A Phase 3, Double-Blind, Placebo-Controlled, Randomized Study to Assess the Safety of Epicutaneous Immunotherapy With DBV712 250 mcg in 1-through 3-year-old Children With Peanut Allergy

The primary objective of this study is to assess the 6-month safety of DBV712 250 micrograms (mcg) in subjects 1 through 3 years of age with peanut allergy.

开始日期2025-06-24

申办/合作机构

DBV Technologies SA

NCT05741476

/ Active, not recruiting临床3期

A Phase 3, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of Epicutaneous Immunotherapy with DBV712 250 Μg in 4-7-year-old Children with Peanut Allergy (VITESSE)

The primary purpose of this study is to assess the efficacy and safety of daily DBV712 250 micrograms (mcg) to induce desensitization to peanut in peanut-allergic children 4-7 years of age over a 12-month double-blind, placebo-controlled (DBPC) Treatment Period.

开始日期2023-02-21

申办/合作机构

DBV Technologies SA

NCT03859700

/ Completed临床3期

EPITOPE Open-label Extension Study to Evaluate the Long-term Clinical Benefit and Safety of DBV712 in Peanut-Allergic Children

Open-label, follow-up study for subjects who completed the EPITOPE study.

开始日期2018-12-06

申办/合作机构

DBV Technologies SA

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项与 Peanut allergy immunotherapy(DBV Technologies SA) 相关的文献（医药）

2025-05-01·Journal of Allergy and Clinical Immunology-In Practice

Long-Term Safety of Epicutaneous Immunotherapy in Peanut-Allergic Children: An Open-Label Active Treatment (REALISE Study)

Article

作者: Petroni, Daniel ; Siri, Dareen ; Sussman, Gordon ; Wood, Robert ; Sindher, Sayantani B ; Lanser, Bruce J ; Kim, Edwin H ; Bois, Timothée ; Chan, Edmond S ; Brown-Whitehorn, Terri F ; Sher, Lawrence D ; Yang, William H ; Rupp, Ned ; Bird, J Andrew ; Chinthrajah, R Sharon ; Berger, William E ; Shreffler, Wayne G ; Scurlock, Amy M ; Bee, Katharine J ; Fineman, Stanley M ; Oriel, Roxanne C ; Fleischer, David M ; Gagnon, Rémi ; Chong, Hey J ; Anvari, Sara ; Bégin, Philippe ; Sampson, Hugh A ; Gonzalez-Reyes, Erika ; Green, Todd D ; Mehta, Hemalini ; Campbell, Dianne E ; Schneider, Lynda C ; Pongracic, Jacqueline A ; MacGinnitie, Andrew

BACKGROUND:

Owing to limited treatment options for peanut allergy, patients remain at risk for allergic reactions due to accidental exposure. Epicutaneous immunotherapy (EPIT) is a novel treatment being investigated for peanut allergy.

OBJECTIVE:

This study assessed long-term safety of EPIT with VIASKIN peanut patch 250 μg (VP250) via an open-label extension of the REAL Life Use and Safety of EPIT (REALISE) trial.

METHODS:

REALISE was a phase 3 trial in peanut-allergic children aged 4 through 11 years that included a 6-month, randomized, double-blind, placebo-controlled treatment phase, followed by an open-label, single-arm, active treatment period for up to 36 months.

RESULTS:

Of the 392 participants (male 54.8%; median age 7.2 y) who received at least 1 dose of treatment, 77.8% completed the 36-month active treatment. Mean adherence to treatment was high at 96.4%. Most participants (98.7%) experienced at least 1 treatment-emergent adverse event (TEAE); the majority were mild or moderate and decreased in frequency and severity over time. Most participants (94.6%) experienced at least 1 treatment-related TEAE. Local skin reactions were the most common treatment-related TEAE with the incidence decreasing from year 1 (87.8%) to year 3 (19.2%). Serious treatment-related TEAEs were reported in 2 participants. No specific safety signals were identified in the 14 participants enrolled with a history of severe anaphylaxis (Anaphylaxis Staging System grade 3).

CONCLUSION:

Consistent with previous phase 3 studies, long-term EPIT with VIASKIN peanut patch 250 μg was well tolerated with high adherence in peanut-allergic children aged 4 through 11 years (clinicaltrials.gov; NCT: NCT02916446).

