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Executives

Carol Hausner - Executive Director of IR and Corporate Communications

Steve Whiteman - Acting Medical Director

John Lambert - Sr. VP of Pharmaceutical Development

Mitch Sayare - CEO

Dan Junius - CFO

Analysts

Brian Rye - Janney Montgomery

Joel Sendek - Lazard Capital Markets

Shiv Kapoor - Ferris, Baker Watts

Robert Manning

ImmunoGen, Inc. (IMGN) Business Update Call December 11, 2007 10:00 AM ET

Operator

Good day, and welcome everyone to this ImmunoGen conference call. At this time, for opening remarks and introductions, I would like to turn the call over to the Executive Director of Investor Relations and Corporate Communications, Carol Hausner. Please go ahead.

Carol Hausner

Thank you. Good morning, everyone, and thank you for joining us on our call to discuss our findings reported at the American Society of Hematology or ASH annual meeting this weekend.

During today's call, we'll make forward-looking statements. Our actual results may differ materially from the projections made. Descriptions of the risks and uncertainties associated with an investment in ImmunoGen are included in our SEC filings, which can also be accessed through our website, www.immunogen.com.

With me today are, Dr. Steve Whiteman, our Acting Medical Director; Dr. John Lambert, Senior Vice President of Pharmaceutical Development; Dr. Mitch Sayare, our CEO; and Dan Junius, our CFO. Steve will discuss the IMGN901, clinical findings we reported on Saturday, and John, will discuss the Clinical Data Sanofi-Aventis reported with our collaboration compounds on Saturday and Sunday.

We'll then open the call for questions. I now turn the call over to Steve.

Steve Whiteman

Thank you, Carol, and good morning. This is Dr. Steve Whiteman, and he’s just going to cover the key points of the presentation around N901-DM1 at the ASH Meeting on Saturday. Again, the results, of this study is based on a Phase I design and patients with refractory/relapse CD56-Positive Multiple Myeloma.

The key objectives, just as a reminder, for this study are to really identify the maximum tolerated dose or the recommended Phase II dose for future studies and to have a better idea about the safety profile and pharmacokinetics of this agent, as well as to look for early signs of clinical activity.

At the presentation on Saturday, 14 patients were presented. These patients have been treated at doses ranging from 40 milligrams to 112 milligrams per meter squared. And at this point, we have three active patients, two at 112 milligrams per meter squared and one at 90 milligrams per meter squared.

Again, the key objective of this study is to really identify the right dose for moving forward. And with this, we're looking mostly at the safety profile of the agent. Insofar, quite remarkably, we have seen no drug-related Grade 3 or Grade 4 adverse events.

We have seen a small number of Grade 1 and Grade 2 drug-related AE but none at 90 and so far, none at 112 milligrams per meter squared. And so, based on this, the plan is to move forward with further dose escalation as long as the last patient at the 112 milligram per meter squared dose continues to or would not have any evidence of dose-limiting toxicity.

The efficacy of the agent is also being investigated, though this study is not really designed to look for activity of the drug per se. We have seen early signs of activity on these two patients so far and the first patient is a 69-year old heavily pretreated patient.

And I should note that all the patients that have been enrolled on this study have already received greater than four prior therapies. So they have actually been a fairly heavily pretreated population of patients.

The first patient, again, was treated at 60 milligrams per meter squared, and has received now 15 cycles of therapy. And according to the European Bone Marrow Transplant response criteria did achieve a response with a decrease in both serum and urine paraprotein levels.

The second patient, just to highlight again, is a patient who is fairly heavily pretreated, and had received Velcade, Revlimid, arsenic trioxide and other standard approaches to multiple myeloma. This patient was treated at 90 milligrams per meter squared and after four cycles of treatment, again, had a response according to the European Bone Marrow Transplant criteria.

This patient then came off the study really for unrelated issues. The patient did have a bone fracture that needed to be managed and the patient was entered into a rehab program, and at that point was taken off study.

In summary, the Phase I study is still ongoing. Patients are being recruited at the current dose level, 112 milligrams per meter squared. N901 is being very well-tolerated in this patient population with really no safety concerns at all. There has been no evidence of bone marrow suppression or infusion related toxicities.

N901 is also showing early signs of activity in a very heavily pretreated population of patients that have failed essentially all standard approved therapies. And the plan at this point, is to continue the dose escalation to identify the recommended Phase II dose for future studies with this molecule.

Carol Hausner

John?

John Lambert

Good morning, everyone. This is Dr. John Lambert. I'll discuss the clinical findings reported with the TAP compound AVE9633 and with the naked antibody, AVE1642. Both of these compounds, as well as the TAP compound SAR3419 were initially developed by ImmunoGen and were advanced into clinical testing by Sanofi-Aventis.

