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ImmunoGen, Inc. (IMGN - Free Report) announced that it is planning to move its leukemia candidate, IMGN632, into phase I study before the year-end. The company said that the FDA has completed the safety review of its investigational new drug (IND) application for IMGN632, filed in mid-September for treating patients with CD123-positive hematological malignancies, including acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN).

Notably, IMGN632 uses the company’s indolino-benzodiazepine cancer-killing agents known as IGNs.

ImmunoGen’s shares have significantly outperformed the industry year to date. The stock has soared 194.1% compared with the industry’s increase of 2% during the same time.

 

The IND application for IMGN632 was supported by positive data from preclinical studies, which demonstrated IMGN63’s selective activity against AML cells, while sparing normal bone marrow cells.

We remind investors that ImmunoGen had earlier entered into a strategic collaboration and option agreement with Jazz Pharmaceuticals PLC (JAZZ - Free Report) in August for the development and commercialization of IMGN632. The collaboration also included another program’s IMGN779 — a CD33-targeting ADC — already in phase I stage for the treatment of AML.

Notably, ImmunoGen is focused on developing targeted cancer therapeutics using its proprietary ADC technology. In fact, this innovative technology of the company is also used in Roche’s (RHHBY - Free Report) marketed product, Kadcyla and in three other development-stage candidates in its pipeline.

Additionally, the ADC technology is used in development programs by ImmunoGen’s partners Amgen (AMGN - Free Report) , Bayer AG, Biotest, CytomX, Eli Lilly, Novartis, Sanofi and Takeda.

Per the company’s press release, approximately 21,380 patients are expected to be diagnosed with AML this year in the United States. Among them, around 10,590 patients are anticipated to succumb to the disease. Hence, IMGN632’s potential market opportunity is huge in the country, if successfully developed.

Zacks Rank

ImmunoGen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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