參考：
https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-positive-interim-phase-1-data-its-mrna-vaccine
May 18, 2020 at 7:30 AM EDT 2020年5月18日美國東部時間上午7:30
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After two doses all participants evaluated to date across the 25 µg and 100 µg dose cohorts seroconverted with binding antibody levels at or above levels seen in convalescent sera
經過兩次劑量后，所有參與者的血清轉換為25克和100克劑量組，其結合抗體水平均達到或超過恢復期血清中的水平
mRNA-1273 elicited neutralizing antibody titer levels in all eight initial participants across the 25 µg and 100 µg dose cohorts, reaching or exceeding neutralizing antibody titers generally seen in convalescent sera
在25克和100克劑量組中，mRNA-1273在所有8名初始參與者中引起中和抗體滴度水平，達到或超過康復血清中通常見到的中和抗體滴度
mRNA-1273 was generally safe and well tolerated
Mrna-1273基本上是安全的，耐受性良好
mRNA-1273 provided full protection against viral replication in the lungs in a mouse challenge model
Mrna-1273在小鼠攻擊模型中對病毒在肺部的復制提供了完全的保護
Anticipated dose for Phase 3 study between 25 µg and 100 µg; expected to start in July
第三階段研究的預計劑量介於25克至100克之間; 預計於7月開始
Conference call to be held on Monday, May 18 at 8:30 a.m. ET
電話會議將於美國東部時間5月18日星期一上午8:30舉行
CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 18, 2020-- Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced positive interim clinical data of mRNA-1273, its vaccine candidate against novel coronavirus (SARS-CoV-2), from the Phase 1 study led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
2020年5月18日，馬薩諸塞州坎布里奇——(商業線)—— Moderna，inc. ，(納斯達克: MRNA)一家臨床階段的生物技術公司，開創了信使核糖核酸療法和疫苗，為患者創造新一代的變革性葯物，今天宣布了 MRNA-1273的臨床數據，該公司研制的新型冠狀病毒(SARS-CoV-2)候選疫苗 MRNA-1273，來自美國國家過敏與傳染病研究所(NIH)領導的第一階段研究，是 NIH 的一部分。
Immunogenicity data are currently available for the 25 µg and 100 µg dose level (ages 18-55) after two doses (day 43) and at the 250 µg level (ages 18-55) after one dose (day 29). Dose dependent increases in immunogenicity were seen across the three dose levels, and between prime and boost within the 25 µg and 100 µg dose levels. All participants ages 18-55 (n=15 per cohort) across all three dose levels seroconverted by day 15 after a single dose. At day 43, two weeks following the second dose, at the 25 µg dose level (n=15), levels of binding antibodies were at the levels seen in convalescent sera (blood samples from people who have recovered from COVID-19) tested in the same assay. At day 43, at the 100 µg dose level (n=10), levels of binding antibodies significantly exceeded the levels seen in convalescent sera. Samples are not yet available for remaining participants.
目前可以獲得兩次劑量(第43天)后25克和100克劑量水平(18-55歲)以及一次劑量(第29天)后250克水平(18-55歲)的免疫原性數據。 三種劑量水平的免疫原性呈劑量依賴性增強，25克和100克劑量水平的初始和增強之間呈劑量依賴性增強。 所有年齡在18-55歲之間的參與者(每組15人)在接受單次劑量后，於第15天血清轉換所有三種劑量水平。 在第43天，第二劑量后兩周，在25克劑量水平(n15) ，結合抗體水平與恢復期血清(從新型冠狀病毒肺炎康復的人的血液樣本)在同一分析中檢測的水平相同。 在第43天，100克劑量水平(n10) ，結合抗體水平顯著超過恢復期血清中的水平。 剩下的參與者還沒有樣品。
At this time, neutralizing antibody data are available only for the first four participants in each of the 25 µg and 100 µg dose level cohorts. Consistent with the binding antibody data, mRNA-1273 vaccination elicited neutralizing antibodies in all eight of these participants, as measured by plaque reduction neutralization (PRNT) assays against live SARS-CoV-2. The levels of neutralizing antibodies at day 43 were at or above levels generally seen in convalescent sera.
