Clinical Data Published in 'Science' Show Tumor Regressions in Relapsed Lymphoma Patients Treated with T Cell Engaging BiTE Antibody Blinatumomab

Thursday, August 14, 2008 General News
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BETHESDA, Md., Aug. 14 Micromet, Inc.(Nasdaq: MITI), a biopharmaceutical company developing novel, proprietaryantibodies for the treatment of cancer, inflammation and autoimmune diseases,today announced publication of a Phase 1 clinical study(1) on its BiTE(R)antibody blinatumomab (MT103/MEDI-538) in this week's issue of Science. Thearticle is available at Blinatumomab is being co-developedwith MedImmune.

Blinatumomab is a novel antibody therapy that activates a patient'sT cells to seek out and destroy cancer cells. The phase 1 study demonstratedtumor regression, and in some cases, complete remission, in non-Hodgkin'slymphoma patients who relapsed after previous treatments and were consideredto have incurable disease. Most of the remissions are reported to continue,with the longest remission ongoing for more than one year. Results from thisongoing Phase 1 clinical trial with the CD19-specific BiTE antibodyblinatumomab show that all seven patients treated to date at 0.06 mg/m2 perday achieved complete or partial responses. The safety profile observed inthis study supports continued blinatumomab development.

"These results represent significant progress of a T cell engagingantibody for treatment of lymphoma patients as single agent therapy. Weobserved tumor regression in patients at serum levels of blinatumomab, whichare approximately five orders of magnitude lower than serum levels needed byconventional monoclonal antibodies for achieving a tumor regression in thisdisease. This may relate to the high anti-tumor activity of cytotoxic T cellsrecruited by blinatumomab," commented Micromet Senior Vice President and ChiefScientific Officer Patrick Baeuerle.

"This first observation of durable objective responses in relapsed,incurable patients indicates the potential blinatumomab and BiTE antibodies ingeneral may have in fighting cancer," added Micromet Senior Vice President andChief Medical Officer Carsten Reinhardt, M.D.

Typically antibodies cannot engage T cells because T cells lack theappropriate receptors for binding antibodies. Previous attempts have shown thepotential of T cells to treat cancer, but the therapeutic approaches tested todate have been hampered by cancer cells' ability to escape recognition by Tcells. The use of antibodies that are specifically designed to engage T cellsfor attacking cancer cells may provide a more effective anti-tumor approachthan conventional monoclonal antibodies, which require much higher doses andare typically combined with chemotherapies.

Micromet has additional clinical trials with BiTE antibodies underway,including a phase 2 clinical trial to evaluate blinatumomab for the treatmentof patients with acute lymphoblastic leukemia (ALL), and a phase 1 trialinvestigating MT110, a BiTE antibody targeting EpCAM, in patients with lung orgastrointestinal cancers.

Micromet will host a webcast and a conference call on Monday, August 18 at10:00 a.m. Eastern Time, (4:00 p.m. Central European Time), to discuss theseresults. The webcast can be accessed at: Toparticipate in the conference call, dial 866-202-4367 (U.S.) or 617-213-8845(international), passcode: 31176615.

(1) Bargou R et al. (2008) Tumor regression in cancer patients by very lowdoses of a T cell-engaging antibody. Science 321: 974-977 (2008)

About Science

Founded in 1880 on $10,000 of seed money from the American inventor ThomasEdison, Science has grown to become the world's leading outlet for scientificnews, commentary and cutting-edge research, with the largest paid circulationof any peer-reviewed general-science journal. Through its print and onlineincarnations, Science reaches an estimated worldwide readership of more thanone million. In content, too, the journal is truly international in scope;some 35 to 40 percent of the corresponding authors on

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