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Immunogen Doses First Patient in Ovarian Cancer Drug Study

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ImmunoGen, Inc. announced that the first patient has been dosed in FORWARD I, the company's phase III study, assessing the lead pipeline candidate, mirvetuximab soravtansine, as a single-agent therapy for the treatment of platinum-resistant ovarian cancer.  

Mirvetuximab soravtansine (IMGN853) is the first folate receptor alpha (FRα) addressing antibody-drug conjugates (ADCs).

ImmunoGen’s share price has declined 71.9% in the past one year, while the Zacks classified Medical-Drugs industry fell 10.6%.

FORWARD I is a phase III study in which 333 patients will be randomized 2:1 to receive either mirvetuximab soravtansine or the physician's choice of single-agent chemotherapy (pegylated liposomal doxorubicin, topotecan, or weekly paclitaxel). The patients who would be dosed in the trial are the ones diagnosed with platinum-resistant ovarian cancer that express medium or high levels of FRα and also had been under the treatment up to three prior regimens. The primary endpoint of this study is progression free survival (PFS), which will be assessed in the entire study population and in the subset of patients with high FRα expression.

The phase III FORWARD I study was initiated based on positive results from a phase I expansion cohort study on mirvetuximab soravtansine data, which the company announced in December 2016. The study was conducted in patients with FRα-positive platinum-resistant ovarian cancer. The results of which showed that mirvetuximab soravtansine is active in platinum-resistant ovarian cancer, with encouraging response rates and progression-free survival combined with a manageable safety profile,

We note that the candidate is also in Phase Ib/II testing in combination regimens for earlier-stage disease.

According to the latest release, the patients suffering from platinum-resistant ovarian cancer are prone to high risks. So better therapies are required that provide better results in terms of efficacy and tolerability.  It is estimated that about 23,000 women are diagnosed annually with ovarian cancer in the US.

Further, it is also estimated that 19,000-24,000 women have platinum-resistant ovarian cancer requiring second-line or later treatment. The company estimates that 60% of ovarian cancer cases have medium or high FRα expression. This indicates significant market opportunity for mirvetuximab soravtansine, if approved.

Zacks Rank & Key Picks

ImmunoGen currently carries a Zacks Rank #3 (Hold).  Some better-ranked stocks in the health care sector include Enzo Biochem, Inc. (ENZ - Free Report) , Sunesis Pharmaceuticals, Inc. and Anika Therapeutics Inc. (ANIK - Free Report) . While Enzo Biochem and Sunesis sport a Zacks Rank #1 (Strong Buy), Anika carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.

Enz Biochem’s loss estimates for 2017 narrowed 5.88% over the past 60 days. The company recorded a positive earnings surprise in three of the last four quarters, the average being 22.50%. Its share price was up 39.7% in the past one year.

Anika’s earnings estimates for 2016 and 2017 were up 3.9% and 0.5%, respectively, over the last 60 days. The company recorded a positive earnings surprise in each of the last four quarters, the average being 33.14%. Its share price was up 37% in the past one year.

Sunesis’ loss estimates narrowed 5.06% and 8.80% for 2016 and 2017, respectively, over the past 60 days. The company recorded a positive earnings surprise in three of the last four quarters, the average being 0.54%.

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