Dermavant Sciences GmbH

Insight 数据库「医药交易」模块显示，本周全球范围内共发生 30 项医药交易（截至 11 月 1 日），涉及 GSK、诺华、艾伯维、渤健、宜明昂科、扬子江、欧加隆公司等。 其中： 诺华超 20 亿美元布局分子胶蛋白降解剂，GSK 3 亿美元预付款收购恩沐生物一款 T 细胞衔接器（TCE）； 艾伯维动作频繁，先是约 14 亿美元收购 CNS 新锐获得阿尔茨海默病（AD）疗法，后又斥资 15 亿美元合作开发基于 TCE 平台的新型抗体疗法； 部分合作进展不顺，如小野制药放弃收购 Equillium 公司的伊托珠单抗，微芯生物与海正药业则提前终止了糖尿病新药西格列他钠的推广合作； 另外还有其他公司达成新合作，涉及小分子胶降解剂、下一代合成肽、CAR-T 等创新产品。 下面，Insight 数据库将节选部分备受关注的交易案例做介绍，仅供读者参阅。 诺华、艾伯维、GSK等跨国药企布局新疗法   诺华达成超 20 亿美元合作 Monte Rosa Therapeutics 宣布与诺华达成合作，诺华将获得 MRT-6160 及其他靶向 VAV1 的分子胶蛋白降解剂的全球独家开发、制造和商业化权利。根据协议，Monte Rosa 将获得 1.5 亿美元的预付款，并有资格获得高达 21 亿美元的开发、监管和销售里程碑付款。 MRT-6160 是一款强效、高选择性口服 VAV1 降解剂，具有潜力成为多种免疫介导疾病的治疗选择，包括多发性硬化、类风湿性关节炎、炎症性肠病和皮肤病。目前，该产品正在健康志愿者中进行 1 期临床试验。   艾伯维约 15 亿美元合作开发新型抗体疗法 艾伯维和 EvolveImmune Therapeutics 宣布达成一项约 15 亿美元的合作，将利用后者的 T 细胞衔接器（TCE）平台开发针对实体瘤和血液系统恶性肿瘤的新型抗体疗法。根据协议，EvolveImmune 公司将获得总计 6500 万美元的预付款和股权投资，并有资格获得高达 14 亿美元的里程碑等款项。 EvolveImmune 公司致力于开发潜在「first-in-class」的多功能生物制品，以克服一系列在实体瘤和血液瘤中由癌症引起的免疫缺陷。其专有平台旨在提供强效、选择性和整合性的 T 细胞共刺激，以增强和维持 T 细胞的肿瘤杀伤能力。   艾伯维 14 亿美元收购 CNS 新锐 艾伯维与 Aliada Therapeutics 宣布达成最终协议，将以约 14 亿美元款项收购 Aliada，并获得其主要项目阿尔茨海默病（AD）疗法 ALIA-1758。这项收购预计将在 2024 年第四季度完成。 Aliada 公司致力于利用新型血脑屏障（BBB）穿越技术开发治疗中枢神经系统（CNS）疾病创新疗法。ALIA-1758 正是采用其创新递送技术，通过 TfR 将靶向焦谷氨酸化淀粉样蛋白（3pE-Aβ）抗体运输穿越 BBB 的在研 AD 疗法，目前正处于 1 期临床试验阶段。   渤健 14.5 亿美元布局小分子降解剂 渤健和 Neomorph 公司宣布开展一项研究合作，旨在发现和开发分子胶降解剂，用于治疗阿尔茨海默病及罕见神经系统和免疫系统等疾病。对此，Neomorph 公司将获得总款项可高达 14.5 亿美元的预付款以及各种潜在里程碑付款。 Neomorph 公司专注于开发「不可成药靶点」的分子胶蛋白降解剂。此次合作旨在利用该公司专有的分子胶发现平台，以加速新型小分子治疗性分子胶降解剂的识别和验证，渤健将负责推进临床候选药物的进一步开发和潜在商业化。   GSK 8.5 亿美元收购恩沐生物一款 TCE 葛兰素史克与恩沐生物（Chimagen）宣布，前者以 3 亿美元的预付款从后者收购一款 TCE 产品 CMG1A46 的全部全球权利。根据协议，恩沐生物将有资格获得该产品的开发和商业里程碑付款，总额为 5.5 亿美元。 CMG1A46 是一种靶向 CD19 和 CD20 的 T 细胞衔接器（TCE），对 CD19 和 CD20 阳性 B 细胞具有高亲和力，对 CD3 具有低亲和力。目前，该产品正在美国和中国进行白血病和淋巴瘤的 1 期临床试验。GSK 计划开发和商业化 CMG1A46，并重点关注 B 细胞驱动的自身免疫性疾病。 其它授权合作   宜明昂科与扬子江达成合作 宜明昂科与扬子江战略合作签约仪式成功举行，前者将根据协议与扬子江药业集团药物研究院开展各领域合作。双方将在药品研发、生产、销售，以及投融资并购、技术支持与咨询服务等方面开展长期合作，并有望优先在透明质酸酶（皮下药物递送）方面建立合作，开展抗体新药开发。 宜明昂科致力于开发肿瘤免疫疗法，其核心产品 SIRPα-Fc 融合蛋白 IMM01 已进入 3 期临床阶段。该公司创始人、董事长田文志博士表示，期待此次合作能够充分发挥各方的优势和特色，并加速和优化其在研管线的开发进程。   微芯生物与海正药业提前终止推广合作 微芯生物发布公告称，因原协议相关授权终止，已与海正药业提前终止西格列他钠片（双洛平）的推广合作。该公司将收回原协议约定的西格列他钠片在河南、浙江、江苏等 19 个省份的独家市场推广权，微芯销售团队将负责该药在中国大陆地区的全部推广活动。 