) recently announced that it has begun a mid-stage registrational
trial of its lead pipeline candidate, blinatumomab, in adult
patients with B-precursor relapsed refractory acute lymphoblastic
The trial was advised to be conducted by the US Food & Drug
Administration (FDA) to support accelerated approval of
blinatumomab. The trial is a single-arm study which will evaluate
65 patients with the primary endpoint of complete remission (
) or CR with partial recovery of blood counts (CRh). Micromet
expects to complete enrollment for the trial by year-end 2012. The
mid-stage study will be followed by a late-stage trial (with a time
dependent endpoint) to evaluate the safety and efficacy of
blinatumomab versus chemotherapy in adult patients with relapsed
refractory B precursor ALL. Design details of the late-stage trial
will be provided in 2012.
Blinatumomub is one of the leading BiTE antibodies that Micromet
is developing. BiTE antibodies represent a new class of antibodies
that activate the T-cells of a patient's immune system to eliminate
cancer cells. The company is developing the candidate on its
Currently, Micromet is conducting another mid-stage study (n=20)
of blinatumomab in adults suffering from relapsed or refractory
B-precursor ALL. This study is evaluating the efficacy, safety and
tolerability of blinatumomab in patients who do not respond to
standard chemotherapy. Updated data from the trial is expected at
the American Society of Hematology (
) meeting in December 2011. We believe this data presentation is a
major near-term catalyst for the company as it will provide further
visibility on the clinical potential of blinatumomab.
Relapsed/refractory ALL is an aggressive cancer of the blood and
bone marrow. This disease is difficult to treat and has limited
treatment options. No new drug has been approved for the treatment
of this disease in the last 30 years. The disease affects 5,330
patients in the US annually.
Currently, we have a Neutral stance on Micromet. The stock
carries a Zacks #3 Rank (short-term Hold recommendation).
We believe blinatumomab holds tremendous potential in the
treatment of ALL. Besides, Micromet's partnerships with large
pharma and biotech companies could generate substantial future
royalty revenues for the company. Micromet has entered into
contracts with pharma giants like
), which are focused on developing BiTE antibodies against
disclosed/undisclosed solid tumor targets.
However, we believe that Micromet requires the strength of a
large established player to accelerate blinatumomab's development
in order to gain a head-start over potential competitors on
approval. We are also concerned about its early stage pipeline.
Accordingly, we prefer to remain on the sidelines.
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