Elevation Oncology Provides Updates on Differentiated ADC Programs and Upcoming Milestones
Elevation Oncology (NASDAQ: ELEV) has announced significant progress in its cancer therapy programs. The company has initiated dosing in a Phase 1 clinical trial combining its Claudin 18.2 ADC EO-3021 with ramucirumab or dostarlimab for advanced gastric/GEJ cancer patients.
Initial monotherapy data from August 2024 showed promising results with a 42.8% confirmed overall response rate in a biomarker-enriched population, demonstrating competitive efficacy and a differentiated safety profile. The company is now focusing on first- and second-line treatment of advanced gastric/GEJ cancer.
Key upcoming milestones include additional monotherapy data from dose escalation and expansion cohorts in 1H 2025, initial combination cohort data in 4Q 2025 or 1Q 2026, and preclinical data presentation for HER3 ADC EO-1022 in 1H 2025. The company's current cash position is expected to fund operations into 2026.
Elevation Oncology (NASDAQ: ELEV) ha annunciato progressi significativi nei suoi programmi di terapia oncologica. L'azienda ha iniziato la somministrazione in un trial clinico di Fase 1 che combina il suo ADC Claudin 18.2 EO-3021 con ramucirumab o dostarlimab per pazienti con cancro gastrico avanzato/GEJ.
I dati iniziali della monoterapia di agosto 2024 hanno mostrato risultati promettenti con un tasso di risposta globale confermato del 42,8% in una popolazione arricchita di biomarcatori, dimostrando un'efficacia competitiva e un profilo di sicurezza differenziato. L'azienda si sta ora concentrando sul trattamento di prima e seconda linea del cancro gastrico/GEJ avanzato.
I principali traguardi futuri includono ulteriori dati sulla monoterapia da coorti di aumento della dose ed espansione nella prima metà del 2025, dati iniziali dalla coorte combinata nel quarto trimestre del 2025 o nel primo trimestre del 2026, e presentazione di dati preclinici per HER3 ADC EO-1022 nella prima metà del 2025. La posizione attuale di liquidità dell'azienda dovrebbe finanziare le operazioni fino al 2026.
Elevation Oncology (NASDAQ: ELEV) ha anunciado avances significativos en sus programas de terapia contra el cáncer. La empresa ha comenzado la dosificación en un ensayo clínico de Fase 1 que combina su ADC Claudin 18.2 EO-3021 con ramucirumab o dostarlimab para pacientes con cáncer gástrico/GEJ avanzado.
Los datos iniciales de monoterapia de agosto de 2024 mostraron resultados prometedores con una tasa de respuesta general confirmada del 42.8% en una población enriquecida con biomarcadores, demostrando una eficacia competitiva y un perfil de seguridad diferenciado. La empresa ahora se enfoca en el tratamiento de primera y segunda línea del cáncer gástrico/GEJ avanzado.
Los hitos clave que se avecinan incluyen datos adicionales de monoterapia de cohortes de escalamiento de dosis y expansión en el primer semestre de 2025, datos iniciales de la cohorte combinada en el cuarto trimestre de 2025 o primer trimestre de 2026, y la presentación de datos preclínicos para HER3 ADC EO-1022 en el primer semestre de 2025. Se espera que la posición de efectivo actual de la empresa financie las operaciones hasta 2026.
Elevation Oncology (NASDAQ: ELEV)는 암 치료 프로그램에서 중요한 진전을 발표했습니다. 이 회사는 진행성 위암/GEJ 환자를 위해 Claudin 18.2 ADC EO-3021을 ramucirumab 또는 dostarlimab과 결합한 1상 임상 시험을 시작했습니다.
2024년 8월의 초기 단독 요법 데이터는 생물표적이 풍부한 집단에서 42.8%의 확인된 전체 반응률을 보이며 경쟁력 있는 효능과 차별화된 안전성 프로필을 입증했습니다. 이 회사는 현재 진행성 위암/GEJ의 1차 및 2차 치료에 집중하고 있습니다.
앞으로의 주요 이정표로는 2025년 상반기에 용량 증가 및 확장 집단의 추가 단독 요법 데이터, 2025년 4분기 또는 2026년 1분기에 초기 조합 집단 데이터, 그리고 2025년 상반기에 HER3 ADC EO-1022의 전임상 데이터 발표가 포함됩니다. 회사의 현재 현금 상황은 2026년까지 운영을 지원할 것으로 예상됩니다.
Elevation Oncology (NASDAQ: ELEV) a annoncé des avancées significatives dans ses programmes de thérapie contre le cancer. L'entreprise a commencé l'administration d'un essai clinique de Phase 1 combinant son ADC Claudin 18.2 EO-3021 avec ramucirumab ou dostarlimab pour des patients atteints de cancer gastrique avancé/GEJ.
