临床试验进展 - 完成了VERITAC-3 Phase 3试验的入组病人[2] - 预计2024年第四季度完成VERITAC-2 Phase 3试验的入组,并在2024年第四季度或2025年第一季度公布试验结果[3] - 公司正在推进VERITAC-2临床试验的患者入组和数据读取工作,计划在2024年提交首个新药申请[28] 新药研发 - 公司的PROTAC LRRK2降解剂ARV-102在小鼠和非人灵长类动物中表现出良好的靶点结合和降解作用,并且与激酶抑制剂相比肺部功能风险较低[12][13] - 公司的PROTAC BCL6降解剂ARV-393在多种B细胞淋巴瘤细胞系和动物模型中表现出抗肿瘤活性,并已启动首次人体试验[14] - 公司PROTAC蛋白降解技术平台有望带来更多新疗法[28] 商业合作 - 与Novartis签订许可协议和资产购买协议,获得1.5亿美元的一次性预付款,未来还有最高10.1亿美元的里程碑付款和销售提成[4] - 公司与Novartis的交易将带来里程碑付款和特许权使用费收入[28] - 公司正与辉瑞合作确定palbociclib与vepdegestrant在ER+/HER2-晚期乳腺癌患者中的联合用药剂量[28] 公司运营 - 公司高管团队得到加强,任命了新的首席财务官、研发总裁、首席科学官和首席商务官[5] - 公司现金、现金等价物、受限现金和可供出售证券为12.342亿美元,预计可为公司运营提供资金支持到2027年[18] - 公司2024年6月30日现金、现金等价物和可供出售证券合计达到12.79亿美元[33] - 第二季度收入为7650万美元,较上年同期增加22%,主要来自与Novartis的协议[22] - 第二季度研发费用为9370万美元,较上年同期下降9.4%[20] - 第二季度管理费用为3130万美元,较上年同期增加21.8%[21] - 公司2024年上半年收入为1.018亿美元,同比增长17.2%[34] - 公司2024年上半年研发费用为1.78亿美元,同比下降10.4%[34] - 公司2024年上半年净亏损为1.046亿美元,每股亏损1.46美元[34] - 公司正在推进ARV-766的开发和商业化[28]

文章核心观点 - 公司任命Dr. Malte Peters为首席执行官,Terry Coelho为执行副总裁兼首席财务官 [1][2][3] - 公司正在对业务运营和战略进行全面审查,以确定实现HB-200全部潜力并为股东创造价值的最佳路径 [4][5][6] - 公司任命Sean Cassidy加入董事会,担任审计委员会主席 [7][18][19] 关于Dr. Malte Peters - 拥有20多年制药和生物技术行业高管经验,在肿瘤和免疫学领域具有深厚的临床开发经验 [9][10][11][12][13] - 曾在MorphoSys担任首席研发官,负责公司研发管线,包括三项关键性临床试验的设计和执行 [10] - 曾在诺华肿瘤部门担任多个领导职位,为28种癌症疗法的获批做出贡献 [11] 关于Terry Coelho - 拥有35年跨国领导和高管经验,在制药、消费品和化工行业的各个领域都有丰富经验 [14][15] - 曾担任Gamida Cell、CinCor Pharma和BioDelivery Sciences International等公司的首席财务官 [15] - 在Novartis制药公司肿瘤部门和Mars公司都有多年工作经历 [15] 关于HB-200 - HB-200是公司的主要肿瘤候选药物,由两种单载体化合物组成,针对HPV16引起的头颈部鳞状细胞癌 [20][21][22] - HB-200联合pembrolizumab获得FDA快速通道和EMA PRIME认定,基于临床前数据显示的疗效 [22][23] 关于HB-500 - HB-500由两种基因工程复制载体组成,旨在提供针对HIV-1抗原的免疫应答 [24] 关于HOOKIPA - HOOKIPA是一家临床阶段生物制药公司,专注于基于自有载体平台开发新型免疫治疗 [25] - 公司还与Gilead合作开发HBV和HIV的功能性治愈方案 [25]

Arvinas, Inc. (ARVN) shares soared 9.2% in the last trading session to close at $32.73. The move was backed by solid volume with far more shares changing hands than in a normal session. This compares to the stock's 20.2% gain over the past four weeks.The stock rallied, driven by optimism over the company’s ongoing pipeline progress. Arinivas is currently evaluating its lead candidate, vepdegestrant, in two late-stage studies — VERITAC-2 and VERITAC-3 — as a monotherapy to treat second-line breast cancer and ...

