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GeoVax Reports Positive Interim Data From Phase 2 Clinical Trial of GEO-CM04S1 as a Universal Covid-19 Vaccine Booster

GeoVax Reports Positive Interim Data From Phase 2 Clinical Trial of GEO-CM04S1 as a Universal Covid-19 Vaccine Booster

GeoVax 報告了 GEO-CM04S1 作爲通用 Covid-19 疫苗助推器 2 期臨床試驗的積極中期數據
GlobeNewswire ·  02/06 22:00

Results Demonstrate Potential Protective Immunity Against Multiple SARS-CoV-2 Variants

結果顯示潛在的保護性免疫力 對抗多種SARS-CoV-2變體

ATLANTA, GA, Feb. 06, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced positive initial safety and immune response findings from its Phase 2 clinical trial at one month following administration of its Covid-19 vaccine, GEO-CM04S1. The trial, evaluating GEO-CM04S1 as a heterologous booster in 63 healthy adults who had previously received the Pfizer or Moderna mRNA vaccine (ClinicalTrials.gov Identifier: NCT04639466), was fully enrolled at the end of Sept 2023.

喬治亞州亞特蘭大,2024 年 2 月 6 日(GLOBE NEWSWIRE)— 通過 NewMediaWir — 開發針對癌症和傳染病的免疫療法和疫苗的生物技術公司GeoVax Labs, Inc.(納斯達克股票代碼:GOVX)今天在注射Covid-19疫苗 GEO-CM04S1 一個月後宣佈了其2期臨床試驗的積極初步安全和免疫反應結果。該試驗評估了先前接種過輝瑞或摩德納 mRNA 疫苗的 63 名健康成年人的 GEO-CM04S1 作爲異源增強劑(ClinicalTrials.gov 標識符: NCT04639466),已於 2023 年 9 月底註冊完畢。

The study is designed to evaluate the safety and immunogenicity of two GEO-CM04S1 dose levels. The trial remains blinded to dose of vaccine received, with study subjects being followed for a total of one year. To date, there have been no serious adverse events, and adverse events were in line with other routine vaccinations. The immunological responses measured throughout the study period include both neutralizing antibodies against SARS-CoV-2 variants and specific T-cell responses. Consolidated data from all subjects tested one-month post-vaccination, documented statistically significant increases in neutralizing antibody responses against multiple SARS-CoV-2 variants, ranging from the original Wuhan strain through Delta and Omicron XBB 1.5; additional testing against the JN.1 variant is underway.

該研究旨在評估兩種 GEO-CM04S1 劑量水平的安全性和免疫原性。該試驗仍然對接種的疫苗劑量視而不見,對研究對象進行了總共一年的隨訪。迄今爲止,沒有發生嚴重的不良事件,不良事件與其他常規疫苗接種一致。在整個研究期間測得的免疫反應包括針對SARS-CoV-2變體的中和抗體和特異性T細胞反應。疫苗接種後一個月接受測試的所有受試者的綜合數據顯示,針對多種SARS-CoV-2變體(從最初的武漢菌株到Delta和Omicron XBB 1.5)的中和抗體反應在統計學上顯著增加;針對JN.1變體的額外測試正在進行中。

GEO-CM04S1 is a next-generation Covid-19 vaccine based on GeoVax's MVA viral vector platform, which supports the presentation of multiple vaccine antigens to the immune system in a single dose. GEO-CM04S1 encodes for both the spike (S) and nucleocapsid (N) antigens of SARS-CoV-2 and is specifically designed to induce both antibody and T-cell responses to those parts of the virus less likely to mutate over time. The more broadly functional engagement of the immune system is designed to protect against severe disease caused by continually emerging variants of Covid-19. Vaccines of this format should not require frequent and repeated modification or updating. These latest findings lend support to previously published findings in cell transplant patients of the ability of GEO-CM04S1 to stimulate functional antibody responses against a broad array of evolving SARS-CoV-2 virus variants (Chiuppesi et al, Vaccines, Sept 2023).

GEO-CM04S1 是基於 GeoVax 的 MVA 病毒載體平台的下一代 Covid-19 疫苗,該平台支持以單劑量向免疫系統提供多種疫苗抗原。GEO-CM04S1 同時編碼 SARS-CoV-2 的刺突抗原 (S) 和核衣殼 (N) 抗原,專門設計用於誘導抗體和 T 細胞對病毒中不太可能隨時間推移發生變異的部分的反應。免疫系統的功能更廣泛的作用旨在預防由不斷出現的Covid-19變種引起的嚴重疾病。這種格式的疫苗不應需要頻繁和反覆的修改或更新。這些最新發現支持了先前在細胞移植患者中發表的關於 GEO-CM04S1 能夠刺激對各種不斷演變的 SARS-CoV-2 病毒變體的功能性抗體反應的發現(Chiuppesi 等人, 疫苗,2023 年 9 月)。

Kelly McKee, Jr., MD, MPH, GeoVax Chief Medical Officer, stated, "There is a critical need to address the recognized shortcomings of currently approved SARS-CoV-2 vaccines. Annual (or even more frequent) vaccination in a seemingly never-ending race to keep pace with this rapidly evolving virus is an unsustainable strategy. GEO-CM04S1 continues to demonstrate the ability to elicit broadly reactive functional antibodies in conjunction with robust and durable T-cell responses, offering the prospect of a next-generation solution to address these shortcomings."

