Souped-Up Herceptin Aims to Validate ImmunoGen’s Long-Sought Dream Cancer Drug

3/6/09Follow @xconomy

Nowhere but America makes it possible for a company to pursue its dreams for 28 years without making a profit. Even in the most optimistic times, it’s hard to explain.

So how can it possibly be, in the depths of recession, that things are looking up at Waltham, MA-based ImmunoGen? This company has been around since 1981, burned through more than $300 million in investors’ money, and still doesn’t have an FDA-approved drug to show for it. Yet the stock chart says ImmunoGen (NASDAQ: IMGN) is up 60 percent from where it was exactly one year ago. I got some insight into why from new CEO Dan Junius.

The answer is that ImmunoGen is pursuing one of the grand dreams in cancer research, and evidence is slowly mounting that suggests it may actually work for patients. The idea is to develop an engineered antibody drug that can hit cancer cells, spare healthy ones, and unload a potent toxin inside tumors for that extra killing kick. Some of the biggest-selling cancer drugs today, like Genentech’s trastuzumab (Herceptin), are engineered antibodies that hit a specific target on cells, yet lack that knockout punch. Couldn’t they be even better as targeted “smart bombs?” Nobody has turned this idea into commercial gold, but Genentech is betting big on just such a souped-up version of the original trastuzumab that uses ImmunoGen technology. The new drug is now entering the final stage of clinical trials, and with luck, it could be on the market next year.

“Genentech is showing the power of the technology,” Junius says. He adds: “We’re only on the very leading edge of a field that has tremendous potential.”

The data backs up this assertion, at least with the new Genentech drug for breast cancer. Preliminary results from 107 patients in a mid-stage clinical trial showed that about 40 percent had partial or complete tumor shrinkage after taking the drug, trastuzumab-DM1. This happened even after their disease had spread through the body and they had stopped responding to traditional treatment combinations of Herceptin, chemotherapy, or another targeted drug, GlaxoSmithKline’s lapatinib (Tykerb). Just two patients quit taking infusions of the drug because of side effects that were possibly drug-related, researchers said in December at the San Antonio Breast Cancer Symposium.

This finding has prompted Genentech, and its majority owner, Switzerland-based Roche, to push the throttle down into the final phase of clinical trials. Those companies recently started a 580-patient study enrolling patients worldwide. Even before that trial is done, it’s possible Genentech may be able to ask the FDA for approval based on compelling final results of the mid-stage trial, Junius says. That means the souped up drug could arrive on the market as early as 2010. But Genentech is clearly thinking way beyond next year. It said this week that trastuzumab-DM1 appears to be so tolerable that it is looking at studying the drug in earlier stage breast cancer, the so-called adjuvant setting, to prevent breast cancer from relapsing.

What makes this possible is the technology ImmunoGen has been honing for more than 20 years on how to make the proper package of antibody and toxin. One of the key tricks … Next Page »

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  • geordie

    IMGN getting close to goal.