7일 얼라이언스 '혈장 치료제 글로벌 개발 전략' 발표
高 면역글로불린 회복기 환자 혈장 내 다양한 면역 항체 추출해 만드는 '혈장 치료제'
[보건타임즈] GC녹십자가 참여한 얼라이언스(CoVIg-10 Plasma Alliance/동맹, 결성)가 '코로나 19 혈장 치료제 개발'에 힘을 모은다.
얼라이언스는 글로벌 혈액제제 기업들이 이번 중국 후한발 코로나 19사태에 대응, 이를 치료할 특정 제품을 개발하기 위해 스스로 합류, 결성한 집합체다.
얼라이언스엔 GC녹십자가 합류한 가운데 CSL Behring, Takeda, Biotest, BPL, LFB, Octapharma 등 글로벌 혈액제제 상위기업 '톱10'이 참여하고 있다.
이처럼 전 세계로 확산한 코로나 19에 대응, 특정 제품 개발을 위해 글로벌 혈액제제 업계가 결성된 것은 이번이 첫 사례다.
7일 얼라이언스는 세계적인 혈액제제 업계가 힘을 모아 코로나 19에 대응, 회복기 환자를 치료할 혈장 치료제 글로벌 개발 전략을 발표했다.
이에 따르면 얼라이언스 소속 기업은 코로나 19에 감염된 미국과 유럽 등지 회복기 환자의 혈장 내 다양한 면역 항체를 추출해 만드는 고 면역글로불린을 공동으로 개발하기로 합의했다.
이들 기업은 회복기 환자의 혈장 확보, 임상시험, 제품 제조 등 치료제 주요 개발 단계에서 전문 지식과 자원을 공유하기로 했으며 선두기업들의 역량을 한데 모은 만큼, 개발 기간과 치료제 공급체계 구축 기간이 단축될 것으로 전망했다.
이에 GC녹십자는 자체 개발 중인 GC5131 A를 국내에서만 상용화하며 해외의 경우 공동 개발에 참여할 전략이다.
이와 함께 얼라이언스는 미국 국립보건원(NIH) 산하 국립알레르기∙전염병 연구소(NIAID)와 협력, 이른 여름부터 성인 환자를 대상으로 코로나 19 혈장 치료제 치료적 확증을 위한 임상을 진행할 계획이다.
현재 얼라이언스는 코로나 19 회복기 환자의 혈장을 확보하기 위해 혈액제제 기업 이외에 마이크로소프트, 우버 헬스 등 다른 산업의 대규모 조직과 협업하고 있다.
GC녹십자는 전 세계가 지금껏 유래가 없는 코로나 19사태 위기에 직면한 만큼 글로벌 피어(동종업계) 기업들이 적극적으로 기술과 자원을 공유해야 치료제 개발 속도를 더욱더 높일 수 있을 것으로 내다봤다.
7일 얼라이언스가 7일 발표한 보도자료 코로나 19에 대응, 회복기 환자를 치료할 혈장 치료제 글로벌 개발 전략은 이렇다.
CoVIg-19 PLASMA ALLIANCE BUILDS STRONG MOMENTUM THROUGH EXPANDED MEMBERSHIP AND CLINICAL TRIAL COLLABORATION
Rapidly expanding support for the Alliance is increasing donations of convalescent plasma to begin clinical production, while NIH collaboration confirms clinical trial approach
Alliance urges anyone who has recovered from COVID-19 to consider donating today
Osaka, JAPAN, and King of Prussia, PA, USA – 7 May, 2020 – The CoVIg-19 Plasma Alliance, an unprecedented plasma industry collaboration recently established to accelerate the development of a plasma-derived hyperimmune globulin therapy for COVID-19, is rapidly building momentum. Its membership has expanded globally to include 10 plasma companies, and now also includes global organizations from outside the plasma industry who are providing vital support to encourage more people to donate plasma.
In addition to those announced at its inception - Biotest, BPL, CSL Behring, LFB, Octapharma and Takeda - the Alliance welcomes new industry members ADMA Biologics, BioPharma Plasma, GC Pharma, and Sanquin. Together, these organizations will contribute specialist advisory expertise, technical guidance and/or in-kind support to contribute to the Alliance goal of accelerating development and distribution of a potential treatment option for COVID-19.
In parallel, the Alliance has confirmed it will work with the National Institute of Allergy and Infectious Diseases (NIAID) at the NIH to test the safety, tolerability and efficacy of the hyperimmune therapy in adult patients with COVID-19. This global study is scheduled to start early summer.
and will form the foundation for the potential regulatory approval of the hyperimmune therapy.
“The hyperimmune has the potential to be one of the earliest treatment options for COVID-19 and we look forward to working with NIAID and health authorities to bring this therapy to patients as early as possible,” said Bill Mezzanotte, Executive Vice President, Head of R&D, CSL Behring and Co-leader of the CoVIg-19 Plasma Alliance. “One of the stated goals of the alliance is to be an effective partner for important institutions such as NIAID and also to develop coherent Regulatory strategies which give global health authorities the confidence to streamline the approval process of the hyperimmune.”
Key to developing this potential hyperimmune globulin treatment is the collection of convalescent plasma.
To amplify awareness, the Alliance has gained support from large organizations outside of the plasma industry.
Examples of those offering resources to the Alliance include Microsoft and Uber Health. Microsoft is providing technology support, including the Alliance website and the Plasmabot for donor recruitment. The Plasmabot streamlines the process for a potential donor to quickly gain information about their nearest collection center from across the member network. In parallel, Uber Health has agreed to donate 25,000 round-trip rides to transport potentially eligible donors to and from plasma collection centers. These rides will be coordinated by the plasma collection center directly for individuals with confirmed appointments.
“Partnership and collaboration are critical to the success of the CoVIg-19 program,” said Julie Kim, President of Plasma-Derived Therapies Business Unit, Takeda and co-leader of the CoVIg-19 Plasma Alliance. “We now have enough plasma to initiate clinical manufacturing, but more is needed to ensure both speed and scale. The growing and active involvement of leading companies from outside the plasma industry, who support this Alliance as well as convalescent plasma for transfusion initiatives – demonstrates the potential of convalescent plasma to fight this public health crisis. Together, we all share the same goal – to save lives by using the power of convalescent plasma in different ways.”
The success of the CoVig-19 program depends heavily right now on the support of people across the world to donate convalescent plasma. We encourage those who have recovered from COVID-19 and who are interested in contributing to our development program – or to any other – by donating their plasma to visit the website for more information.
기사최종편집일: 2024-04-18 16:45:00
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