Tag: ALL

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: Study Demonstrates Micromet’s Blinatumomab Produces High Single-Agent Activity in Patients with Relapsed Acute Lymphoblastic Leukemia

75% of patients achieved a complete remission, with no evidence of remaining leukemic cells in blood or bone marrow
– Data add to a growing body of clinical evidence demonstrating blinatumomab’s potential to be used across the course of the disease

Data to be presented tomorrow at the 16th Annual Meeting of the European Hematology Association (EHA) in London, UK, show that Micromet’s blinatumomab produced a high complete remission rate in adult patients with acute lymphoblastic leukemia (ALL) who had relapsed following treatment with standard therapy. 1 Blinatumomab is the most advanced of a new class of agents called BiTE® antibodies, designed to harness the body’s T cells to kill cancer cells.

Interim results from this phase 2 single-arm trial showed that 75% of patients (9 of 12) achieved a complete remission (CR) or CR with partial recovery of blood counts (CRh*) following treatment with blinatumomab.  All nine responding patients achieved a complete molecular response, or had no evidence of leukemic cells in their bone marrow, a key prognostic factor for patient survival.  Notably, four patients with genetic abnormalities typically associated with poorer outcomes all achieved a CR or CRh*.

Current treatment for Philadelphia negative relapsed/refractory ALL consists of combinations of toxic chemotherapy drugs that in the majority of cases fail to drive the disease into remission.  In more than 30 years, no new drug has been approved for use in this setting, leaving physicians with few options to improve long-term patient outcomes other than variations in the dose and schedule of old drugs with limited efficacy.  With current approaches, complete remission rates range from 17-45%. 2-6 Standard chemotherapy is associated with a mortality rate of up to 23%. 7 The average five-year survival rate for adult ALL patients after first relapse is 7%. 5

 

Click here to read the abstract

 

References:

  1. Topp, M.S. et. al. Haematologica. 2011; abstract no. 844
  2. Kantarjian H, et al. Cancer. 2010;116:5568–5574.
  3. Advani AS, et al. Br J Haematol. 2010;151(5):430.
  4. Oriol A, et al. Haematologica. 2010;98(4):589-596.
  5. Fielding  A, et al. Blood. 2007;109(3):944-950.
  6. O’Brien S, et al. Cancer. 2008;113:3186–3191.
  7. Bassan R, et al. J Clin Oncol. 2011;29(5):532-543.

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.