Immunogen macht beständig Fortschritte - 500 Beiträge pro Seite

[tigertim]

Marktgeschehen beiseite - fundamental gesehen, Immunogen ist und bleibt m.E. eine der attraktivsten Biotechaktien überhaupt...

Laut CEO Mitch Sayare am 30.1.02, läuft alles nach Plan:
http://www.imgn.com/mess_ceo.html

CEO’s Message

Since my last message in November we have made excellent progress on a number of fronts. We have executed on our business plan, landing a deal with still another company to use our technology platform; we’ve continued to make solid progress in clinical trials on two products; and we’ve significantly extended our Investor Relations (IR) outreach to a wider institutional audience. Despite these successes, our stock price has languished; largely, I believe, because Wall Street has been distracted by the negative news of other companies. Indeed, the last couple of months have seen several examples of missed endpoints in late-stage clinical trials. Since we can’t control the Street, or how other companies conduct themselves, we focus on factors that we can control: specifically, our fundamentals. Let me discuss some of our recent accomplishments.

In late November, we announced a partnership with Boehringer Ingelheim (BI). BI is among the twenty largest pharmaceutical companies and a world leader in antibody production. This is our first single-target deal with a pharmaceutical company. BI has licensed the right to use our DM1 TAP technology with antibodies targeting CD44. The CD44v6 splice variant is selectively expressed in several types of squamous cell cancers, including head and neck cancer and some lung and breast cancers. The antibody BI developed to target CD44v6 has been tested in clinical trials both as a naked antibody and chemically linked to a radioisotope. It has not shown any activity in these studies and is an excellent candidate for use with our TAP technology. The Anti-CD44v6-DM1 product already has a name, bivatuzumab mertansine.

As with our other technology out-license deals, BI is responsible for the development, production and commercialization of bivatuzumab mertansine. We received an upfront payment and expect to receive milestone payments plus royalties on product sales. We also manufacture preclinical and clinical materials for BI and receive manufacturing payments. I am delighted to have BI as a partner and am pleased that we were able to announce the agreement in November. You may recall that I had promised a second partnership by the end of 2001 to complement a deal we completed earlier in the year.

That deal, signed in March 2001, is a multi-target partnership agreement with Millennium Pharmaceuticals. As you may know, Millennium has already identified the first antibody they want to develop into a TAP product. It is their anti-PSMA antibody, J591, for the treatment of prostate cancer. The J591-DM1 TAP is referred to by Millennium as MLN591DM1. Millennium lists it in their investor materials as a product they expect to have in clinical trials this year.

Genentech has publicly stated that they expect to file an IND for Trastuzumab-DM1 in 2002. This is the new name for the TAP comprised of Herceptin® and DM1. At the AACR-NCI-EORTC conference in November, Genentech reported animal data showing that treatment of human cancer growing in mice with Trastuzumab-DM1 yielded far superior anti-tumor activity than did naked Herceptin. These findings were also reported in the December 2001 issue of Hem/Onc Today, a trade publication for hematologists and oncologists.

Turning now to our TAP products already in clinical trials: huC242-DM1/SB-408075 for colorectal, pancreatic and non-small-cell lung cancer and huN901-DM1/BB-10901 for small-cell lung cancer. huC242-DM1/SB-408075 now also has an official name, cantuzumab mertansine. Some explanation of terms is needed. Both the BI product, bivatuzumab mertansine, and this GlaxoSmithKline product have the term “mertansine” in their official names. The “tansine” portion of the common term refers to maytansine, the parent compound of DM1. The “mer” portion refers to the mercapto-based linker used to attach the DM1 to the antibody. The “tuzumab” suffix in both names refers to antibodies that have been humanized (cf. trastuzumab, for Herceptin). The products differ in their antibody component and the prefix of the name addresses that. For example, huC242 targets the CanAg receptor and accounts for the “can” in “cantuzumab.”

