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TC BioPharm Receives MHRA Approval For 18-Month Extrapolated Shelf-Life Of Allogeneic Cell Therapy Product, OmnImmune
TC BioPharm Receives MHRA Approval For 18-Month Extrapolated Shelf-Life Of Allogeneic Cell Therapy Product, OmnImmune
EDINBURGH, Scotland, Sept. 13, 2022 /PRNewswire/ -- TC Biopharm (Holdings) PLC ("TC Biopharm" or the "Company") (NASDAQ:TCBP) (NASDAQ:TCBPW), a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer today announced that it has received approval from the UK regulatory body MHRA to apply an 18-month extrapolated shelf life to its current allogeneic cell therapy product, OmnImmune.
This award enables TC BioPharm to ship and store sufficient product which can then be held cryopreserved at clinical sites to fulfill the requirements not only for its current Advanced Myeloid Leukemia trial ACHIEVE, but also for future clinical trials and eventually commercial treatment of patients. Additionally, TC BioPharm's in-house quality control department will continue to gather data in order to extend the shelf-life of OmnImmune.
"The approval received from the MHRA for our frozen product is another very important piece of a complex jigsaw. It is indeed a further step towards the achievement of a platform to deliver truly off-the-shelf products in the cell therapy space. This milestone is a result of an incredible concerted effort from all the departments within TCB, including Product Development, Quality Control and Assurance, Production and Clinical. It is an exciting time to be working in this sector and I feel incredibly privileged and proud to be part of this amazing team at TC Biopharm."
Bryan Kobel, CEO, commented, "This MHRA approval of our freeze/thawed protocol for an 18-month shelf life is an encouraging step forward in TC BioPharm's developmental trajectory and further validation of the continuous effort and forward thinking of our development team. We are extremely pleased to receive MHRA approval for our Freeze/Thawed product, OmnImmune, the first freeze/thawed gamma delta product in clinical trials. Being able to ship frozen gamma-delta T cells and deliver them clinics all around the world for storage and use in clinical trials as well as commercial treatment increases our economies of scale and our efficiency."
Kobel continued, "This approval brings OmnImmune truly to the forefront as an "off the shelf" cell therapy, with the clinician's ability to bring product from the storage facility to the specialty pharmacy for thawing and deliver the therapeutic to the patient in a short window of time. We look forward to progressing our clinical trials in AML as well as other blood cancers and continue to evaluate partnering opportunities for our allogeneic gamma delta platform and advance our modified CAR gamma delta program."
EDINBURGH, Scotland, Sept. 13, 2022 /PRNewswire/ -- TC Biopharm (Holdings) PLC ("TC Biopharm" or the "Company") (NASDAQ:TCBP) (NASDAQ:TCBPW), a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer today announced that it has received approval from the UK regulatory body MHRA to apply an 18-month extrapolated shelf life to its current allogeneic cell therapy product, OmnImmune.
蘇格蘭愛丁堡,9月亞洲網倫敦2022年3月13日電開發癌症同種異體伽馬-德爾塔T細胞療法的臨牀階段生物技術公司納斯達克(納斯達克代碼:TCBPW)今天宣佈,它已獲得英國監管機構MHRA的批准,可以對其目前的同種異體細胞療法OmnImmune應用18個月的外推保質期。
This award enables TC BioPharm to ship and store sufficient product which can then be held cryopreserved at clinical sites to fulfill the requirements not only for its current Advanced Myeloid Leukemia trial ACHIEVE, but also for future clinical trials and eventually commercial treatment of patients. Additionally, TC BioPharm's in-house quality control department will continue to gather data in order to extend the shelf-life of OmnImmune.
這項獎勵使TC BioPharm能夠運輸和儲存足夠的產品,這些產品隨後可以在臨牀現場進行冷凍保存,以滿足其目前的晚期髓系白血病試驗成果以及未來的臨牀試驗和最終對患者進行商業化治療的要求。此外,TC BioPharm的內部質量控制部門將繼續收集數據,以延長OmnImmune的保質期。
"The approval received from the MHRA for our frozen product is another very important piece of a complex jigsaw. It is indeed a further step towards the achievement of a platform to deliver truly off-the-shelf products in the cell therapy space. This milestone is a result of an incredible concerted effort from all the departments within TCB, including Product Development, Quality Control and Assurance, Production and Clinical. It is an exciting time to be working in this sector and I feel incredibly privileged and proud to be part of this amazing team at TC Biopharm."
