ImmunoGen's Rare Blood Cancer Candidate Gets Breakthrough Tag

ImmunoGen, Inc. IMGN announced that the FDA has granted a Breakthrough Therapy designation to its novel CD123-targeted antibody-drug conjugate (ADC) IMGN632 for the treatment of patients with relapsed/refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare and aggressive form of blood cancer.

The prestigious tag was based on results from the BPDCN cohort of the first-in-human study on IMGN632. The company plans to present the updated data from the BPDCN dose expansion cohort on IMGN632 monotherapy in December.

The Breakthrough Therapy status from the FDA expedites the development and regulatory review of investigational treatments for serious or life-threatening conditions, which based on preliminary clinical evidence, have the potential to substantially improve the clinical outcomes compared to the available therapy.

Shares of ImmunoGen were up 14.2% following the above development on Monday. However, the stock has declined 13.4% so far this year compared with the industry’s decrease of 10%.


IMGN632 is currently being developed in early- to mid-stage studies for the treatment of acute myeloid leukemia (AML) and acute lymphocytic leukemia (ALL).

Two phase II studies are evaluating IMGN632 in combination with Celgene’s [now part of Bristol-Myers BMY] Vidaza and Roche/AbbVie’s ABBV Venclexta in patients with relapsed/refractory AML. Another study is evaluating IMGN632 as a monotherapy for treating minimal residual disease in AML patients following frontline induction therapy. The company is developing IMGN632 in collaboration with Jazz Pharmaceuticals JAZZ for CD123-positive hematologic malignancies.

We remind investors that ImmunoGen’s lead pipeline candidate mirvetuximab soravtansine is being developed as a single-agent therapy for platinum-resistant ovarian cancer and in combination regimens for both platinum-resistant and platinum-sensitive disease.

Notably, mirvetuximab soravtansine enjoys an Orphan Drug status in both the United States and the EU for the treatment of ovarian cancer.

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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