Thursday, May 18, 2017

Editas delays IND for Allergan-partnered CRISPR program

Editas Medicine has delayed the target date for filing an IND for its lead candidate. The setback to the Allergan-partnered CRISPR program stems from delays at a third-party manufacturer working on Leber congenital amaurosis treatment LCA10.

Cambridge, Massachusetts-based Editas had planned to file an IND for LCA10 by the end of the year. Now Editas has delayed that major moment in its short history and that of the broader CRISPR field until the middle of next year. The delay stems from a misstep in the production of a material used in the manufacture of the adeno-associated viral (AAV) vectors Editas will use to deliver its gene editing payloads.

“AAV manufacturing requires several steps to happen in perfect sequence for things to all come together. And we’re using several external contractors to perform these steps. We have to produce the input material that all comes together to then create the AAV in a cell culture systems,” Editas CTO Vic Meyer told investors.

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