ImmunoGen Reports Recent Progress and 2020 Financial Results

Rhea-AI Summary

ImmunoGen Inc. (Nasdaq: IMGN) reported significant progress and financial results for the year ended December 31, 2020. CEO Mark Enyedy highlighted transformative advancements, including the pivotal SORAYA and MIRASOL trials for mirvetuximab soravtansine, and the Breakthrough Therapy designation for IMGN632. The company added over $140 million to its balance sheet in Q4, positioning itself for potential product launches in 2022. Upcoming milestones include top-line data in Q3 2021 and submissions for biologics licenses.

Positive

• Added over $140 million to balance sheet in Q4 2020.
• Progress in pivotal SORAYA and MIRASOL clinical trials.
• Received Breakthrough Therapy designation for IMGN632.
• Expecting top-line data for mirvetuximab in Q3 2021.

Negative

• None.

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, 2020.

“Despite the challenges of the pandemic, 2020 was a transformative year for ImmunoGen, as we adjusted to new ways of working, accelerated our portfolio, strengthened our management team and balance sheet, and positioned the business for two potential product launches next year,” said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. “Within our portfolio, we advanced accrual in the pivotal SORAYA and confirmatory MIRASOL trials for mirvetuximab soravtansine in patients with ovarian cancer to support our projected timelines for top-line data and regulatory submissions. In addition, we established a second registration program with our CD123-targeting ADC, IMGN632, for which we received Breakthrough Therapy designation and aligned with FDA on a path to full approval in BPDCN. Furthermore, we began dosing patients in the Phase 1 study of IMGC936, our first-in-class ADAM9-targeting ADC for solid tumors, and transitioned IMGN151, our next-generation FRα-targeting ADC, into preclinical development. Finally, through a combination of business development and activity under our ATM facility, we added over $140 million to our balance sheet in the fourth quarter.”

Enyedy continued, “With the benefit of our progress in 2020, we enter this year with significant momentum and strong prospects for the business. For mirvetuximab, these include completing enrollment in SORAYA and reporting top-line pivotal data in the third quarter, followed by a planned BLA submission by the end of the year. With IMGN632, we expect top-line pivotal data in BPDCN in 12 to 18 months and anticipate sharing data from our Phase 1b/2 study of IMGN632 in combination with azacitidine and/or venetoclax in AML patients at ASH in December. We also anticipate completing dose escalation in the clinical study of IMGC936, with initial data late this year or early 2022. Finally, we expect to submit the IND for IMGN151 by year-end. Taken together, our pivotal programs, experienced management team, and strong balance sheet position us well to execute on our strategy and transition ImmunoGen to a fully-integrated oncology company with two products on the market in 2022.”

RECENT PROGRESS

• Continued patient enrollment in the pivotal SORAYA and confirmatory MIRASOL trials.
• Advanced our partnership with Huadong Medicine, having received acceptance of the investigational new drug (IND) application for mirvetuximab in China from the National Medical Products Administration (NMPA).
• Aligned with the US Food and Drug Administration (FDA) on a path to full approval for IMGN632, amending our ongoing 801 Phase 1/2 study with a new pivotal cohort of up to 20 frontline blastic plasmacytoid dendritic cell neoplasm (BPDCN) patients.
• Presented updated safety and efficacy findings from the Phase 1/2 expansion study of IMGN632 in patients with relapsed/refractory (R/R) BPDCN during an oral session at the American Society of Hematology (ASH) Annual Meeting in December. Our collaborators at MD Anderson Cancer Center also presented preclinical data at ASH in R/R acute myeloid leukemia (AML) that further support the combination of IMGN632 with Vidaza^® (azacitidine) and Venclexta^® (venetoclax).
• Advanced patient accrual in the Phase 1 dose-escalation study evaluating IMGC936, our novel ADAM9-targeting ADC in co-development with MacroGenics.

UPCOMING EVENTS

• Complete patient enrollment in SORAYA, with top-line pivotal data expected in the third quarter of 2021, and submit the biologics license application (BLA) by the end of 2021 to support potential accelerated approval in 2022.
• Complete patient enrollment in MIRASOL, with top-line data expected in the first half of 2022.
• Present mature data from the Phase 1b FORWARD II cohort evaluating mirvetuximab in combination with Avastin^® (bevacizumab) in platinum agnostic, recurrent ovarian cancer at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.
• Support initiation of two investigator-sponsored trials of mirvetuximab plus carboplatin, including a randomized Phase 2 study in recurrent platinum-sensitive ovarian cancer and a neo-adjuvant study.
• Enroll patients in the pivotal cohort of the 801 Phase 1/2 study of IMGN632 in frontline BPDCN patients and generate top-line data in 12 to 18 months.
• Advance the 802 Phase 1b/2 study of IMGN632 in combination with azacitidine and venetoclax in R/R and frontline AML patients and as a monotherapy in minimal residual disease positive (MRD+) AML following frontline induction therapy.
• Present updated R/R BPDCN and initial AML c

FAQ

What were ImmunoGen's financial results for the quarter ended December 31, 2020?

ImmunoGen reported significant progress and ended the year with a strengthened balance sheet, adding over $140 million in Q4.

What is the status of the SORAYA trial for mirvetuximab?

Patient enrollment in the pivotal SORAYA trial is ongoing, with top-line data expected in the third quarter of 2021.

What major milestones does ImmunoGen expect in 2021?

ImmunoGen anticipates completing enrollment in SORAYA, submitting a BLA by the end of 2021, and generating top-line data for IMGN632 in 12 to 18 months.

What designation did IMGN632 receive from the FDA?

IMGN632 received Breakthrough Therapy designation from the FDA.