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Executives

Carol Hausner – Executive Director, IR & Corporate Communications

Dan Junius – President & CEO

Greg Perry – SVP & CFO

Analysts

Joel Sendek – Lazard Capital Markets

Bret Holley – Oppenheimer

Ling Wang – Brean Murray

Jason Kantor – RBC Capital Markets

Shiv Kapoor – Morgan Joseph

Pamela Bassett – Cantor Fitzgerald

David Miller – Biotech Stock Research

ImmunoGen, Inc. (IMGN) F2Q10 (Qtr End 12/31/09) Earnings Call Transcript January 28, 2010 4:30 PM ET

Operator

Good day, and welcome everyone to the ImmunoGen second quarter fiscal year 2010 earnings results conference call. Today’s call is being recorded. At this time for opening remarks and introductions, I would like to turn the call over to the Executive Director, Investor Relations and Corporate Communications, Carol Hausner. Please go ahead.

Carol Hausner

Thank you. Good afternoon. At 4 o'clock this afternoon we issued a press release that summarizes our financial results for the quarter ending December 31st, 2009, which is the second quarter of our 2010 fiscal year. I hope you have all had a chance to review it. If not it is available on our website. During today’s call, we will 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 also can be accessed through our website, immunogen.com.

In our call today, our Chief Executive Officer, Dan Junius, will provide an update on ImmunoGen, and our Chief Financial Officer, Greg Perry, will discuss our financial results and guidance. We will then open the call to questions. Dan.

Dan Junius

Thank you, Carol, and good afternoon everyone. Thank you for joining us today. The opening quote in our press release this quarter indicated that this is possibly

ImmunoGen’s most significant quarter to date, and it is a statement that was not made lightly. I think in the quarter our technology achieved a new level of validation. We saw significant clinical progress across our product portfolio, both our own products as well as our partners with more visibility coming next year, and we have reached a level of unprecedented interest in our TAP technology.

In my comments, I would like to focus on three dimensions to support our excitement about our progress. First, the clinical data reported with multiple TAP compounds demonstrating activity and safety in solid and liquid tumors. I also want to comment on the tracking towards our first marketed TAP compound, and also how we and our partners are driving deeper and broader clinical progress.

Let me start in going back and talking about the activity and safety that we are seeing in solid and liquid tumors with our TAP compound, and I will start with T-DM1 given that is the most visible compound and the data that they have generated in third-line metastatic breast cancer.

This came out of the San Antonio Breast Cancer Symposium in December. It was a poster presentation that was then changed to an oral discussion session. So, something of an upgrade there, and what it showed was continued compelling activity for this compound. An objective response rate of 32.7% was reported. This coming out of independent radiologic review and this is for patients previously treated with herceptin, taxane, anthracycline, Tykerb and Xeloda, and actually the median of prior drugs treated for metastatic breast cancer was seven. So a heavily pretreated population.

In talking about the objective response rate, it is worth noting that Tykerb plus Xeloda achieved an objective response rate of 23.7, and this was in second-line metastatic breast cancer. The clinical benefit rate, which pulls in patients, who had stable disease of at least six months, was 44.5%, and again this coming from independent review. While progression-free survival and duration of response data is not yet mature, it is expected to be reported in an upcoming medical meeting.

We heard at SABCS that it would probably be reported in March, and what they did disclose is an interim PFS of 7.3 months. Complementing the compelling activity is the tolerability of the compound. Thrombocytopenia was the most common grade 3 and 4 adverse event at 5.5% of patients. They continue to note a lack of clinically significant cardiac changes, and no association with neutropenia or other side-effects that would limit the ability to study T-DM1 in combination or in earlier stage patients.

Moving on to IMGN901, wholly owned by ImmunoGen, we reported findings in solid tumors at AACR-NCI-EORTC in November, specifically in metastatic Merkel cell carcinoma. Of the six patients reported, we had one complete response. This patient has been in remission for over four years. We have a partial response in a patient who continues to improve, with the potential to become a CR and that was after one treatment cycle, and stable disease, in a patient that was receiving IMGN901 fourth line. This patient came into the study with bone metastasis or the patient was very advanced, very advanced cancer.