So first, the AVE9633, it's a TAP compound, it comprises our CDE33-binding antibody and our DM4 cell-killing agent. It's in clinical development for the treatment of acute myeloid leukemia or AML. And the findings that were reported at ASH were from our Phase I dose escalation trial in patients with relapsed or refractory AML.

The trial design was that AVE9633 was given on Day 1 and Day 8 of a 28-day cycle or four week cycle. New cohorts of patients received increasingly higher doses of the drug until dose-limiting toxicity is reported. And the first cohort, which was 30 mgs per meter squared per week, included only one patient.

Thereafter, subsequent cohorts included three patients per dose level until dose-limiting toxicity was seen and that cohort could be expanded to up to six patients. A total of 17 patients received AV9633 in this study, doses ranging from 30 milligram to 150 milligram per meter squared per week.

First, the safety findings. Dose-limiting toxicity was seen at a 150 milligrams per meter squared per week. One patient had keratitis and one patient had elevated liver enzymes. A 150 milligrams per meter squared per week equates to about 4 milligrams per kilogram per week or 8 milligrams per kilogram per cycle and this is a substantial dose comparable to naked antibody levels, for example percept to this dose to 2 milligrams per kilogram on a weekly basis.

The compound was well tolerated and also this is consistent with study findings that AVE9633 had excellent stability while circulating in the blood stream. The most common side effects were infusion reactions, such as fever and chills and these tended to occur only in the first cycle. The plan is to treat three additional patients at the dose level of 130 milligrams per meter squared, which from looks like will be the maximum tolerated dose in this study.

Now regarding evidence of activity, there was evidence of biological activities seen in 7 of the 17 patients. One patient had a complete response with incomplete platelet recovery, know as a CRp. This patient was treated with 105 milligram per meter squared dose level. The patient hasn’t required blood transfusions since being on study and now after four cycles the patient has now on a once monthly maintenance treatment with AVE9633 and remains in CRp now for more than eight months.

Another patient had a positive response on the 130 milligram per meter squared dose level. The disease has since progressed after the third cycle. Four patients had a greater than 50% reduction in their bone marrow blasts. These occurred at doses ranging from 50 to 130 milligram per meter squared. And one patient had complete clearance of blasts from their blood during the first cycle of treatment at the dose level of 75 milligram per meter squared.

Regarding the antigen, it was reported in the poster that the CD33 antigen was saturated at doses starting at 50 milligram per meter squared. And the persistence of saturated depended on both the dose and the tumor burden. It was also noted that there was a drop in the level of saturation between day one and day eight, which suggests a more frequent dosing schedule will beneficial with this compound. And sanofi-aventis have got a study now underway examining the compound when dosed on days one, four and eight in a four-week cycle.

Now, turning to AVE1642. It's a naked antibody also initially developed at ImmunoGen and it's designed to bind to and block the IGF-1 receptor and thus prevent cancer cells from using this pathway to survive exposure to chemotherapeutic agents. So AVE1642 is intended to be used in combination with chemotherapy.

However, it's needed to be studied as monotherapy before it can be tested in combination for safety reasons and to establish the dose to be tested. And so, sanofi-aventis designed a study with two parts. In part one, sanofi-aventis evaluated the compound as monotherapy at three dose levels, 3, 6 and 12 milligrams per kilogram in patients with advanced multiple myeloma and these results were reported at ASH.

The antibody showed an acceptable safety profile indeed to really no safety concerns with this antibody. And from this part of the study they selected doses of 6 milligrams per kilogram and 12 milligrams per kilogram given every three weeks for further study in combination with Velcade in part two of the study and this is now underway.

In preclinical studies AVE1642 showed synergistic activity in combination with Velcade and this forms the basis for the part two of the study. Sanofi-aventis have also begun evaluation of AVE1642 for the treatment of solid tumors in combination with dose docetaxel chemotherapy.

Now I will turn the call back over to Carol.

Carol Hausner

Thanks, John. Operator, we are now ready to open the lines for questions.

Question-and-Answer Session

Operator

(Operator Instructions). We will take our first question from Brian Rye of Janney Montgomery.

Brian Rye - Janney Montgomery

Well, good morning and thanks for taking my questions. I guess a couple of things. First on a more general level, I was wondering if in the wake of all of the data that was presented from numerous companies in the multiple myeloma arena over the weekend. If you can perhaps talk about any update to the company's thoughts regarding how best to proceed or what setting in which to proceed with IMGN 901 in the myeloma setting in combination with Velcade into a Revlimid and sort of -- if this weekend's multitude of data presentation has changed the company's thinking in any way.

