Danish biotechnology firm Genmab's collaboration partner, Janssen Biotech (Janssen) is planning to initiate a Phase II trial of daratumumab to treat patients with smoldering multiple myeloma.
Daratumumab, a human CD38 monoclonal antibody with broad-spectrum killing activity, is currently in clinical development for multiple myeloma (MM). It targets the CD38 molecule which is highly expressed on the surface of multiple myeloma cells.
The company intends to start patient enrolment in 2015 for this (SMM2001) trial, which is designed to evaluate three different dose schedules of daratumumab.
The randomised, open-label, multicentre Phase II trial will enrol around 120 patients with high risk smoldering multiple myeloma.
Janssen Research & Development will conduct the trial, in which patients will be randomised to receive one of three dose schedules of daratumumab.
Genmab chief executive officer Jan van de Winkel said: "Smoldering multiple myeloma is a challenging indication, as physicians will evaluate treating patients at an early stage of the disease, with the intent to extend the period before the disease transitions to symptomatic multiple myeloma."
According to the company, the drug may also have potential in other cancers on which CD38 is expressed, including diffuse large B-cell lymphoma, chronic lymphocytic leukemia, acute lymphoblastic leukemia, plasma cell leukemia, acute myeloid leukemia, follicular lymphoma and mantle cell lymphoma.
The US Food and Drug Administration (FDA) has also granted breakthrough therapy designation for daratumumab to treat patients with MM who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or who are double refractory to a PI and an IMiD.
In August 2012, Janssen secure an exclusive worldwide license from Genmab to develop, manufacture and commercialise daratumumab.