Elevation Oncology Announces Promising Initial Data from Phase 1 Clinical Trial Evaluating EO-3021 in Patients with Advanced Unresectable or Metastatic Solid Tumors Likely to Express Claudin 18.2
Elevation Oncology (Nasdaq: ELEV) announced promising initial data from the Phase 1 clinical trial of EO-3021 in patients with advanced solid tumors likely to express Claudin 18.2. Key highlights include:
1. 42.8% confirmed objective response rate in Claudin 18.2-enriched gastric and GEJ cancer subset.
2. Differentiated safety profile with minimal MMAE-associated toxicities.
3. Advancing to dose expansion phase; additional monotherapy data expected in 1H 2025.
4. Combination portion of Phase 1 trial to begin by year-end 2024.
The trial showed EO-3021 to be generally well-tolerated with no Grade 4 or 5 treatment-related adverse events. The company plans to explore doses of 2.0 mg/kg and 2.5 mg/kg IV Q3W in the expansion phase.
Elevation Oncology (Nasdaq: ELEV) ha annunciato dati iniziali promettenti dal trial clinico di Fase 1 riguardante EO-3021 in pazienti con tumori solidi avanzati che probabilmente esprimono Claudin 18.2. I punti salienti includono:
1. 42,8% di tasso di risposta obiettiva confermata nel sottogruppo di cancro gastrico e GEJ arricchito di Claudin 18.2.
2. Profilo di sicurezza differenziato con tossicità associate a MMAE minime.
3. Passaggio alla fase di espansione della dose; ulteriori dati sulla monoterapia attesi nella prima metà del 2025.
4. La parte combinata del trial di Fase 1 inizierà entro la fine del 2024.
Il trial ha dimostrato che EO-3021 è stato generalmente ben tollerato, senza eventi avversi correlati al trattamento di Grado 4 o 5. L'azienda prevede di esplorare dosi di 2,0 mg/kg e 2,5 mg/kg IV Q3W nella fase di espansione.
Elevation Oncology (Nasdaq: ELEV) anunció datos iniciales prometedores del ensayo clínico de Fase 1 de EO-3021 en pacientes con tumores sólidos avanzados que probablemente expresan Claudin 18.2. Los puntos destacados incluyen:
1. 42.8% de tasa de respuesta objetiva confirmada en el subgrupo de cáncer gástrico y GEJ enriquecido con Claudin 18.2.
2. Perfil de seguridad diferenciado con toxicidades mínimas asociadas a MMAE.
3. Avance a la fase de expansión de dosis; se esperan datos adicionales de monoterapia en la primera mitad de 2025.
4. La parte combinada del ensayo de Fase 1 comenzará a finales de 2024.
El ensayo mostró que EO-3021 fue generalmente bien tolerado, sin eventos adversos relacionados con el tratamiento de Grado 4 o 5. La empresa planea explorar dosis de 2.0 mg/kg y 2.5 mg/kg IV cada tres semanas en la fase de expansión.
Elevation Oncology (Nasdaq: ELEV)가 Claudin 18.2를 발현할 가능성이 있는 진행성 고형 종양 환자를 대상으로 한 EO-3021의 1상 임상 시험에서 유망한 초기 데이터를 발표했습니다. 주요 내용은 다음과 같습니다:
1. Claudin 18.2가 풍부한 위 및 GEJ 암 하위 집단에서 42.8%의 확인된 객관적 반응률.
2. MMAE와 관련된 독성이 최소인 차별화된 안전성 프로필.
3. 용량 확장 단계로 진행 중; 추가 단독 치료 데이터는 2025년 상반기에 예상됨.
4. 1상 임상 시험의 병합 부분이 2024년 말까지 시작될 예정.
임상 시험 결과 EO-3021은 일반적으로 잘 견디는 것으로 나타났으며 4도 또는 5도의 치료 관련 부작용이 없었습니다. 회사는 확장 단계에서 2.0 mg/kg 및 2.5 mg/kg IV Q3W의 용량을 탐색할 계획입니다.
Elevation Oncology (Nasdaq: ELEV) a annoncé des données initiales prometteuses d'un essai clinique de Phase 1 concernant EO-3021 chez des patients atteints de tumeurs solides avancées susceptibles d'exprimer Claudin 18.2. Les principaux points forts incluent:
1. Taux de réponse objectif confirmé de 42,8% dans le sous-groupe de cancers gastriques et GEJ enrichi en Claudin 18.2.
2. Profil de sécurité différencié avec toxicités associées à MMAE minimales.
3. Avancement vers une phase d'expansion de dose ; d'autres données de monothérapie attendues dans le premier semestre 2025.
