Protocols

ImmunoGen gets $25M upfront for ADC therapy; miRagen adds European orphan drug designation; Pierre Fabre buys some preclinical immunotherapies

→  The European Commission granted orphan drug designation to miRagen’s $MGEN MRG-106 for the treatment of cutaneous T-cell lymphoma (CTCL). “The European orphan drug designation for MRG-106 is another regulatory milestone which we believe further validates the medical need for novel therapies in the treatment of CTCL,” said miRagen president and CEO, William Marshall. It earned the FDA’s own orphan designation for treatment of mycosis fungoides—the most common subtype of CTCL—earlier this year. The Boulder, CO-based microRNA biotech found its way into the public markets last November, reverse merging with struggling Signal Genetics and gaining a $40 million round to finance clinical work.

→  Pierre Fabre is acquiring several assets from California’s Igenica Biotherapeutics, with the company highlighting pre-clinical “immunotherapies targeting immune checkpoints that may reverse the resistance to existing immuno therapies” as part of the deal. The agreement also includes a series of early discovery targets. No terms were disclosed.

→  Achaogen is the latest in a line of developers to earn a “Breakthrough Therapy Designation” from the FDA. This time its for plazomicin, aiming to treat bloodstream infections caused by certain Enterobacteriaceae in patients who have limited or no alternative treatment options. The company plans to submit an NDA later this year.

→  $25 million upfront is what Switzerland-based Debiopharm International parted with to acquire ImmunoGen therapy IMGN529/DEBIO 1562. It’s a clinical-stage anti-CD37 ADC for the treatment of patients with B-cell malignancies, such as non-Hodgkin lymphomas (NHL). There’s a cool $5 million milestone payment waiting for ImmunoGen after completion of the transfer. If the drug makes it to Phase III, ImmunoGen is in line for another $25 million. The company announced layoffs back in September.


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RAPS Regulatory Convergence 2017