ImmunoGen scuttles lead PhII armed-antibody trial after tracking infection risk

ImmunoGen garnered considerable attention for the tech support role it played on Roche's ($RHHBY) armed antibody Kadcyla. But an attempt to steer one of its own antibody-drug conjugates through clinical studies ended in disaster today. The biotech ($IMGN) says it has hit the brakes on a Phase II study of IMGN901--its lead pipeline therapy--after researchers concluded that the drug arm experienced a higher risk of infection and one cancer patient died from an infection which was possibly drug-related.

Waltham, MA-based ImmunoGen also says that an independent committee concluded that the drug was not likely to significantly improve the rate of progression-free survival that investigators were tracking in the population of patients with small-cell lung cancer.

The data monitoring committee recommended that researchers stop dosing 198 patients in the drug arm, which received the CD56 targeting antibody-drug conjugate that utilizes etoposide/carboplatin.

The news didn't sit well with investors. ImmunoGen's shares quickly tumbled more than 20% this morning.

The entire cancer R&D field has been closely following an array of ADCs, which link a highly toxic anticancer agent with an antibody able to zero in on a specific target and then drop its therapeutic payload. The technology is playing a leading role in creating more carefully targeted therapies that spare healthy tissue, unlike the shotgun approach of chemotherapy.

This isn't the only tox issue that has come up for ImmunoGen. The Street's Adam Feuerstein writes today that toxicity issues have plagued a variety of ImmunoGen's therapies, signaling a broader platform problem. A few weeks ago investigators reported that SAR56658, partnered with Sanofi ($SNY), ran into tox issues at the higher doses. The same issue affected two internal programs over the summer. As Feuerstein notes, if ImmunoGen's linker used to tie chemo to an antibody is too "loose," the therapy will spill into unintended areas, raising the risk of toxicity.

The biotech says it plans to soldier on.

"This is clearly a disappointing outcome, as there is a tremendous need for new treatment options for SCLC," commented Dr. Charles Morris, ImmunoGen EVP and chief development officer. "We will be analyzing the findings to date in this trial as part of assessing potential next steps for IMGN901."  

ImmunoGen came to prominence primarily as a tech partner in the armed antibody field. It is currently collaborating with its technology on 7 clinical projects. But it also has three other clinical-stage projects of its own, including Kadcyla. Investigators at the company are working on IMGN853 for ovarian, endometrial, and other cancers that express folate receptor a, with IMGN529 targeting non-Hodgkin lymphoma and IMGN289 for lung, head and neck, and other cancers that express EGFR.

- here's the press release
- and the report from The Street

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