4. La partie de combinaison de l'essai de Phase 1 doit commencer d'ici la fin de 2024.
L'essai a montré qu'EO-3021 était généralement bien toléré, sans événements indésirables liés au traitement de Grade 4 ou 5. La société prévoit d'explorer des doses de 2,0 mg/kg et 2,5 mg/kg IV Q3W dans la phase d'expansion.
Elevation Oncology (Nasdaq: ELEV) hat vielversprechende erste Daten aus der Phase-1-Studie zu EO-3021 bei Patienten mit fortgeschrittenen soliden Tumoren, die wahrscheinlich Claudin 18.2 exprimieren, bekannt gegeben. Zu den wichtigsten Highlights gehören:
1. 42,8% bestätigte objektive Ansprechrate in der Claudin 18.2-angereicherten Subgruppe von Magen- und GEJ-Krebs.
2. Differenziertes Sicherheitsprofil mit minimalen MMAE-assoziierten Toxizitäten.
3. Übergang zur Phase der Dosisausweitung; weitere Monotherapiedaten werden in H1 2025 erwartet.
4. Der Kombinationsabschnitt der Phase-1-Studie soll bis Ende 2024 beginnen.
Die Studie zeigte, dass EO-3021 im Allgemeinen gut vertragen wurde, ohne schwerwiegende behandlungsbedingte unerwünschte Ereignisse der Grade 4 oder 5. Das Unternehmen plant, Dosen von 2,0 mg/kg und 2,5 mg/kg IV alle 3 Wochen in der Erweiterungsphase zu untersuchen.
- 42.8% confirmed objective response rate in Claudin 18.2-enriched gastric and GEJ cancer subset
- Minimal MMAE-associated toxicities observed, including no neutropenia or peripheral neuropathy
- Generally well-tolerated safety profile with no Grade 4 or 5 treatment-related adverse events
- Advancing to dose expansion phase of the Phase 1 trial
- Plans to initiate combination therapy studies by year-end 2024
- Less than 10% of patients discontinued EO-3021 due to adverse events
- Four dose-limiting toxicities observed at the 2.9 mg/kg dose level
Insights
The initial data from Elevation Oncology's Phase 1 trial of EO-3021 is highly promising. The 42.8% confirmed ORR in Claudin 18.2-enriched gastric and GEJ cancers is impressive, especially considering the heavily pretreated patient population (median 3 prior lines). This efficacy, combined with the differentiated safety profile showing minimal MMAE-associated toxicities, positions EO-3021 as a potential best-in-class Claudin 18.2 ADC.
The lack of neutropenia and peripheral neuropathy is particularly noteworthy, as these are common issues with MMAE-based ADCs. This improved safety profile could allow for easier combination therapies and potentially longer treatment durations. The biomarker-driven approach, focusing on Claudin 18.2 expression, appears important for maximizing efficacy and will likely be key in future development stages.
This data release is a significant positive for Elevation Oncology. The promising efficacy and safety profile of EO-3021 in gastric and GEJ cancers represent a substantial market opportunity. With gastric cancer being the 5th most common cancer globally, a potentially best-in-class treatment could drive significant revenue growth.
The company's plans to expand into combination therapies in first- and second-line settings could further broaden the drug's potential market. However, investors should note that additional data is not expected until 1H 2025, which may impact short-term stock performance. The company's cash runway and ability to fund ongoing clinical development will be important factors to monitor in the interim.
EO-3021's initial data showcases the potential of next-generation ADC technologies. The site-specific conjugation approach appears to be paying dividends in terms of the improved safety profile. This could give Elevation Oncology an edge in the increasingly competitive Claudin 18.2-targeted space.
The biomarker strategy is crucial and aligns with industry trends towards precision medicine. The stark difference in ORR between Claudin 18.2 high and low expressors (
--
-- EO-3021 demonstrated differentiated safety profile, with minimal MMAE-associated toxicities, including no neutropenia or peripheral neuropathy/hypoesthesia --
-- Advancing into dose expansion portion of Phase 1 trial; additional monotherapy data expected in 1H 2025 --
-- Expect to initiate dosing in combination portion of Phase 1 trial by year-end 2024 --
-- Elevation Oncology to host conference call and webcast today at 8:30 a.m. ET --
"Gastric and GEJ cancers are devastating diseases, which occur frequently in the
"We are pleased to share initial data from our Phase 1 clinical trial of EO-3021," said Valerie Malyvanh Jansen, M.D., Ph.D., Chief Medical Officer of Elevation Oncology. "EO-3021 was designed to maximize efficacy while minimizing the potential for free MMAE, with the goal of offering patients an improved safety profile and physicians a more readily combinable agent. We are encouraged to see the benefits of EO-3021's site-specific conjugation translate clinically, with minimal MMAE-associated toxicities observed in our Phase 1 trial. Coupled with the promising anti-tumor activity reported in patients with gastric or GEJ cancer, the data suggest that EO-3021 is a potential best-in-class Claudin 18.2 antibody drug conjugate. We look forward to advancing into monotherapy dose expansion and initiating our combination cohorts in the months ahead, as well as reporting additional data from our ongoing trial in the first half of 2025."
