Interim data from Micromet's T-cell engaging BiTE antibody study for treating solid tumors

Micromet, Inc. (Nasdaq: MITI), a biopharmaceutical company developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases, today presented first interim data from a phase 1 dose-escalation clinical study for BiTE antibody MT110, the first T-cell engaging antibody for the treatment of solid tumors. The interim data were presented at the Multidisciplinary Congress of the European Cancer Organisation (ECCO) and 34th meeting of the European Society for Medical Oncology (ESMO) in Berlin, Germany. MT110 is designed to direct the patients' own T cells against cancer cells that express the epithelial cell adhesion molecule (EpCAM).

To date, 20 patients with late-stage lung or gastrointestinal cancers have been treated with MT110. The starting dose in this phase 1 dose escalation trial was 1 g per patient per day. Results from doses up to 12 g per patient per day were reported. MT110 is administered by continuous intravenous infusion for a minimum of four weeks with the option of additional treatment cycles until disease progression. No maximum tolerated dose has been reached and dose escalation is ongoing. MT110 is well tolerated with no grade 3 or 4 clinical events related to MT110 therapy observed so far. The most frequent adverse events related to MT110 treatment were mild pyrexia and fatigue. Laboratory analysis of all patients revealed an early clinically asymptomatic increase of liver enzymes that normalized after several days under continued treatment. Other laboratory abnormalities included transient lymphopenia. No cytokine release syndrome, pancreatitis or immune response to MT110 was observed. At the dose levels tested to date, disease stabilization was seen in 7 of 18 evaluable patients after the first cycle of treatment, and dose escalation continues.

"We are very encouraged by the tolerability of MT110 observed in this heavily pre-treated population of cancer patients and look forward to updating our results as we continue to increase the dose," commented Prof. Walter Fiedler from the University Hospital of Hamburg-Eppendorf, Germany, and principal investigator of the study.

"The interim phase 1 results and activity of MT110 at the current dose level are what we expected based on our preclinical data," commented Christian Itin, CEO of Micromet. "We are now looking forward to exploring the clinical activity of MT110 at higher dose levels."

MT110 is the second BiTE antibody undergoing clinical investigation. Micromet also has ongoing trials for blinatumomab (MT103), including a phase 2 trial for acute lymphoblastic leukemia (ALL) and a phase 1 trial for non-Hodgkin's lymphoma.