目前，中和抗體衛生組織的數據只能提供25克和100克劑量組的前4名參與者的數據。 與結合抗體數據一致的是，mRNA-1273疫苗接種在所有8個參與者中引起中和抗體，通過對活 SARS-CoV-2的斑塊減少中和(PRNT)測定。 恢復期血清中和抗體水平在第43天達到或高於恢復期血清水平。
mRNA-1273 was generally safe and well tolerated, with a safety profile consistent with that seen in prior Moderna infectious disease vaccine clinical studies. The sole incidence of a grade 3 adverse event in the 25 µg and 100 µg dose cohorts was a single participant at 100 µg who experienced grade 3 erythema (redness) around the injection site. To date, the most notable adverse events were seen at the 250 µg dose level, comprising three participants with grade 3 systemic symptoms, only following the second dose. All adverse events have been transient and self-resolving. No grade 4 adverse events or serious adverse events have been reported.
Mrna-1273基本上是安全的，耐受性良好，其安全性與先前的現代傳染病疫苗臨床研究結果一致。 在25克和100克劑量組中，只有一名參與者在注射部位周圍出現3級紅斑(發紅) ，發生率為100克。 迄今為止，最值得注意的不良事件發生在250克劑量水平，包括三名患有3級全身症狀的參與者，僅次於第二次劑量。 所有的不良事件都是短暫的和自我解決的。 沒有4級不良事件或嚴重不良事件的報告。
Preclinical results from a viral challenge study in mice conducted in collaboration with NIAID and its academic partners are also available. In this study, vaccination with mRNA-1273 prevented viral replication in the lungs of animals challenged with SARS-CoV-2. Neutralizing titers in Phase 1 clinical trial participants at the 25 µg and 100 µg dose levels were consistent with neutralizing titers that were protective in the mouse challenge model.
與 NIAID 及其學術伙伴合作進行的小鼠病毒挑戰研究的臨床前結果也可以獲得。 在這項研究中，用 mRNA-1273接種疫苗可以阻止 SARS-CoV-2感染動物肺部的病毒復制。 第一階段臨床試驗參與者中和滴度在25克和100克劑量水平與中和滴度一致，在小鼠挑戰模型中具有保護作用。
Based on the interim Phase 1 data, the Moderna-led Phase 2 study will be amended to study two dose levels, 50 µg and 100 µg, with the aim of selecting a dose for pivotal studies. The NIAID-led Phase 1 study is being amended to include a 50 µg dose level cohort across each of the three age groups. Moderna anticipates the dose for the Phase 3 study to be between 25 µg and 100 µg and expects Phase 3 trial initiation in July, subject to finalization of the clinical trial protocol.
根據臨時第一階段的數據，現代主義領導的第二階段研究將進行修改，以研究兩個劑量水平，50克和100克，目的是選擇一個關鍵的研究劑量。 正在對國際艾滋病署牽頭的第一階段研究進行修訂，以便在三個年齡組中的每一個組中納入50克劑量水平的隊列。 現代化預計第三階段研究的劑量將在25克至100克之間，並預計第三階段試驗將在7月開始，取決於臨床試驗方案的最終確定。
“These interim Phase 1 data, while early, demonstrate that vaccination with mRNA-1273 elicits an immune response of the magnitude caused by natural infection starting with a dose as low as 25 µg,” said Tal Zaks, M.D., Ph.D., Chief Medical Officer at Moderna. “When combined with the success in preventing viral replication in the lungs of a pre-clinical challenge model at a dose that elicited similar levels of neutralizing antibodies, these data substantiate our belief that mRNA-1273 has the potential to prevent COVID-19 disease and advance our ability to select a dose for pivotal trials.”
