Elicio Therapeutics Presents Updated Results from ELI-002 Phase 1 AMPLIFY-201 Study at ESMO Immuno-Oncology Congress 2024
Elicio Therapeutics (ELTX) presented updated Phase 1 AMPLIFY-201 trial results for ELI-002, their cancer vaccine targeting KRAS-mutant tumors. With 19.7 months median follow-up, the study showed 16.3-month median recurrence-free survival (mRFS) and 28.9-month median overall survival (mOS) in the full study population of 25 patients with colorectal or pancreatic cancer.
The trial demonstrated strong correlation between T cell response and survival outcomes. Patients with above-median T cell responses hadn't reached mRFS, while those below median achieved 4.0-month mRFS. The vaccine showed favorable safety profile with no Grade 3/4 adverse events. ELI-002's seven-peptide formulation is currently in Phase 2 trials, with interim analysis expected in H1 2025.
Elicio Therapeutics (ELTX) ha presentato i risultati aggiornati della fase 1 dello studio AMPLIFY-201 per ELI-002, il loro vaccino contro il cancro mirato ai tumori mutanti KRAS. Con un follow-up mediano di 19,7 mesi, lo studio ha mostrato un tasso di sopravvivenza libera da recidive mediana (mRFS) di 16,3 mesi e un tasso di sopravvivenza globale mediano (mOS) di 28,9 mesi nella popolazione totale di 25 pazienti affetti da cancro colorettale o pancreatico.
La sperimentazione ha dimostrato una forte correlazione tra la risposta delle cellule T e i risultati di sopravvivenza. I pazienti con risposte delle cellule T superiori alla mediana non avevano raggiunto l'mRFS, mentre quelli sotto la mediana hanno ottenuto un mRFS di 4,0 mesi. Il vaccino ha mostrato un profilo di sicurezza favorevole, senza eventi avversi di grado 3/4. La formulazione a sette peptidi di ELI-002 è attualmente in fase 2 di sperimentazione, con un'analisi intermedia prevista per la prima metà del 2025.
Elicio Therapeutics (ELTX) presentó resultados actualizados del ensayo de fase 1 AMPLIFY-201 para ELI-002, su vacuna contra el cáncer dirigida a tumores mutantes de KRAS. Con un seguimiento medio de 19,7 meses, el estudio mostró una supervivencia libre de recaídas mediana (mRFS) de 16,3 meses y una supervivencia global mediana (mOS) de 28,9 meses en la población total de 25 pacientes con cáncer colorrectal o pancreático.
El ensayo demostró una fuerte correlación entre la respuesta de células T y los resultados de supervivencia. Los pacientes con respuestas de células T superiores a la mediana no habían alcanzado la mRFS, mientras que aquellos por debajo de la mediana lograron una mRFS de 4,0 meses. La vacuna mostró un perfil de seguridad favorable sin eventos adversos de grado 3/4. La formulación de siete péptidos de ELI-002 está actualmente en ensayos de fase 2, con un análisis intermedio esperado para la primera mitad de 2025.
엘리시오 테라퓨틱스 (ELTX)는 KRAS 돌연변이 종양을 표적으로 하는 암 백신 ELI-002에 대한 AMPLIFY-201 임상 시험의 1상 업데이트 결과를 발표했습니다. 19.7개월의 중앙 추적 관찰 기간 동안, 연구는 25명의 대장암 또는 췌장암 환자 전체에서 16.3개월의 재발 없는 생존 중앙값 (mRFS)과 28.9개월의 전체 생존 중앙값 (mOS)을 보여주었습니다.
이번 임상 시험에서는 T 세포 반응과 생존 결과 간의 강한 상관관계를 입증하였습니다. 중앙값 이상의 T 세포 반응을 보인 환자는 mRFS에 도달하지 못했으며, 중앙값 이하의 환자는 4.0개월의 mRFS를 달성했습니다. 이 백신은 3/4 등급의 부작용 없이 우수한 안전성 프로필을 보여주었습니다. ELI-002의 7개 펩타이드 조성물은 현재 2상 시험 중이며, 2025년 상반기 중간 분석이 예상됩니다.
