Vaxcyte Initiates Phase 2 Study for VAX-31 Pneumococcal Vaccine in Infants, Anticipates Topline Data in 2026
Vaxcyte Initiates Phase 2 Study for VAX-31 Pneumococcal Vaccine in Infants, Anticipates Topline Data in 2026
Vaxcyte initiates Phase 2 study for VAX-31, targeting enhanced protection against pneumococcal disease in infants. Topline data expected by mid-2026.
vaxcyte啓動第2階段研究,針對VAX-31,旨在增強對嬰兒肺炎球菌疾病的保護。預計最終數據將於2026年中公佈。
Quiver AI Summary
Quiver AI 概要
Vaxcyte, Inc. has initiated a Phase 2 study of its 31-valent pneumococcal conjugate vaccine candidate, VAX-31, in healthy infants to assess its safety, tolerability, and immunogenicity. The company anticipates reporting topline data from the primary immunization series of this study by mid-2026, with booster dose data to follow about nine months later. VAX-31 is designed to protect against approximately 94% of invasive pneumococcal disease (IPD) and 93% of acute otitis media in U.S. children under five, offering broader coverage against both current and historically prevalent strains compared to standard vaccines. Vaxcyte is also on track to release data from another Phase 2 study, VAX-24, by the end of Q1 2025, as part of their commitment to enhance protections against Streptococcus pneumoniae, a significant public health threat due to rising antimicrobial resistance.
vaxcyte公司已啓動了其31價肺炎球菌結合疫苗候選者VAX-31在健康嬰兒中進行第2階段研究,以評估其安全性、耐受性和免疫原性。該公司預計將於2026年中公佈該研究的主要免疫接種系列的最終數據,並在約9個月後獲得加強劑數據。VAX-31旨在保護美國五歲以下兒童中大約94%的侵襲性肺炎球菌疾病(IPD)和93%的急性中耳炎,相比標準疫苗,對當前和歷史上流行菌株提供了更廣泛的保護。vaxcyte還計劃在2025年第一季度結束時發佈另一項第2階段研究VAX-24的數據,作爲增強對肺炎鏈球菌的保護的承諾的一部分,肺炎鏈球菌因不斷增加的抗生素耐藥性而成爲重要的公共衛生威脅。
Potential Positives
潛在的積極因素
- Company has initiated the Phase 2 study for VAX-31, marking a significant milestone in advancing its pneumococcal conjugate vaccine clinical programs.
- VAX-31 is designed to cover approximately 94% of invasive pneumococcal disease and 93% of acute otitis media in U.S. children under five, indicating a broad spectrum of efficacy.
- The VAX-31 vaccine offers the potential to protect vulnerable populations against both currently circulating and historically prevalent strains, enhancing public health outcomes.
- Company remains on track to announce topline data from the ongoing VAX-24 Phase 2 study by the end of Q1 2025, indicating consistent progress in its vaccine development pipeline.
- 公司已啓動VAX-31第2階段研究,標誌着其推進肺炎球菌結合疫苗臨床項目的重大里程碑。
- VAX-31旨在覆蓋美國五歲以下兒童中約94%的侵襲性肺炎球菌疾病和93%的急性中耳炎,表明其廣譜療效。
- VAX-31疫苗有潛力保護易受感染群體免受當前流行和歷史上普遍菌株的影響,從而增強公共衛生成果。
- 公司將繼續按計劃於2025年第一季度末宣佈正在進行中的VAX-24第2階段研究的最終數據,顯示其在疫苗開發管線中取得穩定進展。
Potential Negatives
潛在負面影響
- Extended timeline for announcing data may indicate slower progress in vaccine development compared to industry standards.
- Company's reliance on future data readouts raises concerns about regulatory and market uncertainties impacting timelines and potential approval.
- Potential risks highlighted regarding product development, including delays and manufacturing challenges, could adversely affect public perception and investor confidence.
- 延長髮布數據的時間表可能表明疫苗開發進展較行業標準較慢。
- 公司對未來數據披露的依賴引發對監管和市場不確定性對時間表和潛在批准的擔憂。
- 針對產品開發的潛在風險在公衆認知和投資者信心方面可能產生不利影響,包括延遲和製造挑戰。
FAQ
常見問題
When will Vaxcyte announce topline data for VAX-31?