Moderna 首席醫療官 Tal Zaks 醫學博士博士說: “這些初步的第一階段數據表明，使用 mRNA-1273接種疫苗會引起免疫反應，其程度與自然感染開始劑量低至25克所引起的免疫反應相當。”。 “結合臨床前接種模型成功阻止病毒在肺部復制的劑量引起相似水平的中和抗體，這些數據證實了我們的信念，即 mRNA-1273具有預防新型冠狀病毒肺炎病的潛力，並提高我們為關鍵試驗選擇劑量的能力。”
“With today’s positive interim Phase 1 data and the positive data in the mouse challenge model, the Moderna team continues to focus on moving as fast as safely possible to start our pivotal Phase 3 study in July and, if successful, file a BLA,” said Stéphane Bancel, Chief Executive Officer at Moderna. “We are investing to scale up manufacturing so we can maximize the number of doses we can produce to help protect as many people as we can from SARS-CoV-2.”
“有了今天積極的中期第一階段數據和老鼠挑戰模型的積極數據，Moderna 團隊繼續集中於盡快安全地開始我們關鍵的第三階段研究在七月，如果成功的話，提交一份 BLA，” Moderna 的首席執行官 st phane Bancel 說。 “我們正在投資擴大生產規模，這樣我們就能最大限度地生產疫苗，以幫助保護盡可能多的人免受 SARS-CoV-2的感染。”
Funding from the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), supported the planning for the Phase 2 and Phase 3 studies of mRNA-1273 and will also support the execution of these studies, as well as the scale-up of mRNA-1273 manufacturing both at the Company’s facilities and that of its strategic collaborator, Lonza Ltd.
美國衛生和公眾服務部負責准備和反應的助理秘書辦公室下屬的生物醫學高級研究和發展管理局衛生研究所提供的資金支持了 mRNA-1273的第二階段和第三階段研究的計划，並將支持這些研究的實施，以及擴大 mRNA-1273在該公司設施和其戰略合作者 Lonza 有限公司的生產規模。
Conference Call and Webcast Information
電話會議及網上廣播資料
Moderna will host a live conference call and webcast at 8:30 a.m. ET on Monday, May 18, 2020. To access the live conference call, please dial 866-922-5184 (domestic) or 409-937-8950 (international) and refer to conference ID 2186342. A webcast of the call will also be available under “Events and Presentations” in the Investors section of the Moderna website at investors.modernatx.com. The archived webcast will be available on Moderna’s website approximately two hours after the conference call.
現代版將在2020年5月18日星期一美國東部時間上午8:30主持電話會議和網絡直播。 要進入現場電話會議，請撥打866-922-5184(國內)或409-937-8950(國際)並參閱會議 ID 2186342。 此次電話會議的網絡直播也將在 Moderna 網站的投資者部分的“活動和演示”欄目下面的 Investors.modernatx.com 中提供。 存檔的網絡廣播將在電話會議后大約兩個小時在 Moderna 的網站上提供。
About mRNA-1273
關於 mRNA-1273
mRNA-1273 is an mRNA vaccine against SARS-CoV-2 encoding for a prefusion stabilized form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators from Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), a part of the NIH. The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to NIH on February 24, 42 days from sequence selection. The first participant in the NIAID-led Phase 1 study of mRNA-1273 was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing.
Mrna-1273是一種針對 SARS-CoV-2編碼的 s 蛋白預融合穩定形式的 mRNA 疫苗，該疫苗是由 Moderna 與美國國家過敏與傳染病研究所疫苗研究中心(VRC)的研究人員合作選擇的，該研究所是 NIH 的一部分。 第一批由流行病防范創新聯盟資助的臨床試驗於2020年2月7日完成，並進行了分析測試; 它於2月24日運抵 NIH，距序列選擇還有42天。 國際艾滋病研究所領導的 mRNA-1273第一階段研究的第一位參與者於3月16日服葯，從序列選擇到第一階段研究服葯共63天。
On May 6, the U.S. Food and Drug Administration (FDA) completed its review of the Company’s Investigational New Drug (IND) application for mRNA-1273 allowing it to proceed to a Phase 2 study, which is expected to begin shortly. On May 12, the FDA granted mRNA-1273 Fast Track designation. Moderna is finalizing the protocol for a Phase 3 study, expected to begin in July 2020. A summary of the company’s work to date on SARS-CoV-2 can be found here.
