Tag: BiTE

Company News: Micromet Presents Promising New Data on Anti-Cancer BiTE® Antibody Blinatumomab

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.

A first interim analysis of the time impact of blinatumomab treatment was conducted for the initial 18 patients enrolled to the trial. The median survival had not been reached, with a median follow-up period of 9.7 months. With combination chemotherapy, median survival typically ranges from 3 – 6 months1-5.  12 of the initial 18 patients had a CR or CRh* with a median duration of response of 7.1 months. Based on the results of this study, the Company initiated a global phase 2 study in this patient population in November 2011.

 

Moreover, new findings from a phase 1 trial presented at the meeting demonstrate Micromet’s blinatumomab induces durable responses in patients with extensively pre-treated diffuse large B cell lymphoma (DLBCL).

Data focused on a cohort of 13 patients with DLBCL, of which 11 received the target dose and were evaluable for response. Of these 11 patients, 6 (55%) achieved an objective response following treatment with blinatumomab. 4 of 11 patients (38%) achieved a complete response. Patients were treated with a single course of blinatumomab induction therapy for up to eight weeks. As of October 2011, 5 of 6 patients had ongoing responses for up to 16.6 months. The median duration of response had not been reached with a median observation time of 7.1 months.

All patients enrolled in this study had received prior rituximab-containing regimens. Most had received three or more prior lines of therapy, including 8 of 13 patients with prior autologous stem cell transplant.

Company News: Micromet Announces Solid Tumor BiTE Antibody Collaboration with Amgen

– 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.

Micromet will be primarily responsible for the discovery and pre-clinical development of the BiTE antibodies. Amgen will lead the clinical development, manufacturing, and commercialization of any products resulting from the collaboration.

Company News: Micromet’s BiTE Antibody MT112/BAY 2010112 Demonstrates Potent Activity against Human Prostate Cancer Cells

Micromet, Inc. (NASDAQ: MITI) yesterday evening announced the presentation of pre-clinical data on its BiTE antibody MT112/BAY 2010112, discovered and developed in collaboration with Bayer HealthCare Pharmaceuticals, at the 102nd Annual Meeting of the American Association for Cancer Research (AACR) in Orlando, Florida.

The data (poster # 4561) demonstrate the potent activity of the BiTE antibody against human cancer cell lines and inhibition of tumor growth in animal models.  MT112/ BAY 2010112 directed human and non-human primate T cells against PSMA-positive human prostate cancer cells, resulting in highly efficient cancer cell destruction. In mice, daily doses of MT112/BAY 2010112 as low as 0.05 milligram/kilogram were sufficient to inhibit growth of tumors from human prostate cancer cells.

During the course of the meeting, the Company also presented preclinical data on MT110, its BiTE antibody targeting epithelial cell adhesion molecule (EpCAM).  Results reported (poster # 1790) provide further validation of EpCAM as a cancer stem cell target, and show utility of MT110 to eradicate cancer stem cells derived from breast and hepatocellular carcinoma.

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.

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