Vaxcyte將何時宣佈VAX-31的頂線數據?
Vaxcyte expects to announce topline data from the VAX-31 study in mid-2026 and booster dose data approximately nine months later.
Vaxcyte預計將於2026年中期公佈VAX-31研究的頂線數據,約九個月後公佈增強劑量數據。
What does VAX-31 protect against?
VAX-31能預防什麼?
VAX-31 is designed to cover approximately 94% of invasive pneumococcal disease and 93% of acute otitis media in U.S. children under five.
VAX-31旨在覆蓋美國五歲以下兒童肺炎球菌感染約94%和急性中耳炎約93%。
What is the VAX-31 Phase 2 infant study?
VAX-31第2階段嬰兒研究是什麼?
The Phase 2 infant study evaluates the safety, tolerability, and immunogenicity of VAX-31 compared to Prevnar 20 in healthy infants.
第2階段嬰兒研究評估了健康嬰兒中VAX-31相對於Prevnar 20的安全性、耐受性和免疫原性。
How many infants are participating in the VAX-31 study?
VAX-31研究有多少嬰兒參與?
The VAX-31 study will involve approximately 750 infants in Stage 2, evaluating three dose levels.
VAX-31研究將涉及大約750名嬰兒參與第2階段,評估三個劑量水平。
What significant designation did VAX-31 receive?
VAX-31獲得了來自FDA的突破性療法指定,用於成人預防肺炎球菌感染。
VAX-31 received Breakthrough Therapy designation from the FDA for the prevention of invasive pneumococcal disease in adults.
VAX-31獲得了FDA針對成人預防肺炎球菌感染的突破性療法指定。
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
免責聲明:這是由GlobeNewswire分發的新聞稿的人工智能生成摘要。用於總結這份稿件的模型可能會出錯。請在這裏查看完整發布。
$PCVX Insider Trading Activity
$PCVX內部交易活動
$PCVX insiders have traded $PCVX stock on the open market 106 times in the past 6 months. Of those trades, 0 have been purchases and 106 have been sales.
$PCVX內部人員在過去6個月中以106次的開放市場交易$PCVX股票。其中有0次購買和106次銷售。
Here's a breakdown of recent trading of $PCVX stock by insiders over the last 6 months:
以下是$PCVX股票近6個月內內部人員交易的詳細情況:
- ANDREW GUGGENHIME (PRESIDENT AND CFO) has traded it 16 times. They made 0 purchases and 16 sales, selling 82,000 shares.
- GRANT PICKERING (CHIEF EXECUTIVE OFFICER) has traded it 41 times. They made 0 purchases and 41 sales, selling 129,696 shares.
- MIKHAIL EYDELMAN (SVP, GEN COUNSEL & CORP SEC) has traded it 21 times. They made 0 purchases and 21 sales, selling 18,834 shares.
- JIM WASSIL (CHIEF OPERATING OFFICER) has traded it 21 times. They made 0 purchases and 21 sales, selling 39,000 shares.
- TERI LOXAM has traded it 4 times. They made 0 purchases and 4 sales, selling 6,250 shares.
- ELVIA COWAN (SVP, FINANCE) has traded it 3 times. They made 0 purchases and 3 sales, selling 15,000 shares.
- ANDREW GUGGENHIME(總裁兼首席財務官)共進行了16次交易。他們沒有購買行爲,全部爲賣出行爲,共賣出82,000股。
- GRANt PICKERING(首席執行官)共進行了41次交易。他們沒有購買行爲,全部爲賣出行爲,共賣出129,696股。
- MIKHAIL EYDELMAN(高級副總裁,總法律顧問兼公司秘書)共進行了21次交易。他們沒有購買行爲,全部爲賣出行爲,共賣出18,834股。
- JIm WASSIL(首席運營官)共進行了21次交易。他們沒有購買行爲,全部爲賣出行爲,共賣出39,000股。
- TERI LOXAm共進行了4次交易。他們沒有購買行爲,全部爲賣出行爲,共賣出6,250股。
- ELVIA COWAN(財務高級副總裁)已經進行了3次交易。他們沒有購買,而是賣出了3次,總共賣出了15,000股。
To track insider transactions, check out Quiver Quantitative's insider trading dashboard.
