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ImmunoGen, Inc. (IMGN)
F4Q 2013 Results Earnings Call
August 2, 2013 8:00 AM ET
Carol Hausner - Executive Director, Investor Relations and Corporate Communications
Dan Junius - Chief Executive Officer
Greg Perry - Chief Financial Officer
Dr. Charlie Morris - Chief Development Officer
Simos Simeonidis - Cowen and Company
Adnan Butt - RBC Capital Markets
Matthew Harrison - UBS
Yigal Nochomovitz - Morgan Stanley
Mara Goldstein - Cantor Fitzgerald
Jason Kantor - Credit Suisse
Joel Sendek - Stifel
Thomas Wei - Jefferies
Matt Lowe - JP Morgan
David Miller - Biotech Stock Research
Ryan Martins - Lazard Capital Market
Previous Statements by IMGN
» Immunogen Inc. (IMGN) Management Discusses Q4 2013 Results (Webcast)
» ImmunoGen's Management Presents at Goldman Sachs 34th Annual Global Healthcare Conference (Transcript)
» ImmunoGen's Management Presents at Credit Suisse Antibody Day Conference (Transcript)
» ImmunoGen's CEO Discusses F3Q 2013 Results - Earnings Call Transcript
At this time for opening remarks and introductions, I would like to turn the call over to Executive Director, Investor Relations and Corporate Communications, Carol Hausner. Please go ahead.
Thank you. Good morning. At 6:30 this morning, we issued a press release that summarizes our financial results for our fourth quarter and fiscal year ended June 30th. I hope you’ve all had a chance to review it, if not it’s available on our website.
During today’s call, we will make forward-looking statements. 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, which also can be accessed through our website.
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’ll then open the call to questions. Our Chief Development Officer, Dr. Charlie Morris is here for the Q&A section of the call. Dan?
Thank you, Carol, and good morning, everybody. It’s a pleasure to give you an update for our year end activity and what we’ve seen over the last several months. This includes notable progress, advancing and expanding a line of exciting wholly-owned compounds. With the first full quarter of activity, we are seeing strong update of Kadcyla with additional markets and indications expected, and there are multiple compounds moving to and through the clinic from our partners.
Let me start with the detailed update on 901 which is our lead product candidate. We are developing this in combination with etoposide/carboplatin for first-line treatment of small-cell lung cancer. This is a major unmet need globally. In the U.S. alone there are approximately 28,000 diagnoses every year.
We are currently looking at it for first-line therapy where under the existing therapies in median progression-free survival is 5.5 months with median overall survival of nine to 11 months. The treatment paradigm here has been unchanged for decades.
We are currently accessing IMGN901 in our NORTH randomized Phase II trial. Happy to report here that the pace of patient enrollment is very encourage. This allows me to tell you that we are on track to complete enrollment here by the end of this quarter.
Completing it on that pace should give us the data by mid-2014 to determine the development course of IMGN901. With the decision to invest in full development that would include preparations for the manufacturing of pivotal materials, beings with regulatory agencies, design of registration study, et cetera.
We’ll report this development decision once it’s been made and we plan to report the underlying clinical findings behind that decision at our medical conference as soon as practical thereafter.
I’d like to say we can report this data, we’ll be read to report the data at ASCO 2014 and completing enrollment this quarter with open that possibility, but it is too early to make that commitment. But we are very encouraged here with the pace of enrollment.
For IMGN853, remember this is for solid tumors that highly expressed the fully receptor alpha, that would include ovarian cancer, endometrial cancer and adenocarcinoma non-small cell lung cancer. These are cancers of high unmet need with few options today for platinum resistant ovarian cancer and relapsed endometrial cancer.
We had our first data reported at ASCO this past June. This is from -- for the dose-escalation phase which was design to establish maximum tolerated dose. We tested a variety of levels from 0.15 mg/kg to 7 mg/kg with patients dosed every three weeks. Remember this being a dose-escalation phase we saw a very diverse set of patients. They had different type cancers, different levels of target expression, a variety of prior therapies.
In this dose-escalation phase while we did see evidence of activity which is always a good sign, all were in patients with strong target expressions treated at doses starting at 3.3 milligrams per kilogram or higher.
In one patient, ovarian cancer patient we had a confirm CA-125 response, this patient also had stable disease with six cycles. The patient had 12 prior treatment regiments, three of which were platinum based. In a patient with platinum resistant ovarian cancer, there was an unconfirmed partial response after two cycles and again a CA-125 decrease.
And finally, in a patient with endometrial cancer there was an unconfirmed partial response after four cycles, the CA-125 decrease. This is a patient who had two prior [taxcin] and platinum regiments.
We did encounter a dose limiting toxicity at 7 mg/kg. This is blood vision which is reversible at toxicity that seen with a variety of agents. As a result, we are evaluating 853 and lower doses, dose adjustment has been successful in addressing this condition with other agents.