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VBI Vaccines Announces Poster Presentation at 2024 ASCO Annual Meeting Highlighting New Interim Phase 2b Data From VBI-1901 in Recurrent Glioblastoma Patients

VBI Vaccines Announces Poster Presentation at 2024 ASCO Annual Meeting Highlighting New Interim Phase 2b Data From VBI-1901 in Recurrent Glioblastoma Patients

VBI 疫苗宣佈在 2024 年 ASCO 年會上發佈海報,重點介紹來自 VBI-1901 復發膠質母細胞瘤患者的新中期 2b 期數據
VBI Vaccines ·  05/22 00:00

CAMBRIDGE, Mass. – VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that new interim tumor response data from the ongoing randomized, controlled Phase 2b study of VBI-1901, the Company's cancer vaccine immunotherapeutic candidate in recurrent glioblastoma (GBM), were accepted for poster presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.

馬薩諸塞州劍橋——由免疫學驅動、追求強有力的疾病預防和治療的生物製藥公司VBI Vaccines Inc.(納斯達克股票代碼:VBIV)(VBI)今天宣佈,正在進行的針對該公司複發性膠質母細胞瘤(GBM)的癌症疫苗免疫療法候選藥物 VBI-1901 的隨機對照2b期研究的新中期腫瘤反應數據已獲准在會上發表海報 2024 年美國臨床腫瘤學會 (ASCO) 年會。

The presentation at ASCO will provide an update to the encouraging data previously shared at the World Vaccine Congress Washington in April, including additional data from those initially evaluable patients, as well as data from new patients who have since been randomized into the Phase 2b study.

ASCO的演講將提供先前令人鼓舞的數據的最新情況 在四月份的華盛頓世界疫苗大會上分享,包括來自最初可評估的患者的其他數據,以及此後被隨機分配到2b期研究的新患者的數據。

Presentation Details

演示詳情

  • Title: Randomized Phase 2b trial of a CMV vaccine immunotherapeutic candidate (VBI-1901) in recurrent glioblastomas
  • Date: Saturday, June 1, 2024
  • Poster Session: Central Nervous System Tumors
  • Poster Session Time: 9:00 AM – 12:00 PM CDT
  • 標題: 複發性膠質母細胞瘤中CMV疫苗免疫療法候選藥物(VBI-1901)的隨機2b期試驗
  • 日期: 2024 年 6 月 1 日,星期六
  • 海報會議: 中樞神經系統腫瘤
  • 海報發佈會時間: 中部夏令時間上午 9:00 — 下午 12:00

Phase 2b Study Design
Multi-center, randomized, controlled, open-label study in up to 60 patients with first recurrent GBM

第 2b 階段研究設計
多中心、隨機、對照、開放標籤的研究,涉及多達60名首次復發的GBM患者

  • Patients will be randomized in a 1:1 ratio across two study arms:
    • Intradermal VBI-1901 + GM-CSF: 10 μg dose every 4 weeks until clinical disease progression
    • Monotherapy standard-of-care: either intravenous carmustine or oral lomustine, every 6 weeks until disease progression or intolerable toxicity
  • Endpoints include:
    • Safety and tolerability
    • Overall survival (OS) – median and overall
    • Tumor response rate (TRR)
    • Progression-free survival (PFS)
    • Immunologic responses
    • Reduction in corticosteroid use relative to baseline
    • Change in quality of life compared to baseline
  • 患者將按照 1:1 的比例在兩個研究組中隨機分配:
    • 皮內 VBI-1901 + GM-CSF:每 4 周給藥 10 μg,直到臨床疾病進展
    • 單一療法護理標準:靜脈注射卡莫司汀或口服洛莫司汀,每隔 6 周直至疾病進展或出現不可耐受的毒性
  • 終端包括:
    • 安全性和耐受性
    • 總生存率 (OS) — 中位數和總生存率
    • 腫瘤反應率 (TRR)
    • 無進展生存 (PFS)
    • 免疫學反應
    • 與基線相比,皮質類固醇的使用量減少
    • 與基線相比生活質量的變化

The U.S. Food and Drug Administration (FDA) has considered demonstration of a statistically significant improvement in overall survival relative to a randomized control arm to be clinically significant and has recognized this as criteria to support the approval of new oncology drugs.1

美國食品藥品監督管理局(FDA)認爲,與隨機對照組相比,總體存活率的顯著改善具有臨床意義,並認爲這是支持新腫瘤藥物批准的標準。1

For more information about the Phase 2b study, visit clinicaltrials.gov and reference trial identifier: NCT03382977.