2025-04-01·PEDIATRIC ALLERGY AND IMMUNOLOGY

Epicutaneous immunotherapy: A review of safety and efficacy

Review

作者: Greenhawt, Matthew ; Anagnostou, Aikaterini

Abstract:

Epcutaneous immunotherapy (EPIT) is a novel, non‐oral route of allergen immunotherapy, utilizing the skin and its robust density of epidermal Langerhans cells (LC) for antigen presentation. This space is non‐vascularized and impermeable, which limits allergen exposure into the bloodstream but preserves antigen presentation to regional lymph nodes to generate gut‐homing regulatory T cells. The EPIT patch utilizes natural water loss from the skin to absorb electrosprayed allergen through condensation. EPIT represents an alternative, non‐oral route of immunotherapy for food allergy, with good efficacy and strong safety profiles across multiple phase 2 and 3 studies for milk and peanut. Efficacy appears the best in very young children (1–3 years old), which has been shown to continue to enhance with extended treatment duration up to 36 months. Efficacy in slightly older children ages 4–11 years of age is less clear, but appears to be better in children ages 4–7 years of age. In clinical trials of milk and peanut EPIT, most subjects experienced adverse effects, mainly mild‐to‐moderate skin reactions localized around the patch placement site, which improve with continued duration of wear. Rates of treatment‐related anaphylaxis have been very low across all studies and ages, ranging from 1.6% to 4%, and were lowest in the infant and toddler population. While further studies of safety (1‐ to 3‐year‐olds) and efficacy (4‐ to 7‐year‐olds) are ongoing, EPIT is a potentially valuable addition to the current landscape of food allergy therapies, in particular for infants and toddlers where families may be seeking a non‐oral route of treatment.image

2025-03-01·Clinical and Translational Allergy

Epicutaneous immunotherapy for food allergy: A systematic review and meta‐analysis

Review

作者: Lee, Bohee ; Kuitunen, Ilari ; Csonka, Péter

Abstract:

Background:

Food allergies pose a global healthcare challenge, underscoring the need for effective interventions. This study evaluated the efficacy and safety of epicutaneous immunotherapy (EPIT) for food allergen desensitisation.

Methods:

We conducted a systematic review of randomised controlled trials by searching Ovid EMBASE, PubMed and Scopus in April 2024. Using a random‐effects meta‐analysis, we evaluated the clinical effectiveness and harms of EPIT, reporting results as risk ratios with 95% confidence intervals (CI).

Results:

After screening 460 abstracts and 35 full reports, 11 were included: nine on peanuts and two on cow's milk (CM). Peanut EPIT had a 51.2% treatment response versus 22.4% for placebo (RR 2.16, CI 1.49–3.12; four studies; moderate certainty). The RR for milk EPIT response rate was 1.78 (CI 1.06–3.00; one study). Five peanut studies (1396 patients) reported EPIT‐related adverse events (RR 1.39, CI 0.94–2.05; low certainty).

Conclusions:

EPIT offers a moderate treatment response with a favourable safety profile and significant improvements in quality of life. Current knowledge of EPIT remains limited, with evidence confined to peanut and CM allergies. There is a lack of research on sustained unresponsiveness achieved through food EPIT.

