Month: 2024-08

上海, 2024年8月22日 - (亞太商訊 via SeaPRwire.com) — 雲頂新耀（HKEX 1952.HK）是一家專注於創新藥研發、臨床開發、製造和商業化的生物製藥公司，今日宣佈正式啟動一款個性化腫瘤疫苗EVM16的研究者發起的臨床試驗項目（IIT）EVM16CX01。該研究由北京大學腫瘤醫院和復旦大學附屬腫瘤醫院發起，用於評估EVM16注射液單藥及聯合PD-1抗體治療在晚期或復發實體瘤受試者的安全性、耐受性、免疫原性和初步療效的劑量遞增及擴展研究。這是EVM16開展的首次人體試驗。EVM16是一款雲頂新耀自主研發的新型mRNA個性化腫瘤治療性疫苗，根據每位患者特有的腫瘤細胞突變，使用自主研發的人工智能算法，預測出具有較高免疫原性潛力的新抗原。通過脂質納米顆粒（LNP）遞送系統在體內進行高效的抗原呈遞，激活新抗原特異性T細胞，進而達到殺傷腫瘤細胞和治療癌症的目的。雲頂新耀首席執行官羅永慶表示：「EVM16是雲頂新耀自主研發的首款個性化mRNA腫瘤疫苗，此次臨床試驗項目的正式啟動意味著公司基於自主知識產權的mRNA平台所開發的腫瘤疫苗產品進入人體試驗階段，有望為腫瘤治療領域開發出新一代免疫療法。在構建腎科、感染、自身免疫性疾病領導地位的同時，雲頂新耀也快速進入腫瘤治療性疫苗等創新性治療領域，開拓新藍海。我們期待早日看到個性化腫瘤疫苗成為新的臨床治療手段，服務更多患者。」Globocan 2022年統計數據顯示，全球新發腫瘤人數1997.6萬人，因腫瘤死亡的人數為974.4萬人1。以PD-1/PD-L1抑制劑為主的免疫療法已經成為某些腫瘤治療非常重要的一部分，但僅對部分患者有效，腫瘤治療領域急需在此基礎上開發新一代免疫療法。個性化mRNA腫瘤疫苗則成為極具潛力的新一代免疫療法。在臨床前研究中，EVM16在多種小鼠模型中都激發出了強烈的新抗原特異性T細胞免疫反應，在小鼠黑色素瘤B16F10模型中實現了顯著的腫瘤生長抑制效果。雲頂新耀自研的算法已找到多個已知和之前未報道的腫瘤抗原，並且在多個獨立驗證研究中的預測表現相當或優於行業領先算法，臨床前數據還證明了EVM16疫苗與PD-1抗體聯用後的協同抗腫瘤效果，支持個性化腫瘤疫苗與免疫檢查點抑制劑在臨床中的聯用。在臨床前安全性評估試驗中，EVM16疫苗也展現了良好的安全性。這些結果綜合說明，EVM16注射液安全性良好，和免疫檢查點抑制劑聯用有望給腫瘤患者帶來更多臨床獲益。雲頂新耀利用自主知識產權的mRNA平台開發預防及治療性的mRNA產品，且擁有這些產品的全部知識產權及全部全球權益，並同時具備治療性mRNA產品全產業鏈的開發和製造能力。自研團隊基於經過臨床驗證的mRNA技術平台，多路徑開發腫瘤及其他治療藥物。目前正在研發多個mRNA腫瘤治療藥物，包括個性化腫瘤疫苗（PCV）、腫瘤相關抗原（TAA）腫瘤疫苗、免疫調節腫瘤疫苗，自體生成CAR-T產品 ，並開發新一代脂質納米粒（LNP）遞送系統以增強細胞介導的免疫反應。此外，雲頂新耀擁有自有商業化規模生產基地，位於浙江嘉善、符合全球良好生產規範（GMP）標準認證的生產基地，於2022年12月正式投入運行並成功完成了臨床批次生產，為實現mRNA技術平台的本土化研發、生產以及商業化運營奠定堅實的基礎。