要跟蹤內部交易,請查看Quiver Quantitative的內部交易特斯拉-儀表。
$PCVX Hedge Fund Activity
$PCVX 對沖基金活動
We have seen 211 institutional investors add shares of $PCVX stock to their portfolio, and 117 decrease their positions in their most recent quarter.
我們看到有211家機構投資者將$PCVX股票加入其投資組合,而另有117家在最近一個季度減少了持倉。
Here are some of the largest recent moves:
以下是一些最近最大的交易動態:
- JANUS HENDERSON GROUP PLC added 2,052,989 shares (+23.1%) to their portfolio in Q3 2024
- VANGUARD GROUP INC added 1,643,488 shares (+16.8%) to their portfolio in Q3 2024
- PRICE T ROWE ASSOCIATES INC /MD/ added 1,292,970 shares (+40.7%) to their portfolio in Q3 2024
- DEUTSCHE BANK AG\ added 1,018,122 shares (+782.8%) to their portfolio in Q3 2024
- POLAR CAPITAL HOLDINGS PLC added 995,779 shares (+inf%) to their portfolio in Q3 2024
- CLEARBRIDGE INVESTMENTS, LLC added 973,139 shares (+522.8%) to their portfolio in Q3 2024
- CAPITAL RESEARCH GLOBAL INVESTORS added 764,677 shares (+18.5%) to their portfolio in Q3 2024
- JANUS HENDERSON GROUP PLC在2024年第3季度將2,052,989股(+23.1%)加入其投資組合。
- VANGUARD GROUP INC在2024年第3季度將1,643,488股(+16.8%)加入其投資組合。
- PRICE t ROWE ASSOCIATES INC /MD/在2024年第3季度將1,292,970股(+40.7%)加入其投資組合。
- 德意志銀行股份公司在2024年第三季度將其投資組合增加了1,018,122股(+782.8%)
- POLAR CAPITAL HOLDINGS PLC在2024年第三季度將其投資組合增加了995,779股(+inf%)
- 明策集團投資有限公司在2024年第三季度將其投資組合增加了973,139股(+522.8%)
- 資本集團全球投資者在2024年第三季度將其投資組合增加了764,677股(+18.5%)
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
要追蹤對沖基金的股票組合,請查看Quiver Quantitative的機構持股儀表板。
Full Release
全面發佈
-- Company Expects to Announce VAX-31 Infant Study Topline Safety, Tolerability and Immunogenicity Data from Primary Immunization Series in Mid-2026, Followed by Topline Data from the Booster Dose Approximately Nine Months Later --
-- 公司預計將於2026年中期公佈VAX-31嬰兒研究初步安全性、耐受性和免疫原性數據,隨後大約九個月後公佈來自增強劑量的初步數據 --
-- VAX-31 is Designed to Cover Approximately 94% of Invasive Pneumococcal Disease and Approximately 93% of Acute Otitis Media in U.S. Children Under Five --
-- vaxcyte-31旨在覆蓋美國五歲以下兒童中約94%的侵襲性肺炎球菌疾病和約93%的急性中耳炎--
-- VAX-31 Offers Potential to Protect Vulnerable Population by Providing Greater Coverage Against Both Currently Circulating and Historically Prevalent Strains Relative to Standard-Of-Care Pneumococcal Conjugate Vaccines --
-- VAX-31有望通過對標準疫苗提供更大覆蓋面,從而保護易受傷害人群免受目前流行和歷史上流行菌株的侵害 --
-- Company Remains on Track to Announce VAX-24 Phase 2 Infant Study Topline Data from Primary Immunization Series by End of First Quarter of 2025 --
-- 公司計劃將於2025年第一季度結束前公佈VAX-24階段2嬰兒研究初步數據 --
SAN CARLOS, Calif., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, today announced the initiation of the Phase 2 study of VAX-31 in healthy infants and that the first study participants have been dosed. This study is evaluating the safety, tolerability and immunogenicity of VAX-31, a 31-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD). The Company expects to share topline data from the primary three-dose immunization series of the study in mid-2026, followed by topline data from the booster dose approximately nine months later.
