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Vaxcyte Initiates Phase 2 Study Evaluating VAX-31 for the Prevention of Invasive Pneumococcal Disease in Infants

Vaxcyte Initiates Phase 2 Study Evaluating VAX-31 for the Prevention of Invasive Pneumococcal Disease in Infants

Vaxcyte啓動了第二階段研究,評估VAX-31在預防嬰兒侵襲性肺炎球菌病中的有效性。
Vaxcyte ·  12/03 13:00

-- 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 --

-- VAX-31旨在覆蓋美國五歲以下兒童中大約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."

瓦斯塞特公司的首席執行官兼聯合創始人格蘭特·皮克林表示:「VAX-31嬰兒第2期研究的啓動標誌着我們繼續推進PCV臨床計劃的重要里程碑,其中還包括正在進行中的VAX-24嬰兒第2期研究。」 PCV對抗肺炎鏈球菌至關重要,由於細菌耐藥性日益增加,這是一種嚴重的公共健康威脅。作爲當今臨床中最廣譜的PCV候選者,VAX-31有潛力擴大覆蓋範圍,並提供針對當前循環中和歷史上佔優勢的毒素的保護。我們期待於2026年中期分享VAX-31嬰兒第2期研究主要免疫系列的安全性、耐受性和免疫原性的上線數據,並在約九個月後分享來自增強劑劑量的上線數據。”

"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."

瓦斯塞特公司的執行副總裁兼首席營運官吉姆·瓦西爾表示:「儘管當前疫苗的有效性得到證實,肺炎鏈球菌仍是五歲以下兒童全球可預防死亡的主要原因,包括腦膜炎和菌血症在內的IPD在嬰兒時期仍然持續存在。」 「公共衛生界明確表示,需要一種具有更廣泛覆蓋範圍的肺炎球菌疫苗,以提供更大程度的保護防止這種疾病。 VAX-31的設計覆蓋了美國五歲以下兒童中大約94%的IPD和大約93%的急性中耳炎,相對於常規護理PCV,VAX-31具有提供更大覆蓋範圍的潛力。」

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
肺炎球菌病(PD)是由肺炎鏈球菌引起的感染。它可能導致侵襲性肺炎球菌疾病(IPD),包括腦膜炎和細菌血症,以及非侵襲性PD,包括肺炎、中耳炎和鼻竇炎。在美國,據估計,肺炎球菌性肺炎每年導致約15萬次住院。肺炎鏈球菌被世界衛生組織列爲迫切需要解決的頭號耐藥病原體之一,美國疾控中心將耐藥肺炎鏈球菌列爲「嚴重威脅」。在五歲以下兒童中,肺炎鏈球菌是全球可預防接種疫苗引起死亡的主要原因。肺炎球菌還導致美國超過50%的細菌性腦膜炎病例。抗生素用於治療PD,但部分細菌菌系已經對治療產生抗藥性。PD導致的發病率和死亡率很高,尤其對於幼兒和老年人而言,突顯了更廣譜疫苗的必要性。

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價值預防性肺炎球菌疫苗,正在進入第三階段成人臨床項目,並目前正在進行第二階段嬰兒臨床項目評估,旨在預防侵襲性肺炎球菌疾病(IPD),尤其在嬰兒、幼兒、老年人以及免疫功能缺陷或某些慢性健康狀況患者中病情尤爲嚴重。IPD伴隨高死亡率、抗生素耐藥性和腦膜炎。VAX-31是臨床上覆蓋範圍最廣的肺炎球菌疫苗,並有潛力提供保護,不僅可對當前流行和歷史上流行的血清型提供保護。VAX-31的設計旨在在單一疫苗中,覆蓋美國50歲及以上成人中95%以上的IPD流行株,有可能相較於當前標準照護的成人肺炎球菌疫苗,提供額外12-40%的覆蓋率。在嬰兒中,它的設計旨在覆蓋約94%的IPD和約93%的因肺炎鏈球菌引起的五歲以下兒童的急性中耳炎。

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重新設計高度複雜疫苗的製造方式,包括愛文思控股化學和從Sutro Biopharma, Inc.獨家授權的XpressCF無細胞蛋白合成平台。與傳統的基於細胞的方法不同,公司生產難以製造的蛋白質和抗原的系統旨在加速其高效創造和交付高保真度疫苗的能力,並提供增強的免疫益處。vaxcyte的產品管道還包括VAX-A1,這是一種旨在預防A組鏈球菌感染的預防性疫苗候選;VAX-PG,這是一種旨在減緩或停止牙周病進展的治療性疫苗候選;以及VAX-GI,這是一種旨在預防志賀氏菌感染的疫苗候選。vaxcyte致力於根除或治療侵襲性細菌感染,因爲不加以控制會產生嚴重且昂貴的健康後果。有關更多信息,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
[email protected]

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
[email protected]

Jennifer Zibuda, Senior Director, Investor Relations
Vaxcyte, Inc.
860-729-8902
[email protected]

投資者關係高級總監Jennifer Zibuda
vaxcyte, 公司
860-729-8902
[email protected]


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