-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, Hk8yqYyDrcfjz7QhXkhhh6zml1Gy6hH60jkarrXTR4HF5NPssRhpPd/BW54tgRu5 4zmtf5cfapr+laqcCCclsA== 0000855654-06-000053.txt : 20061211 0000855654-06-000053.hdr.sgml : 20061211 20061211162654 ACCESSION NUMBER: 0000855654-06-000053 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20061211 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20061211 DATE AS OF CHANGE: 20061211 FILER: COMPANY DATA: COMPANY CONFORMED NAME: IMMUNOGEN INC CENTRAL INDEX KEY: 0000855654 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 042726691 STATE OF INCORPORATION: MA FISCAL YEAR END: 0606 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-17999 FILM NUMBER: 061268762 BUSINESS ADDRESS: STREET 1: 128 SIDNEY ST CITY: CAMBRIDGE STATE: MA ZIP: 02139 BUSINESS PHONE: 6179952506 MAIL ADDRESS: STREET 1: 128 SIDNEY ST CITY: CAMBRIDGE STATE: MA ZIP: 02139 8-K 1 form8_k.htm IMMUNOGEN, INC. FORM 8-K ImmunoGen, Inc. Form 8-K


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 11, 2006

ImmunoGen, Inc.
(Exact name of registrant as specified in its charter)


 
Massachusetts
0-17999
04-2726691
 
 
(State or other jurisdiction of incorporation)
(Commission File Number)
(IRS Employer Identification No.)
 


128 Sidney Street, Cambridge, MA 02139
(Address of principal executive offices) (Zip Code)


Registrant's telephone number, including area code: (617) 995-2500

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 8.01 - OTHER EVENTS

On December 11, 2006, ImmunoGen, Inc. (Nasdaq: IMGN) issued a press release to announce the presentation of initial findings from a Phase I study evaluating the Company’s huN901-DM1 TAP compound for the treatment of multiple myeloma at the annual meeting of the American Society of Hematology (ASH) in Orlando, FL. This Phase I study is designed to evaluate huN901-DM1 for the treatment of relapsed multiple myeloma. To qualify for enrollment, patients must have relapsed or relapsed/refractory multiple myeloma that expresses the CD56-antigen targeted by huN901-DM1; approximately 70% of multiple myeloma cases express this antigen. The initial findings show evidence of anticancer activity among the three patients receiving the higher of the two huN901-DM1 dose levels evaluated to date.

ImmunoGen also disclosed progress with the TAP compound, AVE9633, which is in development by sanofi-aventis for the treatment of acute myeloid leukemia (AML). The favorable tolerability profile of AVE9633 demonstrated in this first trial enables the compound to be evaluated in additional Phase I studies with a more frequent dosing schedule better suited to the highly proliferative nature of AML. A second Phase I study is underway in Europe.

The Company’s TAP technology uses tumor-targeting antibodies to deliver a potent cell-killing agent specifically to cancer cells.





 
ITEM 9.01. FINANCIAL STATEMENTS AND EXHIBITS

Exhibit No.
 
Exhibit
99.1
 
Press Release of ImmunoGen, Inc. dated December 11, 2006
     






 
2

 
 

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.
 
 
   
ImmunoGen, Inc.
 
   
(Registrant)
 
 
 
Date: December 11, 2006
 
/s/ Daniel M. Junius
 
 
 
 
   
Daniel M. Junius
   
Executive Vice President and Chief Financial Officer
     


 
3

 
 

EXHIBIT INDEX



Exhibit No.
 
Exhibit
99.1
 
Press Release of ImmunoGen, Inc. dated December 11, 2006
     

 
 
 
 
 
 
4

 
EX-99.1 2 exhibit99_1.htm EXHIBIT 99.1 Exhibit 99.1

128 Sidney Street, Cambridge, MA 02139-4239                                        TEL: (617) 995-2500 FAX: (617) 995-2510

Contacts:
 
Investors
Carol Hausner
Executive Director, Investor Relations and
Corporate Communications
Tel: (617) 995-2500
 info@immunogen.com
Media
Kathryn Morris
KMorrisPR
(845) 635-9828
Kathryn@kmorrispr.com

For Immediate Release
 
ImmunoGen, Inc. Announces Presentation at ASH of
Encouraging Findings with HuN901-DM1 for the Treatment of Multiple Myeloma

- The Company Also Announces Progress with AVE9633 for Acute Myeloid Leukemia -

CAMBRIDGE, MA, December 11, 2006 - ImmunoGen, Inc. (Nasdaq: IMGN) announced the presentation today of encouraging initial findings from a Phase I study evaluating the Company’s huN901-DM1 Tumor-Activated Prodrug (TAP) compound for the treatment of multiple myeloma at the annual meeting of the American Society of Hematology (ASH) in Orlando, FL. These initial findings show evidence of anticancer activity among the patients receiving the higher of the two huN901-DM1 dose levels evaluated to date. ImmunoGen also announced progress with the TAP compound, AVE9633, which is in development by sanofi-aventis for the treatment of acute myeloid leukemia (AML). The Company’s TAP technology uses tumor-targeting antibodies to deliver a potent cell-killing agent specifically to cancer cells.