Elicio Therapeutics (ELTX) a présenté les résultats mis à jour de l'essai de phase 1 AMPLIFY-201 pour ELI-002, leur vaccin contre le cancer ciblant les tumeurs mutées KRAS. Avec un suivi médian de 19,7 mois, l'étude a montré une surduration médiane sans récidive (mRFS) de 16,3 mois et une surduration globale médiane (mOS) de 28,9 mois dans l'ensemble de la population étudiée de 25 patients atteints de cancer colorectal ou pancréatique.
L'essai a démontré une forte corrélation entre la réponse des cellules T et les résultats de survie. Les patients avec des réponses de cellules T supérieures à la médiane n'avaient pas atteint la mRFS, tandis que ceux sous la médiane ont obtenu une mRFS de 4,0 mois. Le vaccin a présenté un profil de sécurité favorable sans événements indésirables de grade 3/4. La formulation à sept peptides d'ELI-002 est actuellement en phase 2 d'essai, avec une analyse intérimaire prévue pour le premier semestre 2025.
Elicio Therapeutics (ELTX) hat aktualisierte Ergebnisse der Phase-1-Studie AMPLIFY-201 für ELI-002, ihren Impfstoff gegen Krebs, der auf KRAS-mutierte Tumoren abzielt, vorgestellt. Bei einer medianen Nachbeobachtungszeit von 19,7 Monaten zeigte die Studie eine mediane rezidivfreie Überlebenszeit (mRFS) von 16,3 Monaten und eine mediane Gesamtüberlebenszeit (mOS) von 28,9 Monaten in der gesamten Studienteilnehmergruppe von 25 Patienten mit kolorektalem oder Pankreaskrebs.
Die Studie zeigte eine starke Korrelation zwischen der T-Zell-Reaktion und den Überlebensresultaten. Patienten mit übermedianen T-Zell-Reaktionen hatten die mRFS noch nicht erreicht, während die unter der Medianreaktion 4,0 Monate mRFS erzielten. Der Impfstoff zeigte ein günstiges Sicherheitsprofil ohne Grad-3/4-Nebenwirkungen. Die sieben-Peptid-Formulierung von ELI-002 befindet sich derzeit in Phase-2-Studien, mit einer Zwischenanalyse, die für das erste Halbjahr 2025 erwartet wird.
- Strong survival data with 16.3-month mRFS and 28.9-month mOS
- Favorable safety profile with no Grade 3/4 adverse events
- Strong correlation between T cell response and survival outcomes
- Phase 2 trial fully enrolled with interim analysis expected H1 2025
- Below-median T cell responders showed only 4.0-month mRFS
- sample size of 25 patients in Phase 1 trial
Insights
The updated Phase 1 results for ELI-002 demonstrate compelling clinical potential in KRAS-mutant cancers. The 16.3-month median recurrence-free survival and 28.9-month median overall survival are particularly noteworthy for high-risk pancreatic and colorectal cancer patients. The strong correlation between T cell response and survival outcomes provides important validation of the vaccine's mechanism of action.
Most significantly, patients with above-median T cell responses haven't reached median RFS, while those with below-median responses showed only 4.0-month RFS (HR=0.226; p=0.0184). This stark difference suggests the vaccine's effectiveness is directly tied to immune response strength. The favorable safety profile with no Grade 3/4 adverse events further enhances the risk-benefit ratio.
The data from AMPLIFY-201 is particularly impressive for pancreatic cancer patients, where the 28.9-month median overall survival compares favorably to historical controls. The consistent efficacy across both pancreatic (PDAC) and colorectal (CRC) cancer cohorts suggests broad applicability in KRAS-mutant tumors. The biomarker reductions and T cell responses indicate successful targeting of minimal residual disease, a critical factor in preventing recurrence.
Looking ahead, the seven-peptide formulation (ELI-002 7P) in Phase 2 could potentially address an even broader spectrum of KRAS mutations, expanding the therapeutic potential. The upcoming interim analysis in H1 2025 will be important for validating these promising early results in a randomized setting.
