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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.
苏格兰爱丁堡,9月亚洲网伦敦2022年3月13日电开发癌症同种异体伽马-德尔塔T细胞疗法的临床阶段生物技术公司纳斯达克(纳斯达克代码:TCBPW)今天宣布,它已获得英国监管机构MHRA的批准,可以对其目前的同种异体细胞疗法OmnImmune应用18个月的外推保质期。
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.
这项奖励使TC BioPharm能够运输和储存足够的产品,这些产品随后可以在临床现场进行冷冻保存,以满足其目前的晚期髓系白血病试验成果以及未来的临床试验和最终对患者进行商业化治疗的要求。此外,TC BioPharm的内部质量控制部门将继续收集数据,以延长OmnImmune的保质期。
"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对我们冷冻产品的批准是复杂拼图中的又一块非常重要的部分。这确实是朝着在细胞治疗领域提供真正现成产品的平台又迈进了一步。这一里程碑是TCB内部所有部门令人难以置信的协同努力的结果,包括产品开发、质量控制和保证、生产和临床。在这个领域工作是令人兴奋的时刻,我感到非常荣幸和自豪能成为TC Biopharm这个令人惊叹的团队的一员。
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."
首席执行官布莱恩·科贝尔评论说:“MHRA批准我们为期18个月的冷冻/解冻协议是TC BioPharm公司发展轨迹上令人鼓舞的一步,也进一步验证了我们开发团队的持续努力和前瞻性思维。我们非常高兴MHRA批准我们的冷冻/解冻产品OmnImmune,这是第一个处于临床试验中的冷冻/解冻伽马三角洲产品。能够运输冷冻的伽马-三角洲T细胞并将它们运送到世界各地的诊所用于临床试验和商业治疗,增加了我们的规模经济和效率。”
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接着说:“作为一种‘现成’细胞疗法,这一批准使OmnImmune真正走到了前沿,临床医生能够将产品从储存设施带到专业药房解冻,并在短时间内将治疗药物提供给患者。我们期待着在急性髓细胞白血病和其他血癌方面的临床试验取得进展,并继续评估与我们的同种异体伽马三角洲平台合作的机会,并推进我们修改后的汽车伽玛三角洲计划。”
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在美国,moomoo上的投资产品和服务由Moomoo Financial Inc.提供,一家受美国证券交易委员会(SEC)监管的持牌主体。 Moomoo Financial Inc.是金融业监管局(FINRA)和证券投资者保护公司(SIPC)的成员。
在新加坡,moomoo上的投资产品和服务是通过Moomoo Financial Singapore Pte. Ltd.提供,该公司受新加坡金融管理局(MAS)监管(牌照号码︰CMS101000) ,持有资本市场服务牌照 (CMS) ,持有财务顾问豁免(Exempt Financial Adviser)资质。本内容未经新加坡金融管理局的审查。
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