This is a very difficult disease, metastatic Merkel cell. There are no approved treatments in the median survival for these patients when diagnosed in 6.8 months. So we view this activity to be pretty exciting. I should note that we earlier reported data on 901 in small cell lung cancer, a cancer that shares characteristics with metastatic Merkel cell, and here we reported a 25% clinical benefit rate but that includes patients with objective responses and extended stable disease.

We also recently reported data on 901 in liquid tumors, specifically in multiple myeloma, where we reported encouraging findings in heavily pretreated patients at ASH in December. The data from this comes from the dose escalation phase of this study. The study has now achieved MTD, so we are at the expansion phase, but the patients reported and received a median of six prior regimens. Out of this study, we had four objective responses and significant stable disease.

And of note, a significant proportion of patients in this study remained on IMGN901 longer than it has been on their last regimen of approved drugs. We also over the last quarter reported data or it was reported by partners on SAR3419 and BTO62 and those being in development by Sanofi-Aventis, and Biotest respectively. While they showed encouraging efficacy and safety in treatment of non-Hodgkin lymphoma and multiple myeloma respectively.

So, just to summarize this element, collectively these data support our position that our TAP technology can achieve effective new treatments for solid and liquid tumors. And equally importantly the safety of our TAP technology continues to be impressive. It supports using very advanced patients such as third-line metastatic breast cancer, second-line treatment of small cell lung cancer and metastatic Merkel cell carcinoma, and also supports expanded use either in an earlier stage cancer and/or as part of combination regimens.

The second point I referenced is how we're tracking towards our first marketed TAP compound. In here Genentech has noted that they plan to discuss T-DM1 data with the FDA. This is consistent with previous statements that if third line data are compelling, they will discuss earlier approval pathways with the FDA. There is a potential for filing in the first half of 2010 and approval by late 2010.

Now this would be in the US as they have indicated that filing in Europe is targeted for 2012 and would be based on their Phase III trial, EMILIA, in the second-line study. I think this is great news for patients, and obviously a defining event for ImmunoGen and if approved would bring our TAP technology into the mainstream of cancer treatment. So, very significant from our standpoint.

The last point I referenced is how between ImmunoGen and our partners we are achieving deeper and broader clinical progress. Here again I will start with Genentech, whose is implementing pivotal trials to take T-DM1 into earlier stages of breast cancer. You have the potentially pivotal trial in third-line metastatic breast cancer as discussed. They have initiated a Phase III trail in second-line metastatic breast cancer. That is the EMILIA study that has been underway for about a year now, and at San Antonio, we learnt that they plan to start a Phase III trial in first-line metastatic breast cancer in mid-2010.

Along that same line, they noted that enrolment is completed in the first line Phase II study, and we can expect interim findings to be submitted for presentation at a medical meeting this year. Also disclosed at San Antonio by one of their investigators is that the protocol for adjuvant use is near completion.

Now this isn’t confirmation that there will be going into adjuvant therapy, but I think it is an encouraging step on that path that there is focus on what a protocol would look like for that line of treatment. We have others getting deeper into clinical progress, including ImmunoGen. We are exploring initiation of an IMGN901 pivotal test in 2011, most likely in Merkel cell carcinoma, and we also have Sanofi-Aventis with SAR3419 expecting to advance into Phase II in the second half of this year.

Our TAP compound have advanced that they are now being assessed as part of combination regimens in addition to monotherapy. This is directly attributable to our TAP technology achieving targeted activity and having a favorable toxicity profile. We don't see bone marrow suppression or other side-effects that can limit the ability to combine.

And clinical findings to date indicate that this is an important differentiation of our approach. T-DM1 is now being tested with approved agents taxol and taxotere, as well as with experimental therapies for pertuzumab and PI3Kinase inhibitor. The first line Phase III trial that we will be starting shortly will have a T-DM1 monotherapy arm or herceptin plus taxane arm, which is the current standard of care, but also a T-DM1 plus pertuzumab arm. So, we will get a look in that particular study at what we can see from T-DM1 in combination.

We also should be seeing over the course of the year, hopefully combination data from some of Roche’s earlier combination studies. For IMGN901 patient enrolment is open in our multiple myeloma combination study, and the development plan in solid tumors may include evaluation as part of a combination regimen in small cell lung cancer.

That would allow us to evaluate it as first-line treatment. The tolerability seen to date as well as preclinical data support combination studies in both multiple myeloma and in small cell lung cancer. And finally in terms of our pipeline broadening, we expect to see six – we have six clinical stage compounds today, and we expect that each will have clinical data reported this year in 2010.

