Elicio Therapeutics Reaches Alignment with FDA on ELI-002 Registrational Strategy
Elicio Therapeutics (ELTX) has received supportive FDA feedback regarding the registrational strategy for its cancer immunotherapy candidate ELI-002. The FDA alignment covers key elements of the potential Phase 3 study design, including dose, schedule, patient population (KRAS-mutated pancreatic adenocarcinoma), and primary endpoint analysis of disease-free survival.
The company's Phase 2 randomized study of ELI-002 is fully enrolled, with a formal interim analysis of disease-free survival expected in H1 2025. Positive results could support rapid advancement into Phase 3 development. The therapy has shown encouraging clinical results with a favorable safety profile and strong correlation between T cell response, tumor biomarker reductions, and reduced risk of recurrence or death.
ELI-002 is being developed as an off-the-shelf monotherapy for patients who completed chemotherapy but remain at elevated risk of disease recurrence.
Elicio Therapeutics (ELTX) ha ricevuto riscontri positivi dalla FDA riguardo alla strategia di registrazione per il suo candidato immunoterapico contro il cancro ELI-002. L'allineamento con la FDA copre elementi chiave del potenziale design dello studio di Fase 3, inclusi dose, programma, popolazione di pazienti (adenocarcinoma pancreatic KRAS-mutato) e analisi dell'endpoint primario della sopravvivenza senza malattia.
Lo studio randomizzato di Fase 2 dell'azienda su ELI-002 è completamente arruolato, con un'analisi intermedia formale della sopravvivenza senza malattia prevista per la prima metà del 2025. Risultati positivi potrebbero supportare un rapido avanzamento verso lo sviluppo della Fase 3. La terapia ha mostrato risultati clinici promettenti con un profilo di sicurezza favorevole e una forte correlazione tra la risposta delle cellule T, le riduzioni dei biomarcatori tumorali e il rischio ridotto di recidiva o morte.
ELI-002 è in fase di sviluppo come monoterapia pronta all'uso per i pazienti che hanno completato la chemioterapia ma rimangono a rischio elevato di recidiva della malattia.
Elicio Therapeutics (ELTX) ha recibido comentarios de apoyo de la FDA sobre la estrategia de registro para su candidato a inmunoterapia contra el cáncer ELI-002. La alineación con la FDA abarca elementos clave del potencial diseño del estudio de Fase 3, incluidos la dosis, el calendario, la población de pacientes (adenocarcinoma pancreático mutado por KRAS) y el análisis del punto final primario de supervivencia libre de enfermedad.
El estudio aleatorizado de Fase 2 de la empresa sobre ELI-002 está completamente inscrito, con un análisis interino formal de la supervivencia libre de enfermedad esperado para la primera mitad de 2025. Resultados positivos podrían apoyar un avance rápido hacia el desarrollo de la Fase 3. La terapia ha mostrado resultados clínicos alentadores con un perfil de seguridad favorable y una fuerte correlación entre la respuesta de las células T, las reducciones de los biomarcadores tumorales y el riesgo reducido de recurrencia o muerte.
ELI-002 se está desarrollando como una monoterapia lista para usar para pacientes que han completado la quimioterapia pero siguen en alto riesgo de recurrencia de la enfermedad.
엘리시오 테라퓨틱스 (ELTX)는 암 면역 요법 후보인 ELI-002의 등록 전략에 대해 FDA의 지지를 받았습니다. FDA의 협의는 잠재적인 3상 연구 설계의 주요 요소인 용량, 일정, 환자 집단(KRAS 변이 췌장 선암), 그리고 질병 없는 생존 분석의 주요 목표를 포함합니다.
회사의 ELI-002에 대한 2상 무작위 연구는 완전히 등록되었으며, 질병 없는 생존에 대한 공식 중간 분석이 2025년 상반기에 예상됩니다. 긍정적인 결과는 3상 개발로의 빠른 진전을 지원할 수 있습니다. 이 요법은 임상 결과가 고무적이며, 안전성 프로필이 우수하고 T 세포 반응, 종양 바이오마커 감소, 재발 또는 사망 위험 감소 간의 강한 상관관계를 보여주었습니다.
ELI-002는 화학요법을 완료했지만 질병 재발 위험이 높은 환자를 위한 준비된 단일 요법으로 개발되고 있습니다.
Elicio Therapeutics (ELTX) a reçu des retours positifs de la FDA concernant la stratégie d'enregistrement de son candidat en immunothérapie contre le cancer ELI-002. L'accord avec la FDA couvre des éléments clés de la conception potentielle de l'étude de phase 3, incluant la dose, le calendrier, la population de patients (adénocarcinome du pancréas muté KRAS) et l'analyse du critère principal de survie sans maladie.
L'étude randomisée de phase 2 de l'entreprise sur ELI-002 est entièrement enrôlée, avec une analyse intermédiaire formelle de la survie sans maladie attendue pour le premier semestre 2025. Des résultats positifs pourraient soutenir une avancée rapide vers le développement de la phase 3. La thérapie a montré des résultats cliniques encourageants avec un bon profil de sécurité et une forte corrélation entre la réponse des cellules T, les réductions des biomarqueurs tumoraux et le risque réduit de récidive ou de décès.
ELI-002 est en cours de développement comme une monothérapie prête à l'emploi pour les patients ayant terminé la chimiothérapie mais restant à risque élevé de récidive de la maladie.
Elicio Therapeutics (ELTX) hat positives Feedback von der FDA zur Registrierungsstrategie für seinen Krebsimmuntherapiekandidaten ELI-002 erhalten. Die Übereinstimmung mit der FDA umfasst wichtige Elemente des potenziellen Designs der Phase-3-Studie, einschließlich Dosis, Zeitplan, Patientenkollektiv (KRAS-mutiertes Pankreasadenokarzinom) und primäre Endpunktanalyse des progressionsfreien Überlebens.
