Micromet: Data from MT103 indicate biological, clinical activity in non-Hodgkins lymphoma

By E. Janene Geiss

Philadelphia, June 19 - Micromet, Inc. announced Monday preliminary data from an ongoing phase 1 trial on MT103, also known as MEDI-538, show no limiting toxicities and show clinical responses with continuous infusion of MT103 over a four- to eight-week period at escalating dose levels in patients with relapsed, indolent non-Hodgkins lymphoma.

So far, 19 patients with a median number of four previous lines of therapy have been included, according to a company news release.

In the first three cohorts, no dose-limiting toxicities have been observed, officials said.

Evaluation of dose level 4 (15 mg/m2/24h) is ongoing.

Pharmacodynamic effects have been observed at 5 and 15 mg/m2/24 h with complete depletion of malignant B cells as well as significant T-cell expansion in the majority of patients, officials said.

Three out of five patients receiving 15 mg/m2/24 h of MT103 for at least two weeks showed clinical responses assessed by central radiology.

One patient had a complete tumor response and two patients showed partial tumor responses according to standardized Cheson criteria, officials said.

The most common adverse events of grade 3 or higher were lymphopenia (63%), leukopenia (47%), neutropenia and enzyme abnormality (both 16%), officials said.

The company said these encouraging results underline the potential of cytotoxic T cells, when targeted by MT103/MEDI-538, to induce clinical responses in a human cancer.

The data were presented at the 11th Congress of the European Hematology Association.

MT103 is a recombinant single-chain bispecific antibody derivative out of Micromet's BiTE platform targeting the CD19 antigen, which is uniquely expressed on B cells.

The BiTE molecule is being co-developed by Micromet and MedImmune, Inc. for the treatment of B cell-derived lymphomas and leukemias.

MedImmune is a Gaithersburg, Md., biopharmaceutical company.

Micromet is a Carlsbad, Calif., biopharmaceutical company focused on developing products for cancer and inflammatory and autoimmune diseases.

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