Our expectation is that that clinical pipeline will increase to 8 in the next several months with the advancement of two more compounds from Sanofi-Aventis. Finally, we expect at least three more compounds to enter the clinic in 2011 through our partners, and we should also see solid progress with our own preclinical pipeline. We are working to bring an ImmunoGen proprietary compound into the clinic in late 2011.

So, all of this makes for an exciting time at ImmunoGen. We have the potential for strong milestone payments and even the start of royalty payments by late 2010. We are generating exciting clinical data across a broad and exciting pipeline. These findings are fuelling unprecedented interest in our technology by major pharmaceutical firms, and most importantly, we are seeing our technology getting to the point where it is making a real difference for patients in cancer.

So with that, let me turn it over to Greg to review our financials.

Greg Perry

Thank you, Dan. Our net loss for the second quarter 2010 fiscal year was $13 million or $0.23 a share compared to $7.1 million or $0.14 a share for the same quarter last year. This change in our net loss was attributable to lower revenue as anticipated.

Our second quarter revenues were lower than in the same quarter last year, some 3.1 million versus 9.3 million respectively. The biggest driver of this difference was that our revenues last year, included a 4 million milestone payment.

Our expenses in the second quarter of this fiscal year were in line with the same quarter last year, 16.1 million versus 16.4 million respectively. We finished this quarter with 52.4 million of cash. While the first six months of fiscal year 2010 were consistent with our expectations, we're updating our guidance for our full 2010 fiscal year to reflect changes in the expected timing of certain milestone payments and expenses going forward.

For example, a milestone payment we expected to receive in the fourth quarter of our 2010 fiscal year is now expected to be received early in our 2011 fiscal year. At the same time, we are accelerating certain investments in IMGN901 clinical supplies into our 2010 fiscal year to ensure that availability of these materials doesn't limit the aggressive clinical program we are implementing. Our updated guidance for our 2010 fiscal year is that our net loss for this year will be between 53 million and 56 million, that our cash used in operations will be between 38 million and 41 million, and that we will end this fiscal year with cash and marketable securities of 33 million to 35 million.

A couple of comments when looking at our projections regarding our cash usage and end of year cash balance. We haven't included in these projections any major new deals. That is because there is just too much inherent uncertainty around the magnitude and timing of such deals to include them in our guidance. Also, we expect our cash usage to peak in our fiscal year ending June 30, 2010, and then start to decline primarily because of increased milestone payments.

We are seeing a high level of interest in our products and our technology, and we are pleased that Amgen has now taken a second license to use our technology. We are committed to ensuring that we do the right deals, ones that fully recognize the substantial value of our technology and products. Dan.

Dan Junius

Thank you, Greg. Let me just walk through some of the activity that we are looking for over the first and second half of calendar 2010, and these really are highlights as opposed to an exhaustive list. For T-DM1 in third-line metastatic breast cancer, we expect to have updated PFS and duration of response data at an upcoming medical conference, as well as plans regarding regulatory fillings in the US.

And finally also in the first half it is our expectation that we will see a filing in the US for marketing approval. In other trials for T-DM1 we look for initiation of the Phase III trial in first-line metastatic breast cancer around midyear, and then over the course of the year, we look for clinical data presentations. For example, the first-line metastatic breast cancer Phase II may be a first or second half event that is not entirely clear.

For IMGN901, we look in the first half to provide the development plan that we are putting in place for solid tumors, and then for IMGN388 and the biogenetic compound, BIIB015, we will see the first clinical data on those compounds at ASCO this year.

In terms of preclinical or actually with the initiation of a new clinical study, we will see the first of the Sanofi-Aventis preclinical compounds moving into the clinic in the first half of this year. And as Greg noted, in terms of business development, we do expect that we will see business development activity over the course of the year, timing and scope difficult to predict.

Moving on to the second half of 2010, the second of the Sanofi-Aventis preclinical compounds would be entering the clinic. I noted the non-Hodgkin lymphoma compound the target CD19, SAR3419 should be initiating Phase II clinical testing sometime in the second half of the year, and then we look with IMGN388 to see initiation of up to two additional clinical trials.

In solid tumors, we would look to report clinic data for IMGN901, with the report findings in Merkel cell carcinoma, small cell lung cancer, ovarian cancer from the expansion phase of the study that is currently underway. And we also would expect to initiate a disease specific trial in solid tumors in the second half of this year.

