A number of compounds are in development through our collaborators. These include:

• Trastuzumab-DM1 (T-DM1) – This compound consists of our DM1 cell-killing agent attached to Genentech’s HER2-binding antibody, trastuzumab. It is in development by Genentech under an agreement that provides Genentech with the exclusive right to use our maytansinoid TAP technology with antibodies that target HER2. On April 10, 2008, Genentech disclosed that they plan to make a T-DM1 Phase III go/no go decision in 2008. They also disclosed that they expect to report T-DM1 Phase I data at the 2008 ASCO annual meeting.

  In April 2006, Genentech initiated Phase I clinical testing of T-DM1 in patients with HER2-overexpressing metastatic breast cancer that had progressed on a chemotherapy regimen that included Herceptin® (trastuzumab). The first trial initiated evaluates T-DM1 when administered once every three weeks. In this dose-escalation trial, increasing doses of T-DM1 were administered to new cohorts of patients until the maximum tolerated dose (MTD) was established. A growing body of findings from this trial have been presented over the past year, including at the American Society of Clinical Oncology (ASCO) meeting in June 2007.

  The most complete findings to date were recently reported at the 30th Annual San Antonio Breast Cancer Symposium in December 2007. Here it was reported that 12 of the 15 patients treated with T-DM1 at the MTD had either an objective response (a PR) or stable disease (5 and 7 patients, respectively) and that many of these had been sustained for an extended period of time.

  In July 2007, Genentech initiated a Phase II study of T-DM1 in patients with HER2-overexpressing metastatic breast cancer that has progressed during prior treatment with a HER2-directed therapy. Genentech also is conducting a Phase I trial that evaluates T-DM1 when dosed on a weekly basis.

• AVE9633 – This TAP compound was created by ImmunoGen and licensed to sanofi-aventis from our preclinical pipeline as part of a broader collaboration between the companies. AVE9633 consists of our huMy9-6 CD33-binding antibody and our DM4 cell-killing agent. It is in clinical development by sanofi-aventis for the treatment of acute myeloid leukemia.

  Clinical findings from a AVE9633 Phase I study were reported at the American Society of Hematology (ASH) annual in December 2007. The compound was found to be well tolerated and to demonstrate evidence of anticancer activity, which was seen in 7 of the 17 patients enrolled in the study. A separate trial is underway that evaluates AVE9633 when administered more frequently – on Days 1, 4, and 7 in a 28-day cycle.




• AVE1642 – We also created AVE1642 and licensed it to sanofi-aventis, who advanced it into clinical testing in October 2006. AVE1642 is a “naked” (non-conjugated) antibody that binds to the IGF-1 receptor, to block a pathway used by cancer cells to survive exposure to chemotherapy agents. Thus, it is expected that AVE1642 will be used in combination with chemotherapeutic agents.

  Initial clinical findings with AVE1642, given as monotherapy, also were reported at the ASH meeting in December 2007. Studies are now underway that evaluate the compound when used in combination with Velcade (bortezomib) for the treatment of multiple myeloma, and when used in combination with Taxotere (docetaxel) for the treatment of solid tumors.




• SAR3419 – This TAP compound also was licensed to sanofi-aventis in 2003 from our preclinical pipeline. It targets CD19, which is found on a number of B-cell cancers including non-Hodgkin’s lymphoma. This compound advanced into clinical testing in October 2007. Additional SAR3419 preclinical findings were reported at the ASH annual meeting in December 2007.

In addition to the six compounds already in clinical testing, other compounds are in development through our own programs and those of our collaborators. The information on these that has been disclosed includes:

• Our collaborator Biogen Idec has submitted an IND for their Cripto-targeting TAP compound, BIIB015.



• Biotest AG licensed the exclusive right to use our TAP technology with antibodies to a target found on multiple myeloma cells and other cancers, and has recently submitted an IND for their BT-062 TAP compound. We have the right to opt-in on US development and commercialization of BT-062 during its clinical development.



• Genentech has taken exclusive licenses to use our TAP technology with therapeutic antibodies to three undisclosed targets in addition to their license for HER2, and also has the right to test our technology with antibodies to additional targets.



• Two additional compounds - SAR566658 and SAR650984 - have been disclosed in our collaboration with sanofi-aventis. SAR566658 is a TAP compound for the treatment of breast and ovarian cancers and other solid tumors, and SAR650984 is a naked antibody for hematological malignancies.

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