Recombinant, tumour-derived idiotype vaccination for indolent B cell non-Hodgkin's lymphomas:: a focus on FavId™
Recombinant, tumour-derived idiotype vaccination for indolent B cell non-Hodgkin's lymphomas:: a focus on FavId™
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DOI：
10.1517/14712598.5.6.841
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发表时间：
2005-06-01
影响因子：
4.6
通讯作者：
Timmerman, JM
中科院分区：
文献类型：
--
作者：
Hurvitz, SA;Timmerman, JM
Favld (TM)（Favrille, Inc.，圣地亚哥，加利福尼亚州，美国）是一种针对 B 细胞非霍奇金淋巴瘤的个性化治疗疫苗产品，由个体患者的肿瘤细胞定制制造。该研究药物由与高免疫原性载体蛋白匙孔血蓝蛋白 (Id-KLH) 化学缀合的重组肿瘤特异性免疫球蛋白（独特型 [Id]）组成。该疫苗产品通过皮下联合注射与细胞因子佐剂粒细胞巨噬细胞集落刺激因子（GM-CSF）进行注射，目的是刺激肿瘤特异性T细胞和体液免疫。治疗性 Id 疫苗在滤泡性淋巴瘤的早期临床试验中显示出有希望的结果，并且多项 III 期试验正在进行中。 Favld 相对于其他 Id 疫苗制剂的优势包括其利用重组杆状病毒的快速高效生产技术，生产时间仅需 8-12 周。在 II 期研究中，发现 Favld Id-KLH 联合 GM-CSF 疫苗对滤泡性淋巴瘤具有安全性、免疫原性和临床活性。目前，FavId 正在一项针对滤泡性淋巴瘤的随机、安慰剂对照 III 期试验中进行测试，旨在缩短利妥昔单抗细胞减灭术后的疾病进展时间。如果在这项关键试验中发现有效，Favld 将代表一种毒性很小且新颖的作用机制的淋巴瘤肿瘤选择性免疫疗法。
Favld (TM) (Favrille, Inc., San Diego, CA, USA) is a personalised therapeutic vaccine product for B cell non-Hodgkin's lymphoma, custom-manufactured from individual patient's tumour cells. This investigational agent consists of recombinant tumour-specific immunoglobulin (idiotype [Id]) chemically conjugated to the highly immunogenic carrier protein keyhole limpet haemocyanin (Id-KLH). The vaccine product is administered by subcutaneous co-injection with the cytokine adjuvant granulocyte-macrophage colony-stimulating factor (GM-CSF) with the goal of stimulating tumour-specific T cell and humoral immunity. Therapeutic Id vaccines have shown promising results in early phase clinical trials in follicular lymphoma, and several Phase III trials are ongoing. Favld's advantages over other Id vaccine formulations include its rapid and efficient manufacturing technology utilising recombinant baculovirus, with a production time of only 8-12 weeks. In Phase II studies, Favld Id-KLH plus GM-CSF vaccines have been found to be safe, immunogenic and clinically active in follicular lymphoma. At present, FavId is being tested in a randomised, placebo-controlled Phase III trial in follicular lymphoma, aimed at improving the time to disease progression when administered following cytoreduction with rituximab. If found to be efficacious in this pivotal trial, Favld would represent a tumour-selective immunotherapy for lymphoma with little toxicity and a novel mechanism of action.