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Evaxion to Present New Positive Data From Ongoing Phase 2 Study on Lead Vaccine Candidate EVX-01 at the American Society of Clinical Oncology Annual Meeting 2024

Evaxion to Present New Positive Data From Ongoing Phase 2 Study on Lead Vaccine Candidate EVX-01 at the American Society of Clinical Oncology Annual Meeting 2024

Evaxion 將在美國臨床腫瘤學會 2024 年年會上公佈正在進行的關於主要候選疫苗 EVX-01 的 2 期研究的新陽性數據
Evaxion Biotech ·  05/23 12:00
  • EVX-01 induced positive clinically relevant immune responses in all assessed patients
  • Booster immunizations tended to increase the immune response
  • The observed immune responses were mediated by both CD4+ and CD8+ T-cells
  • EVX-01 在所有接受評估的患者中均誘發了與臨床相關的免疫反應陽性
  • 加強免疫接種往往會增加免疫反應
  • 觀察到的免疫反應由 CD4+ 和 CD8+ T 細胞介導

COPENHAGEN, Denmark, May 23, 2024 (GLOBE NEWSWIRE) -- Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, today announces its participation in the American Society of Clinical Oncology (ASCO) Annual Meeting, where it will present positive immune data form its ongoing EVX-01 Phase 2 study. The study assesses the personalized cancer vaccine EVX-01 in combination with anti-PD1 therapy in patients with advanced melanoma. The conference will take place in Chicago, IL, from May 31 – June 4, 2024.

丹麥哥本哈根,2024年5月23日(環球新聞專線)——專門開發人工智能免疫疫苗的臨床階段TechBio公司Evaxion Biotech A/S(納斯達克股票代碼:EVAX)(“Evaxion” 或 “公司”)今天宣佈參加美國臨床腫瘤學會(ASCO)年會,屆時它將介紹其正在進行的 EVX-01 二期研究的陽性免疫數據。該研究評估了針對晚期黑色素瘤患者的個性化癌症疫苗 EVX-01 與抗 PD1 療法的聯合療法。該會議將於2024年5月31日至6月4日在伊利諾伊州芝加哥舉行。

"We continue to see encouraging results from our ongoing Phase 2 study with EVX-01. The immune signatures induced by EVX-01 are both specific and strong, with booster immunizations pointing to further increased immune responses. The data makes us optimistic about the potential clinical benefit of EVX-01, and we eagerly await further data readouts on this novel personalized cancer vaccine. With our AI-Immunology platform, we can precisely select vaccine targets and design personalized vaccines that match each patient's unique tumor signature and immune characteristics. This represents a novel approach to addressing an unmet medical need that remains dire, and we are excited about the interest we are seeing in the EVX-01 program," said Christian Kanstrup, CEO at Evaxion.

“我們繼續看到正在進行的 EVX-01 二期研究取得令人鼓舞的結果。EVX-01 誘導的免疫特徵既特異又強,加強免疫接種表明免疫反應進一步增強。這些數據使我們對 EVX-01 的潛在臨床益處持樂觀態度,我們熱切地等待有關這種新型個性化癌症疫苗的更多數據公佈。藉助我們的人工智能免疫學平台,我們可以精確選擇疫苗靶點並設計出符合每位患者獨特的腫瘤特徵和免疫特徵的個性化疫苗。Evaxion首席執行官克里斯蒂安·坎斯特魯普說,這是一種解決仍然嚴峻的未得到滿足的醫療需求的新方法,我們對看到的對 EVX-01 計劃的興趣感到興奮。

This ongoing Phase 2 study currently confirms findings from the previous Phase 1 study, reaffirming the ability of Evaxion's AI-Immunology platform to precisely select therapeutically relevant vaccine targets and generate new valuable insights. Key highlights from the Phase 2 study are:

這項正在進行的2期研究目前證實了先前1期研究的結果,重申了Evaxion的人工智能免疫學平台精確選擇與治療相關的疫苗靶標併產生新的有價值見解的能力。第二階段研究的主要亮點是:

  • Analyses of patient samples demonstrated EVX-01 vaccine-induced specific and robust immune responses, mediated by both CD4+ and CD8+ T-cells
  • Booster immunizations tended to increase the immune response and did not impose any safety concerns
  • The EVX-01 vaccine candidate was found to be well-tolerated with only grade 1 and 2 adverse events
  • 對患者樣本的分析顯示,EVX-01 疫苗誘導的特異而強大的免疫反應,由 CD4+ 和 CD8+ T 細胞介導
  • 加強免疫接種往往會增加免疫反應,不會帶來任何安全問題
  • EVX-01 候選疫苗被發現耐受性良好,只有 1 級和 2 級不良事件

Poster Details:

海報詳情:

Abstract Title: "Immunogenicity of an AI-designed personalized neoantigen vaccine, EVX-01, in combination with anti-PD-1 therapy in patients with metastatic melanoma"
Abstract #: 9561
Poster Bd #: 345
Track: Melanoma/Skin Cancers
Location: Hall A – McCormick Place
Date/Time: Saturday, June 1, 1:30 – 4:30 p.m. CDT
Presenter: Mads Lausen Nielsen, Senior Scientist
摘要標題: “人工智能設計的個性化新抗原疫苗 EVX-01 與抗PD-1療法聯合用於轉移性黑色素瘤患者的免疫原性”
摘要 #: 9561
海報牀 #: 345
追蹤: 黑色素瘤/皮膚癌
地點: A廳 — 味好美廣場
日期/時間: 中部夏令時間 6 月 1 日星期六下午 1:30 — 4:30
演示者: Mads Lausen Nielsen,資深科學家

About EVX-01 Phase 2 Clinical Trial

關於 EVX-01 2 期臨床試驗

EVX-01 is Evaxion's lead clinical asset and constitutes a peptide-based personalized cancer vaccine. The ongoing Phase 2 clinical study is a self-sponsored, open-label, single-arm, multi-center trial carried out in collaboration with Merck Sharp & Dohme LLC that, together with leading principal investigators and research centers from Italy and Australia. It aims to evaluate the efficacy and safety of EVX-01 vaccination in combination with the anti-PD1 treatment pembrolizumab (more commonly known as KEYTRUDA) in treatment-naive patients with metastatic or unresectable malignant stage III or IV melanoma. More information can be accessed under clinical trial ID NCT05309421.