And secondly, looking at -- I guess previous data for C242 in a solid tumor and the AVE9633 data both have some vision issues that have popped up keratitis here. So, I think some visual acuity problems or an issue noted in the C242 Phase I study. I'm curious if there is any relationship or if you can provide just a bit more color on what’s maybe behind those observances?

Steve Whiteman

Ryan, this is Steve Whiteman. I'll be happy to at least address your first question. Obviously with the 901 in multiple myeloma, our first goal is really to finish the current Phase I study and hopefully also to gather some additional activity data as we complete that study. That's our first goal. But obviously looking down the road, which is very important for us as a company to know exactly where we are going. We are planning to really talk to a number of key thought leaders as well as to take a look at data ourselves. We are sort of envisioning at this point, multiple pathways forward, including single agent Phase II, but also combination Phase I studies as well, and in combination with what agent, I would leave that open at this point.

Obviously, we're well aware and looking at data with Velcade, Revlimid and other agents as well, but have not definitively selected an agent or honestly pathway forward yet. But, we are looking at that quite closely and are planning to have a number of key meetings, particularly with outside experts as well, in the first quarter of next year, to provide a little more definitive pathway forward.

Carol Hausner

And the question about keratitis, John, do you want to talk a bit about that?

John Lambert

Yes, I will be happy to make some comments on that. Yes, we have seen one case of keratitis in this AVE9633 reported by sanofi and we saw a few cases at high doses with huC242-DM4 or IMGN242 as it is now called.

I think it's still, I think, first I should say keratitis has proven to be -- it's not progressive, it's proven to be reversible, that's one thing. There are several issues of related factors that these are often elderly population, especially in the AML but that was reported by sanofi.

So, some of these elderly patients may be predisposed to seeing toxicity. For example, they frequently have dry eye syndrome and some of the patients, have actually had evidence of cataracts, too.

So it's not clear to us yet, there isn't enough data to say this will be a general phenomenon. I think the dose level of our Phase II in gastric cancer with the C242 compound, it looks like this has not really been a significant factor in toxicity and I would ask Steve to further comment on that.

Steve Whiteman

Yes, Brian, the only other comment I would make is, again, just to echo what John has just said and again with what we have seen, it appears to be reversible and rather easy to manage at this point, but it is something that we are continuing to monitor for and will be reevaluating as we go forward. But at this point we really don't see any concerns that are at the level not to proceed with what our plans are. And again everything seems to be manageable and reversible at this stage.

Brian Rye - Janney Montgomery

Okay. Thank you and appreciate the call.

Carol Hausner

All right.

Mitch Sayare

Brian, it’s Mitch, let me just step in here for a second and just refocus on the first question you asked just for a moment. We're of the view; I mean, Steve is absolutely right. We will be convening an expert group to help us through the process of evaluating the data and determining what the best courses for moving this product forward to the next step, be it a single agent studies or combination studies and we have a fair amount of detail and animal data that support specific combinations.

But I just want to say that the two responses that we have seen thus far in this patient population, at a dose at which we've shown no toxicity supporting the view that we can probably dose escalate this product and see what we can get as we do. To me it's quite compelling. We think we are in superb shape with this product and expect to be able to dose escalate and move it forward quickly. Our accrual rate is picking up. There is genuine excitement amongst investigators with this product if you stop by the poster, you would have, I am sure you saw that yourself and so we're actually quite excited about this and hope that we will be able to report data on further accruals as time goes on.

Brian Rye - Janney Montgomery

Great. Thanks, Mitch.

Operator

And our next question comes from Joel Sendek from Lazard Capital Markets.

Joel Sendek - Lazard Capital Markets

Thanks. So a follow-up on that question with regard to 901, I guess, two parts. First, is there a possibility that you would go higher then 112, as you continue to escalate, given the benign toxicity, so far, maybe not in this trial or maybe in a separate or an extension study? Then I have a question about the future as well.

Steve Whiteman

Sure, Joe. Absolutely, I mean the design of this study is that we would continue escalating the dose until by protocol defined criteria we would get to a point where we'll just simply not be safe to go any higher. So and right now at the 112-dose we have not seen anything at all that would preclude us from escalating the dose higher.

Though again, I just would state that we have one-additional patient to be treated at 112 before making that final decision. But again, if that last patient at 112 again continues to show that this is extremely well-tolerated, even at the 112-dose, we would go higher.

