GeoVax Presents Data on GEO-CM04S1, a Next Generation Covid-19 Vaccine
GeoVax Presents Data on GEO-CM04S1, a Next Generation Covid-19 Vaccine
Presentation Made During the 24th Annual World Vaccine Congress
ATLANTA, GA, April 04, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire -- GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that its Chief Scientific Officer, Mark Newman, PhD, presented data on GEO-CM04S1, the Company's next-generation Covid-19 vaccine candidate, during the 24th Annual World Vaccine Congress in Washington, DC.
During his presentation, titled "Vaccine Induction of Broadly-Specific Antibody and T Cell Responses to Combat SARS-CoV-2 Variation", Dr. Newman described GeoVax's development program for GEO-CM04S1. The data presented were generated in collaboration with scientists at Georgia State University using the human ACE2 transgenic mice, one of the "gold standard" small animal models used for studying Covid vaccines. GEO-CM04S1 incorporates both the spike (S) and nucleocapsid (N) antigens of SARS-CoV-2 and is specifically designed to induce broadly specific antibody and T cell responses. The animal studies were designed to characterize the contributions of immune responses to both the S and N and documented the additive effects, which were most evident in the control of disease and the associated lung inflammation and damage.
Dr. Newman commented after his presentation, "GEO-CM04S1 continues to meet our highest expectations, inducing immune system-based protection that is broadly specific and functional against Covid variants. I anticipate similar findings will be observed in our Phase 2 clinical trials as the studies are unblinded later this year."
About GEO-CM04S1
GEO-CM04S1 is 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.
GEO-CM04S1 is currently being evaluated in three ongoing Phase 2 clinical trials:
As a primary vaccine in immunocompromised patients (with hematologic cancers receiving cell transplants or CAR-T therapy). ClinicalTrials.gov Identifier: NCT04977024. A recent presentation of unpublished data from the open-label portion of the trial indicates that GEO-CM04S1 is highly immunogenic in these patients, inducing both antibody responses, including neutralizing antibodies, and T cell responses.
As a booster vaccine in immunocompromised patients with chronic lymphocytic leukemia (CLL), a recognized high-risk group for whom current mRNA vaccines and monoclonal antibody (MAb) therapies appear inadequate relative to providing protective immunity. ClinicalTrials.gov Identifier: NCT05672355.
As a booster vaccine for healthy patients who have previously received the Pfizer or Moderna mRNA vaccine. This trial was fully enrolled in September 2023 and final results are expected in Fourth Quarter 2024, reflecting a 12-month tracking of study patients. ClinicalTrials.gov Identifier: NCT04639466.
在第24屆年度世界疫苗大會上發表的演講
喬治亞州亞特蘭大,2024年4月4日(GLOBE NEWSWIRE)——通過NewMediaWire——開發免疫療法和癌症和傳染病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,其首席科學官馬克·紐曼博士在華盛頓特區舉行的第二十四屆年度世界疫苗大會上公佈了該公司下一代Covid-19候選疫苗 GEO-CM04S1 的數據。
紐曼博士在題爲 “疫苗誘導廣義特異性抗體和T細胞反應以對抗SARS-CoV-2變異” 的演講中描述了GeoVax的 GEO-CM04S1 開發計劃。提供的數據是與佐治亞州立大學的科學家合作使用人類ACE2轉基因小鼠生成的,ACE2轉基因小鼠是用於研究Covid疫苗的 “黃金標準” 小動物模型之一。GEO-CM04S1 包含 SARS-CoV-2 的刺突抗原 (S) 和核衣殼 (N) 抗原,專爲誘導廣泛特異的抗體和 T 細胞反應而設計。動物研究旨在表徵免疫反應對硫和氮的貢獻,並記錄了累加效應,這在疾病控制和相關的肺部炎症和損傷方面最爲明顯。
紐曼博士在演講後評論說:“GEO-CM04S1 繼續滿足我們的最高期望,提供基於免疫系統的保護,這種保護對Covid變種具有廣泛特異性和功能性。我預計在今年晚些時候我們的2期臨床試驗中也將觀察到類似的發現,因爲這些研究是非盲的。”
關於 GEO-CM04S1
GEO-CM04S1 基於 GeoVax 的 MVA 病毒載體平台,該平台支持以單劑量向免疫系統呈現多種疫苗抗原。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。
GEO-CM04S1 目前正在進行三項正在進行的 2 期臨床試驗中進行評估:
作爲免疫功能低下患者(接受細胞移植或CAR-T療法的血液系統癌症)的主要疫苗。ClinicalTrials.gov 標識符:NCT04977024。最近公佈的來自該試驗開放標籤部分的未公開數據表明,GEO-CM04S1 在這些患者中具有很強的免疫原性,可誘發包括中和抗體在內的抗體反應和 T 細胞反應。
作爲免疫功能低下慢性淋巴細胞白血病(CLL)患者的強化疫苗,慢性淋巴細胞白血病(CLL)是公認的高風險人群,目前的mRNA疫苗和單克隆抗體(mAb)療法似乎不足以提供保護性免疫。ClinicalTrials.gov 標識符:NCT05672355。
作爲先前接種過輝瑞或Moderna mRNA疫苗的健康患者的加強疫苗。該試驗於2023年9月正式入組,最終結果預計將於2024年第四季度公佈,反映了對研究患者的12個月追蹤。ClinicalTrials.gov 標識符:NCT04639466。
譯文內容由第三人軟體翻譯。
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