ImmunoGen, Inc. (NASDAQ:IMGN) Q3 2018 Earnings Conference Call Transcript

Nov 02, 2018 • 08:00 am ET

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ImmunoGen, Inc. (NASDAQ:IMGN) Q3 2018 Earnings Conference Call Transcript

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Presentation
Operator
Operator

Good day and welcome everyone to this ImmunoGen third quarter 2018 financial 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 Sarah Kiely, IR and Corporate Communications. Please go ahead.

Executive
Sarah Kiely

Good morning and thank you for joining today's call. Earlier today, we issued a press release that includes a summary of our recent progress and third quarter 2018 operating results. This press release and a recording of the call can be found under the Investors and Media section of our website at immunogen.com.

On the call, today are our President and CEO, Mark Enyedy; our CMO, Anna Berkenblit; and our CFO, Dave Johnston. Rich Gregory, our CSO will join the team for the Q&A session. During today's call, we will highlight key recent accomplishments and review third quarter financial results and upcoming milestones.

(Forward-Looking Cautionary Statements)

With that, I'll now turn the call over to Mark.

Executive
Mark Enyedy

Thank you, Sarah. Good morning everyone and thank you for joining us today. With the completion of enrollment in our pivotal FORWARD I study, ImmunoGen entered the next stage in our transition to a fully integrated biopharmaceutical company. In particular, during the third quarter, we initiated the activities required to support a BLA filing and launch mirvetuximab to treat patients with platinum-resistant ovarian cancer. These efforts have included completing the product validation runs for drug substance with drug product anticipated for stability testing before year end, establishing the operational metrics and resources necessary to ensure timely readout on the primary endpoint of FORWARD I and moving ahead with pre-launch commercial planning to drive market uptake post-approval. In parallel, we continue to execute towards our other strategic objectives. Beyond the anticipated monotherapy indication, we plan to position mirvetuximab as a preferred partner for combination therapy in ovarian and other cancers.

Last month, we presented favorable tolerability and encouraging anti-tumor activity from the FORWARD II expansion cohort of mirvetuximab in combination with Merck's anti-PD -1 therapy, Keytruda in platinum-resistant disease at ESMO.

With these latest results in hand, we have now reported data this year on more than 100 patients who received mirvetuximab in combination with Avastin, carboplatin or Keytruda. Our investigator community has expressed a high degree of enthusiasm for these mirvetuximab combinations and we will use their input and our data to guide the next steps to expand the label from mirvetuximab in multiple treatment setting.

We are also evaluating our novel IGN ADCs IMGN 779 and IMGN 632 in patients with hematological malignancies. Data from both of these Phase 1 programs have been accepted for oral presentations at ASH next month and preclinical data from 632 will also be presented during poster sessions at the meeting.

Looking beyond our clinical assets, we are making rapid progress with our research portfolio. We have initiated IND enabling activities for IMGC936, our novel ADAM9-targeting ADC program being developed in collaboration with MacroGenics. ADAM9 is expressed on a range of solid tumors