly consistent with our positive Phase 1 results and further enhance our confidence in the ongoing Phase 2 trial, as T cell immune responses in ELI-002 2P and ELI-002 7P Phase 1 trials were significantly correlated with clinical activity in minimal residual disease positive (“MRD+”) patients. These important data set the stage for the final disease-free survival analysis in the AMPLIFY-7P trial, which is anticipated to occur in the fourth quarter of 2025.”
Phase 2 AMPLIFY-7P Immunogenicity Data
| ELI-002 7P (1.4mg & 4.9mg) | ELI-002 7P (4.9 mg) | |
| Phase 1 (n=12) | Phase 2 (n=90) | |
| Patients | MRD+ only | MRD+ & MRD- |
| mKRAS T Cell Response | ||
| T cell Response Rate (%, n) | ||
| Average Fold Changea | 71.1x | 145.3x |
| Median Fold Changea (range) | 18.5x (4.2x to 351x) | 44.3x (2.13x to 1310x) |
| Threshold Above Which Clinical Activity was Correlated (% of Patients Above Threshold) | 9.5xc ( | TBD ( |
| Including CD4 + CD8 T cellsb | ||
| Including Response to 7 mKRAS Antigensa | ||
| Including Response to Patient Tumor Antigena | ||
| Overall Antigen Response Rated |
a Responses shown are best overall responses vs baseline for assessable patients at any timepoint during the assessment period, measured among T cell Responders; TBD = To be Determined; MRD = Minimal Residual Disease
b Measured among evaluable patients with samples assessable by Ex Vivo Intracellular Cytokine Staining assay
c McNeil L.K., et al. 1473 AMPLIFY-7P phase 1a: lymph node-targeted amphiphile therapeutic cancer vaccine in patients with high relapse risk KRAS mutated pancreatic ductal adenocarcinoma and colorectal cancer. Journal for ImmunoTherapy of Cancer. 2024;12. https://doi.org/10.1136/jitc-2024-SITC2024.1473
d Overall Antigen Response Rate calculated as the percentage of positive mKRAS-specific T cell responses among all evaluated patients against all vaccine antigens
ELI-002 2P: Data cutoff 24-Sept-24; ELI-002 7P Phase 1: Data cutoff 24-Sept-24; ELI-002 7P Phase 2: 22-Aug-25
Building on the ELI-002 2P (AMPLIFY-201) and ELI-002 7P (AMPLIFY-7P) Phase 1 trials, which enrolled only MRD+ patients, the Phase 2 AMPLIFY-7P trial also includes MRD-negative (“MRD–”) patients. If Phase 2 results are supportive, expanding to a broader population could enable more PDAC patients to benefit from the vaccine, and also enhance the commercial opportunity for Elicio.
The Company recently published updated Phase 1 ELI-002 2P (AMPLIFY-201) data in Nature Medicine. The results showed that an mKRAS-specific T cell response of approximately 9x over baseline was correlated with clinical activity, including delayed relapse or death in MRD+ patients (i.e., patients who are ctDNA positive or have increased serum tumor biomarkers, such as CA19-9, following completion of locoregional therapy). Responses, including both CD4 and CD8 T cell subsets, showed further correlation with clinical activity.
An Independent Data Monitoring Committee (“IDMC”), following its pre-specified interim review of the unblinded safety and efficacy data in the Company’s Phase 2 AMPLIFY-7P trial, recently recommended that the trial continue to the final analysis without modifications, which Elicio believes is an indication that ELI-002 7P has shown preliminary signals of efficacy.
The Company remains blinded to the Phase 2 trial clinical efficacy outcomes and to any correlation between observed T cell responses and antitumor response in patients.
About ELI-002
Elicio’s lead product candidate, ELI-002, is a structurally novel investigational Amphiphile (“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.
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 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
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 final disease-free survival analysis of the Phase 2 AMPLIFY-7P clinical trial; the potential of Elicio’s product candidates and the anticipated benefits and goals of Elicio’s AMP platform, approaches and technology, including the significant correlation of T-cell immune responses with ELI-002 2P and ELI-002 7P in Elicio’s Phase 1 trials with clinical activity in MRD+ patients; the potential for any correlation between the immunogenicity data from the Phase 2 AMPLIFY-7P trial and clinical efficacy outcomes; Elicio’s belief that the IDMC’s recommendation that the Phase 2 AMPLIFY-7P trial continue to the final analysis without modifications indicates that ELI-002 7P has shown preliminary signals of efficacy; the potential to expand to a broader population with supportive Phase 2 results, to enable more PDAC patients to benefit from the vaccine and to expand Elicio’s commercial opportunity; the potential for future expansion of ELI-002 to other indications, including mKRAS positive lung cancer and other mKRAS positive cancers; 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 disease-free survival 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; Elicio’s estimates regarding future revenue, expenses, capital requirements and need for additional financing; 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 uses 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 Elicio’s 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.
New factors emerge from time to time, and it is not possible for Elicio to predict all such factors, nor can Elicio 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, Elicio’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 13, 2025, and Elicio’s 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
FAQ
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