西格列他钠是一款过氧化物酶体增殖物激活受体（PPAR）全激动剂，已在中国获批用于 2 型糖尿病治疗，并于 2022 年纳入国家医保目录。2020 年 12 月，微芯生物将该产品在中国大陆指定授权区域的市场推广权益独家许可给海正药业。   小野制药放弃收购伊托珠单抗 Equillium 公司宣布，小野制药（Ono）已做出战略商业决定，决定不行使其收购伊托珠单抗（itolizumab）的权利。该决定与任何临床计划的数据无关，也没有观察到或报告安全问题。因此，Equillium 公司保留了其对伊托珠单抗的所有商业权利。 伊托珠单抗是一种靶向 CD6-ALCAM 信号通路的单克隆抗体，在调节驱动许多免疫炎症疾病的效应 T 细胞中起着核心作用。目前，该产品正在急性移植物抗宿主病（aGVHD）患者的 3 期临床研究中进行评估。   欧加隆完成了 Dermavant 的收购 欧加隆宣布完成从 Roivant 公司收购 Dermavant Sciences，包括其创新的皮肤病治疗药物 Vtama（tapinarof）乳膏。Dermavant 是一家专门从事免疫皮肤病学的生物制药公司。根据协议，此次收购涉及总金额达 12 亿美元，包括 1.75 亿美元的前期付款和 7500 万美元的里程碑付款。 Vtama 中文通用名为本维莫德，最初由中国天济医药和中昊药业联合开发，其境外开发权辗转来到 Dermavant 公司手中。该药已在美国和中国等地获批用于斑块型银屑病治疗。   Lyell Immunopharma 完成对 ImmPACT Bio 的收购 Lyell Immunopharma 宣布已完成对细胞治疗新锐 ImmPACT Bio 的收购。此次收购加强了 Lyell 公司 CAR-T 细胞疗法的临床管线，并补充了一套创新技术，旨在产生更持久的功能性 T 细胞，从而取得更持久的结果。 Lyell Immunopharma 是一家临床阶段 T 细胞重编程公司，旨在为实体瘤或血液瘤患者推进下一代 CAR-T 细胞治疗管线。本次收购使该公司增加了一款双靶向 CD19/CD20 的 CAR-T 细胞候选药 IMPT-314，该产品有望在 2025 年启动针对 B 细胞非霍奇金淋巴瘤三线患者的关键试验。   HK inno.N 引进新型免疫疗法 韩国制药公司 HK inno.N 宣布与 Novacell Technology 达成协议，以获得一种新型免疫治疗候选药物。这是一种下一代合成肽，可作为 FPR2（甲酰肽受体 2）激动剂，以增强身体控制过度免疫反应的能力。 HK inno.N 旨在利用炎症抑制和细胞再生特性开发一系列炎症疾病的治疗方法，包括眼科疾病、皮肤病和呼吸系统疾病。此次合作将使该公司进一步扩大其免疫治疗管线成为可能，以解决免疫功能减弱的老龄人口对免疫治疗需求不断增加的问题。   GC Biopharma 与 ovelty Nobility 达成合作 GC Biopharma 与专门从事抗体药物开发的韩国生物技术公司 Novelity Noble 签署联合研发协议，以合作治疗地图样萎缩 (GA)。GA 是一种晚期干性年龄相关性黄斑变性（AMD），可破坏视网膜组织并导致失明。 根据协议，双方将在所有开发阶段进行合作，从确定候选抗体为基础的蛋白质疗法，到临床前、临床试验以及最终商业化。在最初阶段，联合研究将集中于鉴定参与 GA 病理学的靶蛋白并开发抑制它的候选物，然后进行概念验证研究。   以色列创新管理局支持实体瘤免疫疗法开发 Pluri 公司宣布，以色列创新管理局（IIA）将资助 Pluri 与 BIRAD（由 Cohen 教授领导）的合作，以支持用于实体瘤治疗的胎盘粘膜相关不变 T（MAIT）细胞疗法的持续开发。IIA 将在明年为该合作提供资金，合作的目标是有效整合创新技术并推进临床前研究。 在这项合作下，Cohen 教授基于 Siglec 的新型嵌合开关受体（CCR）将被整合到 Pluri 公司的 CAR-MAIT 细胞治疗平台中，以显着提高 CAR-MAIT 的疗效和肿瘤特异性。通过利用双方的互补优势，合作有望推进创新同种异体细胞疗法在实体瘤中的应用。 除了上述案例，本周还有一些其它公司也达成了不同类型的合作，限于篇幅，此处不再一一介绍。欲了解本周更多授权合作信息，可点击阅读原文前往 Insight 数据库「医药交易」模块查看。 封面来源：站酷海洛 Plus 免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。 编辑：馨药 PR 稿对接：微信 insightxb 投稿：微信 insightxb；邮箱 insight@dxy.cn 多样化功能、可溯源数据…… Insight 数据库网页版等你体验 点击阅读原文，立刻解锁！

