BeiGene Biologics' Autologous CAR-T Therapy CTB001 Receives FDA Orphan Drug Designation for Gastric Cancer
Imviva Biotech
Developer of Novel Cancer Cell Immunotherapies
FDA
U.S. Food and Drug Administration
ByMedView
On January 28, Nanjing Bioheng Biotech Co., Ltd. (hereinafter referred to as "Bioheng Biotech") announced in a press release that its anti-Claudin18.2 autologous CAR-T cell therapy product CTB001 has been granted Orphan Drug Designation (ODD) by the U.S. FDA for the treatment of gastric cancer.
Image Source: FDA Official Website
Nanjing Bioheng Biotech Co., Ltd. was founded in 2017 as an innovative biopharmaceutical company focused on the development and commercialization of disease treatment products, with businesses covering fields such as immune cell and gene therapy. In March 2021, Bioheng secured a Series B funding round of 520 million yuan led by Hillhouse Venture Capital, Decheng Capital, and Octagon Capital, bringing its total financing to nearly 700 million yuan.
According to the press release, CTB001 is a fourth-generation autologous CAR-T cell therapy product targeting Claudin18.2, utilizing Nanjing Bioheng Biotech Co., Ltd.'s Explored CAR-T platform technology to enhance the product's anti-tumor efficacy. Claudin18.2 is a pan-cancer target that is abnormally expressed in various primary tumors and metastases, including gastric cancer, pancreatic cancer, cholangiocarcinoma, ovarian cancer, and lung adenocarcinoma.
Nanjing Bioheng Biotech Co., Ltd. stated that CTB001 is the first clinical validation of its proprietary Explored CAR-T platform technology. It is a highly promising immunotherapy treatment that can precisely, rapidly, and efficiently benefit patients with Claudin18.2-positive cancers. The FDA’s granting of orphan drug designation to CTB001 will further accelerate the research, development, and commercialization process of cell and gene therapies. In the future, they look forward to advancing more products into clinical trials, providing additional options to address unmet medical needs.
The press release also stated that the breakthrough in CAR-T therapy has provided new solutions for cancer treatment, with extremely high unmet clinical needs. CTB001 has demonstrated excellent efficacy and safety in exploratory clinical studies, offering strong data support for the upcoming submission in China.
Gastric cancer is a common cancer worldwide and an important cause of cancer-related deaths. Currently, the main treatments for gastric cancer are conventional chemotherapy and surgical resection, with very limited therapeutic drugs and methods available. Moreover, since many patients with gastric cancer cannot tolerate further treatment due to disease progression, first-line therapy often represents the best chance for efficacy in patients with gastric or gastroesophageal junction cancer. It is hoped that these innovative therapies under research will progress smoothly in clinical studies, bringing new treatment options to more patients with gastric cancer as soon as possible.
References:
[1] Nanjing Bioheng Biotech Co., Ltd.'s autologous CAR-T product CTB001 receives U.S. FDA Orphan Drug Designation. Retrieved Jan 28, 2022, from https://mp.weixin.qq.com/s/vJsNsfsgnCy7RIAmSwKVnw
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