Elevation Oncology Presents Preclinical Proof-of-Concept Data for EO-1022 at the American Association for Cancer Research (AACR) Annual Meeting 2025
Elevation Oncology (ELEV) has unveiled preclinical proof-of-concept data for EO-1022, their novel HER3 antibody-drug conjugate (ADC), at the AACR Annual Meeting 2025. EO-1022 is designed with glycan site-specific conjugation and MMAE payloads to treat various solid tumors.
The preclinical data demonstrates that EO-1022 features enhanced stability and anti-tumor activity compared to benchmark HER3 ADCs. Key findings include:
- High stability in human serum with a homogenous drug-to-antibody ratio of 4
- Minimal free payload exposure compared to other HER3 ADCs
- Potent in vitro cytotoxicity dependent on HER3 expression levels
- Anti-tumor activity across various HER3 expression levels, including low HER3-expressing EGFR-mutant lung cancer
The company plans to file an Investigational New Drug (IND) application for EO-1022 in 2026, targeting HER3-expressing tumors, including breast cancer and non-small cell lung cancer.
Elevation Oncology (ELEV) ha presentato dati preclinici di proof-of-concept per EO-1022, il loro nuovo anticorpo coniugato a farmaco (ADC) specifico per HER3, durante l'AACR Annual Meeting 2025. EO-1022 è progettato con coniugazione specifica al sito glicano e carichi MMAE per trattare diversi tumori solidi.
I dati preclinici mostrano che EO-1022 presenta una maggiore stabilità e attività antitumorale rispetto agli ADC HER3 di riferimento. I risultati principali includono:
- Alta stabilità nel siero umano con un rapporto omogeneo droga-anticorpo pari a 4
- Minima esposizione al carico libero rispetto ad altri ADC HER3
- Potente citotossicità in vitro dipendente dai livelli di espressione di HER3
- Attività antitumorale su diversi livelli di espressione di HER3, incluso il cancro polmonare mutato EGFR con bassa espressione di HER3
L’azienda prevede di presentare una domanda di Investigational New Drug (IND) per EO-1022 nel 2026, indirizzandolo verso tumori che esprimono HER3, inclusi il cancro al seno e il carcinoma polmonare non a piccole cellule.
Elevation Oncology (ELEV) ha presentado datos preclínicos de prueba de concepto para EO-1022, su nuevo anticuerpo conjugado a fármaco (ADC) dirigido a HER3, en la Reunión Anual AACR 2025. EO-1022 está diseñado con conjugación específica en sitios de glicanos y cargas útiles de MMAE para tratar diversos tumores sólidos.
Los datos preclínicos demuestran que EO-1022 ofrece mayor estabilidad y actividad antitumoral en comparación con los ADC HER3 de referencia. Los hallazgos clave incluyen:
- Alta estabilidad en suero humano con una relación homogénea de fármaco a anticuerpo de 4
- Mínima exposición a carga libre en comparación con otros ADC HER3
- Potente citotoxicidad in vitro dependiente de los niveles de expresión de HER3
- Actividad antitumoral en varios niveles de expresión de HER3, incluyendo cáncer de pulmón mutante EGFR con baja expresión de HER3
La compañía planea presentar una solicitud de Nuevo Fármaco en Investigación (IND) para EO-1022 en 2026, dirigida a tumores que expresan HER3, incluyendo cáncer de mama y cáncer de pulmón no microcítico.
Elevation Oncology (ELEV)는 2025년 AACR 연례회의에서 새로운 HER3 항체-약물 접합체(ADC)인 EO-1022의 전임상 개념 증명 데이터를 공개했습니다. EO-1022는 글리칸 부위 특이적 접합과 MMAE 탑재체를 이용해 다양한 고형암을 치료하도록 설계되었습니다.
전임상 데이터는 EO-1022가 기존 HER3 ADC 대비 향상된 안정성과 항종양 활성을 가진다는 것을 보여줍니다. 주요 결과는 다음과 같습니다:
- 동질적인 약물-항체 비율 4로 인간 혈청 내 높은 안정성
- 다른 HER3 ADC에 비해 자유 탑재체 노출 최소화
- HER3 발현 수준에 따른 강력한 시험관 내 세포 독성
- 낮은 HER3 발현 EGFR 변이 폐암을 포함한 다양한 HER3 발현 수준에서의 항종양 활성
회사는 2026년에 EO-1022에 대한 임상시험용 신약(IND) 신청을 계획하고 있으며, HER3 발현 종양, 유방암 및 비소세포폐암을 대상으로 합니다.
