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GeoVax Expands Rights Under NIH COVID-19 License to Include Mpox and Smallpox

GeoVax Expands Rights Under NIH COVID-19 License to Include Mpox and Smallpox

GeoVax 擴大了美國國立衛生研究院 COVID-19 許可證下的權利,將Mpox和天花包括在內
GlobeNewswire ·  2023/12/19 22:00

ATLANTA, GA, Dec. 19, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that it has amended a previously executed Patent and Biological Materials License Agreement (the "License Agreement") with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), in support of GeoVax's development of a vaccine against SARS-CoV-2 (COVID-19). The amendment expands GeoVax's commercial license to include Mpox and smallpox as additional indications.

喬治亞州亞特蘭大,2023 年 12 月 19 日(GLOBE NEWSWIRE)——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)今天宣佈,它已經修訂了先前與美國國立過敏和傳染病研究所(NIAID)簽訂的專利和生物材料許可協議(“許可協議”)衛生部(NIH),支持GeoVax開發針對SARS-CoV-2(COVID-19)的疫苗。該修正案擴大了GeoVax的商業許可,將Mpox和天花列爲其他適應症。

The License Agreement, as amended, allows GeoVax to use these materials and patent rights owned by agencies of the United States Department of Health and Human Services (HHS) in combination with the Company's proprietary technology for the creation of preventive Modified Vaccinia Ankara Virus-Virus Like Particle (MVA-VLP) vaccines that prime and/or boost the immune system against SARS-CoV-2 (the virus that causes COVID-19) as well as Mpox and/or smallpox. Financial terms of the License Agreement were not disclosed.

經修訂的許可協議允許GeoVax使用美國衛生與公共服務部(HHS)各機構擁有的這些材料和專利權,結合公司的專有技術,開發預防性改性痘安卡拉病毒樣粒子(MVA-VLP)疫苗,這些疫苗可以增強和/或增強免疫系統對抗SARS-CoV-2(導致 COVID-19 的病毒)以及Mpox和/或天花的免疫系統 x。許可協議的財務條款未披露。

Potential Benefit of the Additional Indications

附加適應症的潛在益處

Modified Vaccinia Ankara (MVA) is the vaccine currently used and stockpiled in the U.S. Strategic National Stockpile for immunization against the Mpox and smallpox viruses. GeoVax previously demonstrated that an experimental HIV vaccine, utilizing MVA as the vaccine vector, protected non-human primates challenged with a lethal dose of the Mpox virus (publication accessible here). Further, in August 2022, researchers at the City of Hope National Medical Center (COH) published results demonstrating that both their proprietary sMVA (synthetic MVA) and GEO-CM04S1 (publication accessible here) elicited robust orthopoxvirus-specific binding and neutralizing antibody responses.

改性安卡拉疫苗(MVA)是目前在美國戰略國家儲備庫中使用和儲存的疫苗,用於對Mpox和天花病毒進行免疫接種。GeoVax此前曾證明,一種利用MVA作爲疫苗載體的實驗性HIV疫苗可以保護受到致命劑量Mpo****挑戰的非人類靈長類動物(出版物可在此處獲取)。此外,2022年8月,希望之城國家醫學中心(COH)的研究人員發表的研究結果表明,他們專有的 smVA(合成 MVA)和 GEO-CM04S1(出版物可在此處獲取)都產生了強烈的正孢病毒特異性結合和中和抗體反應。

GeoVax's COVID-19 vaccine candidates, which can induce strong antibody and T cell responses against the variants of the SARS-CoV-2 virus, also offers the possibility of protection against Mpox and smallpox diseases, further differentiating GEO-CM04S1 as compared to current mRNA-based COVID-19 vaccines. Such attributes may be especially important in vulnerable patient populations, such as the immune-compromised, as well as in geographic areas where both diseases are endemic. Such a vaccine may offer a simplified vaccine regimen for protection against diseases associated with SARS-CoV-2 and orthopoxviruses.

GeoVax 的 COVID-19 候選疫苗可以誘發針對 SARS-CoV-2 病毒變種的強烈抗體和 T 細胞反應,還提供了保護 Mpox 和天花病的可能性,從而進一步將 GEO-CM04S1 與目前基於 mRNA 的 COVID-19 疫苗區分開來。這些特性對於免疫力低下患者群體,以及兩種疾病都流行的地理區域可能尤其重要。這種疫苗可以提供簡化的疫苗方案,以預防與SARS-CoV-2和正孢病毒相關的疾病。

David Dodd, GeoVax President and CEO, commented, "We are delighted to have secured these expanded rights to the NIH MVA technology for further development and commercial use together with our ongoing COVID-19 vaccine program. The addition of the Mpox and smallpox indications to our NIAID License Agreement complements GeoVax's license agreement with COH for GEO-CM04S1, which we also recently amended to obtain development and commercialization rights against orthopoxviruses in addition to SARS-CoV-2. Orthopoxviruses include Mpox, smallpox, and other viruses that cause disease in humans."

GeoVax 總裁兼首席執行官大衛·多德評論說:“我們很高興獲得美國國立衛生研究院 MVA 技術的這些擴大版權,用於進一步開發和商業用途,以及我們正在進行的 COVID-19 疫苗計劃。在我們的 NIAID 許可協議中增加了 Mpox 和天花適應症,這是對 GeoVax 與 COH 簽訂的 GEO-CM04S1 許可協議的補充,我們最近還對該協議進行了修訂,以獲得除 SARS-CoV-2 之外針對正交病毒的開發和商業化權。Orthopoxvirus包括Mpox、天花和其他導致人類疾病的病毒。”

Mr. Dodd continued, "We anticipate that the addition of the Mpox/Smallpox indication to an MVA-vectored COVID-19 vaccine is a viable regulatory pathway and may be an important product differentiator from other competitors. For those regions/populations where Mpox and/or smallpox may be of a concern, we believe our COVID-19 vaccine will be a better choice."

多德先生繼續說:“我們預計,在MVA-Vectored COVID-19 疫苗中加入Mpox/天花適應症是一條可行的監管途徑,也可能是區別於其他競爭對手的重要產品差異化因素。對於那些可能存在Mpox和/或天花問題的地區/人群,我們相信我們的 COVID-19 疫苗將是更好的選擇。”

About GeoVax

關於 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: .

GeoVax Labs, Inc. 是一家處於臨床階段的生物技術公司,爲實體瘤癌和許多世界上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的溶瘤實體瘤基因定向療法 Gedeptin,目前正在進行一項針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,這是一種針對高風險免疫功能低下患者群體的下一代 COVID-19 疫苗。目前正在三項二期臨床試驗中,GEO-CM04S1 被評估爲免疫功能低下的患者(例如血液系統癌症患者和其他目前授權的 COVID-19 疫苗不足的患者群體)的初級疫苗,以及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,評估該疫苗在先前接種過 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擁有一支領導團隊,在過去的幾十年中,他們推動了多家生命科學公司的重大價值創造。想要查詢更多的信息, 訪問我們的網站:.

Forward-Looking Statements

前瞻性陳述

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.

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。我們在此作出的任何前瞻性陳述僅代表其發表之日。可能導致我們實際結果不同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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