April 28, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Buried in a lot of reasonably good news in ImmunoGen, Inc. ’s recent third quarter fiscal year 2015 report on Friday, were two unpleasant surprises—the company had recently regained the rights to SAR3419 from Sanofi, and it had ended Phase I testing for IMGN289.
SAR3419 is a novel anti-CD19 antibody-drug conjugate (ADC). It was jointly being studied by Sanofi and ImmunoGen in aggressive non-Hodgkin’s Lymphoma (NHL) in Phase I, and for acute lymphoblastic leukemia (ALL) in Phase II.
Reports indicate Sanofi pulled the plug on the collaboration deal and returned the rights to SAR3419 to ImmunoGen.
On Nov. 2013, ImmunoGen announced initiating Phase I testing of IMGN289. The compound, also an ADC, is designed to bind and kill cancer cells that highly express EGFR, also known as HER1. Charles Morris, ImmunoGen’s chief development officer, said in a statement that the study was halted because of “an unexpected safety concern.” More preclinical research is expected. No specifics were offered about the nature of the safety issues.
The company reported total revenues of $11.427 billion in the last three months, up from the previous year’s period of $6.875 billion. The company updated its guidance for fiscal year ending June 30, 2015. Its net loss was unchanged, expected to run between $60 million and $65 million. Projected revenues are between $85 million and $95 million, down from previous guidance that pitched revenues at between $100 million and $105 million. The company states this is due to “the expected timing of partner milestone events.”
Not surprisingly, the stock market didn’t like the decreased revenue statements and the termination of the deal with Sanofi. On Dec. 17, 2014, shares sold for $10.73, but took a big drop on Dec. 23, 2014 to $5.77. Shares had been on a mostly upward trend since then, selling for $9.96 on April 24, 2015. Shares are currently selling at $8.63.
“Sanofi has returned the rights to CD19-targeted ADC SAR3419 back to ImmunoGen. Given how highly touted this agent had once been,” said Simos Simeonidis, analyst with RBC Capital Markets in a note, “we view this as a significant hit to the pipeline’s reputation.”
Simeonidis had a similar response to the company’s termination of IMGN289, saying, “Again, given how public ImmunoGen management has been about this agent’s promise, we view this setback as a significant one.”
However, the company did have some promising news, with the most promising being initial data for the use of mirvetuximab soravtansine to treat platinum-resistant ovarian cancer. That data will be presented at the 2015 ASCO Annual Meeting this week and the company has indicated plans to start a Phase II trial by the end of 2015.
“Management has even spoken of the possibility of an accelerated approval path multiple times,” wrote Simeonidis, “so investors expect the data in ovarian and endometrial cancer to be very strong; any potential hiccup there could hurt the stock, especially given the post-ASCO blues that historically follows the excitement and build-up towards the big oncology meeting every year.”
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