Joel Sendek - Lazard Capital Markets

Okay. Great. That's helpful. And then, looking to the future, you've given that type of timeframe with an uncertain number of dose escalations, could you still get data for us, maybe by ASCO of next year or is that open-ended at this point?

Steve Whiteman

It's probably open-ended, I mean, clearly we'll have more data from the current study, Phase I study. But after that, I think we will have to take a look at the data and see where we are at that point. So it would be somewhat open-ended after that.

Joel Sendek - Lazard Capital Markets

Okay. And then with regard to the combinations, potential combination usage obviously you need to see more data and meet with your advisors there, but I'm wondering regarding a potential partnership with this drug, could that play into it as well, when you choose who your partner might be, and what drugs they happen to have available or do you want to get the product further along in your hands before you enter into a discussion like that? What's your philosophy on that?

Mitch Sayare

So, are you saying that we want to do a deal with Millennium or [sanofi] now or later, is that the question that you are asking?

Joel Sendek - Lazard Capital Markets

Yeah, pretty much yes. Can I rephrase it, Mitch?

Mitch Sayare

Yeah, so the answer is later. We want to develop data and get an understanding of what this all looks like before we make any decisions about who’s best to collaborate with.

Joel Sendek - Lazard Capital Markets

Sorry to interrupt, I guess the other idea is maybe, is moving forward with that as a single agent is still a possibility and not partnering it, but then you have to pay for yourself so that brings in that element of the strategy.

Mitch Sayare

Yeah, there is no question about it, we have it budgeted this year in our budget to move this product forward by ourselves and as Steve mentioned, we are looking at a number of different therapeutic modalities, single agents, as well as combination and I should point out that even if we decide to go combination it doesn't mean necessarily that we would collaborate in a meaningful way with whoever the manufacture of that other agent is, it’s [sanofi], Millennium if you remember. Typically one wouldn't be too fast and we may not, so since both are approved therapies.

So it remains to be seen, we have, to put it plainly, Joel, we just haven't made any decisions on that. For the moment, we're carrying it forward by ourselves and are quite happy to collect data until such time, as we can command a meaningful value for this product with a good hard data.

Joel Sendek - Lazard Capital Markets

Okay. Great.

Mitch Sayare

Sure.

Operator

We'll take our next question from Shiv Kapoor, Ferris, Baker Watts.

Shiv Kapoor - Ferris, Baker Watts

Thanks for taking my question. I've got a couple of questions on IMGN901. It seems like you've got an excellent safety profile there and you will continue to dose IMGN901 higher.

I'm wondering what the implications are of the safety on a couple of things. One, could you start a lung cancer trial -- a small cell lung cancer trial with higher doses? It seems like you're almost three times higher than where you saw the dose level being popped earlier. So could you comment on that, please?

Mitch Sayare

Let us just clarify a couple of things and I'll hand it over to Steve. This is Mitch. So we have two ongoing small cell lung cancer studies. One, 60 mgs per meter squared weekly every per four weeks in a six-week cycle, the other, once a day dosing for three days in a 21-day cycle.

As far as I can tell, neither of those -- you're right, neither of those delivers as much drug in a three-week period as the overall three myeloma study does, dosing patients once a week for two weeks in a three-week cycle.

And so it would be lovely if we could go back to either the other two studies and boost the drug dosage. And the 001 study at 60 per four weeks in a six-week cycle is too late. That MTD has been established though it's clear, the protocol is defined, and is there nothing we can do about it, including things like pre-treating the patients and slowing down the infusion rate, which has worked effectively in 002 and 003?

In 002, we haven't reached MTD yet and so the possibility certainly exists to improve or increase the drug concentration for that product. It's pretty unlikely, that we would change the mode of infusion, once a day for three days, given that it's pretty much a Cmax study as we've discuss. And we're getting a lot of useful information out of that compared with what we see in the 003, in the 001 studies dosing patients on a weekly schedule.

So, we haven't actually specifically addressed this question, Shiv. And I'll turn it over to Steve when I am finished here but as I've or up to me and it's not. We're worried. I think we're just going to move forward with 002 and 003 as we are doing and see what we get. Steve?

Steve Whiteman

I think that's fair. And again, I would just highlight the fact that it would be 002 study. We are planning to escalate that dose higher as well. So we're not fixed on a dose yet for 002.

And I think, I've to take a look at the results after all those studies are end, but right now, the 001 study is the weekly study 60 is not planned or designed right now to escalate or change that does at this point.