5月6日，美國食品和葯物管理局(FDA)完成了對該公司關於 mRNA-1273的研究新葯(IND)申請的審查，允許該公司進入第二階段研究，預計不久將開始。 5月12日，FDA 批准了 mRNA-1273快速通道認證。 現代化正在為第三階段研究敲定方案，預計於2020年7月開始。 該公司迄今為止在 SARS-CoV-2方面的工作摘要可以在這里找到。
About Moderna’s Prophylactic Vaccines Modality
關於現代人預防性疫苗的形式
Moderna scientists designed the company’s prophylactic vaccines modality to prevent infectious diseases. More than 1,400 participants have been enrolled in Moderna’s infectious disease vaccine clinical studies under health authorities in the U.S., Europe and Australia. Clinical data demonstrate that Moderna’s proprietary vaccine technology has been generally well-tolerated and can elicit durable immune responses to viral antigens. Based on clinical experience across Phase 1 studies, the company designated prophylactic vaccines a core modality and is working to accelerate the development of its vaccine pipeline.
現代科學家設計了該公司的預防性疫苗模式來預防傳染病。 在美國、歐洲和澳大利亞的衛生當局的監督下，超過1400名參與者參加了 Moderna 的傳染病疫苗臨床研究。 臨床數據表明，Moderna 的專利疫苗技術一般耐受良好，能夠引起病毒抗原的持久免疫反應。 根據第一階段研究的臨床經驗，該公司將預防性疫苗指定為核心模式，並正在努力加速其疫苗管道的開發。
The potential advantages of an mRNA approach to prophylactic vaccines include the ability to combine multiple mRNAs into a single vaccine, rapid discovery to respond to emerging pandemic threats and manufacturing agility derived from the platform nature of mRNA vaccine design and production. Moderna has built a fully integrated manufacturing plant which enables the promise of the technology platform.
預防性疫苗的信使核糖核酸方法的潛在優勢包括將多個信使核糖核酸結合成單一疫苗的能力，對新出現的大流行威脅作出反應的快速發現，以及來自信使核糖核酸疫苗設計和生產平台性質的制造靈活。 現代化已經建立了一個完全集成的制造工廠，使承諾的技術平台。
Moderna currently has nine development candidates in its prophylactic vaccines modality, including:
現代社會目前在預防性疫苗方面有九個候選研發對象，包括:
Vaccines against respiratory infections
呼吸道感染疫苗
Respiratory syncytial virus (RSV) vaccine for older adults (mRNA-1777 and mRNA-1172 or V172 with Merck) 針對老年人的人類唿吸道合胞病毒(RSV)疫苗(mRNA-1777和 mRNA-1172或默克公司的 V172)
RSV vaccine for young children (mRNA-1345) 兒童呼吸道合胞病毒疫苗(mRNA-1345)
Human metapneumovirus (hMPV) and parainfluenza virus type 3 (PIV3) vaccine (mRNA-1653) 人類偏肺病毒及副流感三型病毒疫苗(mRNA-1653)
Novel coronavirus (SARS-CoV-2) vaccine (mRNA-1273) 新型冠狀病毒(SARS-CoV-2)疫苗(mRNA-1273)
Influenza H7N9 (mRNA-1851) H7n9流感病毒(mRNA-1851)
Vaccines against infections transmitted from mother to baby
預防母嬰傳播感染的疫苗
Cytomegalovirus (CMV) vaccine (mRNA-1647) 巨細胞病毒(CMV)疫苗(mRNA-1647)
Zika vaccine (mRNA-1893 with BARDA) 寨卡病毒疫苗(mRNA-1893與 BARDA)
Vaccines against highly prevalent viral infections
針對高度流行病毒感染的疫苗
Epstein-Barr virus (EBV) vaccine (mRNA-1189) 人類皰疹病毒第四型疫苗(mRNA-1189)
To date, Moderna has demonstrated positive Phase 1 data readouts for seven prophylactic vaccines (H10N8, H7N9, RSV, chikungunya virus, hMPV/PIV3, CMV and Zika). Moderna’s CMV vaccine is currently in a Phase 2 dose-confirmation study. Moderna’s investigational Zika vaccine (mRNA-1893), currently in a Phase 1 study, was granted FDA Fast Track designation in August 2019.
