- Current report filing (8-K)
December 07 2009 - 7:35AM
Edgar (US Regulatory)
UNITED STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT
REPORT
PURSUANT
TO SECTION 13 OR 15(d)
OF
THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported):
December 5,
2009
ImmunoGen, Inc.
(Exact name of registrant as specified in its charter)
Massachusetts
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0-17999
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04-2726691
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(State or other
jurisdiction of
incorporation)
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(Commission File
Number)
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(IRS Employer
Identification No.)
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830 Winter Street, Waltham, MA 02451
(Address of principal executive offices) (Zip Code)
Registrants telephone number, including area code:
(781) 895-0600
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of
the following provisions (
see
General
Instruction A.2. below):
o
Written communications
pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o
Soliciting material pursuant
to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR 240.14d-2(b))
o
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR 240.13e-4(c))
ITEM 7.01 REGULATION FD DISCLOSURE
On
December 5, 2009, interim clinical data from a BT-062 Phase I clinical
trial were presented at the annual meeting of the American Society of
Hematology (ASH) held in New Orleans, LA. BT-062 comprises a CD138-targeting
antibody belonging to Biotest AG with ImmunoGens DM4 cancer-cell killing agent
attached using an engineered linker. Biotest is developing BT-062 under a
collaboration agreement with ImmunoGen, and has issued a press release on the
study data reported.
These
clinical data are from a Phase I dose-escalation trial evaluating BT-062 when
administered once every three weeks to patients with relapsed and/or refractory
multiple myeloma. The objective of the trial is to identify the maximum
tolerated dose, dose-limiting toxicities and pharmacokinetics of BT-062 with
this administration schedule as well as to obtain information on its clinical
efficacy.
At
the time of data cut-off for presentation, 25 patients had received one of
seven dose levels of BT-062 ranging between 10 to 200 mg/m(2). These patients
previously had been treated with a median of seven prior therapies, with
approximately one-third of the patients having received at least ten prior
therapies.
BT-062
was found to have an acceptable and manageable toxicity profile. The maximum
tolerated dose was established to be 160 mg/m(2) with this administration
schedule with mucositis reported as the dose-limiting toxicity.
Seventeen
(17) of these patients had received more than one treatment cycle, were
efficacy-evaluable, and were no longer undergoing treatment at the time of data
cut-off for presentation, with three other patients still receiving BT-062. Two
of the 17 patients had objective responses (one partial response and one
minimal response) and remained on treatment with BT-062 for at least 12 weeks. Seven
other patients had stable disease for more than six weeks. Overall, 53% of
these seventeen patients had a sustained delay in the progression of their
cancer in this Phase I study of BT-062.
Biotest
noted that on the basis of the encouraging tolerability and efficacy seen to
date, it plans to assess BT-062 using a more frequent dosing regimen.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
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ImmunoGen, Inc.
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(Registrant)
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Date:
December 7, 2009
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/s/
Gregory D. Perry
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Gregory
D. Perry
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Senior
Vice President and Chief Financial Officer
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2
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