Atossa Therapeutics Streamlines EVANGELINE Breast Cancer Clinical Trial to Prioritize for 2026 NDA-Enabling Activities
Atossa Therapeutics (NASDAQ: ATOS) amended its Phase 2 EVANGELINE study of (Z)-endoxifen in premenopausal ER+/HER2– early breast cancer to a single-arm, open-label, non-registrational design. The amendment reduces planned enrollment from 214 to 40–65 patients, implements a Cohort A two-stage futility rule using Week-4 Ki-67 ≤10% for earlier go/no-go decisions, and retains unchanged patient-safety data collection and DSMC oversight. Run-in data showed a Week-4 Ki-67 ≤10% rate of 86%. The company says the change aims to cut future study costs, accelerate objective readouts, and prioritize NDA-enabling activities in 2026.
Atossa Therapeutics (NASDAQ: ATOS) ha modificato il suo studio di fase 2 EVANGELINE su (Z)-endoxifen in cancro al seno precoce ER+/HER2– in premenopausali, in design a braccio unico, aperto, non registrazionale. La modifica riduce l'iscrizione prevista da 214 a 40–65 pazienti, implementa una regola di futility a due fasi per il Cohort A usando Week-4 Ki-67 ≤10% per decisioni di go/no-go anticipate, e mantiene inalterata la raccolta dei dati sulla sicurezza dei pazienti e la supervisione DSMC. I dati di run-in hanno mostrato una percentuale Week-4 Ki-67 ≤10% pari a 86%. L'azienda afferma che la modifica mira a tagliare i costi futuri dello studio, accelerare i risultati obiettivi e dare priorità alle attività abilitatrici dell'NDA nel 2026.
Atossa Therapeutics (NASDAQ: ATOS) enmendó su estudio de Fase 2 EVANGELINE de (Z)-endoxifen en cáncer de mama temprano ER+/HER2– en mujeres premenopáusicas a un diseño único de brazo, abierto, no registracional. La enmienda reduce la inscripción planificada de 214 a 40–65 pacientes, implementa una regla de futility de dos etapas para el Cohort A usando Ki-67 en la Semana 4 ≤10% para decisiones de ir/no-ir más tempranas, y mantiene sin cambios la recopilación de datos de seguridad de pacientes y la supervisión DSMC. Los datos de run-in mostraron una tasa de Ki-67 Semana 4 ≤10% del 86%. La empresa dice que el cambio tiene como objetivo reducir los costos futuros del estudio, acelerar los resultados objetivos y dar prioridad a las actividades que habilitan la NDA en 2026.
Atossa Therapeutics (NASDAQ: ATOS)는 2상 EVANGELINE 연구를 프리메노포즈 ER+/HER2– 초기에 해당하는 비등록 설계로 단일군, 오픈라벨로 수정했다. 개정안은 계획 모집을 214명에서 40–65명으로 축소하고, Cohort A의 두 단계 무효성 futility 규칙을 Week-4 Ki-67 ≤10%를 이용해 더 이른 시점의 진입/중단 결정을 내리며, 환자 안전 데이터 수집과 DSMC 감독은 변경되지 않도록 유지한다. Run-in 데이터는 Week-4 Ki-67 ≤10% 비율이 86%임을 보여주었다. 회사는 이 변경이 향후 연구 비용을 절감하고 객관적 결과 도출을 가속화하며 2026년의 NDA 달성 활동에 우선순위를 둘 것이라고 말한다.
Atossa Therapeutics (NASDAQ: ATOS) a modifié son étude de phase 2 EVANGELINE sur le (Z)-endoxifen chez les patientes prémenopausées ER+/HER2–, cancer du sein précoce, en un design non registre à bras unique, ouvert. L'amendement réduit le recrutement prévu de 214 à 40–65 patients, met en place une règle de futility en deux étapes pour le Cohort A utilisant le Ki-67 à la semaine 4 ≤10% pour des décisions go/no-go plus précoces, et préserve inchangée la collecte des données de sécurité des patients et la supervision DSMC. Les données de run-in ont montré un taux Ki-67 à la semaine 4 ≤10% de 86%. L'entreprise affirme que ce changement vise à réduire les coûts futurs de l'étude, à accélérer les lectures objectives et à donner la priorité aux activités habilitantes NDA en 2026.
Atossa Therapeutics (NASDAQ: ATOS) hat seine Phase-2-EVANGELINE-Studie zu (Z)-Endoxifen bei prämenopausalem ER+/HER2– frühem Brustkrebs auf ein einarmiges, offenes, nicht-registrational Design geändert. Die Änderung reduziert die geplante Rekrutierung von 214 auf 40–65 Patienten, implementiert eine Cohort-A-Zwei-Phasen-Futility-Regel mit Week-4 Ki-67 ≤10% für frühere Go/No-Go-Entscheidungen und belässt die unveränderte Erfassung der Patientensicherheit und die DSMC-Aufsicht. Run-in-Daten zeigten eine Week-4 Ki-67 ≤10%-Rate von 86%. Das Unternehmen sagt, der Wandel ziele darauf ab, künftige StudiKosten zu senken, objektive Auslesungen zu beschleunigen und NDA-fördernde Aktivitäten im 2026 zu priorisieren.
Atossa Therapeutics (NASDAQ: ATOS) عدّلت دراستها من المرحلة الثانية EVANGELINE حول (Z)-إندوكسيفين في سرطان الثدي المبكر ER+/HER2– عند النساء ما قبل سن اليأس إلى تصميم أحادي الذراع، مفتوح، غير مسجل. التعديل يقلل التسجيل المخطط من 214 إلى 40–65 مريضًا، وينفّذ قاعدة تقويض ثنائية المراحل لـ Cohort A باستخدام Ki-67 الأسبوع الرابع ≤10% لقرارات الذهاب/البقاء المبكرة، ويحافظ على جمع بيانات سلامة المرضى والإشراف DSMC دون تغيير. أظهرت بيانات التشغيل الأولي معدل Ki-67 Week-4 ≤10% بمقدار 86%. تقول الشركة إن التغيير يهدف إلى تقليل تكاليف الدراسة في المستقبل، وتسريع القراءات الموضوعية، وإعطاء أولوية للأنشطة الممكّنة لـ NDA في 2026.