Staying with IMGN901 for multiple myeloma, we would look to report clinical data from the expansion phase of the monotherapy study. This would be in patients, who are less heavily pretreated, and also have the first clinical data from the combination study.

In the back half of this year, it is our expectation based on the data that has been generated thus far that we would see regulatory approval for T-DM1 in third-line use, and then for a number of compounds both T-DM1, SAR3419 and BTO62 we would see additional clinical data reported as well as potentially other studies started.

I think over the course of the back half of the year, you will begin to hear about some of the compounds that we expect to see entering the clinic in 2011. Those would be both ImmunoGen compounds, some of the work we have been doing in our pipeline as well as from our partners.

As Greg noted, we look for strong milestone payments in the back half of a year from partners, and again business development activity it is certainly a potential in the back half of the year as well.

So with that report having been given let me turn it back over to Carol to start the Q&A.

Carol Hausner

Thanks, Dan. We are about to open the call to questions. We do want to ask that each question asker limit their questions to 1 to 2 per person, until each of our analysts have had a chance to ask questions. We will certainly allow you to come back on and ask additional questions. Operator, we are now ready to open the line.

Question-and-Answer Session

Operator

Thank you. (Operator instructions) We will take the first question from Joel Sendek from Lazard Capital Markets.

Joel Sendek – Lazard Capital Markets

Hi. Thanks a lot. I have two kind of related questions on IMGN901. I guess the first is what are your plans for pivotal testing in 2011? Can you give us any sense of whether it's Merkel or myeloma, or what kind of design it will be or what are the contingencies to be able to initiate that pivotal trial? And then a finance related question in 901, you mentioned you are going to move forward with investments in clinical supplies. I'm just wondering how, you know, given the change in your guidance, it seems like those are pretty expensive investments. It is puzzling to me it would cost that much, if you can just give us some more clarity on that. Thanks.

Dan Junius

Hi, Joel. This is Dan. I think the first half of that question. Then Greg will get you – will respond to the second part. The path that we are exploring is in solid tumors and specifically in Merkel cell. We can't provide some of the definition around trial design, et cetera because that is some of what we're exploring at this point. What is going to look like, we're initiating discussions with regulatory authorities to get a sense of what is going to be acceptable as a pivotal study in this type of an orphan indication, but knowing that there is, that there is a clear unmet medical need with this patient population, and the data we generated thus far, it has us encouraged that this can be an accelerated pathway for 901 into that patient population.

Joel Sendek – Lazard Capital Markets

And just to be clear, that is calendar 2011, not fiscal 2011?

Dan Junius

That would be calendar 2011. So, yes.

Joel Sendek – Lazard Capital Markets

Okay.

Dan Junius

While that – so, sometime I would hope to see – it actually it would be potentially booked calendar and fiscal. So, you know, the first half of calendar 2011 is what we would be looking to.

Joel Sendek – Lazard Capital Markets

Okay.

Greg Perry

And on the, Joel on the financial side the change in the net loss guidance is about $9 million, and little less than half of that was associated with expense, which again was primarily driven by investment and clinical supply and that would be cytotoxic agent, a linker, and the antibody production.

Joel Sendek – Lazard Capital Markets

Okay. All right, thanks.

Operator

We will now take the next question from Bret Holley from Oppenheimer.

Bret Holley – Oppenheimer

Yes, hi. Thanks for taking the question. Just, I guess, a follow up to Joel's question. I just wanted to understand what you are looking for in the extension phase of the ongoing trial in Merkel cell as kind of a go/no-go, for going into pivotal. Obviously, you have pretty high activity there and I am just wondering, are there gating factors in the ongoing trial in Merkel cell?

Dan Junius

Well, I think that what we look for there Bret is you know, we think that the data has been very good, and it correlates because of the nature of the disease look small cell, but by the same token it is six patients. And so, I think we want to get a little bit deeper into the study, get some further confirmation of the activity part of the expansion phase, before we plunge into a study. Given that you’ve got especially a rare disease, enrollment is a concern although I would have to say because of the data that we've generated thus far, we actually are pretty happy with the number of patients that we are seeing that will allow us to conduct that study and get that conforming data that we are looking for.

