Elevation Oncology to Discontinue Development of EO-3021; Advancing EO-1022, While Evaluating Strategic Options
Elevation Oncology (NASDAQ: ELEV) announced the discontinuation of EO-3021, its Claudin 18.2 antibody-drug conjugate (ADC) for gastric and gastroesophageal junction cancers, following Phase 1 trial results showing a 22.2% objective response rate, deemed insufficient for competitive positioning.
The company will focus on advancing EO-1022, a HER3 ADC for HER3-expressing solid tumors, with plans to present preclinical data at AACR Annual Meeting 2025 and file an IND in 2026. A significant restructuring includes a 70% workforce reduction, with estimated costs of $3 million.
The company's Chief Medical Officer will step down effective March 31, 2025. With $93.2 million in cash and equivalents as of December 31, 2024, Elevation expects to fund operations into second half of 2026 while evaluating strategic options to maximize shareholder value.
Elevation Oncology (NASDAQ: ELEV) ha annunciato l'interruzione di EO-3021, il suo anticorpo-coniugato farmaco (ADC) per il Claudin 18.2, destinato ai tumori gastrici e della giunzione gastroesofagea, dopo i risultati della fase 1 che hanno mostrato un tasso di risposta obiettivo del 22,2%, ritenuto insufficiente per una posizione competitiva.
L'azienda si concentrerà sullo sviluppo di EO-1022, un ADC per HER3 destinato ai tumori solidi che esprimono HER3, con piani di presentare dati preclinici all'AACR Annual Meeting 2025 e di presentare una richiesta IND nel 2026. Una significativa ristrutturazione include una riduzione del 70% della forza lavoro, con costi stimati di 3 milioni di dollari.
Il Chief Medical Officer dell'azienda si dimetterà con effetto dal 31 marzo 2025. Con 93,2 milioni di dollari in contante e equivalenti al 31 dicembre 2024, Elevation prevede di finanziare le operazioni fino alla seconda metà del 2026, mentre valuta opzioni strategiche per massimizzare il valore per gli azionisti.
Elevation Oncology (NASDAQ: ELEV) anunció la descontinuación de EO-3021, su conjugado anticuerpo-fármaco (ADC) para Claudin 18.2, destinado a cánceres gástricos y de la unión gastroesofágica, tras los resultados de la fase 1 que mostraron una tasa de respuesta objetiva del 22.2%, considerada insuficiente para una posición competitiva.
La empresa se enfocará en avanzar EO-1022, un ADC para tumores sólidos que expresan HER3, con planes de presentar datos preclínicos en la Reunión Anual de AACR 2025 y presentar una solicitud IND en 2026. Una reestructuración significativa incluye una reducción del 70% de la fuerza laboral, con costos estimados de 3 millones de dólares.
El Director Médico de la empresa renunciará con efecto a partir del 31 de marzo de 2025. Con 93.2 millones de dólares en efectivo y equivalentes al 31 de diciembre de 2024, Elevation espera financiar las operaciones hasta la segunda mitad de 2026, mientras evalúa opciones estratégicas para maximizar el valor para los accionistas.
Elevation Oncology (NASDAQ: ELEV)는 위암 및 위식도 접합부 암을 위한 Claudin 18.2 항체-약물 접합체(ADC)인 EO-3021의 중단을 발표했습니다. 이는 1상 시험 결과가 22.2%의 객관적 반응률을 보였으나, 경쟁력 있는 위치를 확보하기에는 부족하다고 판단되었기 때문입니다.
회사는 HER3 발현 고형 종양을 위한 EO-1022의 개발에 집중할 예정이며, 2025 AACR 연례 회의에서 전임상 데이터를 발표하고 2026년에는 IND를 제출할 계획입니다. 주요 구조 조정에는 70%의 인력 감축이 포함되며, 예상 비용은 300만 달러입니다.
회사의 최고 의료 책임자는 2025년 3월 31일부로 사임할 예정입니다. 2024년 12월 31일 기준으로 9320만 달러의 현금 및 현금성 자산을 보유하고 있는 Elevation은 2026년 하반기까지 운영 자금을 지원할 것으로 예상하며, 주주 가치를 극대화하기 위한 전략적 옵션을 평가하고 있습니다.
Elevation Oncology (NASDAQ: ELEV) a annoncé l'arrêt de EO-3021, son anticorps-conjugé médicament (ADC) pour Claudin 18.2, destiné aux cancers gastriques et de la jonction gastro-œsophagienne, suite aux résultats de l'essai de phase 1 montrant un taux de réponse objectif de 22,2 %, jugé insuffisant pour une position compétitive.
L'entreprise se concentrera sur l'avancement de EO-1022, un ADC pour les tumeurs solides exprimant HER3, avec des plans de présentation de données précliniques lors de la réunion annuelle de l'AACR 2025 et de dépôt d'une demande IND en 2026. Une restructuration significative comprend une réduction de 70 % de la main-d'œuvre, avec des coûts estimés à 3 millions de dollars.
Le directeur médical de l'entreprise démissionnera à compter du 31 mars 2025. Avec 93,2 millions de dollars en espèces et équivalents au 31 décembre 2024, Elevation s'attend à financer ses opérations jusqu'à la seconde moitié de 2026 tout en évaluant des options stratégiques pour maximiser la valeur pour les actionnaires.
Elevation Oncology (NASDAQ: ELEV) gab die Einstellung von EO-3021 bekannt, seinem Antikörper-Wirkstoff-Konjugat (ADC) für Claudin 18.2 zur Behandlung von Magen- und gastroösophagealen Übergangstumoren, nachdem die Ergebnisse der Phase-1-Studie eine objektive Ansprechrate von 22,2 % zeigten, die als unzureichend für eine wettbewerbsfähige Positionierung erachtet wurde.