2024年12月03日加利福尼亞州聖卡洛斯(GLOBE NEWSWIRE)-- 疫苗創新公司瓦斯塞特公司(Nasdaq: PCVX)宣佈啓動了VAX-31健康嬰兒第2期研究,並且首批研究參與者已接受了劑量。該研究評估了VAX-31的安全性、耐受性和免疫原性,這是一種設計用於預防侵襲性肺炎球菌疾病(IPD)的31價肺炎球菌結合疫苗(PCV)候選者。該公司預計將於2026年中期分享該研究主要三劑免疫系列的上線數據,隨後再約九個月後分享來自增強劑劑量的上線數據。
"The initiation of the VAX-31 Phase 2 infant study marks a significant milestone as we continue advancing our PCV clinical programs, which also include the fully enrolled, ongoing VAX-24 Phase 2 infant study," said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte. "PCVs are vital to combating
Streptococcus pneumoniae
, a serious public health threat exacerbated by increasing antimicrobial resistance. As the broadest-spectrum PCV candidate in the clinic today, VAX-31 has the potential to expand coverage and provide protection against both currently circulating and historically prevalent serotypes. We look forward to sharing topline data for safety, tolerability and immunogenicity from the VAX-31 Phase 2 infant study's primary immunization series in mid-2026, and from the booster dose approximately nine months later."
"啓動VAX-31第2期嬰兒研究標誌着我們在推進PCV臨床項目方面取得重要里程碑,這還包括正在進行的VAX-24第2期嬰兒研究,"vaxcyte的首席執行官和聯合創始人格蘭特·皮克林格(Grant Pickering)表示。"PCV對抗措斯菌體(pneumococcal vaccine, PCV)是對抗一種嚴重的公共衛生威脅的關鍵措斯菌體,該威脅由於抗菌藥物耐藥性增加而惡化。作爲當今臨床中覆蓋範圍最廣的PCV候選藥物,VAX-31具有擴大覆蓋範圍、提供對抗當前循環血清型和具有歷史流行的血清型的保護的潛力。我們期待在2026年年中從VAX-31第2期嬰兒研究的主要免疫注射系列中分享有關安全性、耐受性和免疫原性的總體數據,並在約9個月後從增強劑劑次分享數據。"
肺炎鏈球菌
"儘管目前疫苗的有效性",社區在與不斷增加的抗微生物藥物耐藥性有關的嚴重公共衛生威脅方面起着至關重要的作用。作爲當今臨床中最廣譜的PCV候選藥物,VAX-31有潛力擴大覆蓋範圍,並對抗當前循環血清型和歷史上流行的血清型提供保護。我們期待在2026年年中從VAX-31第2期嬰兒研究的主要免疫注射系列中分享頂線數據,包括安全性、耐受性和免疫原性,並在約9個月後從增強劑劑次分享數據。"
"Despite the effectiveness of current vaccines,
Streptococcus pneumoniae
is the leading cause of vaccine-preventable deaths globally in children under five and IPD, including meningitis and bacteremia, remains persistent in the first years of life," said Jim Wassil, Executive Vice President and Chief Operating Officer of Vaxcyte. "It has been clearly signaled by the public health community that a pneumococcal vaccine with a broader spectrum of coverage is needed to provide greater protection against this disease. VAX-31 is designed to cover approximately 94% of IPD and approximately 93% of acute otitis media in U.S. children under five, with the potential to offer much greater coverage relative to the standard-of-care PCVs."
"儘管當前疫苗的有效性非常高,
肺炎鏈球菌
生物-疫苗是全球五歲以下兒童疫苗可預防死亡的主要原因,包括流腦和菌血症,這些在生命的最初幾年中仍然持續存在," vaxcyte的執行副總裁和首席運營官Jim Wassil表示。"公共衛生社區明確表明,需要一種覆蓋範圍更廣的防肺炎球菌疫苗,以提供更好的保護措施。VAX-31的設計旨在覆蓋美國五歲以下兒童約94%的流腦和約93%的急性中耳炎,相對於標準抗菌疫苗,具有更大潛力提供更全面的覆蓋面。
About the VAX-31 Phase 2 Infant Study
The VAX-31 Phase 2 infant study is a randomized, double-blind, active controlled, dose-finding, two-stage clinical study evaluating the safety, tolerability and immunogenicity of VAX-31 compared to Prevnar 20 (PCV20) in healthy infants.
