Micromet has presented promising new data from two clinical trials with its lead BiTE® antibody, blinatumomab, at the 53rd American Society of Hematology (ASH) Annual Meeting in San Diego, CA. Blinatumomab is the first of a new class of agents called BiTE® antibodies, designed to harness the body’s T cells to kill cancer cells. The compound is being developed for the treatment of leukemia and B cell lymhoma.

The data show that Micromet’s blinatumomab more than doubled the complete remission rate produced by current standard therapies used to treat adult patients with relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL).

In a phase 2 single-arm dose-ranging trial, 68% of evaluable patients (17/25) across all tested doses and schedules achieved a complete response (CR) or complete response with partial hematologic recovery (CRh*) following treatment with blinatumomab.  Of the 12 evaluable patients who received the selected dose and schedule 75% (9 of 12) achieved a CR or CRh*.  Notably, all responders also achieved a molecular response, or in other words, had no evidence of remaining leukemic cells detectable in the blood or bone marrow.  » Read more...

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.”  » Read more...

Micromet, Inc. (NASDAQ: MITI) today announced that it has initiated a phase 2 trial of its lead product candidate blinatumomab (MT103) in adult patients with relapsed or refractory (r/r) B-precursor acute lymphoblastic leukemia (ALL). Blinatumomab is the first of a new class of agents called BiTE® antibodies, designed to harness the body’s T cells to kill cancer cells.

This phase 2, single-arm study will evaluate the efficacy and safety of blinatumomab in approximately 65 patients with relapsed/refractory Philadelphia-negative B-precursor ALL. Patients will receive blinatumomab daily for 28 days followed by two weeks off blinatumomab over a six week treatment cycle. Patients who achieve a complete remission (CR) or complete response without full recovery of platelets (CRh*) within two cycles of treatment will receive up to three additional cycles of consolidation treatment. The primary endpoint of the study is CR/CRh*. Secondary endpoints include duration of response and overall survival. The study will be conducted at approximately 40 leading cancer centers in the U.S. and EU. The Company currently expects to complete enrollment in this trial by year end 2012.

Additional information regarding this Phase 2 study is available at the U.S. government’s clinical trials database at http://www.clinicaltrials.gov.  » Read more...

- Collaboration on up to three targets and two programs

- Upfront payment of €10 million upon deal execution

– Maximum deal value of €695 million plus royalties and development cost reimbursement

Micromet, Inc. (NASDAQ: MITI) announced today that it has entered into a collaboration agreement with Amgen Inc. for the research of BiTE antibodies against three undisclosed solid tumor targets. Amgen will have the right to pursue development and commercialization of BiTE antibodies against up to two of these targets, to be selected by Amgen.

Under the terms of the agreement, Amgen is expected to pay €10 million upon deal execution.  If milestones in multiple indications and tumor types are achieved, Micromet is eligible to receive up to €342 million in clinical and commercial milestone payments.  Micromet is also eligible to receive up to double-digit royalties on worldwide net sales.

For the second BiTE program, Micromet is eligible to receive an additional cash payment upon initiation of the program, milestones, royalties and development funding comparable to the first program. The combined potential payments to Micromet from both programs, excluding reimbursement of research and development costs, are approximately €695 million.  The initial development plan contemplates €25 million in funding of Micromet R&D activities if two BiTE antibodies are advanced to IND.  All expected costs associated with the research, development and commercialization of the BiTE antibodies will be borne by Amgen.  » Read more...

- 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*.  » Read more...