项与 Peanut allergy immunotherapy(DBV Technologies SA) 相关的新闻（医药）

2025-12-02

·抓马与翠花

食物过敏的治疗：免疫疗法、奥马珠单抗，还是二者联合？

思维导图一、综述基础与食物过敏（FA）背景综述定位与 CME 信息类型：聚焦食物过敏治疗的 Grand Rounds Review（CME 综述），作者团队来自英、美多所机构（如伦敦国王学院、斯坦福大学等）。 CME 学分：由美国过敏、哮喘和免疫学学会（AAAAI）认证，可获取 1.00 AMA PRA Category 1 学分，有效期为 2025 年 4 月 1 日至 2026 年 3 月 31 日，无外部商业支持。目标受众：过敏疾病领域的医师和研究者，核心目的是提供 OIT、奥马珠单抗及二者联合治疗的临床应用指南，强调共同决策（SDM）。 FA 疾病负担患病率：美国数据显示，1/13 学龄儿童和1/10 成人受 FA 影响。危害：包括严格饮食限制导致的营养不足、意外接触过敏原的焦虑、致命性过敏性休克风险、社会活动受限、生活质量（QoL）显著下降及家庭经济负担，避食是传统基础措施，但存在局限性。治疗现状：当前 FDA 批准的主动治疗方案仅口服免疫疗法（OIT）和奥马珠单抗两种。二、口服免疫疗法（OIT）的核心内容1. OIT 定义与治疗机制定义：通过规律、小剂量摄入食物过敏原，逐步诱导免疫系统对过敏原产生耐受，最终实现脱敏（DS，即短期接触不引发反应）或持续无应答（SU，即停止治疗后仍耐受）。标准流程：多采用 “初始加量 + 维持治疗” 两阶段模式（源于 2011 年 Varshney 等研究），初始加量期单日递增剂量并观察，维持期每日在家给药，维持剂量和时长因方案而异。2. 关键临床研究与疗效数据研究名称过敏原研究人群维持剂量核心疗效结果 Varshney 等（2011）花生 1-16 岁儿童 4000mg 花生蛋白 16 例完成者均通过 5000mg 花生 DBPCFC，安慰剂组仅耐受 280mg；3 例因 AE 退出 STOP II 试验花生 7-16 岁儿童（英） 800mg 花生蛋白 6 个月治疗后，49% OIT 组通过 1400mg DBPCFC，避食组 0% Blumchen 等（2019）花生儿童（德，多中心） 125-250mg 花生蛋白 74.2% OIT 组通过 443mg DBPCFC，安慰剂组 16.1% PALISADE 研究花生 4-55 岁 300mg 花生蛋白 4-17 岁应答率 67.2%（≥1043mg 耐受），18-55 岁 41.5%（无统计学意义） POSEIDON 研究花生 1-3 岁儿童同 PALISADE 600mg 脱敏率 73.5%、1000mg 脱敏率 68.4%，均高于 PALISADE 中 4-17 岁儿童（67%、50%） IMPACT 试验花生 12-47.9 月龄儿童 - 12-23.9 月龄缓解率 71%，24-35.9 月龄 35%，36-47.9 月龄 19%；月龄每增 1 个月，缓解 odds 降 7%3. 早期 OIT（e-OIT，<5 岁启动）的优劣势优势免疫可塑性强：幼儿免疫系统未完全定型，TH2 反应较弱，更易诱导耐受；安全性更高：如 POSEIDON 研究中严重过敏反应率仅 2%，远低于 PALISADE 研究中 4-17 岁儿童的 14.2%； QoL 早改善：避免儿童因 FA 产生焦虑和社交隔离；依从性好：家长监督可减少漏服、错服，降低 AE 风险。劣势幼儿易生病：导致 OIT 剂量暂停或减量，延长达标时间；部分食物可能自然脱敏：如鸡蛋、牛奶，e-OIT 必要性需评估；长期效果待明确：SU 的长期稳定性数据不足。4. OIT 的安全性与局限性常见风险：治疗期间 AE 发生率高（如 Varshney 研究中近半数患者出现 AE），诱因包括并发疾病、哮喘控制不佳、空腹服药、服药后运动、月经等（已纳入标准 dosing 指南）；严重风险：嗜酸性食管炎（EoE），部分 e-OIT 研究中已有报道；操作局限：过敏原特异性强（需针对单一过敏原制定方案）、耗时（需长期每日给药）、启动和加量期需医疗监督。三、奥马珠单抗（omalizumab）的临床应用1. 