- Awards Mr. Saik an Inducement Grant in accordance with Nasdaq Listing Rule 5635(c)(4) - NEW HAVEN, Conn., June 24, 2024 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ: ARVN), a clinical- stage biotechnology company creating a new class of drugs based on targeted protein degradation, today announced the appointment of Andrew Saik to the role of Chief Financial Officer and Treasurer reporting to Chairperson, Chief Executive Officer, and President, John Houston, Ph.D. "It is a pleasure to welcome Andrew as our ne ...

- Awards Mr. Saik an Inducement Grant in accordance with Nasdaq Listing Rule 5635(c)(4) - NEW HAVEN, Conn., June 24, 2024 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today announced the appointment of Andrew Saik to the role of Chief Financial Officer and Treasurer reporting to Chairperson, Chief Executive Officer, and President, John Houston, Ph.D. "It is a pleasure to welcome Andrew as our new ...

– Preclinical data for ARV-393 presented at the European Hematology Association 2024 Annual Congress showed anti-tumor activity in models of B-cell lymphoma –  – Preclinical data presented at the Biennial International LRRK2 Meeting highlighted the promise of PROTAC®-induced leucine-rich repeat kinase 2 (LRRK2) degradation as a potential treatment for neurodegenerative diseases –  NEW HAVEN, Conn., June 21, 2024 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:ARVN), a clinical-stage biotechnology company creating ...

文章核心观点 - 公司在欧洲血液病学协会2024年年会和双年国际LRRK2会议上发布了ARV-393和ARV-102的新型前临床数据 [1][2][3][4] - ARV-393是一种针对BCL6蛋白的PROTAC降解剂,在B细胞淋巴瘤模型中显示出抗肿瘤活性,可能成为一种新的治疗方案 [2][3][5] - ARV-102是一种针对LRRK2蛋白的PROTAC降解剂,在动物实验中显示出较LRRK2激酶抑制剂更好的安全性,有望用于治疗神经退行性疾病 [3][4][6][7] 公司概况 - 公司是一家临床阶段生物技术公司,专注于基于靶向蛋白降解的新药研发 [8] - 公司目前有多个候选药物在临床开发,包括针对乳腺癌的vepdegestrant、针对神经退行性疾病的ARV-102,以及针对非霍奇金淋巴瘤的ARV-393 [8] ARV-393 - ARV-393是一种针对BCL6蛋白的PROTAC降解剂 [5] - 在B细胞淋巴瘤模型中,ARV-393能有效降解BCL6蛋白,抑制肿瘤细胞生长,包括在不同亚型的弥漫大B细胞淋巴瘤和伯基特淋巴瘤模型中显示出抑瘤和缩小肿瘤的作用 [2][3] - 公司认为ARV-393有望成为一种治疗未经其他治疗有效的非霍奇金淋巴瘤患者的新疗法 [3] ARV-102 - ARV-102是一种针对LRRK2蛋白的PROTAC降解剂 [6][7] - 在动物实验中,ARV-102能够有效降解LRRK2蛋白,且不会引起与LRRK2激酶抑制剂相关的肺泡II型细胞肥大等不良反应 [3][4] - 公司认为这些结果表明PROTAC降解剂相比激酶抑制剂可能具有更好的治疗窗和安全性,有望用于治疗神经退行性疾病 [4]

NEW HAVEN, Conn., June 17, 2024 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, announced Ian Taylor, Ph.D. has been promoted to President of Research and Development and Angela Cacace, Ph.D. has also been promoted and will succeed Dr. Taylor as Chief Scientific Officer of the company. Dr. Taylor and Dr. Cacace will assume these new roles effective immediately and report to John Houston, Ph.D., Chair ...

NEW HAVEN, Conn., June 17, 2024 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, announced Ian Taylor, Ph.D. has been promoted to President of Research and Development and Angela Cacace, Ph.D. has also been promoted and will succeed Dr. Taylor as Chief Scientific Officer of the company. Dr. Taylor and Dr. Cacace will assume these new roles effective immediately and report to John Houston, Ph.D., Chai ...

NEW HAVEN, Conn., June 03, 2024 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today announced that management will participate in two upcoming investor conferences: Jefferies Global Healthcare Conference on Thursday, June 6 in New York City. John Houston, Ph.D., Chairperson, Chief Executive Officer and President, and Noah Berkowitz, M.D., Ph.D., Chief Medical Officer, will participate in a firesid ...