Bret Holley – Oppenheimer

And by confirming data, are you looking for additional complete responses? And how do the doses compare for the six patients you already dosed and gotten the three pretty robust responses? How does the dosing in the extension compare in those patients?

Dan Junius

Well, none of them were at the MTD. There were all below MTD. So, it wasn't necessarily a, you know, a dose-related response. What we look for – we'd be happy to see complete responses, but given the fact that we’ve got such a short median survival time for patients once diagnosed, if we can generate even a compilation cost what we are seeing thus far with PR, CR, and stable disease that would be a significant benefit to the patient population that's there. So I don't think we need to – and also some of this will come out of what the discussion is with regulators.

I don't think that I want to get decided in this discussion, where the bar is going to be set. I think we need that dialogue to go forward to say what would be acceptable from both the trial design, and what they're not going to necessarily – we're not looking necessarily for a spot as to have them define what the approval level would be, but I think the dialogue will provide us some guidance here.

Bret Holley – Oppenheimer

Can I ask one more question, is on Genentech. Given the number of ADC kind of programs that they have, are you a bit surprised that beyond T-DM1 it has taken a while for the next set of candidates to enter into the clinic, and are those part of the candidates will enter the clinic in 2011?

Dan Junius

Yes, I'm not going to comment on where the candidates would come from, Bret. I mean, it is a fair question, but I think that would be premature on my part. Am I surprised, you know, we worked with them over the course of really six years to get T-DM1 into the clinic, and we know that from a process standpoint, that they are very thorough, they are very deliberate, and once they bring something into the clinic, while that doesn't make them right all of the time, they’ve generally done their homework pretty well and the T-DM1 results certainly speak to that. So from that standpoint, I guess you know, in one sense maybe I would be surprised, because I think we see other partners behave differently but they've got a methodology, and it seems to have worked pretty well for them. So it is tough to argue with.

Bret Holley – Oppenheimer

Okay. Fair enough. Thanks for the questions.

Operator

We'll now take the next question from Ling Wang from Brean Murray.

Ling Wang – Brean Murray

Hi. Thank you for taking my questions. So, the first one is with regard to Genentech's discussion with FDA. I was wondering whether you are aware of you know, the timeline for them to have the discussion, and whether they need to wait for – to see the mature PFS or DOR data before they do that. And, also, my second question, is that – you mentioned adjuvant, the protocol for adjuvant – in adjuvant breast cancer setting, I was wondering whether that sort of you know, Genentech initiated effort for that protocol? Thank you.

Dan Junius

In response to your first question, you know, I suppose it is moot whether we know or we don't because we couldn't say either way, but in terms of waiting for duration of response in PFS, appreciate that the data that they presented in San Antonio had a data cut off of I think it was mid-September.

So their disclosure of what that data is will lag probably considerably from when the data is available to them. So I don't know, whether they have that data at a mature phase or not, but you know, by the end of December, they may have known what they needed to know about PFS and DOR. It simply wasn't available at the cut off time to prepare their poster. So you know, my guess is I just don't know. They may have it, they may not, but I just don't – you shouldn't confuse timelines for disclosure with when data would be available to them. The comment on adjuvant therapy, I repeat the question. I know with adjuvant, but I can't remember what exactly you want to get out on that.

Ling Wang – Brean Murray

Right. You mentioned that the protocol for adjuvant setting was almost complete. I was wondering whether that is some kind of – I mean, I just don't know whether that is what Genentech is collecting feedback from –

Dan Junius

Sure, okay. Yes, and here again that's something we don't have, we don't have insight into the particulars there, but I would think that if investigators working on the Phase II study, the Genentech sponsored Phase II for third line are the ones disclosing what they're doing around a protocol for a Genentech-Roche sponsored therapy. I would expect that the sponsor would be involved in that dialogue. I don't know that, but it only seems to me to be common sense that they would do that because again to the day if such a trial is going to be conducted, the material is going to have to come from the sponsor, and so I would expect that they would be party to those discussions, but I can't confirm that.

Ling Wang – Brean Murray

I see. Thank you. Thanks.

Operator

We'll now take the next question from Jason Kantor with RBC Capital Markets.

Jason Kantor – RBC Capital Markets

Thanks for taking my question. I was on and off, so some of this might have been already covered. But you talk about this timeline for filing and potential approval of T-DM1. This is the timeline that Genentech outlined you know, well over a year ago, I think. Is your information based on something that is new, or are you just reiterating what has been said, or is there new information driving that guidance?

