Amgen and BeiGene's Bispecific Antibody AMG 160 Receives IND Approval in China for Metastatic Castration-Resistant Prostate Cancer

By Wei Weiyang

On June 11, the CDE website showed that the new drug AMG 160, jointly submitted by Amgen and BeOne Medicines, was approved for clinical trials, intended for the treatment of adult metastatic castration-resistant prostate cancer (mCRPC).

AMG160 is a novel HLE-BiTE immunotherapy that directs T cells to selectively kill tumor cells by binding to PSMA on tumor cells and CD3 on T cells. PSMA is a tumor-associated antigen that is overexpressed on the surface of metastatic and hormone-refractory prostate cancer cells.

BiTE is a bispecific antibody technology developed by Amgen that recruits T cells via CD3. The first CD3/CD19 bispecific antibody under this platform, Blincyto (blinatumomab), received FDA approval in 2018. Blinatumomab was also submitted for marketing approval in China on October 29, 2019, and is expected to be approved by the end of this year.

In January this year, BeOne Medicines and Amgen reached a global strategic collaboration in oncology. Under this agreement, BeOne Medicines will be responsible for the commercialization and development in China of three oncology drugs already approved or under application by Amgen in China: XGEVA® (denosumab injection), KYPROLIS® (carfilzomib for injection), and BLINCYTO® (blinatumomab for injection).

Furthermore, BeOne Medicines and Amgen will collaborate on the development of 20 investigational oncology pipeline drugs from Amgen; thus, AMG160 is one of the collaborative products.

The Insight Global New Drug Database (https://db.dxy.cn/v5) shows that AMG160 is currently at the highest global development stage of Phase I clinical trials for the treatment of prostate cancer.

Original Title:Amgen/BeOne Medicines’ Bispecific Antibody AMG 160 Approved for Clinical Trials in Prostate Cancer