To date, findings have been reported from two cantuzumab mertansine Phase I clinical studies. Dr. Anthony Tolcher reported results from the first Phase I study at the American Society of Clinical Oncology (ASCO) meeting in May 2001. Dr. Richard Schilsky reported results from the first twenty-seven patients in the second Phase I study at the AACR-NCI-EORTC conference in November. Initial results from the dose-intensive third study are expected to be presented at this year’s ASCO meeting in May.

Now, a review of the results presented to date. In the first study the product was dosed once every three weeks. This is a long gap between doses—not desirable for treating cancer. However, the principal objectives of Phase I studies are to obtain safety and pharmacokinetic data on a new drug. So the advantage of this design is that it allows the blood levels of the product to drop to near zero before the next dose is administered. This enables an accurate assessment of the product’s half-life and other pharmacokinetic information. For cantuzumab mertansine, the half-life was found to be about two days.

Safety is assessed by monitoring patients for signs of toxicity associated with the administration of the drug. All of our studies so far are designed to establish the maximum tolerated dose (MTD) by increasing the amount of drug administered to each new patient or group of patients on study. Thus starting at a very low dose, escalations occur in each new cohort of patients. Eventually a dosage level is reached where two out of six of the patients at that level experience dose-limiting toxicity. Usually the dosage level preceding the one in which dose-limiting toxicity is seen is considered the MTD.

The studies now ongoing are testing the advantages of giving the cantuzumab mertansine on a more frequent dosing schedule. Among other things, products tend to be better tolerated when smaller amounts are given frequently rather than when larger amounts are given infrequently. In the first study, the maximum tolerated dose of cantuzumab mertansine was 235 mg/m2. When the product was dosed weekly in the second study, the MTD was found to be 115 mg/m2 per week; in other words, 345 mg/m2 for the same three-week period as in the first study. The dose-intensive third Phase I study, in which the agent is administered three times per week for three weeks, is still undergoing dose escalation. We can only disclose that we are very pleased with the dosing levels achieved so far.

All of these Phase I studies include dose escalation until dose-limiting toxicity occurs. The dose-limiting toxicity that we have seen to date has been limited to asymptomatic, reversible elevation of liver enzymes in the blood—with a recovery to baseline levels of liver enzymes in about seven to ten days. Fatigue has also been reported. But what is perhaps just as important is what the dose-limiting toxicities have not been. We have not seen GI tract-, cardio-, pulmonary-, neuro-, or nephro-toxicities. We have not seen hair loss, neutropenia or other negative hematologic changes, and we have not seen any of the other serious side effects often associated with cancer treatments.

These studies are being conducted in patients who have failed a number of previous treatments. Even so, evidence of biological activity at the higher dosage levels was reported in patients in both studies, as noted in the press releases we issued at the time. I won’t bore you with the details here again, but suffice it to say, we are very excited by these data, even though they’re entirely anecdotal. Please keep in mind, the only legitimate way to evaluate the efficacy of a new drug is statistical and Phase I studies are not designed to have statistical significance.

The Phase I/II study with our second product, huN901-DM1/BB-10901, is making good progress. Data from the Phase I portion of this study is also expected to be presented at the ASCO meeting in May. The study is being conducted at the CTRC in San Antonio and at MD Anderson in Houston. The product is administered weekly in this study and MTD has not yet been reached.

In early January we announced the issuance of U.S. Patent 6,333,410 B1, which covers the production of thiol-containing maytansinoids such as DM1. This patent is significant because it protects another step important to the commercialization of DM1-containing TAP products. It can also extend the period that we receive royalties from some of our partners.

On January 23, we announced the issuance of U.S. Patent 6,340,701 on novel taxane compounds and their use with cell-binding agents such as monoclonal antibodies. The taxane family includes Taxol® and Taxotere®. These products are both widely used for the treatment of breast, ovarian, and lung cancer. Taxol sales exceeded a billion dollars in 2001. The taxane derivatives we developed are significantly more potent than these agents and therefore lend themselves to delivery to cancer cells using monoclonal antibodies. We expect to use these taxanes in our internal pipeline. They also provide another platform technology we can license to other companies.

