Tag: MITI

Company News: Micromet Announces IND for MT111 Trial Obtained by Partner MedImmune

Micromet, Inc. (NASDAQ: MITI) today announced that MedImmune, licensee for Micromet’s MT111, plans to initiate a Phase 1 trial in patients with advanced gastrointestinal cancers based on an investigational new drug (IND) application recently accepted by the U.S. Food and Drug Administration (FDA).

MT111, also known as MEDI-565, is a BiTE® antibody designed to direct a patient’s T cells, the body’s most potent killer cells, against cancer cells that express carcinoembryonic antigen (CEA). CEA is a protein found on the surface of a number of gastrointestinal cancers, including colorectal, esophageal and gastric cancers.

MT111 will be Micromet’s third BiTE antibody to progress to clinical trials. Moreover, MedImmune’s decision demonstrates its ongoing confidence in the BiTE principle. Last year, MedImmune had decided to hand back to Micromet all rights to blinatumomab, a BiTE molecule in development for blood cancers.
Blinatumomab last months entered a pivotal trial in adult patients with MRD-positive acute lymphoblastic leukemia (ALL) and a Phase II trial in adult patients with relapsed/refractory ALL.

Company News: Micromet Initiates Pivotal Study of Lead Compound Blinatumomab

Micromet Inc (NASDAQ:MITI), a biotech company located in the US and in Germany, today announced the start of two Phase II trials of Blinatumomab, a so-called BiTE antibody which is designed to recruit T killer cells of the patient’s body to the cancer cells.

The so-called BLAST study (Blinatumomab Adult ALL MRD Study of T cell engagement) is designed to evaluate the efficacy, safety and tolerability of blinatumomab in up to 130 adult patients suffering from B-precursor acute lymphoblastic leukemia (ALL) who received chemotherapy but still have leukemia cells in the bone marrow (so-called minimal residual disease – MRD). About 70 centers in Europe and the US will take part in the study which will take about 2 years to complete. Primary endpoint is MRD response, i.e. disappearance of leukemia cells in the bone marrow.

If successful, the study could  serve as the basis for filing for approval.

A further Phase II study initiated today is designed to evaluate the efficacy, safety and tolerability of blinatumomab in 20 adult patients suffering from B-precursor acute lymphoblastic leukemia (ALL) who are resistant or intolerant to standard chemotherapy.

Details can be found in the press releases describing the BLAST trial and the refractory ALL trial.