EVX-01 是 Evaxion 的主要臨床資產,是一種基於肽的個性化癌症疫苗。正在進行的2期臨床研究是一項自發贊助、開放標籤、單臂、多中心試驗,由默沙東夏普和多姆有限責任公司與來自意大利和澳大利亞的主要研究人員和研究中心合作開展。它旨在評估 EVX-01 疫苗接種與抗 PD1 療法 pembrolizumab(通常稱爲 KEYTRUDA)聯合使用的療效和安全性)用於未接受治療的轉移性或不可切除的惡性III期或IV期黑色素瘤患者。可以在臨床試驗 ID 下訪問更多信息 NCT05309421

About EVAXION

關於 EVAXION

Evaxion Biotech A/S is a pioneering TechBio company based upon its AI platform, AI-Immunology. Evaxion's proprietary and scalable AI prediction models harness the power of artificial intelligence to decode the human immune system and develop novel immunotherapies for cancer, bacterial diseases, and viral infections. Based upon AI-Immunology, Evaxion has developed a clinical-stage oncology pipeline of novel personalized vaccines and a preclinical infectious disease pipeline in bacterial and viral diseases with high unmet medical needs. Evaxion is committed to transforming patients' lives by providing innovative and targeted treatment options. For more information about Evaxion and its groundbreaking AI-Immunology platform and vaccine pipeline, please visit our website.

Evaxion Biotech A/S是一家基於其人工智能平台AI免疫學的開創性TechBio公司。Evaxion 專有且可擴展的人工智能預測模型利用人工智能的力量來解碼人體免疫系統,開發針對癌症、細菌性疾病和病毒感染的新型免疫療法。基於人工智能免疫學,Evaxion開發了臨床階段的新型個性化疫苗腫瘤產品線,以及針對未滿足大量醫療需求的細菌和病毒性疾病的臨床前傳染病管線。Evaxion致力於通過提供創新的有針對性的治療方案來改變患者的生活。如需了解有關 Evaxion 及其開創性的人工智能免疫學平台和疫苗管道的更多信息,請 訪問我們的網站

Forward-Looking Statement

前瞻性陳述

This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words "target," "believe," "expect," "hope," "aim," "intend," "may," "might," "anticipate," "contemplate," "continue," "estimate," "plan," "potential," "predict," "project," "will," "can have," "likely," "should," "would," "could," and other words and terms of similar meaning identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including, but not limited to, risks related to: our financial condition and need for additional capital; our development work; cost and success of our product development activities and preclinical and clinical trials; commercializing any approved pharmaceutical product developed using our AI platform technology, including the rate and degree of market acceptance of our product candidates; our dependence on third parties including for conduct of clinical testing and product manufacture; our inability to enter into partnerships; government regulation; protection of our intellectual property rights; employee matters and managing growth; our ADSs and ordinary shares, the impact of international economic, political, legal, compliance, social and business factors, including inflation, and the effects on our business from the worldwide ongoing COVID-19 pandemic and the ongoing conflict in the region surrounding Ukraine and Russia and the Middle East; and other uncertainties affecting our business operations and financial condition. For a further discussion of these risks, please refer to the risk factors included in our most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. We do not assume any obligation to update any forward-looking statements except as required by law.

本公告包含經修訂的1933年《證券法》第27A條和經修訂的1934年《證券交易法》第21E條所指的前瞻性陳述。“目標”、“相信”、“期望”、“希望”、“目標”、“打算”、“可能”、“預測”、“考慮”、“繼續”、“估計”、“計劃”、“潛力”、“預測”、“項目”、“將會”、“可能”、“可能”、“應該”、“會”、“可能” 等詞語具有相似含義的術語用於識別前瞻性陳述。由於各種因素,實際結果可能與此類前瞻性陳述所示結果存在重大差異,包括但不限於以下方面的風險:我們的財務狀況和對額外資本的需求;我們的開發工作;我們的產品開發活動以及臨床前和臨床試驗的成本和成功;使用我們的人工智能平台技術開發的任何經批准的藥品的商業化,包括候選產品的市場接受率和程度;我們對第三方的依賴,包括進行臨床測試和產品製造;我們無法建立合作伙伴關係;政府監管;保護我們的知識產權;員工事務和管理增長;我們的ADS和普通股,包括通貨膨脹在內的國際經濟、政治、法律、合規、社會和商業因素的影響,以及全球持續的 COVID-19 疫情以及烏克蘭、俄羅斯和中東周邊地區的持續衝突對我們業務的影響;以及影響我們業務的其他不確定性運營和財務狀況。有關這些風險的進一步討論,請參閱我們最新的20-F表年度報告和向美國證券交易委員會(SEC)提交的其他文件中包含的風險因素,這些文件可在以下網址查閱 www.sec.gov。除非法律要求,否則我們不承擔任何更新任何前瞻性陳述的義務。

Contact Information Evaxion Biotech A/S Christian Kanstrup Chief Executive Officer cka@evaxion-biotech.com

聯繫信息 Evaxion Biotech A/S Christian Kanstrup 首席執行官 cka@evaxion-biotech.com

譯文內容由第三人軟體翻譯。


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