药物机制与批准背景机制：抗 IgE 单克隆抗体，靶向过敏反应关键驱动因子 IgE，降低过敏反应阈值；批准时间：2024 年初获 FDA 批准，用于≥1 岁 IgE 介导 FA 患者，减少多过敏原意外摄入引发的过敏反应；既往应用：此前用于哮喘治疗，安全性已验证，但 < 6 岁患者数据有限（OUtMATCH 试验纳入≥1 岁患者，安全性与安慰剂相当，仅注射部位反应有差异）。2. 单药治疗的疗效与特点核心研究（OUtMATCH 试验第一阶段）：人群：177 例对花生 + 至少 2 种其他食物过敏的儿童 / 青少年；方案：16 周奥马珠单抗 / 安慰剂注射，后行 DBPCFC；结果：67% 活性组耐受 1044mg 累积花生蛋白（安慰剂组 7%），69% 耐受 2 种过敏原，47% 耐受 3 种（腰果除外）。优势多过敏原保护：无需针对单一过敏原，适合多食物过敏患者；治疗负担低：每 2-4 周注射 1 次，可自我注射；安全性好：无严重 AE 差异（除注射部位反应）。劣势保护水平低于 OIT：仅提供 “安全网”，无法实现食物纳入饮食；价格高：经济负担较重；效果不可预测：不同过敏原的保护水平差异大；仍需避食：无法替代避食，仅应对意外摄入。3. 奥马珠单抗联合 OIT 的优势核心获益：加快达标速度：缩短 OIT 维持剂量到达时间；降低 AE 风险：尤其在 OIT 加量期，减少过敏反应频率；支持多过敏原 OIT：如某 II 期研究中，83% 联合组通过 2 种过敏原 2g DBPCFC，安慰剂组仅 33%；局限性：无法提升 SU 率：需持续 OIT 维持以保留脱敏效果；成本叠加：同时承担两种治疗费用，且仍需 OIT 的医疗监督和每日给药。四、治疗方案对比与共同决策（SDM）1. 三种治疗方案核心差异（整理自原文图 2）对比维度过敏原免疫疗法（OIT）奥马珠单抗（单药） OIT + 奥马珠单抗（联合）保护水平高（多数患者）中低（约 2/3 患者）高（多数患者）过敏原覆盖单一过敏原多过敏原多过敏原治疗频率每日口服每 2-4 周注射每日口服 + 每 2-4 周注射治疗负担高（耗时、需监督）低（注射频率低、可自我操作）中高（OIT 负担 + 注射）关键风险 AE 常见、EoE 风险、食物厌恶者不适用价格高、恐针者不适用、保护不可预测价格高、AE 常见、恐针 / 食物厌恶者不适用适用人群关注单一过敏原、愿承担高治疗负担者需多过敏原安全网、追求低治疗负担者关注多过敏原、需加快 OIT 达标者患者目标将单一食物纳入日常饮食避免意外摄入反应、正常参与社交将多种食物纳入日常饮食2. 共同决策（SDM）的实施核心框架：采用渥太华决策支持框架，以患者偏好和价值观为核心，明确医师与患者的协作角色；实施步骤：评估患者认知：了解患者对 FA 诊断和治疗的理解程度；明确治疗目标：询问患者是否希望纳入食物、减少意外风险等；提供循证信息：清晰说明各方案的疗效、风险、成本及对 QoL 的影响；考量社会因素：关注边缘化群体的资源可及性、收入 / 教育水平对治疗认知的影响；制定随访计划：明确后续沟通方式，区分 “医师引导” 或 “患者引导” 的 SDM 模式；辅助工具：需完善 FA 专用决策辅助工具（当前稀缺），可通过印刷或网络形式提供证据，减少决策冲突。五、未来研究方向（整理自原文图 3）研究类别核心研究需求临床转化价值个体化食物 AIT 探索 DS/SU 的生物标志物；减少给药频率；放宽 OIT “黄金规则”；实现饮食正常化优化剂量方案（加量速度、维持剂量）；无需口服食物挑战（DBPCFC）；无需 SU 观察期 e-OIT 与标准 AIT 对比不同年龄组免疫变化差异；基线 sIgE 与启动年龄的交互作用；EoE 结局对比明确 e-OIT 启动的合理年龄；为年长患者优化 AIT 方案 AIT 方式对比比较 OIT 与 SLIT（舌下）、EPIT（表皮）、肽免疫疗法的疗效 / 安全性基于疗效、可行性、依从性，为患者选择最优 AIT 方式联合疗法 OIT 与生物制剂联合；SLIT/EPIT 向 OIT 过渡的可行性提升 AIT 达标率、DS/SU 率，惠及单一疗法无效患者治疗可及性评估患者 / 照护者 QoL 影响；开展卫生经济学分析推动保险报销，提升 OIT 等疗法的可及性和可行性关键问题与答案问题 1：早期口服免疫疗法（e-OIT）相比年长人群 OIT，在疗效和安全性上有哪些核心优势？背后的免疫学机制是什么？