[新聞] Dynavax and Medigen Announce Collabo........

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1.原文連結：縮址 https://reurl.cc/9Ej0Wa 原連結 https://www.globenewswire.com/news-release/2020/07/23/2066551/0/ en/Dynavax-and-Medigen-Announce-Collaboration-to-Develop-a-Novel -Adjuvanted-COVID-19-Vaccine-Candidate.html 2.原文內容： July 23, 2020 08:00 ET | Source: Dynavax Technologies Corporation Collaboration focused on developing an adjuvanted COVID-19 vaccine using Medigen’s subunit vaccine candidate with Dynavax’s CpG 1018 In preclinical testing, the combination generated strong virus neutralizing antibody responses Medigen anticipates initiating a Phase 1 clinical trial evaluating the combination in September 2020 EMERYVILLE, Calif. and TAPEI, Taiwan, July 23, 2020 (GLOBE NEWSWIRE) -- Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, and Medigen Vaccine Biologics Corporation (MVC) (TPEx: 6547.TWO), a biopharmaceutical company focusing on the development and production of vaccines and biologics, today announced their collaboration to develop an adjuvanted vaccine candidate to protect against COVID-19. The collaboration is evaluating the combination of MVC’s stable prefusion form of the SARS-CoV2 recombinant spike protein with Dynavax’s advanced adjuvant CpG 1018™, the adjuvant contained in Dynavax’s U.S. FDA-approved adult hepatitis B vaccine. “The COVID-19 pandemic is straining healthcare systems across the globe, making a safe, effective and affordable vaccine an important tool in combatting the disease and protecting patients, especially for low and middle-income countries (LMICs),” said Charles Chen, Chief Executive Officer of Medigen. “In preclinical testing, the combination of Dynavax’s proven adjuvant with our recombinant spike protein vaccine candidate generated strong virus neutralizing antibody responses and cellular immunity. These results support advancing evaluation of the combination into Phase 1 human testing, which we expect to begin in September of this year.” “Combining our technology with Medigen’s reinforces the collaborative approach needed to address this pandemic,” commented Ryan Spencer, Chief Executive Officer of Dynavax. “CpG 1018 is expected to enhance the immune response and may play an important role in developing an effective vaccine, especially for populations traditionally less responsive to vaccination such as older adults who are at greatest risk for severe disease from COVID-19.” MVC’s subunit vaccine is based on the stable prefusion form of the SARS-CoV2 recombinant spike protein with global technology license from the U.S Vaccine Research Center at National Institutes of Health (NIH). Preclinical studies demonstrated that the vaccine candidate adjuvanted with CpG 1018 generated strong immune responses in experimental animals. About Vaccine Adjuvants An adjuvant is a pharmacological or immunological agent that modifies the effect of other agents. Adjuvants are added to a vaccine to boost the immune response to produce more antibodies and longer-lasting immunity, thus minimizing the dose of antigen needed. Adjuvants may also be