Dan Junius

It's reiterating that guidance Jason, and we can't see anything that would contradict it is the way I would put it.

Jason Kantor – RBC Capital Markets

Okay. And are you responsible, are they responsible for the commercial material, and is that ready to go, if you were to get approval this year?

Dan Junius

We're not responsible for – recall that back in early 2006 right around the time they initiated their first Phase I. They contracted with us to put together a manufacturing process that they could then transfer to a CMO. That work was done and completed in, I believe it was early 2007, and has been available and implemented by Genentech's CMO, and so the material that they’ve used for everything after their non-pivotal studies.

So, you know, so that would be after the initial Phase I and the first Phase II that was non-pivotal is pivotal material coming from sources that they have in place that there are you know, fully capable of making material for them. Again, because this is now – that is a source that's controlled by Genentech, we don't have visibility into where that is, except that given the breath of the trials underway they are producing material at some level of volume and given the amount of time that they've had to get processes and supply chains in place, my guess is that that's well along.

Jason Kantor – RBC Capital Markets

And does your guidance contemplate a milestone payment for approval and potentially some initial sales, or is that just all upside?

Greg Perry

That was – as we discussed on the last quarterly call would be fiscal year 2011 event.

Jason Kantor – RBC Capital Markets

Got you, okay.

Operator

We'll now take the next question from Shiv Kapoor of Morgan Joseph.

Shiv Kapoor – Morgan Joseph

Good afternoon. Thanks for taking my questions. Let's start with – can you give us some more color on why you have lowered your guidance? Has there been a slight delay in the milestone? Is this milestone related to a specific partner, or is this a clarification on the milestone?

Greg Perry

You know the – as I mentioned, in terms of the net loss change, which is about 9 million, a little more than half of that is associated with timing on a milestone, which shifts from our second half of fiscal year 2010 to first half of fiscal year 2011. So that is related to certain milestones, and again we think that that is principally timing.

Little less than half of that is associated with some expense, and again that is related to pulling in some clinical supply material expense associated with IMGN901. The milestones that we are talking about are not related in any way to T-DM1.

Shiv Kapoor – Morgan Joseph

Okay. One thing that we haven't covered in this call as much is prospects for any more collaborative deals this year. Do you still expect some collaborative deals this year, and can you give us some color on whether this could be earlier compound in the clinic?

Dan Junius

(inaudible)

Greg Perry

Well, in terms of technology deals, we haven't – we haven't been specific on it, Shiv, just because these processes sort of have their own rhythm to them and pace. We have noted a couple of times that there is of late strong interest in the technology. And so, we are engaged in working with people that understand it and see what the depth of it is and how that can be structured in a way that works for both parties.

At the same time, there is also interest in clinical compounds, particularly IMGN901. 388 as you know, has – there is already an opt-in provision with Centocor, but 901 with the data that has been generated there, it is something that has attracted some interest and we just have to see how that evolves, whether that is something that works its way to a partnership that again meets our needs and interests and those of a prospective partner.

Shiv Kapoor – Morgan Joseph

Thanks.

Dan Junius

But, specific, is it this year, is it next year. It will be as quickly as we can prudently move these along to both parties benefit, and if that turns out to be this year, well that is great. If it takes until next year, we will deal with that.

Shiv Kapoor – Morgan Joseph

All right. Thanks.

Operator

We will now take the next question from Pamela Bassett with Cantor Fitzgerald.

Pamela Bassett – Cantor Fitzgerald

Hi. Thanks for taking my questions. Congratulations on the progress. Actually, most of my questions have been answered. Just a follow-up to the partnering question, could you lay out what your strategy is for partnering in 901, and are you going to hold back on additional indications, pursuing additional indications until you partner that?

Dan Junius

It probably won’t be an indication split on partnering, Pamela. I think that as we look at 901.

Pamela Bassett – Cantor Fitzgerald

Actually, I'm sorry, I wasn't thinking about split, I was thinking more about funding.

Dan Junius

Well, we may – it may impact the pace at which we attack certain things, and I think that will be dictated as data is generated over the next, over these trials over the next year. When we think about 901 and partnering, you know, that is one of the issues that comes into play, because you have got so many indications to pursue, to intelligently and aggressively pursue it, you have got – you are going to need significant resources to do that, and potentially global resources.