參考文獻：1. Globocan 統計資料: https://gco.iarc.who.int/media/globocan/factsheets/populations/900-world-fact-sheet.pdf關於EVM16EVM16是一款雲頂新耀醫藥科技有限公司自主研發的新型mRNA個性化腫瘤疫苗。EVM16是用菌種庫製備得到的線性化質粒DNA為模版，經體外轉錄、純化、除菌過濾製備出mRNA原液，採用脂質納米顆粒（LNP）技術將mRNA原液包封在由特定脂質組分組成的納米級脂質顆粒中，加入其他輔料經無菌灌裝製成。EVM16根據每位患者獨有的腫瘤細胞突變，使用自主研發的人工智能算法，預測出具有較高免疫原性潛力的新抗原，採用脂質納米顆粒（LNP）遞送系統將能高效表達腫瘤新抗原的mRNA遞送至人體內。受試者接種EVM16注射液後，mRNA被遞送入細胞內生成新抗原肽段，誘導機體產生新抗原特異性的T細胞免疫反應，來殺傷清除表達新抗原的腫瘤細胞而達到抑制腫瘤生長和治療癌症的目的。關於EVM16CX01研究項目此研究是一項評估EVM16注射液單藥及聯合PD-1抗體治療對晚期或復發實體瘤受試者的安全性、耐受性、免疫原性和初步療效的劑量遞增及擴展研究，也是EVM16的首次人體試驗。主要研究目的包括評估EVM16單藥以及EVM16聯合PD-1抗體在晚期或復發性實體瘤受試者中的安全性和耐受性，確定EVM16的II期推薦劑量（RP2D）；次要目的包括評估EVM16在晚期或復發性實體瘤受試者中的免疫原性，以及評估EVM16聯合PD-1抗體在晚期或復發性實體瘤受試者中的初步有效性。關於雲頂新耀雲頂新耀是一家專注於創新藥和疫苗研發、臨床開發、製造和商業化的生物製藥公司，致力於滿足亞洲市場尚未滿足的醫療需求。雲頂新耀的管理團隊在中國及全球領先製藥企業從事過高質量研發、臨床開發、藥政事務、化學製造與控制（CMC）、業務發展和商業化運營，擁有深厚的專長和豐富的經驗。雲頂新耀已打造多款疾病首創或者同類最佳的藥物組合，公司的治療領域包括腎科疾病、感染性和傳染性疾病、自身免疫性疾病。有關更多信息，請訪問公司網站： www.everestmedicines.com前瞻性聲明本新聞稿所發佈的信息中可能會包含某些前瞻性表述，乃基於本公司或管理層在做出表述時對公司業務運營情況及財務狀況的現有看法、相信、和現有預期，可能會使用“將”、“預期”、“預測”、“期望”、“打算”、“計劃”、“相信”、“預估”、“確信”及其他類似詞語進行表述。這些前瞻性表述並非對未來業績的保證，會受到風險、不確定性及其他因素的影響，有些乃超出本公司的控制範圍，難以預計。因此，受我們的業務、競爭環境、政治、經濟、法律和社會情況的未來變化及發展等各種因素及假設的影響，實際結果可能會與前瞻性表述所含資料有較大差別。本公司及各附屬公司、各位董事、管理人員、顧問及代理未曾且概不承擔更新該稿件所載前瞻性表述以反映在本新聞稿發佈日後最新信息、未來項目或情形的任何義務，除非法律要求。 Copyright 2024 亞太商訊 via SeaPRwire.com.