關於VAX-31第2階段嬰兒研究
VAX-31第2階段嬰兒研究是一項隨機、雙盲、積極對照、劑量尋找、兩階段臨床研究,評估VAX-31與Prevnar 20(PCV20)在健康嬰兒中的安全性、耐受性和免疫原性。
-
Stage 1 of the study is evaluating the safety and tolerability of VAX-31 at three dose levels (low, middle and high) and compared to PCV20 in approximately 48 infants in a dose-escalation approach. In the low, middle and high doses, all serotypes were dosed at 1.1mcg, 2.2mcg and 3.3mcg, respectively, except serotypes 1, 5 and 22F, which were dosed at 1.65mcg, 3.3mcg, and 4.4mcg, respectively. Participants who receive VAX-31 in Stage 1 will continue the standard dosing regimen as part of Stage 2 and will be included in the safety, tolerability and immunogenicity analysis of the study.
-
Stage 2 of the study will evaluate the safety, tolerability and immunogenicity of VAX-31 at the same three dose levels and compared to PCV20 in approximately 750 infants.
-
In line with recommendations from the Advisory Committee on Immunization Practices (ACIP), the study design includes a primary immunization series consisting of three doses given at two months, four months and six months of age, followed by a subsequent booster dose at 12-15 months of age.
-
The key prespecified immunogenicity study endpoints include an assessment of immune responses for each of the VAX-31 dose levels in comparison with PCV20 for the 20 common and 11 unique serotypes in VAX-31. Post-primary series (post-dose 3 or PD3) immune responses will be assessed based on serotype-specific immunoglobulin G (IgG) seroresponse rates (proportion of participants achieving the accepted IgG threshold value of ≥0.35mcg/mL) at 30 days PD3. IgG geometric mean titers will be assessed at 30 days PD3 and post-dose 4 (PD4), along with other key immunogenicity endpoints.
-
All participants in the study will be evaluated for safety through six months following the booster dose.
-
The study is being conducted at approximately 50 sites in the United States.
-
研究的第1階段評估了VAX-31在三個劑量水平(低、中和高)的安全性和耐受性,並與PCV20相比,採用劑量遞增的方法在大約48名嬰兒中進行。在低、中和高劑量中,所有血清型的劑量分別爲1.1微克、2.2微克和3.3微克,除了血清型1、5和22F,其劑量分別爲1.65微克、3.3微克和4.4微克。在第1階段接受VAX-31的參與者將繼續作爲第2階段的一部分進行標準劑量方案,並將被納入研究的安全性、耐受性和免疫原性分析中。
-
研究的第2階段將評估VAX-31在同樣三個劑量水平的安全性、耐受性和免疫原性,並與PCV20相比,大約有750名嬰兒參與。
-
根據免疫規劃諮詢委員會(ACIP)的建議,研究設計包括一個首要免疫系列,包括在兩個月、四個月和六個月時分別接種三劑,然後在12-15個月時接種後續增強劑量。
-
預先確定的關鍵免疫學研究終點包括對VAX-31各劑量水平與PCV20在VAX-31的20種常見和11種獨特血清型進行免疫應答評估。基於血清型特異性免疫球蛋白G(IgG)血清應答率(達到≥0.35微克/毫升的接受IgG閾值值的參與者比例)在PD3的30天時將評估劑量後免疫應答。 IgG幾何均值滴度將在PD3的30天時和劑量後4(PD4)時進行評估,以及其他關鍵的免疫學終點。
-
所有參與研究的參與者將在接種增強劑後六個月內進行安全評估。
-
該研究正在美國約50個地點進行。
About Pneumococcal Disease
Pneumococcal disease (PD) is an infection caused by
Streptococcus pneumoniae
bacteria. It can result in invasive pneumococcal disease (IPD), including meningitis and bacteremia, and non-invasive PD, including pneumonia, otitis media and sinusitis. In the United States, pneumococcal pneumonia is estimated to result in approximately 150,000 hospitalizations each year.