Les données initiales de monothérapie d'août 2024 ont montré des résultats prometteurs avec un taux de réponse globale confirmé de 42,8% dans une population enrichie en biomarqueurs, démontrant une efficacité compétitive et un profil de sécurité différencié. L'entreprise se concentre désormais sur le traitement de première et deuxième ligne du cancer gastrique/GEJ avancé.
Les principales étapes à venir incluent des données supplémentaires sur la monothérapie provenant des cohortes d'escalade de dose et d'expansion au premier semestre 2025, des données initiales de la cohorte combinée au quatrième trimestre 2025 ou au premier trimestre 2026, et une présentation des données précliniques pour HER3 ADC EO-1022 au premier semestre 2025. La position actuelle de liquidités de l'entreprise devrait financer ses opérations jusqu'en 2026.
Elevation Oncology (NASDAQ: ELEV) hat bedeutende Fortschritte in seinen Krebsbehandlungsprogrammen bekannt gegeben. Das Unternehmen hat die Dosisgabe in einer Phase 1-Studie begonnen, die sein Claudin 18.2 ADC EO-3021 mit Ramucirumab oder Dostarlimab für Patienten mit fortgeschrittenem Magen/GEJ-Krebs kombiniert.
Die ersten Monotherapie-Daten aus August 2024 zeigten vielversprechende Ergebnisse mit einer bestätigten Gesamtansprechrate von 42,8% in einer biomarker-reichen Population und demonstrierten wettbewerbsfähige Wirksamkeit und ein differenziertes Sicherheitsprofil. Das Unternehmen konzentriert sich jetzt auf die Erst- und Zweitlinientherapie von fortgeschrittenem Magen/GEJ-Krebs.
Wichtige bevorstehende Meilensteine umfassen zusätzliche Monotherapie-Daten aus Dosissteigerung und Erweiterungskohorten im ersten Halbjahr 2025, erste Daten aus der Kombinationstherapie im vierten Quartal 2025 oder ersten Quartal 2026 sowie die Präsentation von präklinischen Daten zu HER3 ADC EO-1022 im ersten Halbjahr 2025. Die derzeitige Liquiditätsposition des Unternehmens dürfte die Betriebskosten bis 2026 decken.
- 42.8% confirmed overall response rate in Phase 1 trial for EO-3021
- Minimal hematological toxicity and hepatotoxicity in initial trial results
- Cash runway extended into 2026
- Expansion into combination therapy trials with established drugs
- Initial combination therapy data not expected until Q4 2025/Q1 2026
- EO-1022 program still in preclinical stage with IND filing not planned until 2026
Insights
The initiation of combination therapy trials for EO-3021 represents a strategic advancement in Elevation's clinical development program. The 42.8% confirmed ORR in monotherapy demonstrates compelling efficacy, particularly noteworthy for gastric/GEJ cancers where response rates typically hover around 20-30% with standard treatments. The minimal hematological toxicity profile positions EO-3021 favorably against existing ADCs, which often struggle with safety concerns.
The combination strategy with dostarlimab in first-line and ramucirumab in second-line settings shows careful consideration of current treatment paradigms. Testing EO-3021 with a PD-1 inhibitor could potentially enhance immune response while maintaining a manageable safety profile - a critical factor in front-line therapy where quality of life considerations are paramount.
The company's cash runway extending into 2026 provides adequate operational flexibility through multiple key clinical readouts. The focused development strategy targeting first- and second-line gastric/GEJ cancer represents a substantial market opportunity, estimated at $4-5 billion globally. The prospective Claudin 18.2 expression testing implementation (≥25% tumor cells at IHC 1+/2+/3+) demonstrates a refined patient selection strategy that could enhance trial success rates and commercial potential.
Multiple catalysts in 2025 including monotherapy data in 1H and combination data in 4Q25/1Q26 provide clear value-driving milestones. The advancement of EO-1022 targeting HER3-expressing tumors adds pipeline depth and diversification, though this remains a longer-term value driver with IND filing in 2026.
The two-pronged combination approach is particularly well-conceived. In first-line, combining with dostarlimab could potentially improve upon the current immunotherapy-chemotherapy standard without adding significant toxicity. The second-line ramucirumab combination aims to address the tolerability issues of current paclitaxel-based regimens while maintaining efficacy. The biomarker strategy requiring ≥25% Claudin 18.2 expression demonstrates sophisticated patient selection that should optimize response rates.
The preliminary safety profile showing minimal hematological toxicity and absence of peripheral neuropathy is particularly encouraging for combination strategies, where overlapping toxicities often limit treatment options. This could provide a significant advantage over competing ADC programs in development.