Shiv Kapoor - Ferris, Baker Watts

Okay. So second question on 901, it's good that you -- we have got safety now on the drug, however, it seems like you can escalate for, you can keep on escalating from here that might actually postpone the initiation of the next steps, sort of the next trial with either Bortezomib or Revlimid. What’s your current thinking on, when we can see these any initiation on Phase II trial with this compound in multiple myeloma?

John Lambert

I mean, at this point we still need to follow through with the 003 study to identify that dose what would go into a Phase II single agent or Phase I combination. And again obviously it’s important because the time we spent on that now were actually shortened the development cycles later on where if we don’t have the right dose now, we will end up I’ll say paying for it later on when we are doing either a combinations or single agents study.

So, it is critical at this point to, I’ll say follow through with that and identify the dose where that will be, I think it’s only a speculation. We're believing that we are getting into a pretty good range right now and clearly want to see activity as well as toxicity profiles at the current dose and higher doses before making any definitive plan as far as our next step in our development strategy. But we essentially just need to follow through with it and identify what that dose is going to be.

Shiv Kapoor - Ferris, Baker Watts

Okay.

Mitch Sayare

Can I just, it's Mitch again, Shiv.

Shiv Kapoor - Ferris, Baker Watts

Sorry.

Mitch Sayare

You probably don’t want to hear from me, because I have, but anyhow at 112 that’s about 3 mg/kg and which I should remind you Genentech saw some fairly substantial responses in Herceptin DM1, 6 out of 16 at 3.6 mg/kg. So we're getting into a range, where you would expect to see activity albeit it's completely different product and disease, but nevertheless we're pretty optimistic here.

Shiv Kapoor - Ferris, Baker Watts

Wonderful. Do you know what the next dose level might be after 112?

John Lambert

I believe it's 140.

Shiv Kapoor - Ferris, Baker Watts

I see.

John Lambert

Milligrams per meter squared.

Shiv Kapoor - Ferris, Baker Watts

One last question on AVE9633, has that and just a clarification, has the second Phase I that's evaluating the drug three times for recover 28-day cycle, has that already started?

John Lambert

Yeah.

Shiv Kapoor - Ferris, Baker Watts

And when should we expect results from that?

John Lambert

Yes, it has started. I mean in the end you would have to ask sanofi-aventis for when, I mean.

Steve Whiteman

Yeah, that's the answer?

John Lambert

And I should also say that besides this is both the US and Europe. So they have at least got quite a number of sites active in this, to try to get the data as quickly as possible. But in the end you would, it's really a question for that clinical development, not ours.

Shiv Kapoor - Ferris, Baker Watts

Okay. Just kind of reference point, can you tell us how many sites are they enrolling now versus the prior Phase I?

John Lambert

I think 5, but I'm not 100% certain of that.

Shiv Kapoor - Ferris, Baker Watts

Okay. I will follow-up. Thanks a lot.

Steve Whiteman

Sure.

Operator

Our next question comes from Robert Manning.

Robert Manning

Just help me, I have a little bit of color on the degree of excitement around in 901 at this point, I know, you partly answered this. But if I understand correctly, if the 90 milligrams per meter squared level and up 4 out of 5 had stable disease. None have progressed well under treatment, none of those four the three still being on treatment and one dropping out because of the fracture.

Can you give us any color just as to how impressive that is? As a layman I looked at all of the other abstracts I could find on antibodies versus multiple myeloma and the only thing that looks comparable in terms of the excitement, or in terms of the numbers, was a combination of a [CN-2328] with Velcade, which of course is a combination rather than a monotherapy. But to me is lay person this is so really impressive, but I am just wondering what you can tell us about it, how impressive it is compared to all the other stuff going on that you know about against multiple myeloma. Thanks.

Carol Hausner

Steve, yes.

Steve Whiteman

Robert, I think we are very excited about it because again when you put everything into the mix, this is a very heavily pre-treated patient population that essentially failed standard approved therapies to see even disease stabilization in this population of patients that tend to be progressive and having an accelerated disease at this stage to have stable disease, I think it's very encouraging and very reassuring that we are on the right path going forward.

I think our excitement is also around the fact that the drug is so well tolerated at these doses and that we could increase the dose even further with the potential for seeing even better signs of activity. It's also, I think something, that I would highlight. So, I would reassure you and sort of reemphasize your level of excitement, I think it has matched mine here as well.

Robert Manning

Thanks.

Steve Whiteman

You're welcome.

Operator

At this time, we have no further questions. I would like to turn the conference back over to Ms. Hausner, for any closing or final remarks.

Carol Hausner

Let me thank you for your interest this morning and as always you can call me at 617-995-2500 with additional questions. Take care. Bye-bye.

Operator

That does conclude today's conference. We thank you for your participation, please have a good day.

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