Elevation Oncology Expands Pipeline with Nomination of EO-1022, a HER3 ADC for the Treatment of HER3-expressing Solid Tumors
Elevation Oncology (ELEV) has nominated EO-1022 as its HER3 ADC development candidate for treating HER3-expressing solid tumors. EO-1022 combines seribantumab, an anti-HER3 monoclonal antibody, with an MMAE payload using Synaffix's technology platform. The company has secured a global license agreement with Synaffix for their GlycoConnect®, HydraSpace®, and SYNstatin E™ technologies.
HER3 is expressed in various cancers including breast cancer, EGFR-mutant non-small cell lung cancer, and pancreatic cancer. The company plans to present preclinical data in 1H 2025 and file an IND application in 2026. Seribantumab has already demonstrated a well-tolerated safety profile in over 900 patients across multiple studies.
Elevation Oncology (ELEV) ha nominato EO-1022 come candidato allo sviluppo di un ADC per HER3 per il trattamento dei tumori solidi che esprimono HER3. EO-1022 combina seribantumab, un anticorpo monoclonale anti-HER3, con un payload di MMAE utilizzando la piattaforma tecnologica di Synaffix. L'azienda ha ottenuto un accordo di licenza globale con Synaffix per le loro tecnologie GlycoConnect®, HydraSpace® e SYNstatin E™.
HER3 è espresso in vari tipi di cancro, tra cui il cancro al seno, il cancro polmonare non a piccole cellule con mutazione EGFR e il cancro pancreatico. L'azienda prevede di presentare dati preclinici nella prima metà del 2025 e di presentare una domanda IND nel 2026. Seribantumab ha già dimostrato un profilo di sicurezza ben tollerato in oltre 900 pazienti in diversi studi.
Elevation Oncology (ELEV) ha nominato a EO-1022 como su candidato al desarrollo de un ADC para HER3 para tratar tumores sólidos que expresan HER3. EO-1022 combina seribantumab, un anticuerpo monoclonal anti-HER3, con una carga de MMAE utilizando la plataforma tecnológica de Synaffix. La compañía ha asegurado un acuerdo de licencia global con Synaffix para sus tecnologías GlycoConnect®, HydraSpace® y SYNstatin E™.
HER3 se expresa en varios tipos de cáncer, incluido el cáncer de mama, el cáncer de pulmón no microcítico con mutación EGFR y el cáncer de páncreas. La compañía planea presentar datos preclínicos en la primera mitad de 2025 y presentar una solicitud IND en 2026. Seribantumab ya ha demostrado un perfil de seguridad bien tolerado en más de 900 pacientes en múltiples estudios.
Elevation Oncology (ELEV)는 HER3를 발현하는 고형종양 치료를 위해 EO-1022를 HER3 ADC 개발 후보로 지정했습니다. EO-1022는 Synaffix의 기술 플랫폼을 이용하여 anti-HER3 단일클론항체인 seribantumab과 MMAE 페이로드를 결합합니다. 이 회사는 Synaffix의 GlycoConnect®, HydraSpace® 및 SYNstatin E™ 기술에 대한 전 세계 라이센스 계약을 체결했습니다.
HER3는 유방암, EGFR 돌연변이를 가진 비소세포 폐암, 췌장암 등 다양한 암에서 발현됩니다. 이 회사는 2025년 상반기에 전임상 데이터를 발표할 계획이며 2026년에 IND 신청을 할 예정입니다. Seribantumab은 여러 연구에서 900명 이상의 환자에게서 잘 견뎌진 안전성 프로파일을 이미 입증했습니다.
Elevation Oncology (ELEV) a nommé EO-1022 comme son candidat au développement d'un ADC HER3 pour traiter les tumeurs solides exprimant HER3. EO-1022 associe le seribantumab, un anticorps monoclonal anti-HER3, à une charge de MMAE utilisant la plateforme technologique de Synaffix. L'entreprise a sécurisé un accord de licence mondial avec Synaffix pour ses technologies GlycoConnect®, HydraSpace® et SYNstatin E™.