迄今為止，Moderna 已證實7種預防性疫苗(H10N8、 H7N9、 RSV、基孔肯雅病毒、 hmpv / piv3、 CMV 和寨卡病毒)的1期數據顯示為陽性。 現代人巨細胞病毒疫苗目前正在進行第二階段劑量確認研究。 現代人正在研究的寨卡疫苗(mRNA-1893) ，目前處於第一階段研究中，在2019年8月被 FDA 授予快速通道稱號。
About Moderna
關於 Moderna
Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The company’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.
現代人正在推進信使核糖核酸(mRNA)科學，為患者創造一種新的轉化葯物。 信使核糖核酸葯物旨在引導人體細胞產生細胞內、細胞膜或分泌的蛋白質，這些蛋白質具有治療或預防作用，並有可能治療廣泛的疾病。 該公司的平台建立在基礎和應用信使核糖核酸科學、傳遞技術和制造領域不斷進步的基礎上，為現代人提供了並行開發新開發候選產品的能力。 現代人正在獨立並與戰略合作者開發傳染病、免疫腫瘤學、罕見疾病和心血管疾病的治療學和疫苗。
Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense, and the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been ranked in the top ten of Science’s list of top biopharma industry employers for the past five years. To learn more, visit www.modernatx.com.
總部位於馬薩諸塞州坎布里奇的現代化公司目前與阿斯利康公司、默克公司、美國國防部下屬的國防高級研究計划局以及美國衛生與公眾服務部負責准備和反應的助理國務卿辦公室下屬的美國生物醫學高級研究和發展管理局研究與發展部建立了戰略聯盟。 在過去的五年里，現代版一直在《科學》雜志的頂級生物制葯行業雇主名單上排名前十。 欲了解更多信息，請訪問 www.modernatx.com。
Forward Looking Statement
前瞻性聲明
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding the Company’s development of a potential vaccine against the novel coronavirus, the parameters and timing of the Phase 1 and planned Phase 2 and 3 studies of mRNA-1273, the Company’s investment in manufacturing, and the Company’s intentions regarding vaccine dose production. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “could”, “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others: the fact that there has never been a commercial product utilizing mRNA technology approved for use; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the fact that the safety and efficacy of mRNA-1273 has not yet been established; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and those other risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date hereof.
本新聞稿載有經修訂的1995年《私人證券訴訟改革法》含義范圍內的前瞻性聲明，包括關於該公司開發新型冠狀病毒潛在疫苗、第一階段的參數和時間以及計划中的 mRNA-1273第二和第三階段研究、該公司對制造業的投資以及該公司關於疫苗劑量生產的意圖。 在某些情況下，前瞻性陳述可以通過諸如“ will”、“ may”、“ should”、“ could”、“ expects”、“ plants”、“ aims”、“ expected”、“ believes”、“ estimates”、“ predicts”、“ potential”、“ continue”或這些術語的否定或其他類似術語等術語來確定，盡管並非所有前瞻性陳述都包含這些詞語。 這份新聞稿中的前瞻性聲明既不是承諾也不是保證，你不應過分依賴這些前瞻性聲明，因為它們涉及已知和未知的風險、不確定性和其他因素，其中許多是 Moderna 無法控制的，可能導致實際結果與這些前瞻性聲明所表達或暗示的結果有重大差異。 這些風險、不確定性和其他因素包括: 從來沒有一種商業產品使用獲准使用的信使核糖核酸技術; Moderna 使用的快速反應技術仍在開發和實施; 全球新型冠狀病毒肺炎大流行可能造成的不利影響，例如監管審查延誤、制造和供應鏈中斷、對醫療系統的不利影響和全球經濟中斷，以及 Moderna 最近提交美國的表格10-Q 季度報告中”風險因素”標題下所描述的其他風險和不確定性。 美國證券交易委員會(SEC)以及 Moderna 隨后向 SEC 提交的備案文件(可在 SEC 網站 www.SEC. gov 查閱)中查閱。 除法律規定外，現代版不打算或不負責在出現新的信息、未來發展或其他情況時更新或修訂本新聞稿所載的任何前瞻性聲明。 這些具有前瞻性的聲明是基於 Moderna 當前的期望，並且僅在此日期發表。
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