AstraZeneca (NASDAQ: AZN), a leading UK pharmaceutical company, has received approval from the National Medical Products Administration (NMPA) in China to initiate a clinical study for its drug candidate AZD0486 (TNB-486) in patients with recurrent or refractory B-cell acute lymphoblastic leukemia.
AZD0486 is a bispecific antibody (BsAb) that targets both CD19 and CD3, functioning as a bispecific T-cell engager (BiTE). This innovative drug was acquired through AstraZeneca’s USD 1.265 billion purchase of TeneoTwo in July 2022. The acquisition agreement included a USD 100 million upfront payment to TeneoTwo, with additional payments tied to research and development milestones of up to USD 805 million and commercial milestones of up to USD 360 million.
Previous clinical studies for AZD0486 in B-cell non-Hodgkin’s lymphoma (B-NHL) have demonstrated an impressive 81.2% objective response rate (ORR), with some patients achieving complete remission (CR). Notably, the drug showed an 87.5% CR rate in follicular lymphoma (FL), indicating its potential efficacy in treating these types of cancers.
This clinical study approval in China is a significant step for AstraZeneca as it continues to expand the global development of AZD0486 and seeks to bring this promising therapy to patients in need.- Flcube.com
