Cancer Therapies Stock News Bites: ImmunoGen (NASDAQ: $IMGN) Reports Recent Progress and 2019 Financial Results
Accelerated Approval Pathway Defined for Mirvetuximab Soravtansine in Ovarian Cancer; Pivotal SORAYA Trial Expected to Enroll First Patient in Q1 2020
Phase 3 Confirmatory MIRASOL Trial for Mirvetuximab Enrolling Patients
Updated IMGN632 AML and BPDCN Monotherapy Data Presented at ASH
$97.6 Million Net Proceeds from Public Offering Extends Cash Runway to Second Half of 2022
February 14, 2020 (Investorideas.com Newswire) Investorideas.com (www.investorideas.com) Cancer Therapies Stock News Bites- WALTHAM, Mass - ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today reviewed recent progress in the business and reported financial results for the quarter and year ended December 31, 2019.
"Following the results of FORWARD I, we moved decisively to restructure the business to reduce our costs, prioritized our portfolio to focus on our most promising programs, and worked constructively with FDA to define an accelerated path to approval for mirvetuximab," said Mark Enyedy, ImmunoGen's President and Chief Executive Officer. "With the benefit of these steps, we have emerged from a challenging year with significant momentum driven by the start of our registration program for mirvetuximab in platinum-resistant ovarian cancer and continued progress with our portfolio of early-stage products. In particular, we have enrolled the first patient in the confirmatory MIRASOL Phase 3 trial for mirvetuximab, presented clinical data at ASH in December demonstrating IMGN632's encouraging anti-tumor activity and favorable tolerability in patients with AML and BPDCN, and, most recently, raised roughly $98 million in a follow-on offering to strengthen our balance sheet."
Enyedy added, "We enter 2020 with a number of important upcoming milestones to drive value in the business. For mirvetuximab, these include opening our pivotal SORAYA trial in the first quarter, continuing to enroll MIRASOL, initiating an additional combination study in platinum-sensitive disease, and presenting data from our platinum-agnostic and platinum-sensitive combination studies. Building upon the encouraging data we reported in 2019, we will continue to advance IMGN632 in the clinic and look forward to presenting BPDCN and MRD+ monotherapy and AML combination data this year. In addition, we expect the IND for IMGC936, our novel ADAM9-targeting ADC, to be filed during the first half of the year. With these catalysts ahead, we look forward to a productive next twelve months."
- Received guidance from the U.S. Food and Drug Administration (FDA) that SORAYA, a new single-arm study in platinum-resistant ovarian cancer, could support accelerated approval for mirvetuximab.
- Enrolled the first patient in our confirmatory Phase 3 MIRASOL trial.
- Presented preclinical combination data and updated clinical monotherapy data for IMGN632 with additional patients enrolled in acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN) expansion cohorts at the American Society of Hematology (ASH) Annual Meeting in December.
- Continued enrollment for IMGN632 monotherapy in Phase 1 expansion cohorts in patients with AML, BPDCN, relapsed acute lymphocytic leukemia (ALL), and minimal residual disease positive (MRD+) AML patients following frontline induction therapy.
- Advanced IMGN632 combination therapy studies with Vidaza®(azacitidine) and Venclexta® (venetoclax) in relapsed/refractory unfit AML patients.
- Progressed investigational new drug (IND)-enabling activities for IMGC936, a novel ADAM9-targeting ADC in co-development with MacroGenics.
- Outlicensed our epithelial cell adhesion molecule (EpCAM)-targeting Probody™-drug conjugate to CytomX in exchange for an upfront fee and milestone and royalty payments.
- Raised $97.6 million in a follow-on offering completed in January.
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