Dynavax and Medigen Announce Collabo........ - 股票

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。

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