Streptococcus pneumoniae
is among the World Health Organization's top antibiotic-resistant pathogens to be urgently addressed, and the U.S. CDC lists drug-resistant
Streptococcus pneumoniae
as a "serious threat." In children under five,
Streptococcus pneumoniae
is the leading cause of vaccine-preventable deaths globally. Pneumococci also cause over 50% of all cases of bacterial meningitis in the United States. Antibiotics are used to treat PD, but some strains of the bacteria have developed resistance to treatments. The morbidity and mortality due to PD are significant, particularly for young children and older adults, underscoring the need for a broader-spectrum vaccine.
關於肺炎球菌疾病
肺炎球菌疾病(PD)是由細菌引起的感染。
肺炎鏈球菌
細菌引起的。它可能導致侵襲性肺炎球菌疾病(IPD),包括腦膜炎和菌血症,以及包括肺炎、中耳炎和鼻竇炎在內的非侵襲性PD。在美國,據估計,肺炎球菌疾病每年導致約15萬次住院。
肺炎鏈球菌
是世界衛生組織急需解決的頂級耐藥病原體之一,美國疾控中心將藥物耐藥列爲"嚴重威脅"。在五歲以下兒童中,產生生物-疫苗預防性死亡的主要原因。肺炎球菌也導致美國50%以上的細菌性腦膜炎病例。抗生素被用於治療PD,但一些細菌株對治療產生了耐藥性。由於PD造成的發病率和死亡率相當顯著,特別是對於幼兒和老年人而言,強調了對更廣譜生物-疫苗的需求。
肺炎鏈球菌
是美國疾病控制和預防中心列爲"嚴重威脅"的兒童五歲以下生物-疫苗死亡的主要原因。肺炎球菌也導致美國50%以上的細菌性腦膜炎病例。抗生素被用於治療 PD,但一些細菌株對治療產生了耐藥性。PD造成的發病率和死亡率相當顯著,特別是對於幼兒和老年人而言,強調了對更廣譜生物-疫苗的需求。
肺炎鏈球菌
生物-疫苗預防性死亡的主要原因是全球通發生在五歲以下兒童。肺炎球菌也導致美國50%以上的細菌性腦膜炎病例。抗生素被用於治療 PD,但一些細菌株對治療產生了耐藥性。PD造成的發病率和死亡率相當顯著,特別是對於幼兒和老年人而言,強調了對更廣譜生物-疫苗的需求。
About VAX-31
VAX-31, a 31-valent PCV candidate advancing to a Phase 3 adult clinical program and currently being evaluated in a Phase 2 infant clinical program, is designed to prevent IPD, which is especially serious in infants, young children, older adults and those with immune deficiencies or certain chronic health conditions. IPD is associated with high case-fatality rates, antibiotic resistance and meningitis. VAX-31 is the broadest-spectrum PCV in the clinic and has the potential to provide protection against both currently circulating and historically prevalent serotypes. VAX-31 was designed to increase coverage, in a single vaccine, to more than 95% of IPD circulating in adults in the United States aged 50 and older, with the potential to provide an incremental 12-40% of coverage over current standard-of-care adult PCVs. In infants, it was designed to cover approximately 94% of IPD and approximately 93% of acute otitis media due to
Streptococcus pneumoniae
in children under five years of age in the United States.