HER3 est exprimé dans divers cancers, y compris le cancer du sein, le cancer du poumon non à petites cellules avec mutation EGFR, et le cancer du pancréas. L'entreprise prévoit de présenter des données précliniques au premier semestre 2025 et de soumettre une demande IND en 2026. Le seribantumab a déjà démontré un profil de sécurité bien toléré chez plus de 900 patients à travers plusieurs études.
Elevation Oncology (ELEV) hat EO-1022 als Kandidaten für die Entwicklung eines HER3-ADC zur Behandlung von HER3-exprimierenden soliden Tumoren nominiert. EO-1022 kombiniert Seribantumab, einen anti-HER3-Monoklonalen Antikörper, mit einem MMAE-Payload unter Verwendung der Technologieplattform von Synaffix. Das Unternehmen hat einen globalen Lizenzvertrag mit Synaffix für deren Technologien GlycoConnect®, HydraSpace® und SYNstatin E™ gesichert.
HER3 wird in verschiedenen Krebserkrankungen exprimiert, darunter Brustkrebs, EGFR-mutiertes nicht-kleinzelliges Lungenkarzinom und Bauchspeicheldrüsenkrebs. Das Unternehmen plant, im 1. Halbjahr 2025 präklinische Daten zu präsentieren und 2026 einen IND-Antrag einzureichen. Seribantumab hat bereits ein gut toleriertes Sicherheitsprofil bei über 900 Patienten in mehreren Studien gezeigt.
- Secured exclusive global license for Synaffix's ADC technology platform
- Seribantumab already demonstrated safety in 900+ patients
- Pipeline expansion with new HER3 ADC candidate targeting multiple solid tumors
- No clinical trials before 2026 (IND filing planned)
- Early-stage development with no efficacy data available yet
Insights
The development of EO-1022 represents a significant advancement in targeted cancer therapy. The combination of seribantumab with MMAE payload using Synaffix's site-specific conjugation technology could potentially improve the therapeutic window of HER3-targeted treatment. The antibody's proven safety profile in over 900 patients provides a strong foundation for its use as an ADC.
The target selection is particularly strategic, as HER3 expression across multiple solid tumors including breast cancer, EGFR-mutant non-small cell lung cancer and pancreatic cancer suggests broad therapeutic potential. The site-specific glycan conjugation technology could offer improved stability and homogeneity compared to traditional ADC approaches, potentially leading to better efficacy and safety profiles.
The pipeline expansion through EO-1022 and the exclusive licensing agreement with Synaffix significantly strengthens Elevation Oncology's market position in the competitive ADC space. The deal structure, focusing on HER3 exclusivity with Synaffix's technology platform, provides a strategic advantage in developing potentially best-in-class ADC therapeutics. With a market cap of
The timeline to IND filing in 2026 with preclinical data expected in 1H 2025 provides clear development milestones for investors to track progress. The company's focus on leveraging proven antibody technology with advanced ADC conjugation methods could potentially reduce development risks.
-- EO-1022 is comprised of seribantumab, an anti-HER3 monoclonal antibody, and an MMAE payload –
-- Following recently signed global license agreement with Synaffix, EO-1022 leverages the company's GlycoConnect® and HydraSpace® ADC technologies for glycan site-specific conjugation and SYNstatin E™ linker-payload --
– Elevation Oncology expects to present EO-1022 preclinical data in 1H 2025 and to file an IND application in 2026 –
HER3 is a protein expressed across several types of solid tumors, including breast cancer, EGFR-mutant non-small cell lung cancer and pancreatic cancer, and often associated with poor clinical outcomes. EO-1022 is a differentiated ADC containing seribantumab, an anti-HER3 monoclonal antibody (mAb), and a monomethyl auristatin E (MMAE) payload, with site-specific conjugation to the glycan. EO-1022 is being developed for the treatment of patients living with solid tumors that express HER3.
