Biotech Values

[rwwine]

FWIW - IMGN

I recently started a position in this company. The following is a nice summary of their current projects.

http://www.immunogen.com/f05_prod.html

Currently, three TAP compounds are in clinical testing: huN901-DM1, developed and owned by ImmunoGen; MLN2704, developed by Millennium Pharmaceuticals, Inc. with our TAP technology; and huMy9-6-DM4 developed by ImmunoGen and licensed to Aventis (now sanofi-aventis). We expect to initiate patient dosing with another TAP compound that is wholly-owned by ImmunoGen – huC242-DM4 – in mid-2005. Additional TAP compounds are in development.

HuN901-DM1 – We developed huN901-DM1 for the treatment of cancers that express the CD56 antigen. These include small-cell lung cancers (SCLC), other cancers of neuroendocrine origin, and certain hematologic malignancies. HuN901-DM1 comprises our huN901 antibody – which targets CD56 – and our DM1 cell-killing agent. ImmunoGen developed and humanized the huN901 antibody, and the huN901-DM1 TAP compound is wholly-owned by us.

Two clinical trials are underway with huN901-DM1 in SCLC: a Phase I/II study with a weekly-dosing schedule and a Phase I study with an accelerated dosing schedule. We plan to report initial findings from the Phase II leg of the Phase I/II study at the American Society of Clinical Oncology (ASCO) annual meeting in May 2005. The findings from the Phase I leg were reported at a previous ASCO: the compound was found to be well tolerated at doses that provide evidence of anticancer activity.

We are in the process of expanding the huN901-DM1 clinical program to include assessment of the compound in CD56-expressing hematological malignancies, or “liquid tumors.” We expect to initiate a clinical trial with huN901-DM1 in multiple myeloma in the spring of 2005.

MLN2704 – Millennium created this TAP compound using a Millennium antibody that targets the prostate-specific membrane antigen (PSMA) and our DM1 cell-killing agent. PSMA is expressed on virtually all prostate cancers. In November 2002, Millennium announced their initiation of Phase I testing with MLN2704, and we announced that we earned a milestone payment with this event. In October 2003, Millennium announced their initiation of a Phase I/II multidose trial with MLN2704. In December 2003, Millennium announced MLN2704 had been granted fast track status by the US FDA, and in March 2004, Millennium announced that the compound had been selected by the FDA for the agency’s Continuous Marketing Application (CMA) Pilot 2 program. Findings from the first MLN2704 study were reported at ASCO in 2004, and Millennium has said that the initial findings from the Phase I/II multidose study are expected to be reported at ASCO in 2005. Requests for information on MLN2704 should be directed to Millennium.

HuMy9-6-DM4 – ImmunoGen created this TAP compound for the treatment of acute myeloid leukemia. It comprises our huMy9-6 antibody – which targets CD33 – and our DM4 cell-killing agent. We licensed this compound to Aventis from our preclinical portfolio as part of a broader collaboration between the two companies. Aventis subsequently became sanofi-aventis, and in March 2005, sanofi-aventis advanced huMy9-6-DM4 into clinical testing. We earned a $2 million milestone payment with their initiation of clinical testing.

HuC242-DM4 – We created huC242-DM4 for the treatment of cancers that express the CanAg antigen. These include colorectal, pancreatic, and other gastrointestinal cancers, as well as many non-small-cell lung cancers. HuC242-DM4 comprises our huC242 antibody, which targets CanAg, and our DM4 cell-killing agent. The compound is wholly-owned by ImmunoGen. We expect to begin Phase I clinical testing with huC242-DM4 in mid-2005.

An earlier version of this compound – cantuzumab mertansine (huC242-DM1) – was advanced into clinical testing by SmithKline Beecham (now GlaxoSmithKline). In Phase I studies, cantuzumab mertansine was found to be well tolerated and to demonstrate evidence of anticancer activity. Once we re-gained all of our product rights from GlaxoSmithKline, we tested cantuzumab mertansine against alternative product designs, including huC242-DM4, in multiple preclinical models. We concluded that huC242-DM4 was the best product design for this antibody and antigen, and thus are advancing huC242-DM4.

Other compounds in preclinical development – These include: an anti-IGF-IR antibody and a TAP compound for B-cell malignancies that we licensed to Aventis as part of our broader collaboration; a TAP compound comprising Genentech’s trastuzumab (Herceptin®) antibody and our DM1; and TAP compounds in development by Biogen Idec and by Centocor to undisclosed targets.