答案：疗效优势 e-OIT（尤其 5 岁前启动）脱敏率显著更高，如 POSEIDON 研究（1-3 岁儿童）中，600mg 花生蛋白脱敏率达 73.5%、1000mg 脱敏率达 68.4%，而同期 PALISADE 研究（4-17 岁人群）中对应脱敏率仅 67% 和 50%；IMPACT 试验显示，12-23.9 月龄儿童花生过敏缓解率 71%，远高于 36-47.9 月龄儿童的 19%，且月龄每增加 1 个月，缓解概率下降 7%。安全性优势 e-OIT 严重过敏反应发生率更低，POSEIDON 研究中 1-3 岁儿童严重过敏反应率仅 2%，无严重病例，而 PALISADE 研究中 4-17 岁人群严重过敏反应率达 14.2%，且 4.3% 为严重病例；加拿大真实世界数据显示，学龄前儿童花生 / 树坚果 e-OIT 严重过敏反应率仅 0.4% 或无。免疫学机制幼儿处于免疫发育关键窗口期，免疫系统可塑性强，具体表现为：TH2 细胞程序未定型（IL-4 分泌量低）、IgE 反应不成熟（TCR 亲和力弱、GATA-3 表达不稳定）、不易发生过敏原特异性 IgE 表位扩散；而随年龄增长，TH2 细胞因子分泌增加，IgE 表位多样性扩大（如 LEAP 研究中 30 月龄后避食儿童出现花生 IgE 表位扩散），导致脱敏难度升高。问题 2：奥马珠单抗单药治疗与 OIT 在食物过敏（FA）治疗中的定位有何本质区别？临床选择时需优先考虑患者的哪些核心因素？答案：本质区别定位维度奥马珠单抗（单药） OIT 治疗目标 “风险控制”：提供多过敏原意外摄入的 “安全网”，无法将过敏原纳入饮食 “主动脱敏”：实现过敏原耐受，最终将其纳入日常饮食过敏原覆盖广谱：无需针对单一过敏原，可保护多种食物过敏特异：需针对单一 / 少数过敏原制定方案治疗负担低：每 2-4 周注射 1 次，可自我操作，无需每日给药高：每日口服，启动 / 加量期需医疗监督保护水平中低：仅提升反应阈值，无法完全避免反应高：多数患者可耐受较高剂量过敏原临床选择核心因素治疗目标若患者希望 “正常食用某类食物”，优先 OIT；若仅需 “减少意外摄入风险”，可选奥马珠单抗；过敏原数量单食物过敏优先 OIT，多食物过敏（如同时对花生、鸡蛋、牛奶过敏）可优先奥马珠单抗或联合治疗；治疗负担耐受度时间紧张、无法每日给药者选奥马珠单抗；能接受每日操作和医疗监督者选 OIT；特殊情况恐针者排除奥马珠单抗，食物厌恶者排除 OIT；经济条件有限者需考量奥马珠单抗的高成本。问题 3：共同决策（SDM）在食物过敏（FA）治疗中为何至关重要？临床实践中需如何落地以保障患者利益？答案：重要性原因治疗方案无 “绝对最优” OIT、奥马珠单抗及联合治疗各有优劣（如 OIT 疗效高但负担重，奥马珠单抗负担低但保护弱），无统一适用方案；患者个体差异大年龄（e-OIT vs 年长 OIT）、过敏食物数量、生活习惯（如社交频率）、QoL 需求（如是否在意饮食限制）、经济条件均影响治疗适配性；减少决策冲突 FA 治疗周期长（OIT 需数年），患者 / 照护者的主动参与可提升依从性，降低因方案不适导致的中途退出。临床落地路径采用结构化框架基于渥太华决策支持框架，先评估患者对 FA 的认知（如是否了解 OIT 的 AE 风险），再解答疑问，避免信息不对称；明确患者价值观通过提问（如 “你更在意能吃花生，还是更在意避免每日服药？”），优先满足核心需求（如儿童患者需考虑家长对治疗安全性的担忧）；整合社会因素关注边缘化群体（如低收入家庭）的资源可及性（如 OIT 的医疗监督是否方便）、高收入 / 高教育群体对 OIT 的认知偏差，确保公平性；利用辅助工具开发 FA 专用决策辅助工具（如印刷版 “方案对比表”、网络版风险 - 获益计算器），提升患者对方案的理解；建立随访机制明确后续沟通节点（如 OIT 加量期每周反馈），允许患者根据治疗反应（如 AE 频率）调整方案，实现动态 SDM。文献地址： Brough HA, Kim EH, Anagnostou A, Lanser BJ, Chinthrajah RS, Sindher SB. Treatment of Food Allergy: Immunotherapy, Omalizumab, or Both. J Allergy Clin Immunol Pract. 2025 Apr;13(4):731-739. doi: 10.1016/j.jaip.2024.12.011 . Epub 2024 Dec 17. PMID: 39701277. 封面来自网络