有關2b期研究的更多信息,請訪問clinicaltrials.gov和參考試驗標識符:NCT03382977。

About GBM and VBI-1901

關於 GBM 和 VBI-1901

Scientific literature suggests CMV infection is prevalent in multiple solid tumors, including glioblastoma (GBM). GBM is among the most common and aggressive malignant primary brain tumors in humans. In the U.S. alone, more than 12,000 new cases are diagnosed each year. The current standard of care for treating GBM is surgical resection, followed by radiation and chemotherapy. Even with aggressive treatment, GBM progresses rapidly and has a high mortality.

科學文獻表明,鉅細胞病毒感染在包括膠質母細胞瘤(GBM)在內的多種實體瘤中很常見。GBM 是人類中最常見和最具侵略性的惡性原發性腦腫瘤之一。僅在美國,每年就有超過12,000例新發病例被診斷出來。目前治療GBM的護理標準是手術切除,然後是放療和化療。即使進行了積極的治療,GBM進展迅速,死亡率也很高。

VBI-1901 is a novel cancer vaccine immunotherapeutic candidate developed using VBI's enveloped virus-like particle (eVLP) technology to target two highly immunogenic cytomegalovirus (CMV) antigens, gB and pp65. The FDA has granted VBI-1901 Fast Track Designation and Orphan Drug Designation for the treatment of recurrent glioblastoma. These designations are intended to provide certain benefits to drug developers, including more frequent meetings with the FDA, and Accelerated Approval and Priority Review, if relevant criteria are met, among other benefits.

VBI-1901 是一種新型癌症疫苗免疫療法候選藥物,使用 VBI 的包膜病毒樣顆粒 (eVLP) 技術開發,可靶向兩種高免疫原性的鉅細胞病毒 (CMV) 抗原 gB 和 pp65。美國食品藥品管理局已授予 VBI-1901 快速通道認證和孤兒藥稱號,用於治療複發性膠質母細胞瘤。這些指定旨在爲藥物開發商提供某些好處,包括更頻繁地與美國食品藥品管理局會面,以及在滿足相關標準的情況下加快批准和優先審查等好處。

About VBI Vaccines Inc.

關於 VBI 疫苗公司

VBI Vaccines Inc. ("VBI") is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through its innovative approach to virus-like particles ("VLPs"), including a proprietary enveloped VLP ("eVLP") platform technology and a proprietary mRNA-launched eVLP ("MLE") platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. VBI is committed to targeting and overcoming significant infectious diseases, including hepatitis B, coronaviruses, and cytomegalovirus (CMV), as well as aggressive cancers including glioblastoma (GBM). VBI is headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel.

VBI Vaccines Inc.(“VBI”)是一家由免疫學驅動的生物製藥公司,致力於強有力的疾病預防和治療。通過其針對病毒樣顆粒(“VLP”)的創新方法,包括專有的包膜VLP(“eVLP”)平台技術和由mRNA推出的專有eVLP(“MLE”)平台技術,VBI開發了模仿病毒自然呈現的候選疫苗,旨在激發人類免疫系統的先天力量。VBI致力於靶向和克服重大傳染病,包括乙型肝炎、冠狀病毒和鉅細胞病毒(CMV),以及包括膠質母細胞瘤(GBM)在內的侵襲性癌症。VBI總部位於馬薩諸塞州劍橋,在加拿大渥太華設有研究機構,在以色列雷霍沃特設有研究和製造基地。

References:

參考文獻:

1. Oncology Center of Excellence, Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration. Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics; Guidance for Industry. FDA.gov. December, 2018

