Immunogen (NASDAQ: IMGN) reported Q3 EPS of ($0.25), $0.01 worse than the analyst estimate of ($0.24). Revenue for the quarter came in at $11.4 million versus the consensus estimate of $20.95 million.

Pipeline Updates

Mirvetuximab soravtansine, a potential new therapy for many cases of ovarian cancer as well as for endometrial cancer and other solid tumors that highly express folate receptor α (FRα); wholly owned by ImmunoGen.

• This ADC now has received orphan designation in ovarian cancer in the EU as well as in the US.
• Initial findings with mirvetuximab soravtansine – used as a single agent – to treat FRα-positive platinum-resistant ovarian cancer will be presented at the 2015 ASCO Annual Meeting. The data are from a disease-specific Phase 1 cohort. ImmunoGen plans to initiate a Phase 2 trial in this indication by the end of 2015 that could potentially support an accelerated registration pathway.
• ImmunoGen also plans to initiate in 2H2015 assessment of mirvetuximab soravtansine used in combination regimens for ovarian cancer.
• Assessment of mirvetuximab soravtansine for the treatment of FRα-positive relapsed/ refractory (R/R) endometrial cancer is ongoing. ImmunoGen is preparing to also assess it for FRα-positive R/R non-small cell lung cancer.
• In addition to the every three week dosing schedule being used in the disease-specific testing underway, dose-finding with a weekly dosing regimen is advancing. The findings to date also have been accepted for presentation at ASCO.

IMGN529, a potential new treatment for B-cell malignancies; wholly owned by ImmunoGen.

• Once the recommended Phase 2 dose is established, ImmunoGen plans to evaluate it specifically for the treatment of R/R diffuse large B-cell lymphomas (DLBCL) and chronic lymphocytic leukemia.
• Preclinical findings with IMGN529 used with rituximab (Rituxan®) will be reported at the International Conference on Malignant Lymphoma in Lugano in June 2015. ImmunoGen is planning to initiate a clinical trial to assess the combination.
• The next IMGN529 clinical data presentation(s) are targeted for the ASH annual meeting in December.

Indatuximab ravtansine (BT-062), a CD138-targeting ADC for multiple myeloma and certain solid tumors; wholly owned by Biotest; ImmunoGen holds rights to opt-in with Biotest on joint US development and commercialization.

• Phase 2 trial ongoing in multiple myeloma; Phase 1 trial ongoing in triple-negative breast cancer and metastatic urinary bladder cancer.

Coltuximab ravtansine (SAR3419), a potential therapy for DLBCL and other B-cell malignancies; demonstrated encouraging activity in the treatment of R/R DLBCL in STARLYTE Phase 2 trial presented at ASCO 2014 and selected for Best of ASCO.

• ImmunoGen recently regained the rights to this promising ADC from Sanofi.

IMGN779, CD33-targeting ADC utilizing one of ImmunoGen’s DNA-acting payload agents; a potential treatment for acute myeloid leukemia and myelodysplastic syndrome; wholly owned by ImmunoGen.

• Remains on track for IND submission in 2H2015.

IMGN289, EGFR-targeting ADC, wholly owned by ImmunoGen.

• The Company has stopped Phase 1 testing and returned the program to research.

Genentech/Roche’s ado-trastuzumab emtansine (Kadcyla®), which uses ImmunoGen’s ADC technology.

• Approved in the US, Europe, and other geographies based on the results from the EMILIA Phase 3 trial; in development by Roche for a number of indications, with data from the MARIANNE Phase 3 trial to be presented at ASCO.
• ImmunoGen recently reported a monetization transaction pertaining to the royalties earned on Kadcyla sales.

For earnings history and earnings-related data on Immunogen (IMGN) click here.