Elevation Oncology (ELEV) a dévoilé des données précliniques de preuve de concept pour EO-1022, leur nouvel anticorps conjugué à un médicament (ADC) ciblant HER3, lors de la réunion annuelle AACR 2025. EO-1022 est conçu avec une conjugaison spécifique au site glycanique et des charges MMAE pour traiter divers tumeurs solides.
Les données précliniques montrent qu’EO-1022 présente une stabilité améliorée et une activité antitumorale supérieure aux ADC HER3 de référence. Les résultats clés incluent :
- Haute stabilité dans le sérum humain avec un ratio médicament-anticorps homogène de 4
- Exposition minimale à la charge libre comparée à d’autres ADC HER3
- Puissante cytotoxicité in vitro dépendante du niveau d’expression de HER3
- Activité antitumorale sur différents niveaux d’expression de HER3, y compris le cancer du poumon muté EGFR avec faible expression de HER3
L’entreprise prévoit de déposer une demande d’Investigational New Drug (IND) pour EO-1022 en 2026, ciblant les tumeurs exprimant HER3, notamment les cancers du sein et du poumon non à petites cellules.
Elevation Oncology (ELEV) hat auf der AACR-Jahrestagung 2025 präklinische Proof-of-Concept-Daten für EO-1022, ihren neuartigen HER3-Antikörper-Wirkstoff-Konjugat (ADC), vorgestellt. EO-1022 ist mit glykan-spezifischer Konjugation und MMAE-Wirkstoffen entwickelt, um verschiedene solide Tumore zu behandeln.
Die präklinischen Daten zeigen, dass EO-1022 im Vergleich zu Benchmark-HER3-ADCs eine verbesserte Stabilität und antitumorale Aktivität aufweist. Zentrale Ergebnisse sind:
- Hohe Stabilität im menschlichen Serum mit einem homogenen Wirkstoff-zu-Antikörper-Verhältnis von 4
- Minimale freie Wirkstofffreisetzung im Vergleich zu anderen HER3-ADCs
- Starke in-vitro-Zytotoxizität abhängig vom HER3-Expressionsniveau
- Antitumorale Aktivität bei verschiedenen HER3-Expressionsniveaus, einschließlich EGFR-mutiertem Lungenkrebs mit niedriger HER3-Expression
Das Unternehmen plant, 2026 einen Antrag auf Erlaubnis zur klinischen Prüfung (IND) für EO-1022 einzureichen, mit dem Ziel HER3-exprimierende Tumore, darunter Brustkrebs und nicht-kleinzelligen Lungenkrebs, zu behandeln.
- Demonstrated enhanced stability and anti-tumor activity in preclinical studies
- Potential for improved safety profile due to minimal systemic exposure to free payload
- Shows efficacy across various HER3 expression levels, expanding potential patient population
- Clear development timeline with IND filing planned for 2026
- Still in early preclinical stage with no human trial data
- IND filing not expected until 2026, indicating lengthy timeline to market
- Will face competition from existing HER3 ADCs in development
Insights
Elevation's novel HER3 ADC shows promising preclinical stability and anti-tumor activity, but remains years from clinical development.
Elevation Oncology's presentation of preclinical data for EO-1022 represents a meaningful early milestone in their cancer therapy pipeline. The site-specific glycan conjugation approach shows technical advantages over conventional stochastic conjugation methods used in benchmark HER3 ADCs, potentially addressing a key limitation in ADC development. Their data demonstrates superior stability in human serum with a homogeneous drug-to-antibody ratio of 4 and minimal free payload release.
The technical significance here is substantial: conventional ADCs typically suffer from heterogeneity in payload attachment, which can compromise therapeutic index through inconsistent drug delivery and increased toxicity. EO-1022's design, utilizing the validated MMAE payload with site-specific conjugation, potentially offers a more precise therapeutic approach.
Particularly noteworthy is the compound's demonstrated activity across varying levels of HER3 expression, including low-expressing tumors. This suggests potential versatility across multiple indications, including the specifically mentioned breast cancer and non-small cell lung cancer markets.
While these results are encouraging, investors should recognize this remains early-stage research with IND filing targeted for 2026, placing any potential approval and commercialization several years away. The data supports Elevation's technological approach but represents just one step in a lengthy development journey that will require successful translation to human clinical trials to validate these preclinical observations.
