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ImmunoGen, Inc. (NASDAQ:IMGN)

Business Update Call

December 11, 2007 10:00 am ET

Executives

Carol Hausner - ExecutiveDirector of IR and Corporate Communications

Steve Whiteman - Acting MedicalDirector

John Lambert - Sr. VP ofPharmaceutical Development

Mitch Sayare - CEO

Dan Junius - CFO

Analysts

Brian Rye - Janney Montgomery

Joel Sendek - Lazard CapitalMarkets

Shiv Kapoor - Ferris, Baker Watts

Robert Manning

Operator

Good day, and welcome everyone tothis ImmunoGen conference call. At this time, for opening remarks andintroductions, I would like to turn the call over to the Executive Director ofInvestor Relations and Corporate Communications, Carol Hausner. Please goahead.

Carol Hausner

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

During today's call, we'll makeforward-looking statements. Our actual results may differ materially from the projectionsmade. Descriptions of the risks and uncertainties associated with an investmentin ImmunoGen are included in our SEC filings, which can also be accessedthrough our website, www.immunogen.com.

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

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

Steve Whiteman

Thank you, Carol, and goodmorning. This is Dr. Steve Whiteman, and he’s just going to cover the keypoints 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 withrefractory/relapse CD56-Positive Multiple Myeloma.

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

At the presentation on Saturday,14 patients were presented. These patients have been treated at doses rangingfrom 40 milligrams to 112 milligrams per meter squared. And at this point, wehave three active patients, two at 112 milligrams per meter squared and one at90 milligrams per meter squared.

Again, the key objective of this studyis to really identify the right dose for moving forward. And with this, we'relooking 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 Grade1 and Grade 2 drug-related AE but none at 90 and so far, none at 112 milligramsper meter squared. And so, based on this, the plan is to move forward withfurther dose escalation as long as the last patient at the 112 milligram permeter squared dose continues to or would not have any evidence of dose-limitingtoxicity.

The efficacy of the agent is alsobeing investigated, though this study is not really designed to look foractivity of the drug per se. We have seen early signs of activity on these twopatients so far and the first patient is a 69-year old heavily pretreatedpatient.

And I should note that all thepatients that have been enrolled on this study have already received greaterthan four prior therapies. So they have actually been a fairly heavilypretreated population of patients.

The first patient, again, wastreated at 60 milligrams per meter squared, and has received now 15 cycles oftherapy. And according to the European Bone Marrow Transplant response criteriadid achieve a response with a decrease in both serum and urine paraproteinlevels.

The second patient, just tohighlight again, is a patient who is fairly heavily pretreated, and hadreceived Velcade, Revlimid, arsenic trioxide and other standard approaches tomultiple myeloma. This patient was treated at 90 milligrams per meter squaredand after four cycles of treatment, again, had a response according to theEuropean Bone Marrow Transplant criteria.

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

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

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

Carol Hausner

John?

John Lambert

Good morning, everyone. This isDr. John Lambert. I'll discuss the clinical findings reported with the TAP compoundAVE9633 and with the naked antibody, AVE1642. Both of these compounds, as wellas the TAP compound SAR3419 were initially developed by ImmunoGenand 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 inclinical development for the treatment of acute myeloid leukemia or AML. And the findingsthat were reported at ASH were from our Phase I dose escalation trial inpatients with relapsed or refractory AML.

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

Thereafter, subsequent cohorts included threepatients per dose level until dose-limiting toxicity was seen and that cohort couldbe expanded to up to six patients. A total of 17 patients received AV9633 inthis study, doses ranging from 30 milligram to 150 milligram per meter squaredper week.

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

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

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

Another patient had a positiveresponse on the 130 milligram per meter squared dose level. The disease hassince 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 to130 milligram per meter squared. And one patient had complete clearance ofblasts from their blood during the first cycle of treatment at the dose levelof 75 milligram per meter squared.

Regarding the antigen, it wasreported in the poster that the CD33 antigen was saturated at doses starting at50 milligram per meter squared. And the persistence of saturated depended onboth the dose and the tumor burden. It was also noted that there was a drop inthe level of saturation between day one and day eight, which suggests a morefrequent dosing schedule will beneficial with this compound. And sanofi-aventishave 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 anaked antibody also initially developed at ImmunoGen and it's designed to bindto and block the IGF-1 receptor and thus prevent cancer cells from using thispathway to survive exposure to chemotherapeutic agents. So AVE1642 is intendedto be used in combination with chemotherapy.

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

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

In preclinical studies AVE1642showed synergistic activity in combination with Velcade and this forms thebasis for the part two of the study. Sanofi-aventis have also begun evaluationof AVE1642 for the treatment of solid tumors in combination with dose docetaxelchemotherapy.

Now I will turn the call backover to Carol.

Carol Hausner

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

Question-and-Answer Session

Operator

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

Brian Rye - Janney Montgomery

Well, good morning and thanks fortaking 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 fromnumerous companies in the multiple myeloma arena over the weekend. If you canperhaps talk about any update to the company's thoughts regarding how best toproceed or what setting in which to proceed with IMGN 901 in the myelomasetting in combination with Velcade into a Revlimid and sort of -- if thisweekend's multitude of data presentation has changed the company's thinking inany way.

And secondly, looking at -- Iguess previous data for C242 in a solid tumor and the AVE9633 data both havesome vision issues that have popped up keratitis here. So, I think some visualacuity problems or an issue noted in the C242 Phase I study. I'm curious ifthere is any relationship or if you can provide just a bit more color on what’smaybe 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, ourfirst goal is really to finish the current Phase I study and hopefully also togather some additional activity data as we complete that study. That's ourfirst goal. But obviously looking down the road, which is very important for usas a company to know exactly where we are going. We are planning to really talkto 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, includingsingle agent Phase II, but also combination Phase I studies as well, and incombination with what agent, I would leave that open at this point.