Atossa Therapeutics (NASDAQ: ATOS) 将其二期 EVANGELINE 研究对 (Z)-羟基药物在绝经前 ER+/HER2– 早期乳腺癌的设计修改为单臂、开放标签的非注册性设计。修改将计划招募人数从 214 降至 40–65 名患者，为 Cohort A 实施两阶段 futility 规则，使用第4周 Ki-67 ≤10% 进行更早的 go/no-go 决策，并保持患者安全数据收集和 DSMC 监督不变。跑步入组数据表明第4周 Ki-67 ≤10% 的比率为 86%。公司表示，此变更旨在降低未来研究成本、加速客观结果的获得，并优先开展在 2026 实现 NDA 的工作。
- Planned enrollment cut from 214 to 40–65 patients
- Run-in Week-4 Ki-67 ≤10% rate of 86%
- Two-stage futility rule enables earlier go/no-go decisions
- Focus on NDA-enabling activities in 2026
- Study changed to non-registrational Phase 2 design
- Smaller 40–65 patient size reduces statistical power versus 214
Insights
Streamlining EVANGELINE shrinks sample size, speeds early biological readouts, and redirects resources to NDA work in
The company shifts EVANGELINE to a smaller, single-arm Phase 2 (now 40–65 patients versus the original 214) and adopts a two-stage futility rule in Cohort A using Week-4 Ki-67 ≤
Key dependencies and risks include reliance on short-interval biological signals rather than larger randomized comparisons, and the non-registrational design limits definitive efficacy claims. The prior run-in Ki-67 signal of
Concrete items to monitor: the formal two-stage futility thresholds and outcomes at Week-4 for Cohort A, Week-24 RECIST results for Cohort B, and whether planned NDA-enabling activities proceed during
Changes are expected to reduce future study costs, accelerate objective readouts, and extend operating runway under current plans
"This amendment is about efficiency, focus, and financial discipline," said Steven Quay, M.D., Ph.D., Atossa's Chairman and Chief Executive Officer. "By streamlining EVANGELINE, we are rationalizing study spending and concentrating our strong balance sheet on the NDA-enabling package we plan to advance in 2026, without changing our safety oversight or commitment to rigorous data."
Capital Allocation Highlights
- Prioritizing runway and catalysts: The amended design is expected to reduce future EVANGELINE study costs and further focus on NDA-enabling work under Atossa's 2025-2026 operating plan
- Faster, objective decision points: Cohort A patients with an initial Ki-67 of >
10% employ a pre-specified two-stage futility rule using short-interval, objective endpoints (e.g., Week-4 Ki-67 ≤10% ) to enable earlier go/no-go decisions. Cohort B will be for patients with initial Ki-67 of <10% - Safety unchanged: There is no change to patient-safety data collection or Data Safety Monitoring Committee (DSMC) oversight with this amendment
- Operational focus: A single-arm, open-label structure concentrates efforts on one regimen and the data elements most relevant to a future NDA
EVANGELINE Design Snapshot (As Amended)
- Study type: Single-arm, open-label, non-registrational Phase 2 in premenopausal women with ER+/HER2– breast cancer in the pre-surgical setting
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Cohort A (signal-seeking): Two-stage futility design assessing the Week-4 Ki-67 ≤
10% rate to allow early stop if not promising - Cohort B (estimation): Week-24 objective response (RECIST 1.1, central review)
- Rationale: Focus on objective, short-interval endpoints to inform development decisions efficiently while preserving patient safeguards
- Study size change: The original EVANGELINE study design included 214 patients. This amendment reduces the patient total to 40-65 patients
Clinical context
EVANGELINE run-in data previously presented at the 2024 San Antonio Breast Cancer Symposium showed a Week-4 Ki-67 ≤
ABOUT EVANGELINE
EVANGELINE is a single-arm, open-label, non-registrational Phase 2 study evaluating investigational (Z)-endoxifen in premenopausal women with ER+/HER2– breast cancer in the pre-surgical setting. The trial uses short-interval, objective endpoints with a pre-specified two-stage futility rule to enable faster, data-driven decisions.
Participating
ABOUT (Z)-ENDOXIFEN
(Z)-endoxifen is an investigational, active metabolite of tamoxifen being developed by Atossa for hormone receptor–positive breast-cancer settings. Its safety and efficacy have not been established.
ABOUT ATOSSA THERAPEUTICS
Atossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company developing innovative therapies for significant unmet needs in breast cancer. Atossa's strategy emphasizes disciplined capital allocation, focusing resources on programs and data packages that can enable future regulatory submissions and potential commercialization. For more information, visit the Company's website at www.atossatherapeutics.com and refer to Atossa's filings with the
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the anticipated impact of the EVANGELINE amendment; expected reductions in future study costs; expected timelines, operating runway, and capital allocation; and plans for NDA-enabling activities in 2026. Forward-looking statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially. These risks include, without limitation, clinical, regulatory, operational, financial, and market risks; the possibility that study timelines or costs differ from current expectations; that clinical results may not support further development or regulatory submissions; and other risks described in Atossa's most recent periodic reports filed with the SEC, including the "Risk Factors" sections therein. Atossa undertakes no obligation to update forward-looking statements except as required by law.
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SOURCE Atossa Therapeutics Inc
FAQ
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