HuN901-DM1 Clinical Findings Reported at ASH

The findings to date from this ongoing trial are being presented today (poster #3574) by Asher Chanan-Khan, MD, of the Roswell Park Cancer Institute in Buffalo, NY. This Phase I study is designed to evaluate huN901-DM1 for the treatment of relapsed multiple myeloma. To qualify for enrollment, patients must have relapsed or relapsed/refractory multiple myeloma that expresses the CD56-antigen targeted by huN901-DM1; approximately 70% of multiple myeloma cases express this antigen. All of the patients enrolled to date received four or more chemotherapeutic regimens prior to entering the study. HuN901-DM1 is the only anticancer agent administered during this trial.

In this study, huN901-DM1 is administered weekly for two consecutive weeks in a three-week cycle. A primary objective of the trial is to determine the maximum tolerated dose (MTD) of huN901-DM1 in multiple myeloma patients with this dosing schedule. To establish the MTD, sequential new cohorts of patients receive increasing doses of huN901-DM1 until dose-limiting toxicity is encountered. Two huN901-DM1 dose levels had been evaluated at the time of the ASH meeting: 40 mg/m2/day and 60 mg/m2/day. The MTD has not yet been defined and patient enrollment continues.

Evidence of antitumor activity was reported among the small group of patients receiving the higher of the two dose levels evaluated to date. One of the three patients receiving the 60 mg/m2/day dose had a minimal objective response by European Bone Marrow Transplant (EBMT) criteria. This patient had a 39% reduction in her serum M component, a disappearance of her urine M component, and no evidence of disease progression in her skeleton or bone marrow. She had previously been treated with thalidomide, lenalidomide, multiple chemotherapy regimens, and radiation therapy. To date, this patient has received 12 cycles of treatment with huN901-DM1 (24 doses over 36 weeks). Another of the three patients receiving 60 mg/m2/day remained on treatment for five cycles, and the most recently enrolled patient has had stable disease for at least two cycles and continues to receive huN901-DM1.

 
1

 
Robert J. Fram, MD, Vice President, Clinical Development, commented, “These findings, while preliminary, are very encouraging. HuN901-DM1 has been well tolerated and a patient who failed multiple prior therapies had an objective response at the higher of the two doses evaluated to date.”

HuN901-DM1 is designed to target and kill CD56-expressing cancer cells. The compound comprises the CD56-targeting antibody, huN901, and the potent cell-killing agent, DM1. Its antibody component serves to target the compound specifically to the cancer cells and its DM1 component functions to kill the cancer cells. Targeting of huN901-DM1 to the myeloma cells in the marrow was confirmed in this study using immunohistochemistry. There have been no reports of clinically significant myelosuppression with huN901-DM1 either in this study or in the two studies underway that evaluate the compound for the treatment of small-cell lung cancer and other CD56-expressing solid tumors.

Clinical Progress with AVE9633

Findings were published in an abstract (abstract #4548) to the ASH meeting on a second TAP compound, AVE9633, in development for the treatment of a hematological malignancy. This compound comprises the CD33-targeting antibody, huMy9-6, and the potent cell-killing agent, DM4, and is in Phase I clinical testing for the treatment of AML. AVE9633 was developed by ImmunoGen and licensed to sanofi-aventis, which is responsible for the clinical development of the compound.

The findings are from the first Phase I trial initiated with AVE9633. In this trial, the compound was dosed once per three weeks to provide information on the safety and pharmacokinetics of single administrations of AVE9633. The compound was found to be well tolerated: doses up to 260 mg/m2 were administered without dose-limiting toxicity.

The favorable tolerability profile of AVE9633 demonstrated in this first trial enables the compound to be evaluated in additional Phase I studies with a more frequent dosing schedule better suited to the highly proliferative nature of AML. A study evaluating AVE9633 when dosed weekly for two consecutive weeks in a four-week cycle is underway in Europe. While data from the European Phase I study have not yet been reported, to date they are encouraging.

About ImmunoGen, Inc.

ImmunoGen, Inc. develops targeted anticancer biopharmaceuticals. The Company’s proprietary TAP technology uses tumor-targeting antibodies to deliver a potent cell-killing agent specifically to cancer cells. Five anticancer compounds are in clinical testing through ImmunoGen and the Company’s collaborators - huN901-DM1 and huC242-DM4, which are wholly owned by ImmunoGen, AVE9633 and AVE1642, in development by sanofi-aventis, and trastuzumab-DM1, in development by Genentech. Amgen (formerly Abgenix), Biogen Idec, Biotest AG, Boehringer Ingelheim, Centocor, Genentech, Millennium Pharmaceuticals, Inc., and sanofi-aventis have licensed the right to develop and/or test TAP compounds to specific targets; ImmunoGen also has a broader collaboration with sanofi-aventis.

This press release includes forward-looking statements. For these statements, ImmunoGen claims the protection of the safe harbor for forward-looking statements provided by the Private Securities Litigation Reform Act of 1995. It should be noted that there are risks and uncertainties related to the Company’s development of its own products, as well as to the development of products by our collaborators. A review of these risks can be found in ImmunoGen’s Annual Report on Form 10-K for the fiscal year ended June 30, 2006 and other reports filed with the Securities and Exchange Commission.


# # #
 
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