October 14, 2016
By Alex Keown, BioSpace.com Breaking News Staff
MENLO PARK, Calif. – Shortly after taking over the helm of new gene therapy company Adverum Biotechnologies, newly-dubbed Chief Executive Officer Amber Salzman has delayed enrollment of patients in the Phase 1/2 clinical trial for ADVM-043 until the fourth quarter of 2017.
When Adverum launched earlier this year, following a merger plan after Avalanche Biotechnologies acquired the French company Annapurna, the plan had been to begin its first dosing trials by the end of 2016. In a statement, the company said it “decided to upgrade the ADVM-043 manufacturing process by implementing its proprietary baculovirus-based production system and plans to transfer the third-party contract manufacturing for ADVM-043 to a large-scale contract manufacturer.” The company said the upgrade is intended to increase the production scale of the gene therapy aimed at treating Alpha-1 Antitrypsin (A1AT) Deficiency, a genetic disorder that can lead to serious respiratory and liver disease. By increasing the production scale, Adverum said that will allow the company to comply with industry standards so “that the same production process is used from clinical trials through commercial stage.”
In a statement, Salzman said the company plans to meet with the U.S. Food and Drug Administration (FDA) in early 2017 to review the modified plans and prepare for the dosing trial to being at the end 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,” Salzman said in a statement.
That shift in strategy seems to have made investors happy, as pre-market shares of Adverum are up more than 8 percent, hitting $3.99, up from Thursday’s closing price of $3.67 per share.
Salzman’s CEO spot was announced this morning after serving as chief operating officer of the company following the merger. She served as co-founder, president and chief executive officer of Annapurna Therapeutics prior to the merger, according to her bio on the company website. Before founding Annapurna, Salzman held various roles at various pharmaceutical companies, particularly those with a focus on rare diseases. She also helmed Cardiokine Inc. before that company was acquired by Cornerstone Therapeutics. She also served as a member of GlaxoSmithKline ’s R&D executive team where she “planned and managed drug-development projects and clinical trials comprising more than 30,000 patients worldwide,” according to her bio.
Former CEO Paul B. Cleveland was named executive chairman of the company’s board of directors. He said after 10 months helming the newly formed company it was time to turn over the reins of the company.
Avalanche, the parent company of Adverum, ran into problems last year when analysts began to question its wet AMD drug, AVA-101. Analysts questioned if there was truly any statistical difference between the drug and placebo. Those questions sent share prices of Avalanche down the mountain and Cleveland stepped in to right the company through the questions and the renaming into Adverum.