2025-11-12

·GlobeNewswire-Health Care

DBV Technologies Announces Last Patient Visit Completed in VITESSE Phase 3 Clinical Trial of VIASKIN® Peanut Patch in Peanut Allergic Children Aged 4-7 Years

Châtillon, France, November 11, 2025 DBV Technologies Announces Last Patient Visit Completed in VITESSE Phase 3 Clinical Trial of VIASKIN® Peanut Patch in Peanut Allergic Children Aged 4-7 Years Company remains on track for VITESSE topline data in Q4 of this year DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT – CUSIP: 23306J309), a clinical-stage biopharmaceutical company, today announced that the last patient visit has been completed in the Company’s Phase 3 VITESSE clinical trial of the VIASKIN® Peanut patch in peanut allergic children aged 4-7 years. With the completion of the double-blind, placebo-controlled treatment phase of the study, DBV remains on track to announce topline data from VITESSE in the fourth quarter of this year. “Last patient last visit represents a very important milestone for DBV, as it brings us one step closer to the potential of bringing this treatment option to peanut allergic children, their physicians and caregivers, if approved,” stated Daniel Tassé, Chief Executive Officer of DBV Technologies. “We’re grateful to the investigators, internal teams, and most importantly patients and caregivers for their time and commitment to this study. We look forward to sharing topline results this quarter.” The VITESSE Phase 3 trial in peanut-allergic children ages 4 – 7 is a 12-month study evaluating the efficacy and safety of the VIASKIN® Peanut patch in 654 subjects (randomized 2:1), representing individuals across 86 sites in the U.S., Canada, Europe, the UK, and Australia. VITESSE is currently the largest treatment intervention study in peanut allergy. About DBV TechnologiesDBV Technologies is a clinical-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need. DBV is currently focused on investigating the use of its proprietary VIASKIN® patch technology to address food allergies, which are caused by a hypersensitive immune reaction and characterized by a range of symptoms varying in severity from mild to life-threatening anaphylaxis. Millions of people live with food allergies, including young children. Through epicutaneous immunotherapy (EPIT), the VIASKIN® patch is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin. EPIT is a new class of non-invasive treatment that seeks to modify an individual’s underlying allergy by re-educating the immune system to become desensitized to allergen by leveraging the skin’s immune tolerizing properties. DBV is committed to transforming the care of food allergic people. The Company’s food allergy programs include ongoing clinical trials of VIASKIN Peanut in peanut allergic toddlers (1 through 3 years of age) and children (4 through 7 years of age). DBV Technologies is headquartered in Châtillon, France, with North American operations in Warren, NJ. The Company’s ordinary shares are traded on segment B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing five ordinary shares) are traded on the Nasdaq Capital Market (Ticker: DBVT; CUSIP: 23306J309). For more information, please visit www.dbv-technologies.com and engage with us on X (formerly Twitter) and LinkedIn. VIASKIN is a registered trademark of DBV Technologies. Forward Looking StatementsThis press release may contain forward-looking statements and estimates, including statements regarding the therapeutic potential of VIASKIN® Peanut patch and EPIT, designs of DBV’s anticipated clinical trials, DBV’s planned regulatory and clinical efforts including timing and results of communications with regulatory agencies, plans and expectations regarding initiation of the confirmatory study, plans and expectations with respect to the submission of BLAs to FDA, anticipated support for the BLA submission, , and the ability of any of DBV’s product candidates, if approved, to improve the lives of patients with food allergies. These forward-looking statements and estimates are not promises or guarantees and involve substantial risks and uncertainties. At this stage, DBV’s product candidates have not been authorized for sale in any country. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, and DBV’s ability to successfully execute on its budget discipline measures. A further list and description of risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements in this press release can be found in DBV’s regulatory filings with the French Autorité des Marchés Financiers (“AMF”), DBV’s filings and reports with the U.S. Securities and Exchange Commission (“SEC”), including in DBV’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on April 11, 2025, as amended by Amendment No. 1 on Form 10-K/A filed with the SEC on April 28, 2025, and as amended further by Amendment No. 2 on Form 10-K/A filed with the SEC on May 14, 2025, and future filings and reports made with the AMF and SEC by DBV. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. Other than as required by applicable law, DBV Technologies undertakes no obligation to update or revise the information contained in this Press Release. Investor Contact Katie MatthewsDBV Technologieskatie.matthews@dbv-technologies.com Media ContactBrett WhelanDBV Technologiesbrett.whelan@dbv-technologies.com Attachment Version PDF

临床3期免疫疗法

2025-10-30

·dbv-technologies.com

DBV Technologies Announces Appointment of Philina Lee, Ph.D. to Board of Directors