Dermavant Sciences has shared positive long-term results for its plaque psoriasis-approved Vtama (tapinarof) cream in adults and children as young as two years old with atopic dermatitis (AD). Commonly referred to as eczema, AD is one of the most common inflammatory skin diseases, affecting over 26 million people in the US and up to 10% of adults and 20% of children worldwide. Dermavant previously reported positive results from the identically-designed phase 3 ADORING 1 and ADORING 2 trials, which evaluated the efficacy and safety of Vtama cream, 1% in adult and paediatric AD patients as young as two years with moderate-to-severe disease at baseline. The ADORING 3 48-week long-term extension study enrolled eligible patients from ADORING 1 and 2, as well as a four-week maximal usage pharmacokinetics study, and Vtama cream-naive patients aged two to 17 years with either mild, moderate or severe AD who did not meet inclusion in ADORING 1 and 2. Final data presented at the Annual Fall Clinical Dermatology Conference showed that 51.9% of patients entered with or achieved complete disease clearance at least once during the 48-week study, while 81.6% entered with or achieved clear or almost clear skin at least once. After entering ADORING 3 with or first achieving complete disease clearance and discontinuing Vtama, the average duration of the first treatment-free interval was 79.8 consecutive days, and patients whose disease returned to mild or above off-treatment were able to gain complete clearance when re-treated. There was also no evidence of loss of response in patients receiving either continuous or intermittent Vtama treatment, and the therapy was shown to be well tolerated. The US Food and Drug Administration has already accepted Dermavant’s supplemental new drug application for Vtama in AD, with the regulator expected to make its decision in the fourth quarter of this year. Commenting on the latest data, Robert Bissonnette, chief executive officer at dermatology clinical research organisation Innovaderm Research, said: “These results, combined with those from the ADORING 1 and 2 pivotal studies, demonstrate Vtama cream’s potential ability to not only effectively and safely treat patients as young as two years of age with AD, but may also enable a majority to achieve complete disease clearance, and maintain either clear or almost clear skin for an average of over two and a half months while off all treatment.”

