Elevation Oncology Receives Fast Track Designation from the FDA for EO-3021 for the Treatment of Adult Patients with Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer Expressing Claudin 18.2
Elevation Oncology (Nasdaq: ELEV) announced that the FDA has granted Fast Track designation to EO-3021, a differentiated antibody drug conjugate, for treating advanced or metastatic gastric and gastroesophageal junction (GC/GEJ) cancer expressing Claudin 18.2 that has progressed after prior therapy. This designation is based on nonclinical and initial clinical data from the ongoing Phase 1 trial, which showed a confirmed overall response rate of 42.8% in a Claudin 18.2-enriched subset of GC/GEJ cancer patients. The company observed differentiated tolerability with minimal MMAE-associated toxicities. Elevation Oncology plans to report additional data in the first half of 2025 and initiate the combination portion of the study later this year.
Elevation Oncology (Nasdaq: ELEV) ha annunciato che la FDA ha concesso la designazione Fast Track per EO-3021, un farmaco congiunto a base di anticorpi differenziato, per il trattamento del cancro gastrico e gastroesofageo avanzato o metastatico (GC/GEJ) che esprime Claudin 18.2 e che è progredito dopo una terapia precedente. Questa designazione si basa su dati non clinici e clinici iniziali provenienti dallo studio di Fase 1 in corso, che hanno mostrato un tasso di risposta generale confermato del 42.8% in un sottoinsieme di pazienti con cancro GC/GEJ arricchito per Claudin 18.2. L'azienda ha osservato una tollerabilità differenziata con tossicità associate a MMAE minime. Elevation Oncology prevede di riportare ulteriori dati nella prima metà del 2025 e di avviare la parte combinata dello studio entro la fine dell'anno.
Elevation Oncology (Nasdaq: ELEV) anunció que la FDA ha otorgado la designación de Vía Rápida a EO-3021, un conjugado de fármaco anticuerpo diferenciado, para el tratamiento de cáncer gástrico y de unión gastroesofágica avanzado o metastásico (GC/GEJ) que expresa Claudin 18.2 y que ha progresado tras la terapia previa. Esta designación se basa en datos no clínicos y clínicos iniciales del ensayo en fase 1 en curso, que mostraron un tasa de respuesta global confirmada del 42.8% en un subconjunto enriquecido de pacientes con cáncer GC/GEJ que expresan Claudin 18.2. La compañía observó una tolerancia diferenciada con toxicidades mínimas asociadas a MMAE. Elevation Oncology planea informar datos adicionales en la primera mitad de 2025 y comenzar la parte de combinación del estudio más adelante este año.
Elevation Oncology (Nasdaq: ELEV)은 FDA가 EO-3021에 대해 신속 심사 지정을 부여했다고 발표했습니다. 이는 Claudin 18.2를 발현하는 진행성 또는 전이성 위 및 위식도 접합부암(GC/GEJ)의 치료를 위한 차별화된 항체 약물 복합체입니다. 이 지정은 진행 중인 1상 시험의 비임상 및 초기 임상 데이터에 기반하여, Claudin 18.2가 농축된 GC/GEJ 암 환자 집단에서 확인된 전체 반응률이 42.8%로 나타났습니다. 회사는 MMAE와 관련된 독성이 최소화된 차별화된 내약성을 관찰했습니다. Elevation Oncology는 2025년 상반기에 추가 데이터를 발표하고, 올해 말에 연구의 조합 부분을 시작할 계획입니다.
Elevation Oncology (Nasdaq: ELEV) a annoncé que la FDA a accordé la désignation Fast Track à EO-3021, un conjugué anticorps-médicament différencié, pour le traitement du cancer gastrique avancé ou métastatique et du junction gastro-œsophagien (GC/GEJ) exprimant Claudin 18.2 qui a progressé après une thérapie antérieure. Cette désignation est basée sur des données non cliniques et des données cliniques initiales de l'essai de Phase 1 en cours, qui ont montré un taux de réponse global confirmé de 42,8% dans un sous-groupe de patients atteints de cancer GC/GEJ enrichi en Claudin 18.2. La société a observé une tolérance différenciée avec des toxicités associées à MMAE minimales. Elevation Oncology prévoit de rapporter des données supplémentaires dans la première moitié de 2025 et de lancer la partie combinée de l'étude plus tard cette année.