Updated Phase 1 data include a 16.3-month median recurrence-free survival (“mRFS”) and 28.9-month median overall survival (“mOS”) from full study population
Strong correlation observed between mRFS and strength of T cell response
Event-driven interim analysis from randomized Phase 2 trial expected in H1 2025
BOSTON, Dec. 12, 2024 (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, presented updated results from the Phase 1 AMPLIFY-201 clinical trial (NCT04853017) of ELI-002, an Amphiphile (“AMP”) cancer vaccine that targets KRAS-mutant tumors, at the ESMO Immuno-Oncology Congress 2024 in Geneva, Switzerland. ELI-002 was evaluated in individuals with mutant KRAS (“mKRAS”)-driven colorectal or pancreatic cancer with residual circulating tumor DNA and/or serum tumor biomarkers, who remain at high risk of disease recurrence following standard locoregional treatment. The updated clinical results, featured in an oral presentation by Shubham Pant, M.D., MBBS, of the University of Texas, MD Anderson Cancer Center, build upon earlier results published in Nature Medicine. With a median study follow-up of 19.7 months, ELI-002 continues to show a favorable safety profile, the ability to elicit mKRAS-specific T cell responses in most patients, and encouraging efficacy data with respect to mRFS and mOS.
Christopher Haqq, M.D., Ph.D., Elicio’s Executive Vice President, Head of Research and Development and Chief Medical Officer, added, “With longer follow-up from AMPLIFY-201, we are encouraged that individuals who received ELI-002 are continuing to do well, exceeding expectations based on historical cohorts of similar populations with KRAS-mutant pancreatic and colorectal cancers. Furthermore, these data show a strong correlation between T cell response, tumor biomarker reductions, and reduced risk of progression or death—which was also observed in the Phase 1 portion of our AMPLIFY-7P trial. As we continue working to bring this potentially transformative off-the-shelf vaccine to cancer patients, we look forward to the interim analysis of the randomized Phase 2 portion of AMPLIFY-7P, expected in the first half of 2025.”
AMPLIFY-201 is a multicenter, open-label, dose-ranging Phase 1 study designed to evaluate the safety and tolerability of the ELI-002 two-peptide formulation (ELI-002 2P). The trial enrolled a total of 25 individuals—including 20 with pancreatic ductal adenocarcinoma (“PDAC”) and five with colorectal cancer (“CRC”). To qualify for enrollment, all study patients underwent successful (R0/R1) surgical resection of tumors harboring two common KRAS mutations (G12D and G12R) but remained at high risk of relapse based on positive minimal residual disease (MRD) status. A seven-peptide formulation of ELI-002 (ELI-002 7P), designed to target additional KRAS mutations (G12D, G12R, G12V, G12C, G12A, G12S and G13D), is currently being evaluated in a fully-enrolled, randomized Phase 2 study (NCT05726864), which an interim analysis is expected in H1 2025.
The presentation featured updated mRFS and mOS data (data cutoff September 24, 2024) as well as previously-presented safety, immunogenicity and biomarker response data (data cutoff September 6, 2023) from 25 evaluable individuals who received doses of ELI-002 2P ranging from 0.1 mg to 10.0 mg. Key observations include:
- A 16.3-month mRFS and 28.9-month mOS for the full study cohort (n=25)
- mRFS has not yet been reached in patients with above-median T cell responses (n=13); patients who achieved below-median T cell responses (n=12) achieved a 4.0-month mRFS (HR=0.226; p=0.0184)
- Similar mRFS was observed between the PDAC subgroup (15.3 months; n=20), the CRC subgroup (16.3 months; n=5) and the full study cohort (16.3 months; n=25)
- 28.9-month mOS was identical for the PDAC subgroup and the full study cohort, comparing favorably to a historical PDAC control group (Groot et al., 2019. Clin Cancer Res 25:4973); mOS was not reached in the CRC subgroup (n=5)
- Ex vivo expansion of mKRAS-specific T cells with concomitant tumor biomarker reductions in most patients
- ELI-002 2P was well-tolerated, with no Grade 3/4 treatment-emergent adverse events, dose-limiting toxicities or cases of cytokine release syndrome observed
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 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, the expected participation and presentation at upcoming conferences and medical meetings, 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 interim analysis of the randomized Phase 2 portion of the AMPLIFY-7P trial, expected 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
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