- VTAMA® (tapinarof) cream, 1% demonstrated early, significant, and meaningful achievement of both no-to-minimal itch (mean weekly PP-NRS≤1) and sleep improvement in ADORING 1 and ADORING 2. - 31.4% and 33.0% of patients treated with VTAMA cream in ADORING 1 and ADORING 2, respectively achieved no-to-minimal itch at Week 8 (P=0.0072 and P=0.0003 versus vehicle). Results were statistically significant at Week 1, with continued improvement through Week 8. - Similarly, sleep improvements with VTAMA cream were statistically significant for patients ≥12 years old and <12 years old versus vehicle at Week 8 (both P<0.0001), with statistical significance achieved at Week 1, the earliest assessment. LONG BEACH, Calif., and BASEL, Switzerland--(BUSINESS WIRE)--Dermavant Sciences, a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, will present data on the achievement of no-to-minimal itch (weekly mean Peak Pruritus Numerical Rating Scale (PP-NRS≤1); also referred to as an itch-free state) and sleep improvement in patients with atopic dermatitis as young as two years old at the American College of Allergy, Asthma and Immunology Annual Meeting, being held in Boston, MA, October 24-28, 2024. The data presented were generated from Dermavant’s Phase 3 ADORING 1 and ADORING 2 pivotal trials studying VTAMA cream, 1% in patients with moderate to severe atopic dermatitis as young as two years old. In the ADORING pivotal trials, adults and children (n=813) were randomized to VTAMA cream or vehicle once daily for eight weeks. In ADORING 1 and ADORING 2, vIGA-AD TM success, defined as vIGA-AD=0 or 1 and ≥2-grade improvement from baseline at Week 8, was achieved by 45% and 46% of patients on VTAMA cream vs 14% (P<0.0001) and 18% (P<0.0001) of patients on vehicle, respectively. The most common adverse reactions (incidence ≥1%) in patients treated with VTAMA cream were folliculitis, nasopharyngitis, headache, asthma, and influenza. Peak Pruritus Numerical Rating Scale (PP-NRS) data, a patient reported outcome, were used to assess pruritus (itch) relief. Sleep improvement was assessed using question two, (Over the last week, on how many nights has your/your child’s sleep been disturbed because of eczema?) on the Patient Oriented Eczema Measure (POEM), using a 5-point scale. Results: A statistically significant improvement in sleep, achievement of no-to-minimal itch (PP-NRS≤1), and mean weekly PP-NRS<2 targets were observed as early as Week 1 (first assessment) with continued improvement observed through Week 8 in patients with atopic dermatitis treated with VTAMA cream versus vehicle. The proportion of patients with atopic dermatitis achieving no-to-minimal itch was statistically significantly higher in VTAMA cream groups compared with vehicle as early as Week 1 (the first assessment) and continued through Week 8 in both ADORING 1 and ADORING 2: 31.4% vs 17.4% (P=0.0072) and 33.0% vs 14.0% (P=0.0003). The proportion of patients with atopic dermatitis achieving PP-NRS<2 was statistically significantly higher in VTAMA cream groups compared with vehicle as early as Week 1 (the first assessment) and continued through Week 8 in both ADORING 1 and ADORING 2: 48.1% vs 28.4% (P=0.0006) and 46.8% vs 19.6% (P<0.0001). Sleep improvement reached statistical significance with VTAMA cream versus vehicle at Week 1, the earliest assessment, and continued through Week 8 in a pooled analyses for ADORING 1 and ADORING 2 in both patients with atopic dermatitis aged 2-11 years and ≥12 years: -1.7 vs -1.0 (P<0.0001) and -1.4 vs -0.8 (P<0.0001). “In the ADORING 1 and ADORING 2 trials, VTAMA cream demonstrated an early, significant, and meaningful achievement of no-to-minimal itch and improvement in sleep, for patients with atopic dermatitis” said Eric Simpson, MD, MCR, the Frances J. Storrs Medical Dermatology Professor and Director of the CLEAR Eczema Center, at the Oregon Health & Science University. “Itch frequently causes