關於VAX-31
VAX-31是一種31價PCV候選疫苗,正在推進到第3期成人臨床項目,並目前正在進行第2期嬰兒臨床項目的評估,旨在預防IPD,這在嬰兒、幼兒、老年人以及免疫缺陷或某些慢性健康狀況嚴重時尤爲緊急。IPD與高病死率、抗生素耐藥性和腦膜炎有關。VAX-31是診所中最廣譜的PCV,具有在單一疫苗中提供對目前流行和歷史上流行的血清型提供保護的潛力。VAX-31的設計旨在在單一疫苗中對美國50歲及以上的成年人流行的IPD提供95%以上的覆蓋率,並有可能對當前標準護理成人PCV提供增加的12-40%覆蓋率。在嬰兒中,它的設計是覆蓋大約94%的IPD和約93%的由於
肺炎鏈球菌
在美國五歲以下的兒童中。
In November 2024, Vaxcyte announced that the FDA granted Breakthrough Therapy designation to VAX-31 for the prevention of IPD in adults. The Breakthrough Therapy designation process is designed to expedite the development and review of drugs that are intended to treat a serious or life-threatening condition.
2024年11月,vaxcyte宣佈FDA授予VAX-31在成年人預防IPD方面突破性療法指定。突破性療法指定流程旨在加快旨在治療嚴重或危及生命的疾病的藥物的開發和審查。
About Vaxcyte
Vaxcyte is a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. The Company is developing broad-spectrum conjugate and novel protein vaccines to prevent or treat bacterial infectious diseases. VAX-31 is a 31-valent, carrier-sparing PCV being developed for the prevention of IPD in adults and infants and is the broadest-spectrum PCV candidate in the clinic today. VAX-24, the Company's 24-valent PCV candidate, is designed to cover more serotypes than any infant PCV on-market and is currently being evaluated in a Phase 2 infant study. Both VAX-31 and VAX-24 are designed to improve upon the standard-of-care PCVs by covering the serotypes in circulation that are responsible for a significant portion of IPD and are associated with high case-fatality rates, antibiotic resistance and meningitis, while maintaining coverage of previously circulating strains that are currently contained through continued vaccination practice.
關於Vaxcyte
vaxcyte是一家生物-疫苗創新公司,致力於研發高保真度疫苗,保護人類免受細菌性疾病的後果。該公司正在開發廣譜共軛疫苗和新型蛋白疫苗,用於預防或治療細菌感染性疾病。VAX-31是一種31價疫苗,無需載體PCV,旨在預防成人和嬰幼兒IPD,是當前診所中最廣譜的PCV候選疫苗。VAX-24,該公司的24價PCV候選疫苗,旨在覆蓋比市場上任何嬰幼兒PCV更多的血清型,在一個第2期嬰幼兒研究中進行評估。VAX-31和VAX-24都旨在通過覆蓋在流通中負責大部分IPD和與高病死率、抗生素抗藥性和腦膜炎相關的血清型,同時保持對目前通過持續接種實踐已被控制的先前流行菌株的覆蓋,來改進標準治療PCV。
Vaxcyte is re-engineering the way highly complex vaccines are made through modern synthetic techniques, including advanced chemistry and the XpressCF cell-free protein synthesis platform, exclusively licensed from Sutro Biopharma, Inc. Unlike conventional cell-based approaches, the Company's system for producing difficult-to-make proteins and antigens is intended to accelerate its ability to efficiently create and deliver high-fidelity vaccines with enhanced immunological benefits. Vaxcyte's pipeline also includes VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease; and VAX-GI, a vaccine candidate designed to prevent Shigella. Vaxcyte is driven to eradicate or treat invasive bacterial infections, which have serious and costly health consequences when left unchecked. For more information, visit
.