-- EO-1022 is a potentially differentiated HER3 ADC designed to address significant unmet needs across multiple
solid tumors --
-- On-track to file IND application in 2026 --
"We designed EO-1022 with several notable features, including glycan site-specific conjugation and MMAE payloads, in order to address the significant need for a novel HER3 ADC that can potentially deliver improved efficacy and safety to patients with a range of solid tumors," said Joseph Ferra, President and Chief Executive Officer of Elevation Oncology. "Today, we are excited to share preclinical proof-of-concept data for EO-1022, which indicate enhanced stability and anti-tumor activity than benchmark HER3 ADCs in the models tested in vitro and in vivo. We believe these findings support the potential of EO-1022 in treating multiple HER3-expressing cancers and look forward to progressing this program toward the clinic."
EO-1022 is an ADC containing seribantumab, a fully human IgG2 anti-HER3 monoclonal antibody, which is site-specifically conjugated at glycan to the monomethyl auristatin E (MMAE) payload with a drug-to-antibody ratio (DAR) of 4. Elevation Oncology designed EO-1022 leveraging the site-specific ADC technology platform licensed from Synaffix B.V. Elevation Oncology is developing EO-1022 for the treatment of solid tumors that express HER3, including breast cancer and non-small cell lung cancer. Elevation Oncology expects to file an Investigational New Drug (IND) application for EO-1022 in 2026.
In a poster titled, "Preclinical discovery and characterization of EO-1022, a site-specific glycan-conjugated anti-HER3 vc-MMAE ADC for treating solid tumors," Elevation Oncology scientists will present in vitro and in vivo data that show:
- EO-1022 is highly stable in human serum, with a homogenous DAR of 4 and minimal free payload compared to seribantumab-vcMMAE and patritumab-DXd, two benchmark HER3 ADCs, both of which use stochastic conjugation. These findings illustrate that a key feature of EO-1022 is minimal systemic exposure to free payload, potentially resulting in reduced payload-associated toxicity in patients and an improved safety profile.
- EO-1022 exhibits potent in vitro cytotoxicity that is dependent on HER3 expression levels.
- EO-1022 elicits anti-tumor activity in in vivo models of low, medium and high HER3 expression levels, including in a patient derived xenograft (PDX) model of low HER3-expressing EGFR-mutant lung cancer.
The poster presentation is now available in the "Publications" section of Elevation Oncology's website: https://elevationoncology.com/resources/publications/.
About EO-1022
Elevation Oncology is developing EO-1022, a potentially differentiated HER3 ADC for the treatment of HER3-expressing solid tumors, including breast cancer and non-small cell lung cancer. EO-1022 consists of seribantumab, a fully human IgG2 anti-HER3 antibody, site-specifically conjugated at glycan to the MMAE payload with a DAR of 4. It leverages seribantumab's desirable internalization properties and advanced site-specific ADC technology which makes possible the use of the potent cytotoxic MMAE payload. Elevation Oncology expects to file an IND application in 2026.
About Elevation Oncology, Inc.
Elevation Oncology is an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs. We are leveraging our antibody-drug conjugate (ADC) expertise to advance EO-1022, a HER3 ADC for the treatment of patients with HER3-expressing solid tumors. EO-1022 is currently progressing through preclinical development, with an investigational new drug (IND) application expected in 2026. For more information, visit www.ElevationOncology.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, anticipated clinical and preclinical development activities, expected timing of regulatory filings, potential benefits of product candidates, potential market opportunities for product candidates and the ability of product candidates to treat their targeted indications. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These forward-looking statements may be accompanied by such words as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "might," "plan," "possible," "potential," "will," "would," and other words and terms of similar meaning. Although Elevation Oncology believes that the expectations reflected in such forward-looking statements are reasonable, Elevation Oncology cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval are inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause Elevation Oncology's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to Elevation Oncology's ability to advance its product candidates, the timing and results of preclinical studies and clinical trials, approvals and commercialization of product candidates, the receipt and timing of potential regulatory designations, Elevation Oncology's ability to fund development activities and achieve development goals, Elevation Oncology's ability to protect intellectual property, Elevation Oncology's ability to establish and maintain collaborations with third parties, and other risks and uncertainties described under the heading "Risk Factors" in documents Elevation Oncology files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and Elevation Oncology undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.
Elevation Oncology Investor and Media Contact
Gracie Tong
Senior Director, Investor Relations and Corporate Communications
gtong@elevationoncology.com
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SOURCE Elevation Oncology
FAQ
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