Elevation Oncology (Nasdaq: ELEV) hat bekannt gegeben, dass die FDA die Fast Track-Designierung für EO-3021, ein differenziertes Antikörper-Arzneimittel-Konjugat, zur Behandlung von fortgeschrittenem oder metastasiertem Magen- und gastroösophagealen Übergangskarzinom (GC/GEJ), das Claudin 18.2 exprimiert und nach vorheriger Therapie fortgeschritten ist, erteilt hat. Diese Designierung basiert auf nichtklinischen und ersten klinischen Daten aus der laufenden Phase-1-Studie, die eine bestätigte Gesamtansprechrate von 42,8% in einer auf Claudin 18.2 angereicherten Untergruppe von Patienten mit GC/GEJ-Karzinom zeigte. Das Unternehmen beobachtete eine differenzierte Verträglichkeit mit minimalen MMAE-assoziierten Toxizitäten. Elevation Oncology plant, in der ersten Hälfte des Jahres 2025 weitere Daten zu berichten und noch in diesem Jahr den Kombinationsanteil der Studie zu beginnen.
- FDA granted Fast Track designation for EO-3021
- 42.8% confirmed overall response rate in Claudin 18.2-enriched subset of GC/GEJ cancer patients
- Differentiated tolerability with minimal MMAE-associated toxicities observed
- Potential for expedited development and review process
- None.
"We are delighted to receive Fast Track designation for EO-3021, which marks an encouraging recognition of the unmet medical need in patients with Claudin 18.2-expressing tumors, as well as the potential for EO-3021 to deliver improved therapeutic outcomes," said Joseph Ferra, President and Chief Executive Officer of Elevation Oncology. "This designation is based on nonclinical and initial clinical data from our ongoing Phase 1 clinical trial. As we announced in August, early results showed a confirmed overall response rate of
Fast Track is a process designed by the FDA to facilitate the development and expedite the review of therapeutic candidates intended to treat serious or life-threatening conditions, for which nonclinical or clinical data demonstrate the potential to address unmet medical needs. Therapeutic candidates that receive FTD may be eligible for more frequent interactions with the FDA to discuss the candidate's development plan. Therapeutic candidates with Fast Track designation may also be eligible for priority review and accelerated approval if supported by clinical data.
About EO-3021
EO-3021 is a differentiated, clinical-stage antibody drug conjugate (ADC) with best-in-class potential comprised of an immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets Claudin 18.2 and a monomethyl auristatin E (MMAE) payload with a cleavable linker that is site-specifically conjugated to Glutamine 295 providing a drug-to-antibody ratio (DAR) of 2. Claudin 18.2 is a specific isoform of Claudin 18 that is normally expressed in gastric epithelial cells. During malignant transformation, the tight junctions may become disrupted, exposing Claudin 18.2 and allowing them to be accessible by Claudin 18.2 targeting agents. Elevation Oncology is evaluating EO-3021 in a Phase 1 trial (NCT05980416) in patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2 including gastric, gastroesophageal junction, pancreatic or esophageal cancers.
Elevation Oncology has the exclusive rights to develop and commercialize EO-3021 in all global territories outside
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 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 ADC designed to target Claudin 18.2 and is currently being evaluated in a Phase 1 trial (NCT05980416) in patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2 including gastric, gastroesophageal junction, pancreatic or esophageal cancers. Additionally, we expect to nominate a development candidate for our second program, a HER3-targeting ADC for the treatment of patients with solid tumors that overexpress HER3, in 2024. 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 announcements of clinical 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
Hannah Deresiewicz, 212-362-1200
EVP, Managing Director, Precision AQ
hannah.deresiewicz@precisionaq.com
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