A month after the FDA kept its clinical hold on Solid Biosciences’ experimental gene therapy treatment, the biotech’s former chief medical officer has landed at Apic.
Jorge Quiroz, M.D., had been CMO of Solid but now takes up the equivalent role, plus executive vice president, at Apic Bio, a rival, though earlier-stage, gene therapy company.
It comes after a tough time at Solid Biosciences, which has seen its gene therapy treatment for Duchenne muscular dystrophy SGT-001 hit with an FDA clinical hold since last November in response to a case of acute kidney injury and other symptoms in a child who received the high dose of SGT-001.
Solid Bio has spent the months since the start of the clinical hold gathering and sharing evidence intended to allay the FDA’s concerns about the trial, but, at the end of July, this still wasn’t enough for the U.S. regulator, which kept the hold in place, wanting to see more manufacturing information, updated safety and efficacy data for all patients and details of total viral load to be administered per patient.
Quiroz was sacked from Solid after the original hold amid a series of restructuring moves aimed at getting the therapy back up and running. He served as an adviser after being kicked out as CMO.
He came to Solid after serving at several major companies in high-up positions, including six years as Roche as its head of neurodevelopment and psychiatry, translational medicine neurosciences, and, before that, four years as director, CNS pain and translational medicine at Johnson & Johnson.
At Apic, he will help lead the company’s R&D efforts, which include its lead program, an adeno-associated virus-based gene therapy for the treatment of copper zinc superoxide dismutase 1 (SOD1) ALS, a genetic form of the disease, as well as for rare, undertreated neurological and liver diseases.
The IND for its ALS attempt is planned for this year.
“We are excited to welcome Jorge to Apic during this critical period for the company and our pipeline. His extensive expertise in the clinical and regulatory development of gene therapies for rare diseases will support the advancement of both our SOD1 amyotrophic lateral sclerosis (ALS) and alpha-1 antitrypsin deficiency (Alpha-1) programs,” said John Reilly, co-founder and CEO of Apic.
“As CMO, Jorge will also lead the development and build out of our early-stage gene therapy programs derived from our THRIVE platform. We look forward to working with Jorge during this next chapter for Apic as we rapidly advance our therapies into the clinic on behalf of patients and families in need.”