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 The information in the following message from ImmunoGen’s CEO should not be deemed to be current except as of the date that the message was first posted on the Company’s website. ImmunoGen specifically disclaims any duty to update the information set forth in any report or statement posted on its website. Please read the Usage Policy. February 4, 2008
New clinical findings recently were reported with four compounds – one in development by us and three by our collaborators. We reported additional findings with our IMGN901 compound for the treatment of multiple myeloma at the American Society of Hematology (ASH) annual meeting in December 2007. At the time of the presentation, four dose levels – 40, 60, 75, and 90 mg/m2 – had been evaluated in three patients each and we’d started evaluation of 112 mg/m2. These study patients all have CD56-expressing multiple myeloma that had failed treatment with a number of prior therapies. At ASH, the study investigators reported that two objective responses were seen in patients who received higher doses. A patient treated with 60 mg/m2 of IMGN901 had a minimal objective response and remained on treatment for 45 weeks. This patient had previously received multiple rounds of thalidomide, Revlimid®, and other approved and experimental agents. Additionally, a patient treated with a higher dose (90 mg/m2) of IMGN901 also had an objective response. This patient was responding well and had achieved a minimal objective response at the time of the data cutoff for presentation at ASH. We’re continuing to dose escalate, and expect to complete this study in 2008. What we learn at these higher doses will inform our next steps with IMGN901. For example, if we see good activity with IMGN901 alone in these patients who have failed multiple prior treatments, then we might consider monotherapy as a pathway to approval for the compound. Alternatively, studying the compound in combination with other approved agents, such as Revlimid, offers the opportunity to make use of our agent in a less heavily pretreated population, also a possible pathway for regulatory approval. We expect to decide on the next steps by mid-2008 and we’ll share them with you at the time. I should note that patient enrollment also is underway in our two trials in CD56-expressing solid tumors – Studies 001 and 002 – and we expect to complete these this year as well. Our collaborator sanofi-aventis reported encouraging clinical findings at ASH for both the AVE9633 TAP compound and the AVE1642 naked antibody. At higher doses, AVE9633 showed good activity in a number of patients and was well tolerated. AVE9633 was dosed on Day 1 and Day 8 in a 28-day cycle in the study reported at ASH. Sanofi-aventis also is assessing the compound when administered on Days 1, 4, and 7 of a 28-day cycle, and believes this dosing schedule will yield even better results. The findings reported at ASH with AVE1642 were from a Phase I study evaluating its safety as monotherapy. As you may know, this naked antibody is designed to block a survival pathway used by cancer cells to resist exposure to chemotherapy. Sanofi-aventis had to test AVE1642 as monotherapy before they could test it in combination with chemotherapy. It was found to be well tolerated as monotherapy and is now being tested in combination with Velcade® for the treatment of multiple myeloma, and also in combination with Taxotere® for the treatment of solid tumors. In mid December, our collaborator Genentech reported additional clinical data with trastuzumab-DM1 (T-DM1) at the San Antonio Breast Cancer Symposium (SABCS). The findings reported were again from the Phase I study evaluating T-DM1 when administered once every three weeks to patients with HER2-positive breast cancer that had progressed on treatment with Herceptin® plus chemotherapy. The data offer additional insight into the duration of the benefit seen with T-DM1 in this trial. It was previously reported that six patients had an objective response to treatment with T-DM1 – the one patient treated at 2.4 mg/kg and five of the fifteen patients treated at 3.6 mg/kg. In San Antonio it was reported that four of these six responses were still ongoing and that the longest at 3.6 mg/kg had persisted for over 11 months at the time of the data cutoff for presentation. It was also reported that, of the ten other patients in the 3.6 mg/kg cohort, seven had stable disease. So twelve of the fifteen patients receiving 3.6 mg/kg had measurable clinical benefit. Let me remind you that all of these patients had seen prior chemotherapy, in fact a median of three prior chemotherapy regimens. All suffered from incurable metastatic breast cancer, and all had been treated with and recently failed Herceptin prior to entry in this study. Before I leave T-DM1, I should note that Roche has now exercised its right to opt in on the international commercialization of T-DM1. As you know, Roche has the ex-USA marketing rights for Herceptin and some other Genentech compounds. All in all, six compounds are now in clinical testing through our own programs and those of our collaborators – the five TAP compounds IMGN901, IMGN242, T-DM1, AVE9633 and SAR3419 – and the AVE1642 naked antibody. Behind these are a number of compounds advancing towards the clinic through our own programs and those of our partners. As I noted, we expect our third wholly-owned compound, IMGN388, to be in the clinic this summer. This TAP compound consists of our DM4 cell-killing agent attached to an antibody developed by Centocor against an integrin target. The target is found on various types of cancers, including ovarian, melanoma, renal, breast, gastric, and colorectal tumors. However, the target is also on endothelial cells that are engaged in forming new blood vessels. So, IMGN388 has the potential to disrupt angiogenesis, as this process is known, which could increase its activity against tumors that express the target and enable it to have activity even against tumors that don’t express the target. It cost us nothing to obtain IMGN388 for our product pipeline, and will cost us very little to conduct an initial clinical evaluation. If IMGN388 is fabulous, then we’ve gained a great product at little cost. If it’s not fabulous, then we’ve invested very little to find that out. We’ll keep you posted on its development. In addition to our own progress, our collaborator Biogen Idec has submitted an IND for their BIIB015 TAP compound, and another of our collaborators is in the process of finalizing the IND submissions for a different TAP compound. And, of course, behind these are a whole host of compounds earlier in preclinical and in research through our own efforts and those of our partners. In fact, we earned a $500,000 milestone payment from sanofi-aventis in the second quarter of our 2008 fiscal year on an achievement related to the advancement of one of the preclinical compounds in this collaboration. As you can tell, we’re really excited about our progress and that of our many collaborators. Here is what we’re expecting in calendar year 2008: For IMGN901
For IMGN242
For IMGN388
For Collaboration Compounds
I look forward to keeping you posted on our progress.
Mitchel Sayare, Ph.D. Chairman, President and CEO
Revlimid® is a registered trademark of Celgene Corporation.
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I’m delighted to report that new clinical data recently were reported on four compounds that are in development by us and our collaborators. You may recall that we also expanded our proprietary pipeline in December 2007 through the addition of IMGN388. In fact, we expect to file an Investigational New Drug (IND) application for this compound during the second quarter of 2008. On top of that, Biogen Idec has submitted the IND for their TAP compound, BIIB015, and another of our collaborators is in the process of finalizing their IND submission for a different TAP compound. What this means is that we expect the number of TAP compounds in the clinic could increase from five to as many as eight by this summer. And, of course, we have a naked antibody compound, AVE1642, in clinical testing through our collaboration with sanofi-aventis that is also making progress.