sleep disturbance in patients with atopic dermatitis, which can be especially burdensome for young patients and their families. In the ADORING pivotal trials, VTAMA cream demonstrated significant itch reduction and sleep improvement, in patients with atopic dermatitis, versus vehicle and was well-tolerated in both adults and children down to two years of age. Subject to FDA approval, VTAMA cream could become a compelling new treatment option for atopic dermatitis patients, most of whom regard itch as one of the most bothersome symptoms of their disease.” About Dermavant’s Phase 3 Program for VTAMA cream in Atopic Dermatitis ADORING is Dermavant’s Phase 3 atopic dermatitis (AD) clinical development program for VTAMA® (tapinarof) cream, 1%, which consists of ADORING 1 (NCT05014568) and ADORING 2 (NCT05032859), as well as ADORING 3 (NCT05142774), a 48-week open-label, long-term extension study. About Atopic Dermatitis Atopic dermatitis (AD), commonly referred to as eczema, is one of the most common inflammatory skin diseases, affects over 26 million people in the U.S. alone and up to 10% of adults worldwide. AD occurs most frequently in children, affecting up to 20% worldwide. The disease results in itchy, red, swollen, and cracked skin, often affecting the folds of the arms, back of the knees, hands, face, and neck. Itching is an especially bothersome symptom in AD, and tends to worsen at night, disturbing sleep and causing fatigue, which in children can lead to inattention at school. People with AD may also experience social and emotional distress due to the visibility and discomfort of the disease. About Dermavant Dermavant Sciences, a subsidiary of Roivant Sciences, is a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology. Dermavant’s focus is to develop therapies that have the potential to address high unmet medical needs while driving greater efficiency in research and clinical development. The company’s medical dermatology pipeline includes earlier-development, late-stage and commercialized, product candidates that target specific unmet needs in two of the largest growing immuno-dermatology markets, plaque psoriasis and atopic dermatitis, as well as other immunological and inflammatory diseases. Dermavant is marketing VTAMA® (tapinarof) cream, 1%, for the topical treatment of plaque psoriasis in adults. The FDA approved VTAMA cream for the topical treatment of mild, moderate, and severe plaque psoriasis in May 2022. Dermavant has been developing VTAMA cream for the treatment of atopic dermatitis in adults and children 2 years of age and older and released positive topline results from its ADORING 1 and 2 pivotal Phase 3 clinical trials in 1H 2023. Dermavant’s pipeline includes DMVT-506, a next generation aryl hydrocarbon receptor (AhR) agonist under development as a potential treatment option for immunological and inflammatory diseases with multiple potential routes of administration. IMPORTANT SAFETY INFORMATION Indication: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults. Adverse Events: The most common adverse reactions (incidence ≥ 1%) in subjects treated with VTAMA cream were folliculitis (red raised bumps around the hair pores), nasopharyngitis (pain or swelling in the nose and throat), contact dermatitis (skin rash or irritation, including itching and redness, peeling, burning, or stinging), headache, pruritus (itching), and influenza (flu). You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. See full Prescribing Information and Patient Information. For more information, please visit and follow us on Twitter ( @dermavant ) and LinkedIn ( Dermavant Sciences ). © 2024 Dermavant Sciences, Inc. All Rights Reserved. Dermavant and VTAMA are the registered trademarks of Dermavant Sciences, GmbH. vIGA-AD is the trademark of Eli Lilly and Co. Contacts dna Communications: Jillian Parker Account Director, Media Relations, Healthcare jparker@dna-comms.com 732-501-2624