Protocols

Daiichi Sankyo gets a “breakthrough” at the FDA; InVivo restructures, cuts jobs

⇨ There’s lots of news about antibody-drug conjugates today. Of note, the FDA has given Daiichi Sankyo’s HER2-targeting ADC DS-8201 its breakthrough drug designation, promising to help speed it through to a marketing decision. Regulators based their decision on data from an ongoing Phase I study. “The Breakthrough Therapy designation for DS-8201 in HER2-positive metastatic breast cancer acknowledges the unmet medical need these patients face when currently approved treatments no longer control their disease,” said Antoine Yver, the oncology R&D chief for Daiichi Sankyo.

Abeona Therapeutics $ABEO also landed a breakthrough designation for their Phase III-ready EB-101 gene therapy program for patients with Recessive Dystrophic Epidermolysis Bullosa. “EB-101 is an autologous gene-corrected cell therapeutic approach that utilizes a patient’s own cells and genetically engineering them to produce the correct version of collagen, which helps hold skin on to the body, thereby reducing the number of painful blisters caused by injury and improving wound healing,” said CEO Timothy J. Miller.

⇨ Cambridge, MA-based InVivo Therapeutics $NVIV is restructuring and focusing on its lead program for spinal cord injury. The biotech cut 13 jobs, or 39% of its work force.

⇨ Longtime Biogen exec Alpna Seth has decided to head west, way west, to rejoin ex-Biogen CEO George Scangos as COO of his upstart biotech. He left the big company in July, according to the Boston Business Journal.



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