1. FDA Grants Breakthrough Therapy Designation to BNT323/DB-1303 in Endometrial Cancer (http://onclive.com)2. Abstract 2793: Preclinical pharmacokinetics in cynomolgus monkeys and first in human dose prediction of DB-1303, a HER2-targeting antibody-drug conjugate | Cancer Research | American Assoc...
映恩生物基于抗体偶联药物(ADC)平台开发的创新药DB-1303被美国食品药品监督管理局(FDA)授予快速通道认定(FastTrackDesignation),用于治疗复发或转移性子宫内膜癌(EndometrialCancer,EC)患者。DB-1303是新一代HER2ADC产品,由抗HER2单克隆抗体、可剪切连接子和专有的拓扑异构酶I抑制剂P1003组成。DB-1303具有抗肿瘤...
1. BioNTech and DualityBio receive FDA breakthrough therapy designation for antibody-drug conjugate candidate BNT323/DB-1303 in endometrial cancer. News Release. BioNTech. December 21, 2023. Accessed December 21, 2023. 2. Moore K, Makker V, Yeku O, et al. DB-1303, a HER2-targeting ADC, ...
1. BioNTech and DualityBio receive FDA breakthrough therapy designation for antibody-drug conjugate candidate BNT323/DB-1303 in endometrial cancer. News Release. BioNTech. December 21, 2023. Accessed December 21, 2023. 2. Moore K, Makker V, Yeku O, et al. DB-1303, a HER2-targeting ADC, ...
This is the first report of dose escalation and expansion results of DB-1303 in patients with HER2-expressing (IHC 1/2/3+ or ISH+) advanced/metastatic endometrial cancer (EC). Results As of May 8, 2023, 32 patients with EC had received 7 or 8 mg/kg doses of DB-1303. The most ...
Among HER2-positive breast cancer, the ORR was 50%, among HER2-positive breast cancer with brain mets, the ORR was 55.6% and DCR of 100%, and among HER2-low breast cancer, the ORR 38.5% and DCR of 84.6%. There was also responses among colorectal, ovarian, endometrial, and others. In...
2. Moore K, Makker V, Yeku O, et al. DB-1303, a HER2-targeting ADC, for patients with advanced/metastatic endometrial cancer: preliminary clinical results from an ongoing phase 1/2a trial (NCT05150691). Int J Gynecol Cancer. 2023;33(suppl 3):A9-A10. ...
Twenty-three pts (44.2%, 23/52) had objective partial tumor response per RECIST 1.1: Thirteen HER2+ breast cancer (BC) (50.0%, 13/26, including 5 pts with brain metastases [55.6%, 5/9]), 5 HER2 low BC (38.5%, 5/13), 2 colorectal cancer (66.7%, 2/3), 1 endometrial carcinoma...