1。美國食品藥品監督管理局腫瘤學卓越中心、藥物評估與研究中心(CDER)和生物製劑評估與研究中心(CBER)。批准癌症藥物和生物製劑的臨床試驗終點;行業指南。FDA.gov。2018 年 12 月

Cautionary Statement on Forward-looking Information

關於前瞻性信息的警示聲明

Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are forward-looking information within the meaning of Canadian securities laws (collectively, "forward-looking statements"). The Company cautions that such forward-looking statements involve risks and uncertainties that may materially affect the Company's results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to, the Company's ability to regain and maintain compliance with the listing standards of the Nasdaq Capital Market, the Company's ability to satisfy all of the conditions to the consummation of the transactions with Brii Biosciences, the Company's ability to comply with its obligations under its loan agreement with K2 HealthVentures, the impact of general economic, industry or political conditions in the United States or internationally; the impact of the COVID-19 endemic on our clinical studies, manufacturing, business plan, and the global economy; the ability to successfully manufacture and commercialize PreHevbrio/PreHevbri; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of pipeline candidates and the commercialization of PreHevbrio/PreHevbri; the ability to obtain appropriate or necessary regulatory approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company's ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the Company's products. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company's filings with the SEC and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the SEC on April 16, 2024, and filed with the Canadian security authorities at sedarplus.ca on April 16, 2024, as may be supplemented or amended by the Company's Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. All such forward-looking statements made herein are based on our current expectations and we undertake no duty or obligation to update or revise any forward-looking statements for any reason, except as required by law.

本新聞稿中的某些前瞻性陳述而不是歷史事實陳述是1995年《私人證券訴訟改革法》安全港條款所指的前瞻性陳述,是加拿大證券法所指的前瞻性信息(統稱爲 “前瞻性陳述”)。公司警告說,此類前瞻性陳述涉及風險和不確定性,可能會對公司的經營業績產生重大影響。此類前瞻性陳述基於管理層的信念以及管理層做出的假設和目前可獲得的信息。由於某些因素,實際業績可能與前瞻性陳述所設想的結果存在重大差異,包括但不限於公司恢復和維持對納斯達克資本市場上市標準的遵守的能力、公司滿足完成與騰盛投資交易的所有條件的能力、公司履行與K2 HealthVentures貸款協議規定的義務的能力、總體經濟的影響、行業的影響或者美國的政治狀況國家或國際;COVID-19 流行對我們的臨床研究、製造、商業計劃和全球經濟的影響;成功製造和商業化 preHEVBRIO/preHEVBRI 的能力;在臨床前或臨床試驗中確定潛在產品有效或安全的能力;建立或維持在研發候選藥物開發和 preHEVBRI 商業化方面的合作的能力;獲得適當藥物的能力或對市場潛在產品進行必要的監管批准;爲開發產品和營運資本獲得未來資金以及以商業上合理的條件獲得此類資金的能力;公司以商業規模或與第三方合作生產候選產品的能力;競爭對手規模和性質的變化;留住關鍵高管和科學家的能力;以及保護和執行與公司產品相關的合法權利的能力。公司向美國證券交易委員會和加拿大證券管理局提交的文件,包括2024年4月16日向美國證券交易委員會提交的10-K表年度報告,以及2024年4月16日在sedarplus.ca向加拿大安全機構提交的10-K表年度報告,包括公司10-Q表季度報告和當前表單報告對這些因素和其他因素的討論,包括與公司相關的風險和不確定性 8-K。鑑於這些風險、不確定性和因素,提醒您不要過分依賴此類前瞻性陳述,本警示聲明對這些前瞻性陳述進行了全面的限定。此處作出的所有此類前瞻性陳述均基於我們當前的預期,除非法律要求,否則我們沒有義務或義務以任何理由更新或修改任何前瞻性陳述。

View source version on businesswire.com: https://www.businesswire.com/news/home/20240522640304/en/

在 businesswire.com 上查看源版本: https://www.businesswire.com/news/home/20240522640304/en/

VBI

Nicole Anderson
Director, Corporate Communications & IR
(617) 830-3031 x124
IR@vbivaccines.com

VBI

妮可安德森
企業傳播與投資者關係總監
(617) 830-3031 x124
IR@vbivaccines.com

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