Die Phase-2-randomisierte Studie zu ELI-002 des Unternehmens ist vollständig eingeschlossen, wobei eine formale Zwischenanalyse des progressionsfreien Überlebens für das erste Halbjahr 2025 erwartet wird. Positive Ergebnisse könnten einen schnellen Übergang in die Phase-3-Entwicklung unterstützen. Die Therapie hat ermutigende klinische Ergebnisse mit einem günstigen Sicherheitsprofil und einer starken Korrelation zwischen T-Zell-Reaktion, Tumor-Biomarker-Reduktionen und reduziertem Risiko für Rückfall oder Tod gezeigt.
ELI-002 wird als sofort einsetzbare Monotherapie für Patienten entwickelt, die die Chemotherapie abgeschlossen haben, aber weiterhin ein erhöhtes Risiko für einen Rückfall der Erkrankung aufweisen.
- FDA alignment on Phase 3 study design elements
- Phase 2 study fully enrolled with interim analysis expected H1 2025
- Favorable safety profile demonstrated in clinical results
- Strong correlation between T cell response and reduced risk of recurrence
- Phase 3 approval still contingent on positive Phase 2 results
- Final FDA approval requires successful completion of planned Phase 3 trial
Insights
The FDA's supportive feedback on Elicio's ELI-002 Phase 3 trial design marks a crucial de-risking event for the company's development program. FDA alignment at this stage typically reduces the risk of costly trial redesigns and potential delays, while also providing a clearer path to market. The agency's acceptance of disease-free survival as the primary endpoint is particularly noteworthy, as it could potentially enable a faster path to approval compared to overall survival endpoints.
The focus on KRAS-mutated pancreatic adenocarcinoma represents a strategic choice targeting a significant unmet medical need. KRAS mutations are found in approximately 90% of pancreatic cancers and have historically been considered 'undruggable,' making this an attractive market opportunity. The positioning of ELI-002 as an off-the-shelf monotherapy for post-chemotherapy patients addresses a critical treatment gap where patients remain at high risk of recurrence.
The upcoming H1 2025 interim analysis of the Phase 2 AMPLIFY-7P study represents a major catalyst for the company. Previous data showing correlation between T cell response, tumor biomarker reductions and improved clinical outcomes provides encouraging signals for the therapy's potential efficacy. The rapid progression to Phase 3 following positive interim results could accelerate the development timeline significantly.
From a risk perspective, investors should note that while FDA alignment on trial design is positive, it doesn't guarantee clinical success or eventual approval. The company's
Received supportive FDA feedback on key elements of the potential ELI-002 Phase 3 study design, including dose, schedule, patient population and primary endpoint analysis
Phase 2 randomized study of ELI-002 fully enrolled, with formal interim analysis of disease-free survival (“DFS”) expected in H1 2025; positive results could support rapid advancement into Phase 3 development
BOSTON, Jan. 22, 2025 (GLOBE NEWSWIRE) -- Elicio Therapeutics, Inc. (Nasdaq: ELTX, “Elicio Therapeutics” or “Elicio”), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, today announced that it has received supportive feedback in an End of Phase 1 Type B meeting with the U.S. Food and Drug Administration (“FDA”) regarding the registrational strategy for ELI-002. Based on the feedback received, Elicio would expect to file a Biologics License Application (“BLA”) if supported by a planned Phase 3 trial.
“The feedback received from the FDA supports our proposed Phase 3 study design, is strongly aligned with our therapeutic approach and is another step forward in our effort to bring this cancer immunotherapy forward to patients,” said Christopher Haqq, M.D., Ph.D., Executive Vice President, Head of Research and Development and Chief Medical Officer of Elicio. “In a recent Type B meeting, we obtained alignment with the FDA on the principal elements of the Phase 3 study design, including the dose, dosing schedule, target patient population (KRAS-mutated pancreatic adenocarcinoma) and the primary study endpoint of disease-free survival, based on modified RECIST criteria.”
Robert Connelly, Chief Executive Officer of Elicio, commented, “We believe that ELI-002 could have a transformational role in the management of difficult-to-treat mKRAS cancers as an off-the-shelf monotherapy treatment for patients who completed neoadjuvant, perioperative or adjuvant chemotherapy and yet remain at elevated risk of disease recurrence. The continued development of ELI-002 is supported by encouraging clinical results that have demonstrated a favorable safety profile, a strong correlation between T cell response, tumor biomarker reductions and reduced risk of recurrence or death. Our ongoing Phase 2 AMPLIFY-7P study, which is fully enrolled, remains on track for a pre-planned interim data analysis in H1 2025. If these results are positive, we intend to rapidly advance the program into a Phase 3 study, which could potentially support regulatory approval.”
About Elicio Therapeutics
Elicio Therapeutics, Inc. (Nasdaq: ELTX) is a clinical-stage biotechnology company advancing novel immunotherapies to prevent the recurrence 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. In preclinical models, Elicio observed lymph node-specific engagement driving immune responses of increased magnitude, function and durability.
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 planned clinical trials, the potential of Elicio’s product candidates, including the potential transformational role ELI-002 could have in the management of difficult-to-treat cancers 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, including advancing ELI-002 into a Phase 3 study and the potential of such study to support regulatory approval; supportive feedback from regulatory authorities like the FDA; the timing of the availability of data from Elicio’s clinical trials, including the timing of the pre-planned interim Phase 2 AMPLIFY-7P data analysis in the first half 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 in the Annual Report on Form 10-K filed with the SEC on March 29, 2024, as amended on April 29, 2024, under the heading “Risk Factors”, and any 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
Carlo Tanzi, Ph.D.
ctanzi@kendallir.com
FAQ
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