小凱利·麥基醫學博士、公共衛生碩士、GeoVax首席醫學官表示:“迫切需要解決目前批准的SARS-CoV-2疫苗中公認的缺陷。在一場看似永無止境的競賽中,每年(甚至更頻繁)的疫苗接種是一種不可持續的策略。GEO-CM04S1 繼續顯示出具有廣泛反應性的功能抗體以及強大而持久的 T 細胞反應的能力,爲解決這些缺陷的下一代解決方案提供了前景。”

"We are thrilled by these data and our investigational vaccine designed to protect against severe disease caused by emerging variants of Covid-19," said David Dodd, GeoVax Chairman and CEO. "These interim data reinforce our resolve to bring our expertise in the development of innovative vaccines to address critical public health needs using new approaches and technologies. We look forward to providing further updates regarding the successful progress of the clinical development of GEO-CM04S1."

GeoVax董事長兼首席執行官戴維·多德表示:“這些數據以及我們的研究疫苗旨在預防由Covid-19的新變種引起的嚴重疾病,這讓我們感到非常興奮。”“這些臨時數據堅定了我們的決心,即利用我們在創新疫苗開發方面的專業知識,使用新方法和技術來滿足關鍵的公共衛生需求。我們期待提供有關 GEO-CM04S1 臨床開發成功進展的進一步最新情況。”

About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world's most threatening infectious diseases. The company's lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax's lead infectious disease candidate is GEO-CM04S1, a next-generation Covid-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized Covid-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable Covid-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: .

關於 GeoVax
GeoVax Labs, Inc. 是一家臨床階段的生物技術公司,爲實體瘤癌和世界上許多最具威脅性的傳染病開發新療法和疫苗。該公司在腫瘤學領域的領先項目是一種新型溶瘤實體瘤基因導向療法Gedeptin,目前正在進行鍼對晚期頭頸癌的多中心1/2期臨床試驗。GeoVax的主要候選傳染病是 GEO-CM04S1,這是針對高風險免疫功能低下患者群體的下一代Covid-19疫苗。GEO-CM04S1 目前正在進行三項二期臨床試驗,被評估爲免疫功能低下患者(例如血液系統癌症患者和其他目前批准的 Covid-19 疫苗不足的患者群體)的主要疫苗,以及作爲慢性淋巴細胞白血病 (CLL) 患者的加強疫苗。此外,GEO-CM04S1 正在進行二期臨床試驗,評估該疫苗在之前接種過 mRNA 疫苗的健康患者中是一種更強大、更耐用的 Covid-19 增強劑。GeoVax 的領導團隊在過去幾十年中推動了多家生命科學公司的重大價值創造。欲了解更多信息,請訪問我們的網站: 。

Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax's business plans. The words "believe," "look forward to," "may," "estimate," "continue," "anticipate," "intend," "should," "plan," "could," "target," "potential," "is likely," "will," "expect" and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax's immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax's viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax's immuno-oncology products and preventative vaccines will be safe for human use, GeoVax's vaccines will effectively prevent targeted infections in humans, GeoVax's immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax's products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

前瞻性陳述
本新聞稿包含有關GeoVax商業計劃的前瞻性陳述。“相信”、“期待”、“可能”、“估計”、“繼續”、“預期”、“打算”、“應該”、“計劃”、“可能”、“目標”、“潛在”、“很可能”、“將”、“期望” 等詞語用於識別前瞻性陳述。我們的這些前瞻性陳述主要基於我們當前對未來事件和財務趨勢的預期和預測,我們認爲這些事件和趨勢可能會影響我們的財務狀況、經營業績、業務戰略和財務需求。由於多種因素,實際結果可能與這些陳述中包含的結果存在重大差異,包括:GeoVax能否從正在進行或未來的臨床試驗中獲得可接受的結果,GeoVax的免疫腫瘤學產品和預防性疫苗可以激發預期的反應,這些產品或疫苗可以有效使用,GeoVax的病毒載體技術可以充分放大對癌症抗原的免疫反應,GeoVax能否開發和生產其免疫腫瘤學產品和預防藥物及時具有所需特性的疫苗,GeoVax的免疫腫瘤學產品和預防性疫苗將可供人類安全使用,GeoVax的疫苗將有效預防人類的靶向感染,GeoVax的免疫腫瘤學產品和預防性疫苗將獲得許可和上市所需的監管批准,GeoVax籌集了完成開發所需的資金,正在開發可能比GeoVax更有效或更易於使用的競爭產品產品,GeoVax 將能夠進入優惠狀態製造和分銷協議以及 GeoVax 無法控制的其他因素。

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

有關我們風險因素的更多信息包含在我們已經提交併將向美國證券交易委員會提交的10-Q表和10-K表的定期報告中。我們在此發表的任何前瞻性陳述僅代表其發表之日。可能導致我們的實際結果出現差異的因素或事件可能會不時出現,我們不可能全部預測。除非法律要求,否則我們沒有義務公開更新任何前瞻性陳述,無論是由於新信息、未來發展還是其他原因。

Company Contact: Investor Relations Contact: Media Contact:
info@geovax.com paige.kelly@sternir.com sr@roberts-communications.com
678-384-7220 212-698-8699 202-779-0929
公司聯繫人: 投資者關係聯繫人: 媒體聯繫人:
info@geovax.com paige.kelly@sternir.com sr@roberts-communications.com
678-384-7220 212-698-8699 202-779-0929

譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
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