Xencor, Inc. has initiated a Phase I clinical trial with its lead product candidate XmAb™2513 in patients with Hodgkin lymphoma (HL) and Anaplastic Large Cell Lymphoma (ALCL).
XmAb2513 is a humanized monoclonal antibody that targets the antigen CD30. It is engineered to contain an XmAb™ Fc domain using Xencor’s Protein Design Automation® platform technology to greatly increase its cytotoxic potency.
The open-label, dose escalation study is designed to define the recommended dose of XmAb2513 for subsequent trials, to determine its safety and tolerability, characterize pharmacokinetics and immunogenicity, and to evaluate its antitumor activity in patients with HL and ALCL who have received two or more prior therapeutic treatments.
“We created XmAb2513 entirely with XmAb technology, optimizing its Fc domain and humanizing its variable region resulting in significantly enhanced potency. In pre-clinical studies, XmAb2513 demonstrated superior activity in killing tumor cells and preventing tumor cell growth, and was well tolerated,” said Jeffrey Bloss, M.D., Chief Medical Officer of Xencor.
“This is a very promising compound within our pipeline, and we believe it has multiple applications in the treatment of lymphoma and other cancers. Starting clinical testing of the first Xmab in our pipeline is an important milestone towards validating our Fc technology in oncology indications.”