used to enhance the efficacy of a vaccine by helping to modify the immune response by particular types of immune system cells. About CpG 1018 Adjuvant CpG 1018 is the adjuvant used in HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], an adult hepatitis B vaccine approved by the U.S. Food and Drug Administration (FDA). Dynavax developed CpG 1018 to provide an increased vaccine immune response, which has been demonstrated in HEPLISAV-B. In pre-clinical and clinical studies, results demonstrated that the addition of CpG 1018 increases antibody concentrations, stimulates helper (CD4+) and cytotoxic (CD8+) T cell populations and generates robust T and B cell memory responses. Additionally, CpG 1018 strongly favors development of the Th1 subset of helper T cells, the type of helper T cell that is essential for protection from infections with viruses and intracellular bacteria. CpG 1018 targets a single, well defined receptor (TLR9) expressed on only a few key cell types and the mechanisms of action as an adjuvant are quite well understood. CpG 1018 provides a well- developed technology and a significant safety database, potentially accelerating the development and large-scale manufacturing of a COVID-19 vaccine. Upon completion of on-going scale up activities, the existing equipment capacity for CpG 1018 will be 600 million to 1.2 billion adjuvant doses annually, depending on final dose selected. About Dynavax Dynavax is a commercial stage biopharmaceutical company developing and commercializing novel vaccines. The Company launched its first commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], in February 2018, following U.S. FDA approval for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. Dynavax is also advancing CpG 1018 as a premier vaccine adjuvant through research collaborations and partnerships. Current collaborations are focused on adjuvanted vaccines for COVID-19, pertussis and universal influenza. For more information, visit www.dynavax.com and follow the company on LinkedIn. About Medigen MVC is a cell-based biopharmaceutical company focusing on the development and production of vaccines and biologics. MVC’s business partners include US NIH, US CDC, UCAB, Taiwan CDC, and Taiwan National Health Research Institute. MVC’s pipeline includes enterovirus EV71 vaccine, dengue vaccine, influenza quadrivalent vaccine which all entered late clinical stage. For more information, visit www.medigenvac.com. About the Novel Coronavirus SARS-CoV-2 (and COVID-19 Disease) SARS-CoV-2 is a new coronavirus identified in late 2019 which belongs to a family of enveloped RNA viruses that include MERS and SARS, both of which caused serious human infections of the respiratory system. The virus causes a disease named COVID-19. Since this outbreak was first reported in late 2019, the virus has infected over 14.7 million people and has caused over 612,000 reported deaths (as of July 22, 2020). It has been declared a pandemic by the World Health Organization (WHO). Currently there is no vaccine available for COVID-19. Forward-Looking Statements This press release contains "forward-looking" statements, including statements regarding the potential to develop a COVID-19 vaccine containing CpG 1018, and to do so on an accelerated basis. