Tag: acute lymphoblastic leukemia

Company News: Keeping an Eye on Micromet

The human immune system is one of the body’s most powerful weapons to combat cancer, and therefore a lot of companies are working to activate it against tumors, writes Siegfried Hofmann in Handelsblatt this week. As an example, he features the BiTE antibodies developed by Micromet, Inc. These BiTE antibodies bind to T cells and subsequently to specific tumor antigens on cancer cells. Thereby, the T cells are activated and start destroying the tumor cells. The first drug candidate is in late-stage clinical development to treat Leukemia, Hofmann writes. The article is also being featured in the internet version of Wirtschaftswoche.

Micromet recently started a Phase 2 trial of its lead product blinatumomab (MT103) in relapsed/refractory acute lymphoblastic leukemia (ALL), a very difficult to treat disease. If initial results generated from this trial are compelling, Micromet plans to discuss with the FDA potential avenues to accelerate blinatumomab’s path to market. Blinatumomab is also being tested for the treatment of non-Hodkin’s Lymphoma (NHL). In addition, the company announced it hired Joseph Lobacki as Senior Vice President and Chief Commercial Officer. Previously, Lobacki was Senior Vice President and General Manager, Transplant and Oncology at Genzyme. Christian Itin, CEO of Micromet said “his extensive sales, marketing and medical affairs experience will be critical as we look to prepare the marketplace for blinatumomab’s potential launch.”

 

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.