MHRA對我們冷凍產品的批准是複雜拼圖中的又一塊非常重要的部分。這確實是朝着在細胞治療領域提供真正現成產品的平臺又邁進了一步。這一里程碑是TCB內部所有部門令人難以置信的協同努力的結果,包括產品開發、質量控制和保證、生產和臨牀。在這個領域工作是令人興奮的時刻,我感到非常榮幸和自豪能成為TC Biopharm這個令人驚歎的團隊的一員。
Bryan Kobel, CEO, commented, "This MHRA approval of our freeze/thawed protocol for an 18-month shelf life is an encouraging step forward in TC BioPharm's developmental trajectory and further validation of the continuous effort and forward thinking of our development team. We are extremely pleased to receive MHRA approval for our Freeze/Thawed product, OmnImmune, the first freeze/thawed gamma delta product in clinical trials. Being able to ship frozen gamma-delta T cells and deliver them clinics all around the world for storage and use in clinical trials as well as commercial treatment increases our economies of scale and our efficiency."
首席執行官布萊恩·科貝爾評論説:“MHRA批准我們為期18個月的冷凍/解凍協議是TC BioPharm公司發展軌跡上令人鼓舞的一步,也進一步驗證了我們開發團隊的持續努力和前瞻性思維。我們非常高興MHRA批准我們的冷凍/解凍產品OmnImmune,這是第一個處於臨牀試驗中的冷凍/解凍伽馬三角洲產品。能夠運輸冷凍的伽馬-三角洲T細胞並將它們運送到世界各地的診所用於臨牀試驗和商業治療,增加了我們的規模經濟和效率。”
Kobel continued, "This approval brings OmnImmune truly to the forefront as an "off the shelf" cell therapy, with the clinician's ability to bring product from the storage facility to the specialty pharmacy for thawing and deliver the therapeutic to the patient in a short window of time. We look forward to progressing our clinical trials in AML as well as other blood cancers and continue to evaluate partnering opportunities for our allogeneic gamma delta platform and advance our modified CAR gamma delta program."
Kobel接着説:“作為一種‘現成’細胞療法,這一批准使OmnImmune真正走到了前沿,臨牀醫生能夠將產品從儲存設施帶到專業藥房解凍,並在短時間內將治療藥物提供給患者。我們期待着在急性髓細胞白血病和其他血癌方面的臨牀試驗取得進展,並繼續評估與我們的同種異體伽馬三角洲平臺合作的機會,並推進我們修改後的汽車伽瑪三角洲計劃。”
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moomoo是Moomoo Technologies Inc.公司提供的金融資訊和交易應用程式。
在美國,moomoo上的投資產品和服務由Moomoo Financial Inc.提供,一家受美國證券交易委員會(SEC)監管的持牌主體。 Moomoo Financial Inc.是金融業監管局(FINRA)和證券投資者保護公司(SIPC)的成員。
在新加坡,moomoo上的投資產品和服務是通過Moomoo Financial Singapore Pte. Ltd.提供,該公司受新加坡金融管理局(MAS)監管(牌照號碼︰CMS101000) ,持有資本市場服務牌照 (CMS) ,持有財務顧問豁免(Exempt Financial Adviser)資質。本內容未經新加坡金融管理局的審查。
在澳大利亞,moomoo上的金融產品和服務是通過Futu Securities (Australia) Ltd提供,該公司是受澳大利亞證券和投資委員會(ASIC)監管的澳大利亞金融服務許可機構(AFSL No. 224663)。請閱讀並理解我們的《金融服務指南》、《條款與條件》、《隱私政策》和其他披露文件,這些文件可在我們的網站 https://www.moomoo.com/au中獲取。
在加拿大,透過moomoo應用程式提供的僅限訂單執行的券商服務由Moomoo Financial Canada Inc.提供,並受加拿大投資監管機構(CIRO)監管。
在馬來西亞,moomoo上的投資產品和服務是透過Moomoo Securities Malaysia Sdn. Bhd. 提供,該公司受馬來西亞證券監督委員會(SC)監管(牌照號碼︰eCMSL/A0397/2024) ,持有資本市場服務牌照 (CMSL) 。本內容未經馬來西亞證券監督委員會的審查。
Moomoo Technologies Inc., Moomoo Financial Inc., Moomoo Financial Singapore Pte. Ltd.,Futu Securities (Australia) Ltd, Moomoo Financial Canada Inc和Moomoo Securities Malaysia Sdn. Bhd., 是關聯公司。
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