Châtillon, France, October 30, 2025 DBV Technologies Announces Appointment of Philina Lee, Ph.D. to Board of Directors DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Market: DBVT), (the “Company” or “DBV”), a clinical-stage biopharmaceutical company, today announced the provisional appointment of a new independent director, Dr. Philina Lee, to its Board of Directors (the “Board”), effective October 30, 2025. Dr. Lee is appointed in replacement of Daniel Soland, subject to the ratification by the Company’s shareholders at the next annual meeting of shareholders. Dr. Lee will also serve as a member of the Compensation Committee of the Board. With this addition, the Company’s Board comprises ten directors. “We are pleased to welcome Philina Lee as a new independent director to the Board,” said Michel de Rosen, Chairman of the Board. “Philina’s extensive experience building successful biopharmaceutical organizations and commercializing pharmaceutical products will add tremendous value as the Company moves closer to potential commercialization.” Dr. Lee joins DBV following a distinguished tenure at Blueprint Medicines where she progressed through increasingly senior roles, culminating in her leadership of the company’s commercial organization as Chief Commercial Officer, overseeing the successful launch and growth of AYVAKIT®. She previously was on the Board of Directors at Fusion Pharmaceuticals, where she served on both the Nomination and Governance Committee and the Research and Development Committee. “I am honored to join DBV’s Board at such a pivotal time for the Company, as it continues to advance VIASKIN® Peanut for children and toddlers with peanut allergy,” said Dr. Lee. “I look forward to serving on the Compensation Committee and contributing to DBV’s growth and success.” About DBV TechnologiesDBV Technologies is a clinical-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need. DBV Technologies is currently focused on investigating the use of its proprietary VIASKIN® patch technology to address food allergies, which are caused by a hypersensitive immune reaction and characterized by a range of symptoms varying in severity from mild to life-threatening anaphylaxis. Millions of people live with food allergies, including young children. Through epicutaneous immunotherapy (EPIT), the VIASKIN® patch is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin. EPIT is a new class of non-invasive treatment that seeks to modify an individual’s underlying allergy by re-educating the immune system to become desensitized to allergen by leveraging the skin’s immune tolerizing properties. DBV Technologies is committed to transforming the care of food allergic people. The Company’s food allergy programs include ongoing clinical trials of VIASKIN Peanut in peanut allergic toddlers (1 through 3 years of age) and children (4 through 7 years of age). DBV Technologies is headquartered in Châtillon, France, with North American operations in Warren, NJ. The Company’s ordinary shares are traded on segment B of Euronext Paris (DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing five ordinary shares) are traded on the Nasdaq Capital Market (DBVT – CUSIP: 23306J309). VIASKIN is a registered trademark of DBV Technologies. Investor Contact Katie MatthewsDBV Technologieskatie.matthews@dbv-technologies.com Media ContactBrett WhelanDBV Technologiesbrett.whelan@dbv-technologies.com Attachment

高管变更免疫疗法

100 项与 Peanut allergy immunotherapy(DBV Technologies SA) 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
花生过敏	申请上市	欧盟	DBV Technologies SA	2020-11-06

