Drug Development, People

Post-merger, gene therapy player Adverum makes Amber Salzman CEO, delays a clinical trial start


Amber Salzman

Avalanche Biotechnologies’ acquisition of Paris-based Annapurna and their merger into a new gene therapy company called Adverum Biotechnologies $ADVM is still playing out.

Five months after the two biotechs announced the deal, former Annapurna CEO Amber Salzman is stepping up to the CEO’s job, and one of her first acts as chief is delaying the start of a key trial by a year. Paul Cleveland, meanwhile, is stepping up to the executive chairman’s post in the quick rearrangement of titles.

Cleveland had promised back in May that Menlo Park, CA-based Adverum would start dosing their first patients for A1AT deficiency by the end of this year.  Salzman, though, now says she wants to shift their manufacturing tech over to a large CMO, and that means that the trial for ADVM-043 won’t get started until the end of next year.

The change-up seems to be playing well with investors this morning. Adverum’s stock is up 15% in pre-market trading.

Avalanche ran head first into a wall of investor skepticism back in 2015 when it tried to dress up messy efficacy data for its lead drug for wet, age-related macular degeneration and present it as a significant success. (In better days, the biotech had partnered with Regeneron in a $640 million deal.) The market wasn’t having it, though, and the stock price collapsed. Then CEO Thomas Chalberg was out the door soon after and the company scrapped plans for a follow-up mid-stage study and then regrouped under the new CEO, Paul Cleveland.

Now it’s up to Salzman, an experienced R&D vet with a stint at GSK on her resume, to set things right.

Says Salzman:

“Our goal is to meet with the FDA to review our modified plans in the first quarter of 2017, to allow us to move ahead with patient enrollment in our planned Phase 1/2 clinical trial for ADVM-043 in the fourth quarter of 2017. We are committed to advancing this novel gene therapy for patients with A1AT deficiency, and are planning to be ready to deliver this potential product through a robust commercial-ready manufacturing process.”

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
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Flatiron Health New York City or San Francisco

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