immunogen inc (IMGN) Key Developments
ImmunoGen, Inc. Announces Encouraging IMGN529 Clinical Data at 56th ASH Annual Meeting and Exposition
Dec 6 14
ImmunoGen, Inc. announced the presentation of encouraging clinical findings with its IMGN529 experimental therapy for B-cell malignancies at the American Society of Hematology (ASH) annual meeting. These include objective responses at doses that were generally well tolerated. ImmunoGen's IMGN529 is a potential new treatment for DLBCL and other non-Hodgkin lymphoma (NHL) subtypes. An ADC, it comprises an antibody that targets CD37, found on B-cell malignancies, with the potent cancer cell-killing agent, DM1, attached. The antibody serves to deliver the DM1 specifically to B cells to kill them and, based on preclinical research, also contributes anticancer activity. IMGN529 is currently in the dose-finding portion of a Phase I clinical trial, which assesses increasing doses of this experimental therapy in new groups of patients with relapsed/refractory NHL. Findings with the first doses evaluated were reported previously. The IMGN529 dose levels evaluated to date range from 0.1 to 1.4 mg/kg, administered once every three weeks. Its MTD has not yet been established, and evaluation of the 1.4 mg/kg level is ongoing. 24 of the 33 patients enrolled to date were evaluable for efficacy. Ten evaluable patients had DLBCL, which had been heavily pretreated, and four (40%) of these patients had an objective response: one had a complete response (CR) and three had partial responses (PRs). The CR and one of the PRs were among patients treated with 1.0 mg/kg, a high IMGN529 dose level to complete evaluation to date. Both of these patients had received multiple prior treatments, including autologous stem cell transplant (ASCT). Ten of the 24 evaluable patients had follicular lymphoma and one of these patients also had a PR. This patient, too, had received multiple treatments including ASCT.
Ventana Medical Systems, Inc. Announces Collaboration to Develop Companion Diagnostics for ImmunoGen, Inc.'s Targeted Anticancer Agents
Oct 28 14
Ventana Medical Systems, Inc. announced it has entered into an agreement with ImmunoGen, Inc. to collaborate on the development of biomarker assays and a companion diagnostic immunohistochemistry (IHC) test for one or more of ImmunoGen's product candidates. Under this agreement, the companies have created an initial test for folate receptor alpha (FRa, also known as folate receptor 1, or FOL1) that is being used in early trials of IMGN853, ImmunoGen's FRa-targeting antibody-drug conjugate (ADC). Cancers that highly express FRa include epithelial ovarian cancer, endometrial cancer, and types of non-small cell lung cancers (NSCLC). The goal of the collaboration is to leverage Ventana's expertise in companion diagnostic development, from prototyping through regulatory approval and commercialization, to identify specific patient populations for ImmunoGen's bio-target directed therapies. This pharma collaboration is one of dozens currently underway where the Ventana Companion Diagnostics team is delivering patient stratifying diagnostic tools that help identify those individuals who are most likely to benefit from specific treatments. In addition to ImmunoGen, Ventana has announced collaborations with Bayer, Pfizer, Boehringer Ingelheim, Takeda's Millennium unit, Genmab, Incyte, MedImmune and more.
ImmunoGen, Inc. Reports Unaudited Consolidated Earnings Results for the First Quarter Ended September 30, 2014; Provides Earnings Guidance for the Fiscal Year 2015
Oct 24 14
ImmunoGen, Inc. reported unaudited consolidated earnings results for the first quarter ended September 30, 2014. For the quarter, the company reported total revenues of $13,203,000 compared to $17,218,000 a year ago. Loss from operations was $21,910,000 compared to $11,337,000 a year ago. Net loss was $22,282,000 or $0.26 per basic and diluted share compared to $11,226,000 or $0.13 per basic and diluted share a year ago. Cash used in operations was $18.9 million compared with $23.6 million in the same period in last year. Capital expenditures were $1.7 million and $0.6 million for the first three months of fiscal year 2015 and fiscal year 2014, respectively.
The company’s fiscal year 2015 financial guidance remains unchanged from that issued in August 2014. The company expects its revenues to be between $100 million and $105 million and net loss to be between $60 million and $65 million. Cash used in operations to be between $55 million and $60 million and its capital expenditures to be between $7 million and $9 million.
ImmunoGen, Inc. Announces Executive Changes
Sep 19 14
ImmunoGen, Inc. announced that Dr. James J. O'Leary, Vice President and Chief Medical Officer of the company of his intention to leave the company's employ in mid-October 2014 for personal reasons. His responsibilities will be assumed by Dr. Charles Q. Morris, Executive Vice President and Chief Development Officer, to whom Dr. O'Leary currently reports.
ImmunoGen, Inc. Hires Sandra E. Poole as Senior Vice President of Technical Operations
Sep 15 14
ImmunoGen, Inc. announced the appointment of Sandra E. Poole as Senior Vice President, Technical Operations. Ms. Poole brings to ImmunoGen more than 25 years of experience related to the development and manufacturing of innovative biopharmaceuticals, most recently as the senior vice president of biologics manufacturing at Genzyme. She reports to Daniel Junius, President and Chief Executive Officer of ImmunoGen.