A2 Bio’s cell therapy gains FDA orphan drug status for colorectal cancer

2024-03-05
Pharmaceutical Technology
细胞疗法临床1期免疫疗法孤儿药基因疗法
A2 Bio’s cell therapy gains FDA orphan drug status for colorectal cancer
Preview
来源: Pharmaceutical Technology
A2B530 cell therapy is being developed to treat colorectal cancer. Credit: Jo Panuwat D / Shutterstock.com.
A2 Bio’s cell therapy gains FDA orphan drug status for colorectal cancer
Preview
来源: Pharmaceutical Technology
A2 Biotherapeutics (A2 Bio) has received the US Food and Drug Administration’s (FDA) orphan drug designation for its cell therapy, A2B530, to treat colorectal cancer.
The designation is a significant milestone for A2B530, the first autologous logic-gated therapy developed from A2 Bio’s Tmod platform.
The cell therapy is aimed at treating germline heterozygous HLA-A*02(+) patients who express carcinoembryonic antigen (CEA) and have lost HLA-A*02 expression.
The Tmod platform’s dual-receptor design, comprising an activator that targets tumour cells and a blocker for normal cells, addresses the issue with other solid tumour cancer treatments. It acts by selectively targeting tumour cells while sparing healthy ones.
A2B530 deploys an activator for CEA and a blocker for HLA-A*02, potentially offering a more precise cancer treatment approach.
See Also:UK NHS introduces new endometrial cancer immunotherapy
A2 Bio’s cell therapy gains FDA orphan drug status for colorectal cancer
Preview
来源: Pharmaceutical Technology
FDA doubles down on patient engagement to support rare disease research
A2 Bio’s cell therapy gains FDA orphan drug status for colorectal cancer
Preview
来源: Pharmaceutical Technology
Orphan drug status brings development incentives for A2 Bio, including tax credits for clinical trial costs, prescription drug user fee exemptions and the possibility of up to seven years of market exclusivity upon regulatory approval.
In May 2023, the company dosed the first subject in the Phase I clinical trial of A2B530.
The multicentre Phase I dose escalation trial EVEREST-1 enrolled patients with colorectal, pancreatic and non-small cell lung cancers to assess safety and establish the recommended dose for A2B530.
A2 Bio chief medical officer William Go stated: “The FDA granting orphan drug designation validates the tremendous unmet need for improved therapies for patients with colorectal cancer.
“This designation supports our commitment to use our novel technology platform to develop new treatment options for patients with difficult-to-treat cancers.”
In December 2020, the company signed an agreement with MSD to continue research and preclinical development of its undisclosed Tmod cell therapy candidate.
The companies jointly financed the clinical development and allogeneic manufacturing works of the product until the start of the Phase I clinical trial.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.
Free WhitepaperCell and gene therapies: Pipe dream to pipeline
The cell and gene industry is gaining momentum, with a new wave of therapies promising to transform the way doctors treat, and even cure, disease. In this report, Cytiva and GlobalData have collaborated to explore the rise of the cell and gene therapy industries, the current state of the market, present and future opportunities for advancement, and the challenges that lie ahead.
A2 Bio’s cell therapy gains FDA orphan drug status for colorectal cancer
Preview
来源: Pharmaceutical Technology
-->
By downloading this case study, you acknowledge that GlobalData may share your information with Cytiva Thematic and that your personal data will be used as described in their Privacy Policy
更多内容，请访问原始网站
文中所述内容并不反映新药情报库及其所属公司任何意见及观点，如有版权侵扰或错误之处，请及时联系我们，我们会在24小时内配合处理。
机构
适应症
靶点
药物
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。