Data from the Ongoing Phase 1 Clinical Trial
EO-3021 was evaluated in the dose escalation stage of a Phase 1 clinical trial in patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2, including gastric, GEJ, pancreatic or esophageal cancers. As of the data cutoff date of June 10, 2024, 32 patients had been treated in the dose escalation portion of the Phase 1 clinical trial at four dose levels (ranging from 1.0 mg/kg to 2.9 mg/kg once every three weeks (Q3W), including 26 patients with gastric or GEJ cancer. The median age was 65 years (ranging from 45 to 83) and the median number of prior lines of therapy was three (ranging from one to seven).
Initial Safety Data
As of the data cutoff of June 10, 2024, EO-3021 was observed to be generally well-tolerated. No Grade 4 or 5 treatment-related adverse events were reported, and less than
Across all grades, the most common treatment-emergent adverse events (reported in ≥
Initial Efficacy Data in Gastric and GEJ Cancer
As of the data cutoff date of June 10, 2024, 15 patients with gastric or GEJ cancers were evaluable for efficacy with measurable disease, at least one post-baseline scan, and available Claudin 18.2 IHC results. Seven of these 15 patients (
- In seven patients with Claudin 18.2 in ≥
20% of tumor cells at IHC 2+/3+, the objective response rate (ORR) was42.8% (three confirmed partial responses, one of which was confirmed following the June 10, 2024, data cutoff) and the disease control rate (DCR) was71.4% , including two patients with stable disease (SD). - In eight patients with Claudin 18.2 in <
20% of tumor cells at IHC 2+/3+, the ORR was0% and the DCR was50% , including four patients with SD.
Clinical Development Plans for EO-3021
Elevation Oncology plans to initiate enrollment in the dose expansion portion of the ongoing Phase 1 clinical trial, further exploring two doses of EO-3021: 2.0 mg/kg IV Q3W and 2.5 mg/kg IV Q3W. These doses were selected with the goal of further characterizing EO-3021 in order to select an optimized dose for further clinical development.
The primary objective of the study is to evaluate the safety, tolerability and preliminary anti-tumor activity of EO-3021 in patients with gastric or GEJ cancer, who have progressed on or after standard therapy or who are intolerable of available standard therapy. An exploratory objective of the study is to assess the association of Claudin 18.2 expression and objective response. Additionally, data from the dose escalation portion of Elevation Oncology's Phase 1 trial suggest that a biomarker patient selection strategy will be an important component of future clinical development. Elevation Oncology is working to identify the appropriate biomarker threshold and plans to introduce a biomarker cutoff as part of the dose expansion portion of this Phase 1 trial. Elevation Oncology expects to share additional data from the Phase 1 trial, including from the dose expansion cohort, in the first half of 2025.
Additionally, Elevation Oncology plans to expand its ongoing Phase 1 clinical trial to include combination cohorts evaluating EO-3021 for the treatment of advanced or metastatic gastric or GEJ cancer in the first- and second-line setting. As previously disclosed, the combination cohorts will evaluate EO-3021 in combination with ramucirumab, a VEGFR2-inhibitor, in the second-line setting, and in combination with dostarlimab, a PD-1 inhibitor, in the first-line setting. Elevation Oncology expects to initiate dosing in the combination portion of the Phase 1 trial by year-end 2024.
Conference Call Information
Elevation Oncology will host a live conference call and webcast at 8:30 a.m. ET today to discuss the initial safety and efficacy data announced today. Participants may register for the conference call here. It is recommended that participants join the call ten minutes prior to the scheduled start.
A webcast of the call will also be available on the Events page of Elevation Oncology's investor relations website at https://investors.elevationoncology.com. The archived webcast will be available on the website approximately two hours after the conference call and will be available for 90 days following the call.
About EO-3021
EO-3021 (also known as SYSA1801) 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. EO-3021 is site-specifically conjugated to the monomethyl auristatin E (MMAE) payload via a cleavable linker with 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 study (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 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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FAQ
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