ImmunoGen, Inc. Announces Favorable IMGN901 Clinical Findings Reported at ASH Annual Meeting
WALTHAM, Mass.--(BUSINESS WIRE)-- Dec. 8, 2008 -- ImmunoGen, Inc. (Nasdaq: IMGN), a biopharmaceutical company that develops targeted anticancer therapeutics using its Tumor-Activated Prodrug (TAP) technology, today announced the presentation of favorable clinical findings with the Company's IMGN901 targeted anticancer compound at the American Society of Hematology (ASH) 50th Annual Meeting and Exposition being held in San Francisco, CA .
"The study findings to date are highly encouraging as IMGN901, used as a single agent, demonstrated biological activity in patients whose multiple myeloma has relapsed after treatment with several well-accepted therapies," commented Asher Chanan-Khan, MD, of the Roswell Park Cancer Institute. "Additionally, the compound has been very well tolerated, and we continue to evaluate alternative dose levels to establish the maximum tolerated dose."
The findings presented today are from a Phase I, dose-escalation clinical trial that evaluates the TAP compound IMGN901 - used as a single agent - for the treatment of multiple myeloma that has failed the approved therapies for this cancer. New cohorts of patients receive increasing doses of IMGN901 until the maximum tolerated dose is established, with evidence of anticancer activity also noted. In this study, IMGN901 is administered weekly for two weeks every three weeks.
Dose evaluation began at 40 mg/m2 and has been escalated - in new cohorts of three patients each - through 112 mg/m2 without the occurrence of dose-limiting toxicity. The only adverse reactions considered to be possibly or probably related to the study drug identified at those doses were grade 1 or 2, the least severe grades as assessed using conventional toxicity grading scales. Grade 3 fatigue was reported in one patient receiving 140 mg/m2, and additional patients are being evaluated at that dose.
Nineteen patients have received IMGN901 in this study, and almost all (17/19) of these patients were heavily pretreated - receiving at least four different multiple myeloma treatment regimens prior to study enrollment. Among the 15 patients who received at least two cycles of treatment with IMGN901, three achieved an objective response, eight reached stable disease, and four continued to have progressive disease. Responses of note include:
-- Two of the three patients who had a minimal objective response continued
treatment with IMGN901 for at least 45 weeks (15 cycles). The third
patient had to withdraw from the study after 12 weeks due to a broken
leg, and was continuing to show disease improvement at the time of her
withdrawal. These patients had all received multiple prior therapies,
including Thalomid(R) (thalidomide), Revlimid(R) (lenalidomide), and -
in the two more recently enrolled patients - Velcade(R) (bortezomib).
-- Six of the eight patients with stable disease remained on treatment for
at least 15 weeks, with the longest remaining on treatment for 33 weeks.
James O'Leary, MD, Vice President and Chief Medical Officer of ImmunoGen, commented, "IMGN901 has demonstrated objective evidence of activity and favorable tolerability in the treatment of CD56-expressing solid tumors as well as in multiple myeloma. Also, its use is not associated with the types of toxicities, such as myelosuppression, that restrict its ability to be combined with other drugs. The profile of IMGN901 provides us with a number of potential development pathways, which we evaluate on an ongoing basis in terms of expected opportunity, cost, and time to market."
About IMGN901
IMGN901 is a potential treatment for multiple myeloma, small-cell lung cancers (SCLC), ovarian cancers, and other solid and liquid tumors that express its CD56 antigen target. This TAP compound consists of ImmunoGen's CD56-binding antibody, huN901, with the Company's potent DM1 cell-killing agent attached and is designed to selectively bind to and kill CD56-expressing cancer cells. In preclinical studies, IMGN901 has demonstrated pronounced anticancer activity when used as a single agent and synergistic efficacy when used in combination with approved multiple myeloma and SCLC therapies. IMGN901 is in Phase I clinical testing for the treatment of CD56-expressing multiple myeloma and solid tumors. It is wholly owned by ImmunoGen.
About ImmunoGen, Inc.
ImmunoGen, Inc. develops targeted anticancer therapeutics using its expertise in cancer biology, monoclonal antibodies and the creation and attachment of potent cell-killing agents. The Company's TAP technology uses antibodies to deliver one of ImmunoGen's proprietary cell-killing agents specifically to cancer targets. In addition to the Company's proprietary clinical pipeline, ImmunoGen collaborators Genentech, sanofi-aventis, Biogen Idec, and Biotest also are testing TAP compounds in the clinic, and the naked antibody AVE1642 is in clinical trials through the Company's collaboration with sanofi-aventis. Other ImmunoGen collaborative partners include Bayer HealthCare and Amgen.
Thalomid® and Revlimid® are registered trademarks of Celgene Corporation.
Velcade® is a registered trademark of Millennium Pharmaceuticals, The Takeda Oncology Company.
CONTACT:
ImmunoGen, Inc.
Carol Hausner
781-895-0600
Executive Director, Investor Relations and Corporate Communications
info@immunogen.com