Obviously, we're well aware andlooking at data with Velcade, Revlimid and other agents as well, but have notdefinitively selected an agent or honestly pathway forward yet. But, we arelooking at that quite closely and are planning to have a number of keymeetings, particularly with outside experts as well, in the first quarter ofnext 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 somecomments on that. Yes, we have seen one case of keratitis in this AVE9633reported by sanofiand we saw a few cases at high doses with huC242-DM4 or IMGN242 as it is nowcalled.

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

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

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

Steve Whiteman

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

Brian Rye - Janney Montgomery

Okay. Thank you and appreciatethe call.

Carol Hausner

All right.

Mitch Sayare

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

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

Brian Rye - Janney Montgomery

Great. Thanks, Mitch.

Operator

And our next question comes from JoelSendek from Lazard Capital Markets.

Joel Sendek - Lazard Capital Markets

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

Steve Whiteman

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

Though again, I just would statethat we have one-additional patient to be treated at 112 before making thatfinal decision. But again, if that last patient at 112 again continues to showthat this is extremely well-tolerated, even at the 112-dose, we would gohigher.

Joel Sendek - Lazard Capital Markets

Okay. Great. That's helpful. Andthen, looking to the future, you've given that type of timeframe with anuncertain number of dose escalations, could you still get data for us, maybe byASCO 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 afterthat, I think we will have to take a look at the data and see where we are atthat point. So it would be somewhat open-ended after that.

Joel Sendek - Lazard Capital Markets

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

Mitch Sayare

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

Joel Sendek - Lazard Capital Markets

Yeah, pretty much yes. Can I rephraseit, Mitch?

Mitch Sayare

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

Joel Sendek - Lazard Capital Markets

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

Mitch Sayare

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

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

Joel Sendek - Lazard Capital Markets

Okay. Great.

Mitch Sayare

Sure.

Operator

We'll take our next question fromShiv 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 anexcellent safety profile there and you will continue to dose IMGN901 higher.

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

Mitch Sayare

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

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

And so it would be lovely if wecould go back to either the other two studies and boost the drug dosage. Andthe 001 study at 60 per four weeks in a six-week cycle is too late. That MTDhas been established though it's clear, the protocol is defined, and is therenothing we can do about it, including things like pre-treating the patients andslowing down the infusion rate, which has worked effectively in 002 and 003?

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

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

Steve Whiteman

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

And I think, I've to take a lookat the results after all those studies are end, but right now, the 001 study isthe weekly study 60 is not planned or designed right now to escalate or changethat 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 seemslike you can escalate for, you can keep on escalating from here that mightactually postpone the initiation of the next steps, sort of the next trial witheither Bortezomib or Revlimid. What’s your current thinking on, when we can seethese any initiation on Phase II trial with this compound in multiple myeloma?

John Lambert

I mean, at this point we stillneed to follow through with the 003 study to identify that dose what would gointo a Phase II single agent or Phase I combination. And again obviously it’simportant because the time we spent on that now were actually shortened thedevelopment cycles later on where if we don’t have the right dose now, we willend up I’ll say paying for it later on when we are doing either a combinationsor single agents study.

So, it is critical at this pointto, 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 apretty good range right now and clearly want to see activity as well astoxicity profiles at the current dose and higher doses before making anydefinitive plan as far as our next step in our development strategy. But weessentially just need to follow through with it and identify what that dose is goingto 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 hearfrom me, because I have, but anyhow at 112 that’s about 3 mg/kg and which Ishould remind you Genentech saw some fairly substantial responses in HerceptinDM1, 6 out of 16 at 3.6 mg/kg. So we're getting into a range, where you wouldexpect 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 thenext 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, hasthat and just a clarification, has the second Phase I that's evaluating thedrug three times for recover 28-day cycle, has that already started?

John Lambert

Yeah.

Shiv Kapoor - Ferris, Baker Watts

And when should we expect resultsfrom that?

John Lambert

Yes, it has started. I mean inthe 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 thatbesides this is both the USand Europe. So they have at least got quite anumber 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 referencepoint, can you tell us how many sites are they enrolling now versus the priorPhase 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 alot.

Steve Whiteman

Sure.

Operator

Our next question comes fromRobert Manning.

Robert Manning

Just help me, I have a little bitof color on the degree of excitement around in 901 at this point, I know, youpartly answered this. But if I understand correctly, if the 90 milligrams permeter squared level and up 4 out of 5 had stable disease. None have progressedwell under treatment, none of those four the three still being on treatment andone dropping out because of the fracture.

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

Carol Hausner

Steve, yes.

Steve Whiteman

Robert, I think we are veryexcited about it because again when you put everything into the mix, this is avery heavily pre-treated patient population that essentially failed standardapproved therapies to see even disease stabilization in this population ofpatients that tend to be progressive and having an accelerated disease at thisstage to have stable disease, I think it's very encouraging and very reassuringthat we are on the right path going forward.

I think our excitement is alsoaround the fact that the drug is so well tolerated at these doses and that wecould increase the dose even further with the potential for seeing even bettersigns of activity. It's also, I think something, that I would highlight. So, Iwould reassure you and sort of reemphasize your level of excitement, I think ithas matched mine here as well.

Robert Manning

Thanks.

Steve Whiteman

You're welcome.

Operator

At this time, we have no furtherquestions. I would like to turn the conference back over to Ms. Hausner, forany closing or final remarks.

Carol Hausner

Let me thank you for yourinterest this morning and as always you can call me at 617-995-2500 withadditional questions. Take care. Bye-bye.

Operator

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

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