-- Initiated dosing in Phase 1 clinical trial cohort evaluating Claudin 18.2 ADC EO-3021 in combination with ramucirumab or dostarlimab in patients with advanced gastric/gastroesophageal junction (GEJ) cancer --
-- Expect to report initial data from combination cohort in 4Q 2025 or 1Q 2026 --
-- On-track to report additional monotherapy data from dose escalation and expansion cohorts of ongoing Phase 1 clinical trial in 1H 2025 --
-- Plan to present preclinical data for HER3 ADC EO-1022 in 1H 2025 and file an Investigational New Drug (IND) application in 2026 --
"We are rapidly advancing EO-3021 to address significant unmet needs in treating earlier lines of advanced gastric/GEJ cancer, where we believe we have a unique ability to improve on the standard of care," said Joseph Ferra, President and Chief Executive Officer of Elevation Oncology. "As we enter 2025, we are honing our focus, leveraging the competitive anti-tumor activity and differentiated safety profile of EO-3021 to explore combination approaches in the first- and second-line settings. With our Phase 1 clinical trial ongoing and now enrolling both monotherapy and combination cohorts, we are in a leading position to explore the compelling potential of EO-3021, our differentiated Claudin 18.2 ADC, to improve outcomes for people living with advanced gastric/GEJ cancer."
Mr. Ferra continued, "We look forward to sharing additional data from our Phase 1 dose escalation and expansion study of EO-3021 in the first half of 2025. With this readout, we aim to build on the promising initial data reported in August 2024, reinforcing EO-3021's robust anti-tumor activity and potential better combinability, while garnering additional insights to inform our go-forward clinical development efforts. We are enthusiastic about the potential of EO-3021 in addressing meaningful market opportunities and look forward to a transformative 2025."
Program Updates and Upcoming Milestones
EO-3021: Elevation Oncology is developing EO-3021, a differentiated, potentially best-in-class antibody drug conjugate (ADC) for the treatment of patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2, including gastric/GEJ cancer.
In August 2024, Elevation Oncology reported promising initial monotherapy data from the dose escalation portion of its ongoing Phase 1 clinical trial of EO-3021, demonstrating competitive efficacy, with a
Based on these data, Elevation Oncology is focusing the clinical development of EO-3021 on the first- and second-line treatment of advanced gastric/GEJ cancer, where EO-3021's key attributes can potentially provide differentiated benefits and address unmet needs in both patient outcomes and safety.
Monotherapy:
The dose expansion portion of Elevation Oncology's Phase 1 clinical trial of monotherapy EO-3021 is ongoing. As of January 2025, Elevation Oncology has implemented prospective Claudin 18.2 expression testing as part of the patient screening process, focusing enrollment on patients with ≥
Combination:
Patient dosing is ongoing in the combination portion of Elevation Oncology's Phase 1 clinical trial of EO-3021. The combination cohorts are evaluating EO-3021 in combination with dostarlimab, a PD-1 inhibitor, in the first line setting and with ramucirumab, a VEGFR2 inhibitor, in the second line setting.
By combining EO-3021 and dostarlimab, an immune checkpoint inhibitor, Elevation Oncology aims to deliver synergistic benefit, potentially offering patients improved outcomes beyond those seen with the existing combination of immunotherapy and chemotherapy. The combination of an immunotherapy and chemotherapy agent is the standard of care for the treatment of gastric/GEJ cancer in the front-line setting.
With the EO-3021 and ramucirumab combination, Elevation Oncology aims to deliver improved tolerability and synergistic anti-tumor activity compared to the approved combination of ramucirumab and paclitaxel. The combination of ramucirumab and paclitaxel is the standard of care for the treatment of second-line gastric/GEJ cancer.
Elevation Oncology expects to report initial data from the combination cohorts in the fourth quarter of 2025 or the first quarter of 2026.
EO-1022: Elevation Oncology is developing EO-1022, a differentiated HER3 ADC for the treatment of patients with HER3-expressing solid tumors, including breast cancer, EGFR-mutant non-small cell lung cancer, and pancreatic cancer. EO-1022 combines seribantumab, a fully human anti-HER3 monoclonal antibody, and a monomethyl auristatin E (MMAE) payload with site-specific conjugation to glycan. It is designed to leverage seribantumab's desirable internalization capability and the latest site-specific ADC technology to deliver a safe, effective option for patients living with solid tumors that express HER3.
Elevation Oncology expects to present preclinical data for EO-1022 in the first half of 2025 and to file an IND application in 2026.
Financial Guidance
Elevation Oncology expects that its cash, cash equivalents and marketable securities as of September 30, 2024, will be sufficient to fund its current operations into 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 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 a Phase 1 trial (NCT05980416) as a monotherapy, and in combinations with dostarlimab or ramucirumab, in patients with advanced, unresectable or metastatic gastric/gastroesophageal adenocarcinoma that express Claudin 18.2. We are also advancing EO-1022, a HER3 ADC for the treatment of patients living with solid tumors that express HER3, through preclinical development. 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 and preclinical results, potential benefits of product candidates, potential market opportunities for product candidates, the ability of product candidates to treat their targeted indications 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
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