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in vaccine research and development, including the timing of completing development, whether CpG 1018 combined with MVC’s subunit vaccine will prove to be beneficial in clinical trials, whether and when the vaccine will be approved for use, and whether sufficient quantities of CpG 1018 and of vaccine will be able to be manufactured, as well as other risks detailed in the "Risk Factors" section of our Annual Report on Form 10-K for the fiscal year ended December 31, 2019, as well as discussions of potential risks, uncertainties and other important factors in our other filings with the U.S. Securities and Exchange Commission. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in our current periodic reports with the SEC. 谷哥翻譯如下 2020年7月23日，美國東部時間|資料來源：Dynavax技術公司合作重點在於使用Medigen的亞單位疫苗候選物和Dynavax的CpG 1018來開發佐劑型 COVID-19疫苗在臨床前測試中，該組合產生了強大的病毒中和抗體反應 Medigen預計於2020年9月啟動評估該組合的1期臨床試驗加利福尼亞州埃默里維爾和台灣TAPEI，2020年7月23日（全球新聞）-專注於新型疫苗的開發和商業化的生物製藥公司Dynavax Technologies Corporation（Nasdaq：DVAX）和 Medigen Vaccine Biologics Corporation（MVC）（TPEx： 6547.TWO）是一家專注於疫苗和生物製劑的開發和生產的生物製藥公司，今天宣布了他們的合作，以開發佐劑疫苗候選物來預防COVID-19。這項合作正在評估MVC的SARS-CoV2重組刺突蛋白的穩定預融合形式與Dynavax先進的佐劑CpG 1018™（Dynavax在美國FDA批准的成人B型肝炎疫苗中所含的佐劑）的組合。 Charles Chen說：“ COVID-19大流行正在使全球的醫療系統緊張，使安全，有效和負擔得起的疫苗成為抵抗疾病和保護患者的重要工具，尤其是對於中低收入國家（LMIC）。” Medigen首席執行官。 “在臨床前測試中，Dynavax經過驗證的佐劑與我們的重組刺突蛋白疫苗候選物的結合產生了強大的病毒中和抗體反應和細胞免疫力。這些結果支持將組合評估進一步評估為階段1的人體測試，我們預計將從今年9月開始。” Dynavax首席執行官Ryan Spencer表示：“將我們的技術與Medigen的技術相結合，可以增強解決這一大流行病所需的協作方法。” “ CpG 1018有望增強免疫反應，並可能在開發有效的疫苗中發揮重要作用，特別是對於傳統上對疫苗反應較弱的人群，例如在COVID-19 嚴重疾病風險最大的老年人中。” MVC的亞單位疫苗基於SARS-CoV2重組刺突蛋白的穩定預融合形式，並獲得了美國國立衛生研究院（NIH）美國疫苗研究中心的全球技術許可。臨床前研究表明，佐劑CpG 1018的候選疫苗在實驗動物中產生了強烈的免疫反應。關於疫苗佐劑佐劑是可改變其他藥物作用的藥物或免疫藥物。將佐劑添加到疫苗中以增強免疫反應，以產生更多的抗體和更持久的免疫力，從而將所需抗原的劑量降至最低。佐劑還可通過幫助改變特定類型的免疫系統細胞的免疫應答來用於增強疫苗的功效。關於CpG 1018佐劑 CpG 1018是HEPLISAV-B®（乙型肝炎疫苗（重組），佐劑）使用的佐劑，是美國食品藥品監督管理局（FDA）批准的成人乙型肝炎疫苗。 Dynavax開發了CpG 1018，以提供增強的疫苗免疫反應，這已在HEPLISAV-B中得到證實。在臨床前和臨床研究中，結果表明添加 CpG 1018可提高抗體濃度，刺激輔助（CD4 +）和細胞毒性（CD8 +）T細胞群體，並產生強大的T和B細胞記憶反應。另外，CpG 1018強烈支持輔助性T細胞Th1亞型的發展，輔助性 T細胞的類型對於保護免受病毒和細胞內細菌感染至關重要。 CpG 1018靶向僅在幾種關鍵細胞類型上表達的單一的，明確定義的受體（TLR9），並且作為佐劑的作用機理已廣為人知。 CpG 1018提供了完善的技術和重要的安全數據庫，有可能加速COVID-19疫苗的開發和大規模生產。完成正在進行的擴大規模活動後，CpG 1018的現有設備能力將每年達到6 億至12億佐劑劑量，具體取決於最終劑量。關於Dynavax Dynavax是一家商業階段的生物製藥公司，致力於開發和銷售新型疫苗。在美國FDA批准用於預防18歲及以下成年人的所有已知乙型肝炎病毒亞型引起的感染後，該公司於2018年2 月推出了其首款商業產品HEPLISAV-B®（佐劑乙肝疫苗（重組））。年紀大了Dynavax還通過研究合作和夥伴關係，將CpG 1018作為主要的疫苗佐劑進行了推廣。目前的合作重點是針對COVID-19，百日咳和通用流感的佐劑疫苗。欲了解更多信息，請訪問 www.dynavax.com並在L上關注該公司 3.心得/評論：谷哥稍微翻譯過後，看來高端近期可能有些許的利多，參考就好。近期疫苗股的確只要有題材，就有漲勢。 -- ╔…………:::: .::::…………══…════─═…………………………╗ │ :: :: :: :::: 愛︱：：︱ ║ ║ :: 愛 :: 一個字 ☆ ︱ ☆ ： │ ︱ :::: :: 世界上最短的咒語 ☆ ︱ │ ︱ :::: :::::::: 誰說誰聽便如此滿足 by OPWing│ ╚………─═… ∵ ……………………══════════……─…╯……╰…╝ -- ※ 發信站: 批踢踢實業坊(ptt.cc), 來自: 118.163.14.180 (臺灣) ※ 文章網址: https://www.ptt.cc/bbs/Stock/M.1595553084.A.567.html

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