"The nomination of our HER3-ADC development candidate marks a key milestone for Elevation Oncology in bolstering our ADC pipeline. EO-1022 combines the seribantumab antibody and state-of the-art ADC site-specific technology. We believe seribantumab is ideally-suited to be used in an ADC due to its selectivity in delivering cytotoxic payload to HER3-expressing cancer cells and its well-tolerated safety profile demonstrated in over 900 patients in multiple studies," said Joseph Ferra, President and Chief Executive Officer of Elevation Oncology. "This program is another step forward in leveraging our ADC and oncology drug development expertise to develop innovative, selective cancer therapies that address significant unmet needs. We look forward to sharing preclinical data for EO-1022 in the first half of 2025, as we continue to advance this asset toward the clinic."
Also today, Elevation Oncology announced that it has entered into a licensing agreement with Synaffix B.V. (Synaffix). This licensing agreement gives Elevation Oncology global access to Synaffix's clinical stage, site-specific ADC technology platform, including GlycoConnect® antibody conjugation technology, HydraSpace® polar spacer technology, as well as the toxSYN® linker-payload, SYNstatin E™. The license granted to GlycoConnect® and HydraSpace® technologies is exclusive to HER3 as a single target in combination with SYNstatin E® linker-payload.
"HER3 is broadly expressed in various cancer types, making it a compelling target for innovative therapeutic strategies. We believe an ADC approach is uniquely positioned to fully unlock the clinical potential of HER3," said David Dornan, Ph.D., Chief Scientific Officer of Elevation Oncology. "We are excited to nominate EO-1022, which leverages Synaffix's state-of-the art site-specific conjugation and differentiated linker-payload for a potentially best-in-class profile. We look forward to advancing our pipeline, as we work towards transforming the care and treatment of patients living with solid tumors that overexpress HER3."
"As a dedicated partner in the ADC space, Synaffix is excited to collaborate with Elevation Oncology to push the boundary of ADC innovation," said Peter van de Sande, Head of Synaffix. "With our state-of-the-art ADC technology platform and established supply chain, Elevation is well-positioned to accelerate the development of its differentiated HER3 ADC."
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 ADC expertise to advance a novel pipeline, initially targeting two clinically validated targets in oncology, Claudin 18.2 and HER3. Our lead candidate, EO-3021, is a potential best-in-class, Claudin 18.2 ADC and is currently being evaluated in the dose expansion portion of a Phase 1 trial (NCT05980416) in patients with advanced, unresectable or metastatic gastric/gastroesophageal adenocarcinoma that express Claudin 18.2. We are also advancing EO-1022, a HER3-targeting ADC for the treatment of patients living with solid tumors that express HER3, through preclinical development. For more information, visit www.ElevationOncology.com.
About Synaffix
Synaffix B.V. is a biotechnology company that enables ADC product candidates using its clinical-stage, site-specific ADC technology platform based on GlycoConnect®, HydraSpace® and toxSYN® technologies, that together enable any company with an antibody to develop proprietary best-in-class ADC products under a single license from Synaffix.
The Synaffix platform enables a rapid timeline to clinic due to the established supply chain of technology components. Synaffix holds granted patents to its technology. The business model of Synaffix is target-specific technology out-licensing, as exemplified through its existing deals with ADC Therapeutics, Mersana Therapeutics, Shanghai Miracogen (acquired by Lepu Biopharma), Innovent Biologics, Kyowa Kirin, Genmab, Macrogenics, Amgen, Hummingbird Biosciences, Chong Kun Dang Pharma, ABL Bio, SOTIO Biotech, Kivu Bioscience, BigHat Biosciences, Illumina and Elevation Oncology.
Synaffix was fully acquired by Lonza (SIX:LONN) in June 2023.
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 preclinical development activities, expected timing of announcements of preclinical results, potential benefits of Elevation Oncology's product candidates, potential market opportunities for Elevation Oncology's product candidates and the ability of Elevation Oncology's 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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