SHANGHAI, Aug 22, 2024 - (ACN Newswire via SeaPRwire.com) - Everest Medicines (HKEX 1952.HK, “Everest”, or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing and commercialization of innovative therapeutics, today announced the launch of an Investigator-Initiated Clinical Trial (IIT) for a personalized mRNA cancer vaccine, EVM16, under the study EVM16CX01, at the Peking University Cancer Hospital and Fudan University's Cancer Hospital. This trial is designed to assess the safety, tolerability, immunogenicity, and preliminary efficacy of EVM16 injection as a monotherapy and in combination with PD-1 antibody for patients with advanced or recurrent solid tumors. EVM16CX01 is the first-in-human (FIH) trial for EVM16.EVM16 is a novel personalized therapeutic mRNA cancer vaccine independently developed by Everest. EVM16 contains neoantigens with high immunogenicity potential that are predicted based on the unique tumor mutations of each patient by Everest’s proprietary neoantigen prediction algorithm. The vaccine uses a lipid nanoparticle (LNP) delivery system to efficiently deliver neoantigen-encoded mRNA in vivo, activating neoantigen-specific tumor-killing T cells and inhibiting tumor growth."EVM16 is the first personalized mRNA cancer vaccine independently developed by Everest using our proprietary mRNA platform. The initiation of this clinical trial is an important milestone that demonstrates our commitment to discover and develop a new generation of mRNA immunotherapies for cancer and autoimmune diseases.” said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines.“While establishing leadership positions in nephrology, infectious disease, and autoimmune diseases, Everest will also focus on innovative modalities such as therapeutic mRNA vaccines. We look forward to seeing personalized cancer vaccines become a new clinical treatment method to serve more patients."According to the Globocan’s data in 2022, there were 19.976 million new cancer cases globally, with 9.744 million cancer-related deaths1. In the last few decades, Immunotherapy including checkpoint inhibitors has become an important part of treating some cancer types. However, they are only effective for some patients, and there is an urgent need to develop new generations of immunotherapies, such as personalized mRNA cancer vaccines, that have demonstrated early promise in clinical development. In preclinical studies, vaccination with EVM16 stimulated a strong neoantigen-specific T cell response in different mouse models and showed significant tumor growth inhibition in the syngeneic B16F10 mouse melanoma model. Preclinical data also demonstrated that the combination of EVM16 and a PD-1 antibody has synergistic effect, which supports the clinical application of the combination of EVM16 with checkpoint inhibitors. In preclinical toxicity studies, repeated dosing with EVM16 was well tolerated and safe. Taken together, the preclinical immunogenicity, efficacy and safety studies demonstrate that EVM16 is safe and has potential to bring benefits to cancer patients.Everest has built end-to-end capabilities across its proprietary mRNA platform. Our R&D team is developing multiple mRNA-based therapeutic products, as well as next generation lipid nanoparticle (LNP) delivery systems to enhance cell-mediated immune response. Our mRNA manufacturing facility in Jiashan, Zhejiang Province in China is designed to comply with global cGMP standards and is able to produce at clinical- and commercial-scale. Everest owns full global intellectual property rights to its mRNA therapeutic programs.Reference:1.Globocan 2022: https://gco.iarc.who.int/media/globocan/factsheets/populations/900-world-fact-sheet.pdfAbout EVM16EVM16 is a novel personalized mRNA cancer vaccine independently developed by Everest Medicines Limited.. EVM16 contains neoantigens with high immunogenicity potential which are predicted by Everest-proprietary algorithm and uses an LNP delivery system to efficiently deliver mRNAs that express tumor neoantigens into the human body. After vaccination with EVM16, neoantigens-encoding mRNAs are delivered into cells to produce neoantigen peptides, which activate neoantigen-specific T cell immune responses to kill tumor cells, thereby inhibiting tumor growthAbout EVM16CX01 studyThe study is a FIH, dose escalation and expansion study to evaluate the safety, tolerability, immunogenicity, and initial efficacy of EVM16 injection as a single and in combination with PD-1 antibody in subjects with advanced or recurrent solid tumors.,. The primary objectives are to evaluate the safety and tolerability of EVM16 monotherapy and EVM16 in combination with PD-1 antibody in subjects with advanced or recurrent solid tumors, and to determine the recommended phase 2 dose (RP2D) of EVM16. The secondary objectives are to evaluate the immunogenicity of EVM16, and the initial efficacy of EVM16 in combination with PD-1 antibody in subjects with advanced or recurrent solid tumors.About Everest MedicinesEverest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company’s core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders.For more information, please visit its website at www.everestmedicines.com.Forward-Looking Statements:This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “confident” and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law. Copyright 2024 ACN Newswire via SeaPRwire.com.