So that is one avenue that is part of our thinking as we look at how we develop 901, and where our partners fit into this strategy. The other side of it is how a deal gets put together and what our ongoing role is. We would like to be able to taking a position of continuing to participate in the development of a compound, because we do think it does offer real opportunity. It also helps us develop capability within the organization that can benefit us long-term.

So, people shouldn't be thinking of the avenue that we would pursue with 901 as coming out with a deal that assembles a technology deal that we might do. We recognize that this is a clinical asset. There is significant clinical data that has been developed at the Phase II ready compound, and we think it makes a pretty compelling case for the right partner.

Pamela Bassett – Cantor Fitzgerald

Is it fair to say that you would want to partner this before you finalize a pivotal trial design?

Dan Junius

Not necessarily. We will continue to – we don't want to – I don't want to see the organization slow down its development of 901. And frankly, one of the reasons that we began engaging partners or potential partners in discussions on 901 was to feasibility test the attractiveness of the compound, as well as the development plan that we are putting in place.

I think if we were to hold off putting a development plan in place for Merkel cell for example, that would simply, that would – we would lose some momentum with the compound, and that is something I simply don't want to do. I think that now that we're on a path for generating good data, we want to be able to continue to move this forward on really as rapidly a pace as we can organizationally support, and as we can financially support. So, we will try to keep all those in balance, but I think if you were to ask for priorities around 901, it would lean more heavily on the solid tumor side given that the level of unmet need and would on liquid tumors, if we had to make some tradeoffs in development. That is probably where there will be made.

Pamela Bassett – Cantor Fitzgerald

Okay, great. Thanks very much.

Operator

We will now take the next question from David Miller from Biotech Stock Research.

David Miller – Biotech Stock Research

Good afternoon, and thanks for taking my questions. The first question I have is on the Merkel cell patients that have response, did they receive any subsequent therapy?

Dan Junius

Not at this point. The two were we have seen an objective response, the long-standing CR has not received further therapy nor has the patient with the partial response. The patient who came off the study because it would have achieved stable disease, I don't know what the further therapy was there.

David Miller – Biotech Stock Research

Okay. What were the MTDs for 901?

Dan Junius

Well, there were somewhat different between the solid tumor study and the multiple myeloma study. You know, and they were sort of little bit of, I will say, a mixed bag David. We saw things such as back and neck pain, fatigue, so it was an amalgam of VLTs as opposed to a singular type of deal.

David Miller – Biotech Stock Research

Right. What were the doses, though, for solid and liquid?

Dan Junius

The liquid tumor was at 112. But the dosing for multiple myeloma is a little different than it is for solid tumors. So multiple myeloma it is every week. It is two weeks in a three-week cycle, and there were at 112 mg per meter squared. And solid tumors it is daily for three days in a 21-day cycle, and that is at 75 mg per meter squared. So over a three-week cycle, you are really delivering the same amount of 901, in both studies but under different dosing regimens.

David Miller – Biotech Stock Research

Okay. And then as a follow-up to Pamela's question, I want to make sure I understand your answer correctly, do I understand it correctly that you would not launch any pivotal 901 trial without a partner?

Dan Junius

No, if that was what you heard that is not what I intended to convey. We are moving forward and at this point it looks like it would be a potentially pivotal Phase II in Merkel cell, and that is where we are devoting both regulatory and clinical resources to examine some of the issues associated with being able to do that. But it is not contingent on a partner.

David Miller – Biotech Stock Research

Okay. So, would it be accurate to say that you would move forward with a Merkel pivotal on your own, but for some of the other indications you would want a partner?

Dan Junius

Well, I think if you start talking about a pivotal study for small cell that gets to be an entirely different issue. We may do a Phase II to explore some of the potential for 901 in combination in small cell, but I think that the – the road gets pretty steep, when you start talking about a pivotal study in small cell. And so we have to think long and hard about that.

David Miller – Biotech Stock Research

Okay. All right. Thanks for taking my questions.

Operator

And at this time, there are no questions. I will turn the call back to Ms. Hausner.

Carol Hausner

Great. Thank you very much. We like to thank you for your interest, and if you have any additional questions you are free to call us at 781-895-0600. Take care.

Operator

This does conclude today's conference call. We thank you for your participation.

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Source: ImmunoGen, Inc. F2Q10 (Qtr End 12/31/09) Earnings Call Transcript
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