OTHER FUNCTIONS SBIR PHASE II TOPIC 275, "DEVELOPMENT OF GENERIC TRASTUZUMAB FOR

该项目的目标是开发STC 101，一种生物相似的赫赛汀。曲妥珠单抗是一种针对HER 2蛋白的单克隆抗体，在20-25%的乳腺癌患者中过表达。由于与处方赫赛汀相关的高成本，这种药物的仿制药将使更广泛的人群更负担得起这种癌症治疗，并降低政府资助的医疗保健计划的成本负担。 STC生物制品公司在解决曲妥珠单抗逆向工程的技术挑战方面具有独特的优势，因为其药物开发平台可快速有效地分析重组蛋白的翻译后修饰。提供了一项概念验证研究，显示了生产与品牌等效药物分析相似的曲妥珠单抗生物仿制药STC 101的可行性。.我们已经彻底分析了三批赫赛汀的翻译后修饰，以量化观察到的变异范围;该信息可作为STC 101工艺优化的指导。在SBIR合同的第二阶段，我们计划完成STC 101的临床前开发。我们建议开发一种可扩展且可重复的工艺来生产STC 101。STC将检查STC 101的活性，并在美国和国外监管批准所需的各种试验中与赫赛汀进行比较。

The goal of this project is to develop STC101, a biosmilar Herceptin¿. Trastuzumab is a monoclonal antibody made against the HER2 protein that is overexpressed in 20-25% of patients with breast cancer. Because of high cost associated with prescribing Herceptin¿, a generic version of this drug would make this cancer treatment more affordable to a wider segment of the population and lower the cost burden on government-sponsored healthcare programs. STC Biologics Inc. is uniquely positioned to address the technical challenge of reverse engineering trastuzumab as its drug development platform offers rapid and efficient analysis of post-translational modifications of recombinant proteins.During the phase I contract, STC Biologics Inc. provided a proof of concept studies showing the feasibility of making a biosimilar trastuzumab, STC101 that is analytically similar to the branded equivalent. . We have thoroughly analyzed three lots of Herceptin¿ for post-translational modifications, to quantify the observed range of variation; this information has served as a guide for STC101 process optimization. During Phase II of the SBIR contract, we plan to complete STC101 preclinical development. We propose to develop a scalable and reproducible process to produce STC101. STC will examine the activity of STC101 and compare to to Herceptin in various assays required for the regulatory approval in the U.S. and abroad.