HOOKIPA Pharma(HOOK)
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HOOKIPA Pharma Announces First Person Dosed in Phase 1b Clinical Trial of HB-500 for the Treatment of HIV
GlobeNewswire News Room· 2024-07-02 04:31
Novel arenaviral therapeutic vaccine, developed in collaboration with Gilead Sciences, Inc. (Gilead), to be evaluated as a potential component of a curative regimen for human immunodeficiency virus (HIV) HOOKIPA achieves a $5 million non-dilutive milestone payment under its collaboration and license agreement with Gilead Under the collaboration agreement, HOOKIPA is responsible for advancing the HIV program through the completion of a Phase 1b clinical trial NEW YORK and VIENNA, July 01, 2024 (GLOBE NEWSWIR ...
HOOKIPA Pharma Announces Updated Phase 2 Clinical Data at the American Society of Clinical Oncology 2024 Annual Meeting
Newsfilter· 2024-06-05 01:00
Encouraging clinical activity with observed deepening of responses in 35 evaluable first line head and neck patients treated with HB-200 plus pembrolizumab In a subset of 17 evaluable patients with PD-L1 combined positive score (CPS) of 20 or higher, the Company's selected registrational pivotal trial population, data showed confirmed ORR of 53%, CR rate of 18%, and DCR of 82% Preliminary progression-free survival (PFS) was 16.3 months and preliminary overall survival (OS) rate was 88% at 9 months for the C ...
HOOKIPA Pharma Announces Positive Clinical Data to be Presented at the American Society for Clinical Oncology 2024 Annual Meeting
globenewswire.com· 2024-05-24 05:01
HOOKIPA to present an oral abstract at the American Society for Clinical Oncology (ASCO) 2024 Annual Meeting on June 4 Updated data of HB-200 plus pembrolizumab demonstrate a favorable safety profile and promising clinical activity In a subset of patients with PD-L1 combined positive score (CPS) of 20 or higher, data showed confirmed objective response rate (ORR) of 53%, complete response (CR) rate of 18%, and disease control rate (DCR) of 82% Company will also present promising preliminary progression-free ...
HOOKIPA Pharma(HOOK) - 2024 Q1 - Quarterly Report
2024-05-09 19:04
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________________ to ________________. Commission File Number: 001-38869 HOOKIPA PHARMA INC. (Exact Name of Registrant as Specified in its Char ...
HOOKIPA Pharma(HOOK) - 2024 Q1 - Quarterly Results
2024-05-09 19:03
Exhibit 99.1 HOOKIPA Pharma Reports First Quarter 2024 Financial Results and Recent Business Highlights ● Phase 2/3 pivotal trial design and protocol for HB-200 in combination with pembrolizumab for the first-line treatment of patients with HPV16+ recurrent or metastatic OPSCC aligns with U.S. Food and Drug Administration (FDA) feedback ● HB-200 program received Priority Medicines (PRIME) designation from the European Medicines Agency (EMA) ● Received FDA clearance for Investigational New Drug (IND) applica ...
HOOKIPA Pharma Reports First Quarter 2024 Financial Results and Recent Business Highlights
Newsfilter· 2024-05-09 19:01
Phase 2/3 pivotal trial design and protocol for HB-200 in combination with pembrolizumab for the first- line treatment of patients with HPV16+ recurrent or metastatic OPSCC aligns with U.S. Food and Drug Administration (FDA) feedback HB-200 program received Priority Medicines (PRIME) designation from the European Medicines Agency (EMA) Received FDA clearance for Investigational New Drug (IND) application for HB-700 for the treatment of KRAS mutated cancers NEW YORK and VIENNA, May 09, 2024 (GLOBE NEWSWIRE) ...
HOOKIPA Pharma Announces Pivotal Phase 2/3 Trial Design for HB-200 in Combination with Pembrolizumab
Newsfilter· 2024-04-25 19:01
HOOKIPA公司最新动态 - HOOKIPA宣布了HB-200与pembrolizumab的关键试验设计和协议,以及在2024年ASCO年会上的口头摘要展示[1][2][3] - 该公司计划在2024年第四季度招募第一位患者[2] - HOOKIPA的首席执行官表示公司与FDA和EMA都有良好的合作,有望更快地实现潜在注册[4] - HB-200与pembrolizumab的关键试验设计包括约250名患者,主要终点为Phase 2部分的客观反应率和Phase 3部分的总生存率[4] - 公司可能会根据试验的Phase 2部分数据寻求加速批准[6] - HOOKIPA将举行电话会议,讨论试验设计和临床发展策略[7] - ASCO 2024年会上将展示HB-200的最新数据[9] - HB-200与pembrolizumab获得FDA的快速通道认定和EMA的PRIME认定[10] - HOOKIPA是一家专注于开发新型免疫疗法的临床阶段生物制药公司,旨在对抗或预防严重疾病[10]
HOOKIPA Pharma Announces FDA Clearance of its Investigational New Drug Application for HB-700 for the Treatment of KRAS-Mutated Cancers
Newsfilter· 2024-04-24 19:01
HOOKIPA Pharma Inc.(NASDAQ:HOOK)新药申请 - 公司宣布获得美国食品药品监督管理局(FDA)对其HB-700的新药申请(IND)的清关[1] - HB-700项目旨在治疗KRAS突变的肺癌、结肠癌、胰腺癌等,针对这些疾病中最常见的五种KRAS突变:G12D、G12V、G12R、G12C和G13D[2] HOOKIPA的HB-700项目 - 公司将在2024年美国临床肿瘤学会(ASCO)年会上发布HB-700项目的临床前数据摘要[3] - HB-700项目旨在治疗KRAS突变的肺癌、结肠癌、胰腺癌等,是一种复制的2-载体疗法,可针对最常见的KRAS突变(G12D、G12V、G12R、G12C和G13D)[4]
Hookipa Pharma: 04/25/24 Update Should Be The First Of Several Positive Catalysts
Seeking Alpha· 2024-04-23 02:20
Human Papilloma Virus (HPV-16) luismmolina/iStock via Getty Images On Friday April 19th, shares of Hookipa Pharma (NASDAQ:HOOK) closed at $0.733/s with a valuation ~$72.53M. To be clear, this company is a High Risk/High Reward play and as such, is probably not a suitable investment for most investor’s portfolios. Typically, I would build a 2% position at most in my portfolio for this type of early clinical development target when I am interested. However, in this particular situation, I have increased my ex ...
HOOKIPA Pharma Announces Grant of Inducement Award Under Nasdaq Listing Rule 5635(c)(4)
Newsfilter· 2024-04-17 04:30
公司背景 - HOOKIPA Pharma Inc.(NASDAQ:HOOK)是一家专注于开发新型免疫疗法的临床阶段生物制药公司[2] - HOOKIPA的研发重点是基于其专有的阿瑞纳病毒平台,设计用于动员和放大靶向T细胞,从而对抗或预防严重疾病[2] - HOOKIPA的产品线包括其全资拥有的调查性阿瑞纳病毒免疫疗法,针对人类乳头瘤病毒16阳性癌症、KRAS突变癌症和其他未命名适应症[2] - HOOKIPA还计划与吉利德合作开发治疗乙型肝炎和艾滋病的功能性治愈方案[2] 财务信息披露 - 公司通过投资者关系网站、SEC文件、新闻稿、公开电话会议和网络直播等渠道向投资者公布重要财务信息[3]