Vaxcyte正在通過現代合成技術(包括先進的化學和獨家從Sutro Biopharma,Inc.獲得許可的XpressCF無細胞蛋白合成平台)重新構建高度複雜疫苗的製造方式。與傳統的基於細胞的方法不同,該公司的系統用於生產難以製造的蛋白質和抗原,旨在加快其有效創建和提供具有增強免疫益處的高保真度疫苗的能力。Vaxcyte的管線還包括VAX-A1,一種預防性疫苗候選者,旨在預防A群鏈球菌感染;VAX-PG,一種治療性疫苗候選者,旨在減緩或停止牙周病的進展;以及VAX-GI,一種旨在預防志賀菌感染的疫苗候選者。Vaxcyte致力於根除或治療侵襲性細菌感染,這些感染如果不加以控制會帶來嚴重且昂貴的健康後果。欲了解更多信息,請訪問
.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements related to the potential benefits of VAX-24 and VAX-31, including breadth of coverage, and the ability to deliver potentially best-in-class PCVs and improve upon the standard-of-care a; the process and timing of anticipated future development of Vaxcyte's vaccine candidates; the design of the VAX-31 infant Phase 2 study, and the timing of its data readouts; the demand for Vaxcyte's vaccine candidates; and other statements that are not historical fact. The words "anticipate," "believe," "could," "expect," "intend," "may," "on track," "potential," "should," "would" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are based on Vaxcyte's current expectations and actual results and timing of events could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, including, without limitation, risks related to Vaxcyte's product development programs, including development timelines, success and timing of chemistry, manufacturing and controls and related manufacturing activities, potential delays or inability to obtain and maintain required regulatory approvals for its vaccine candidates, and the risks and uncertainties inherent with preclinical and clinical development processes; the success, cost and timing of all development activities and clinical trials; and sufficiency of cash and other funding to support Vaxcyte's development programs and other operating expenses. These and other risks are described more fully in Vaxcyte's filings with the Securities and Exchange Commission (SEC), including its Quarterly Report on Form 10-Q filed with the SEC on November 5, 2024 or in other documents Vaxcyte subsequently files with or furnishes to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date, and readers should not rely upon the information in this press release as current or accurate after its publication date. Vaxcyte undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations. Readers should not rely upon the information in this press release as current or accurate after its publication date.
前瞻性聲明
本新聞稿包含根據1995年《私人證券訴訟改革法案》定義的前瞻性聲明。 這些聲明包括但不限於與VAX-24和VAX-31的潛在益處相關的聲明,包括覆蓋範圍以及提供潛在最優PCV和改善標準護理的能力; Vaxcyte疫苗候選品未來開發的流程和時間安排; VAX-31嬰兒2期研究的設計,及其數據揭示的時間安排; 對Vaxcyte疫苗候選品的需求; 以及其他非歷史事實的聲明。 「預計」,「相信」,「可能」,「期待」,「意圖」,「可能」,「按計劃」,「潛在」,「應該」,「將」等詞彙以及其他涉及未來事件、狀況或情況的詞彙或表達方式傳達了未來事件或結果的不確定性,旨在識別前瞻性聲明,雖然並非所有前瞻性聲明均包含這些識別詞彙。 這些前瞻性聲明基於Vaxcyte目前的預期,實際結果及事件時間可能會與此類前瞻性聲明所預期的有實質性差異,原因在於風險和不確定性,包括但不限於與Vaxcyte產品開發計劃相關的風險,包括開發時間表、化學、製造和控制的成功和時間安排以及相關製造活動、可能的延遲或無法獲取和維持其疫苗候選品所需的監管批准的風險,以及臨床前和臨床開發過程固有的風險和不確定性; 所有開發活動和臨床試驗的成功、成本和時間安排以及足夠的現金和其他資金以支持Vaxcyte的開發計劃和其他營業費用的充足性。 這些風險和其他風險在Vaxcyte向證券交易委員會(SEC)提交的文件中更詳細描述,包括其於2024年11月5日向SEC提交的季度報告表10-Q,或Vaxcyte隨後向SEC提交的其他文件。 本新聞稿中包含的所有前瞻性聲明僅適用於其發佈日期,基於管理層在此日期的假設和估計,並且讀者不應當在其發佈日期後依賴本新聞稿中的信息。 Vaxcyte不承擔更新本新聞稿中包含的任何前瞻性聲明的義務或責任,因爲新信息、未來事件或其期望變化。 讀者不應在本新聞稿發佈日期後依賴其中的信息。
Contacts:
Patrick Ryan, Executive Director, Corporate Communications
Vaxcyte, Inc.
415-606-5135
media@vaxcyte.com
聯繫人:
帕特里克·萊恩(Patrick Ryan),董事兼企業傳媒主管
vaxcyte, 公司
415-606-5135
media@vaxcyte.com
Jennifer Zibuda, Senior Director, Investor Relations
Vaxcyte, Inc.
860-729-8902
investors@vaxcyte.com
投資者關係高級總監Jennifer Zibuda
vaxcyte, 公司
860-729-8902
investors@vaxcyte.com