We continue to make strong progress with our internal pipeline. In my last letter I included animal data on our huMy9-6-DM1 product, which is wholly owned by ImmunoGen. Our Anti-IGF-1 Receptor program is also advancing.

On the IR front, we now have coverage by nine analysts. David Webber of FAC/Equities initiated coverage of ImmunoGen in November and Edward Nash re-initiated coverage in January at his new firm, Commerce Capital Markets, Inc. Since my letter in early November, we have presented at a number of major conferences in the healthcare field: the Robertson Stephens 18th Annual Medical Conference in New York; the Stephens Drug Discovery and Development Technologies Conference in Boston; the SG Cowen Global Health Care Conference in Paris; the JP Morgan H&Q 20th Annual Healthcare Conference in San Francisco and Wachovia Securities Integrated Oncology Conference in New York. We have also had one-on-one meetings with a great number of new funds. These activities have helped to attract institutional interest to our stock as well as to retain existing holders.

As you can see, our business model is on track. We are developing our internal pipeline and supporting our own programs through partnerships with leading companies. Our prospects continue to shine brightly and we look forward to telling our story to many new audiences in the coming months.

Note: Herceptin® is a registered trademark of Genentech. Taxol® is a registered trademark of Bristol-Myers Squibb Company. Taxotere® is a registered trademark of Aventis.

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Freue mich auf 2004/5...

tt/zb

[Börsenanalyst]

Richtig.
Ich setze schon lange auf diese Firma und meine Devise langfristig investiert
bleiben, wird sich auszahlen.
Wichtig, dass die Firma in der Krebsforschung weiterkommt und die Fortschritte in den
letzten Jahren sind sehr gut.

Gruß
BB

[tigertim]

ImmunoGen and Millennium Sign Exclusive Product License

CAMBRIDGE, Mass., Feb. 20 /PRNewswire-FirstCall/-- ImmunoGen, Inc. (Nasdaq: IMGN) today announced that the Company and Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM) have signed an exclusive product license for use of ImmunoGen`s proprietary maytansinoid Tumor-Activated Prodrug (TAP) technology with Millennium`s MLN591 antibody. This triggers Millennium`s payment of a product licensing fee to ImmunoGen. In March 2001, the companies announced the formation of a collaboration that provides Millennium with access to ImmunoGen`s TAP technology and enables Millennium to obtain exclusive product licenses for a restricted number of specific antigen targets during the collaboration.

MLN591 is directed towards the extracellular domain of Prostate Specific Membrane Antigen (PSMA), which is expressed by virtually all prostate tumors. DM1 is a highly potent cytotoxic agent developed by ImmunoGen. ImmunoGen`s TAP technology couples the Company`s proprietary anti-cancer agents with tumor- targeting antibodies to achieve antibody-directed killing of cancer cells.

"This product license represents the next step in our collaboration in the development of a TAP product comprised of Millennium`s MLN591 and our DM1," said Mitchel Sayare, Ph.D., Chairman and CEO. "We are delighted with Millennium`s stated goal to initiate clinical trials with MLN591DM1 this year and we will be manufacturing product for Millennium for this purpose."

About ImmunoGen, Inc.

ImmunoGen, Inc. develops innovative biopharmaceuticals for the treatment of cancer. The Company`s TAP technology couples highly potent cytotoxic agents with tumor-targeting antibodies to create effective new treatments for cancer with minimal damage to normal tissue. The Company has partnerships with GlaxoSmithKline, Genentech, British Biotech, Abgenix, Millennium, Boehringer Ingelheim, MorphoSys, Avalon Pharmaceuticals and Raven Biotechnologies. Two TAP products are currently in clinical trials, with additional products expected to start trials in 2002.

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An sich nix neues für Eingeweihte - liest sich aber trotzdem schön. Der Markt kann machen was es will - IMGN ist eine höchst interessante Langfristinvestition (so wie`s sein soll).

tt/zb