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ImmunoGen, Inc. (IMGN)
Q3 2018 Earnings Conference Call
November 2, 2018 08:00 AM ET
Sarah Kiely - Investor Relations and Corporate Communications
Mark Enyedy - President and CEO
Anna Berkenblit - Chief Medical Officer
Dave Johnston - Chief Financial Officer
Rich Gregory - Chief Scientific Officer
Jonathan Chang - Leerink Partners
Debjit Chattopadhyay - H.C. Wainwright
John Newman - Canaccord
Andy Hsieh - William Blair
Kennen MacKay - RBC Capital Markets
Jessica Fye - JPMorgan
Boris Peaker - Cowen
Joseph Catanzaro - Piper Jaffray
Good day, and welcome, everyone, to this ImmunoGen Third Quarter 2018 Financial Results Conference Call. Today's call is being recorded.
Previous Statements by IMGN
» ImmunoGen, Inc. (IMGN) CEO Mark Enyedy on Q2 2018 Results - Earnings Call Transcript
» ImmunoGen's (IMGN) CEO Mark Enyedy on Q1 2018 Results - Earnings Call Transcript
» ImmunoGen's (IMGN) CEO Mark Enyedy on Q4 2017 Results - Earnings Call Transcript
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 the 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 Chief Medical Officer, Anna Berkenblit; and our CFO, Dave Johnston. Rich Gregory, our Chief Scientific Officer, 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.
During the discussion, we will use forward-looking statements, and our actual results may differ materially from such statements. Descriptions of the risks and uncertainties associated with an investment in ImmunoGen are included in our SEC filings.
With that, I'll now turn the call over to Mark.
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 filling and launch mirvetuximab to treat patients with platinum-resistant ovarian cancer. These efforts have included completing the product validation run 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 end point of FORWARD I, and moving ahead with prelaunch 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 planned to position mirvetuximab as a preferred partner for combination therapy and 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, and platinum-resistant disease at ESMO. With these latest results in hand, we have now reported data this year of more than 100 patients who have 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 settings.
We were also evaluating our novel IGN ADCs, IMGN779 and IMGN632 in patients with hematological malignancies. Data from both of these Phase I programs have been accepted for oral presentations at ASH, next month, and preclinical data from 632 will also be presented during post-recession 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, including non-small cell lung, triple negative breast, gastric and pancreatic cancers, and we expect this program to be the next product candidate that we advance into the clinic.
In addition, we presented preclinical data relating to our epithelial cell adhesion molecule, EpCAM-targeting Probody drug conjugate at the European Antibody Congress in October. This EpCAM-targeting PDC, integrated CytomX's PROBODY technology, which enables the selection of targets previously thought to be in compatible with ADC development due to high normal tissue expression. We look forward to sharing more details on this program as it advances.
So significant progress with the business over the last quarter, and an exciting moment in ImmunoGen's evolution as we prepare for our pivotal readout in the first half of 2019.
With that, I’ll turn the call over to Anna to review our clinical progress in more detail. Anna?
Thank you, Mark. In addition to our primary objective of bringing mirvetuximab to market as a single agent therapy for women with platinum-resistant ovarian cancer, we are evaluating mirvetuximab combination regimens in our FORWARD II study to expand the eligible patient population and move mirvetuximab into earlier lines of treatment for ovarian cancer.
As a reminder, FORWARD II is our Phase Ib2 study of mirvetuximab in combination with Avastin or KEYTRUDA, in patients with folate receptor alpha positive platinum-resistant ovarian cancer. As part of FORWARD II, we are also enrolling a triplet combination cohort of mirvetuximab plus carboplatin and Avastin in patients with recurrent platinum-sensitive ovarian cancer. We're making excellent progress with the triplet cohort and expect to complete enrollment of this cohort by the end of the year with initial data in mid-2019.
Earlier this year, at ASCO, we reported data demonstrating encouraging activity from the expansion cohort evaluating mirvetuximab in combination with Avastin in over 50 patients with folate receptor alpha positive platinum resistant ovarian cancer. Based on these promising results, we are planning to initiate a new expansion cohort in the FORWARD II study to evaluate mirvetuximab plus Avastin further in patients with recurrent ovarian cancer. We expect to open this cohort in the first quarter of 2019.