Xencor announced the FDA lifted a partial clinical hold placed on its Phase 1 study of XmAb14045.
Xencor (NASDAQ:XNCR) announced the US Food and Drug Administration (FDA) lifted a partial clinical hold placed on its Phase 1 study of XmAb14045.
As quoted in the press release:
Xencor, a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer, autoimmune diseases, asthma and allergic diseases, today announced the FDA has lifted the partial clinical hold that was placed on the Phase 1 study of XmAb14045, a CD123 x CD3 bispecific antibody molecule being evaluated in patients with relapsed or refractory acute myeloid leukemia and other CD123-expressing hematologic malignancies. The decision follows discussion and agreement with the FDA on amendments to the study protocol, including guidance on the monitoring and clinical management of cytokine release syndrome.
“We are working with investigational sites to resume enrollment based on the amended protocol, through which we have sought to enhance the safety of patients participating in the study,” said Paul Foster, M.D., senior vice president and chief medical officer at Xencor.