Drug Development

Protocols: Editas gets a gene editing collaborator; Regulus hustling up response to clinical hold; Sanofi drug OK’d

Gene editing pioneer Editas has signed on with the experts at the San Raffaele Telethon Institute for Gene Therapy (SR-TIGET) on a new alliance to research and develop genome edited hematopoietic stem cell and T cell therapies. They’ll focus on rare diseases, with a special spotlight on blood and bone marrow.

Bedeviled by a clinical hold, Regulus execs say they are now on track to answering the FDA’s questions so regulators can make up their minds before the end of this year. “We are working expeditiously to resolve the issues outlined in the letter and anticipate a decision from the FDA in the fourth quarter,” said Paul Grint, president and CEO of Regulus.

The FDA has OK’d Sanofi’s Adlyxin (lixisenatide), a new GLP-1 drug. But a long delay has left Sanofi far behind the diabetes pack in the U.S. market.

Yesterday’s news about the failure of TauRx’s first big Phase III for Alzheimer’s whipped up the usual assortment of post mortems. But bottom line: Don’t expect the tau/amyloid beta debate to slacken anytime soon. For its part, Eli Lilly coincidentally put out a statement on its imaging work on tau. “This is the first time an analysis has shown a correlation between tau tangles and cognitive decline in patients living with Alzheimer’s disease,” said Michael Devous, Ph.D., vice president, Avid Radiopharmaceuticals, a wholly owned subsidiary of Lilly. “As tau pathology is considered a biomarker of cognitive decline, understanding the patterns in the tau signal specific to Alzheimer’s disease might be useful in predicting disease progression.” Lots more work to be done.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

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