Das Unternehmen wird sich auf die Weiterentwicklung von EO-1022, einem HER3-ADC für HER3-exprimierende solide Tumoren, konzentrieren und plant, präklinische Daten auf dem AACR-Jahrestreffen 2025 zu präsentieren und 2026 einen IND-Antrag einzureichen. Eine bedeutende Umstrukturierung umfasst eine Reduzierung der Belegschaft um 70%, mit geschätzten Kosten von 3 Millionen Dollar.
Der Chief Medical Officer des Unternehmens wird zum 31. März 2025 zurücktreten. Mit 93,2 Millionen Dollar in Bargeld und Äquivalenten zum 31. Dezember 2024 erwartet Elevation, die Betriebsabläufe bis zur zweiten Hälfte des Jahres 2026 zu finanzieren, während es strategische Optionen zur Maximierung des Aktionärswerts evaluiert.
- Cash runway extended into 2H 2026 with $93.2M available
- 70% workforce reduction to reduce operational costs
- EO-3021 showed favorable safety profile with minimal toxicity
- Strategic pivot to potentially differentiated HER3 ADC program (EO-1022)
- Discontinuation of lead program EO-3021 due to insufficient efficacy
- Significant workforce reduction (70%) indicating major restructuring
- $3M in restructuring costs expected through June 2025
- Loss of Chief Medical Officer
Insights
Elevation Oncology's announcement represents a significant pipeline setback with the discontinuation of EO-3021, their Claudin 18.2 antibody-drug conjugate. Despite showing a
The company is executing a dramatic strategic pivot, implementing a
The "strategic options" language is particularly concerning, typically indicating the board is considering potential sale scenarios or other major corporate changes. While EO-1022 remains in preclinical development with IND filing not expected until 2026, the substantial workforce reduction creates questions about the company's ability to execute effectively on this remaining program.
This announcement fundamentally alters Elevation's risk profile, moving from a company with two clinical-stage assets to a predominantly preclinical organization with a single lead program and substantially reduced operational capabilities. The
The clinical failure of EO-3021 represents a significant setback for Elevation's oncology pipeline. The
Their pivot to EO-1022, a HER3-targeted ADC, represents a strategic shift to a challenging but potentially valuable target. HER3 overexpression occurs across multiple solid tumors and has proven difficult to target effectively. EO-1022's differentiated approach using glycan site-specific conjugation with an MMAE payload could theoretically improve the therapeutic window compared to conventional ADCs, but remains unproven clinically.
The timing is particularly concerning - with only preclinical data to be presented at AACR 2025 and IND filing projected for 2026, Elevation faces a significant development gap after discontinuing their lead program. The
-- Continuing to advance potentially differentiated HER3 ADC, EO-1022, which utilizes an MMAE payload and glycan site-specific conjugation --
-- Plan to present preclinical data for EO-1022 at AACR Annual Meeting 2025 and to file an Investigational New Drug (IND) application in 2026 --
-- Updated clinical data of Claudin 18.2 ADC EO-3021 demonstrate ORR of
-- Implementing workforce reduction of approximately
The decision to discontinue clinical development of EO-3021 was based on data from the dose escalation and expansion stages of Elevation Oncology's Phase 1 trial, in which treatment with EO-3021 as a monotherapy demonstrated an objective response rate (ORR) of
"We are deeply disappointed by these results from our Phase 1 trial. Despite continuing to demonstrate differentiated safety as a more combinable ADC, updated efficacy data suggest that treatment with EO-3021 does not meet our bar for success and is insufficient to provide patients a competitive benefit-risk profile compared to other Claudin 18.2 ADCs in development," said Joseph Ferra, President and Chief Executive Officer of Elevation Oncology. "Based on these data, we have decided to discontinue further development of EO-3021. I want to express my tremendous gratitude to the patients, physicians and site coordinators who participated in the EO-3021 clinical trial."
Mr. Ferra continued, "We are turning our focus to our potentially differentiated HER3 ADC, EO-1022, which incorporates glycan site-specific conjugation and is designed to address significant and emerging unmet needs in many HER3-expressing cancers. We look forward to presenting preclinical data supporting its potential at the AACR Annual Meeting next month. In parallel, we are initiating efforts to evaluate strategic options for the company. With cash into the second half of 2026 and a disciplined operating strategy, we are well-positioned to advance EO-1022 while working to identify and capitalize on the best opportunities to maximize value for our stakeholders."
Corporate Update:
Elevation Oncology is implementing a workforce reduction of approximately
"I want to thank the employees who will be departing as part of this restructuring. Over the past five years, my colleagues have worked tirelessly to advance a novel pipeline of selective medicines, demonstrating a tremendous commitment to making a difference for people living with cancer. I am deeply appreciative of their dedication, support and contributions," added Mr. Ferra.
Based on its current operating plans, Elevation Oncology now expects that its cash, cash equivalents, and marketable securities of
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 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 announcements of preclinical results, potential benefits of product candidates, potential market opportunities for product candidates, the ability of product candidates to treat their targeted indications, expected workforce changes, expected costs and costs associated with the corporate restructuring, the evaluation of strategic options and Elevation Oncology's expectations about its cash runway. 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
What were the Phase 1 trial results for ELEV's EO-3021 that led to its discontinuation?
How will ELEV's 70% workforce reduction impact its financial position?
What are the development timelines for ELEV's EO-1022 HER3 ADC program?
When will ELEV's Chief Medical Officer Valerie Malyvanh Jansen step down?