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临床结果

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02916446 (REALISE Study, Pubmed \| J Allergy Clin Immunol Pract)	临床3期	花生过敏	392	VIASKIN peanut patch 250 μg	範糧鹹鏇襯鹹餘淵醖顧(醖窪顧簾繭窪膚遞鑰鑰) = 夢糧積壓製構夢遞網製糧積壓糧齋製顧構觸憲 (繭壓膚築構網獵窪製鏇 ) 更多	积极	2025-05-01
NCT03211247 (EPITOPE OLE, GlobeNewswire) 人工标引	临床3期	花生过敏	266	Viaskin Peanut (EPITOPE OLE)	淵觸醖憲齋鏇醖遞齋淵(蓋觸壓簾網憲範顧鬱廠) = 襯襯遞繭淵窪艱鏇襯積鹽膚窪窪衊壓鬱簾簾齋 (鬱壓壓繭艱蓋網繭鏇壓 ) 更多	积极	2025-01-08
				Placebo (EPITOPE OLE)	-
NCT03211247 (EPITOPE \| EPITOPE OLE, CTgov)	临床3期	花生过敏	414	Part B Viaskin Peanut 250 mcg (Part B Viaskin Peanut 250 mcg)	餘鹽餘鏇獵簾餘網餘憲 = 獵鹽窪鏇鹹網簾構蓋遞顧獵糧窪齋構鏇餘壓餘 (憲膚網夢網範艱夢齋願, 鬱願鑰鏇齋膚衊糧淵鬱 ~ 選襯鹽範淵觸遞齋糧築) 更多	-	2024-12-16
				Part B Placebo (Part B Placebo)	餘鹽餘鏇獵簾餘網餘憲 = 鏇膚構鹹膚製鏇蓋餘艱顧獵糧窪齋構鏇餘壓餘 (憲膚網夢網範艱夢齋願, 糧襯衊憲淵繭繭構顧構 ~ 艱糧夢網淵窪鏇網觸網) 更多
NCT01955109 (OLFUS-VIPES, CTgov)	临床2期	花生过敏	171	Viaskin Peanut (VIPES Initial Treatment Group: All Viaskin Peanut Doses)	窪顧構齋鹽膚選構襯鹽 = 構鏇窪淵壓觸願遞鏇鑰夢鹽鏇構選觸餘繭廠繭 (觸構齋築範繭窪壓獵淵, 製簾積夢願衊構壓範壓 ~ 構蓋積艱壓構衊鏇襯積) 更多	-	2022-06-30
				Placebo (VIPES Initial Treatment Group: Placebo)	窪顧構齋鹽膚選構襯鹽 = 醖鏇壓繭糧鹽築壓簾願夢鹽鏇構選觸餘繭廠繭 (觸構齋築範繭窪壓獵淵, 繭繭壓範鑰範鏇齋鹹鬱 ~ 壓繭範膚觸壓鹽鬱網衊) 更多
NCT03211247 (EPITOPE, GlobeNewswire) 人工标引	临床3期	花生过敏	362	Peanut allergy immunotherapy	構獵廠膚網鑰襯繭壓獵(壓鹽積糧醖蓋壓襯鏇遞) = 蓋鏇繭遞糧鬱構窪憲範願製膚鏇壓鹹衊壓淵繭 (製艱蓋選積艱鹽築鏇築 ) 更多	积极	2022-06-07
				Placebo	構獵廠膚網鑰襯繭壓獵(壓鹽積糧醖蓋壓襯鏇遞) = 鹹壓鬱襯齋蓋艱壓積鑰願製膚鏇壓鹹衊壓淵繭 (製艱蓋選積艱鹽築鏇築 ) 更多
REALISE (ACAAI2021)	临床3期	花生过敏 skin-prick test \| peanut-specific IgE	393	Viaskin Peanut (VP250)	窪繭遞膚蓋鬱憲製壓壓(醖範淵艱艱壓鏇構襯積) = 16 subjects experienced 17 anaphylactic reactions (none severe) deemed related to VP250 夢簾齋願製糧範餘襯夢 (鹽醖齋醖構鏇鹹鏇夢網 ) 更多	积极	2021-11-04
NCT01675882 (VIPES, CTgov)	临床2期	花生过敏	221	Viaskin Peanut (Viaskin Peanut 50 μg)	齋製醖鏇築夢觸齋廠鑰 = 顧醖鹽鏇獵鹽襯鑰範構鹽鹽築鬱觸鏇網糧網齋 (觸醖壓襯鬱範憲顧範鬱, 衊鹽構齋淵簾觸積齋醖 ~ 製糧鏇糧齋餘獵醖獵願) 更多	-	2021-10-27
				Viaskin Peanut (Viaskin Peanut 100 μg)	齋製醖鏇築夢觸齋廠鑰 = 艱範繭蓋窪選範選餘衊鹽鹽築鬱觸鏇網糧網齋 (觸醖壓襯鬱範憲顧範鬱, 積艱積鹹膚遞窪膚窪製 ~ 積選鹽願襯膚襯遞觸蓋) 更多
REALISE (AAAAI2020)	临床3期	花生过敏 peanut skin-prick test wheal diameter ≥8 mm \| peanut-specific IgE ≥14 kUA/L	393	Viaskin peanut 250 μg	製淵窪夢網範製鏇糧鏇(積鑰鬱鹽衊繭齋鏇餘選) = 憲鑰願齋願鏇艱醖齋壓夢鏇鹹構夢艱選鑰繭鹹 (積鹹顧構鑰鹹糧選構淵 ) 更多	积极	2020-02-01
				Placebo	製淵窪夢網範製鏇糧鏇(積鑰鬱鹽衊繭齋鏇餘選) = 艱鏇鏇壓網積網觸襯鬱夢鏇鹹構夢艱選鑰繭鹹 (積鹹顧構鑰鹹糧選構淵 ) 更多
NCT01904604 (DAIT CoFAR6, CTgov)	临床2期	花生过敏	75	Placebo Viaskin® Patch (Placebo Patch)	糧鏇壓艱醖醖選窪鹹壓 = 壓淵艱築蓋鑰襯遞齋艱蓋餘齋夢鹽鏇鏇襯積醖 (簾鏇積憲廠鬱醖艱膚艱, 壓壓網鹽願鏇選齋選範 ~ 顧糧淵衊鬱願淵簾衊遞) 更多	-	2016-08-26
				DBV712 (100 µg Peanut Patch)	糧鏇壓艱醖醖選窪鹹壓 = 廠膚鏇夢積齋顧遞艱醖蓋餘齋夢鹽鏇鏇襯積醖 (簾鏇積憲廠鬱醖艱膚艱, 艱窪襯廠顧鏇壓齋壓獵 ~ 襯獵衊壓鹹膚艱襯蓋糧) 更多