A month after the FDA stored its scientific maintain on Strong Biosciences’ experimental gene remedy remedy, the biotech’s former chief medical officer has landed at Apic.
Jorge Quiroz, M.D., had been CMO of Strong however now takes up the equal function, plus government vp, at Apic Bio, a rival, although earlier-stage, gene remedy firm.
It comes after a tricky time at Strong Biosciences, which has seen its gene remedy remedy for Duchenne muscular dystrophy SGT-001 hit with an FDA scientific maintain since final November in response to a case of acute kidney harm and different signs in a baby who acquired the excessive dose of SGT-001.
Strong Bio has spent the months for the reason that begin of the scientific maintain gathering and sharing proof meant to allay the FDA’s considerations in regards to the trial, however, on the finish of July, this nonetheless wasn’t sufficient for the U.S. regulator, which stored the maintain in place, desirous to see extra manufacturing data, up to date security and efficacy information for all sufferers and particulars of whole viral load to be administered per affected person.
Quiroz was sacked from Strong after the unique maintain amid a collection of restructuring strikes aimed toward getting the remedy again up and operating. He served as an adviser after being kicked out as CMO.
He got here to Strong after serving at a number of main firms in high-up positions, together with six years as Roche as its head of neurodevelopment and psychiatry, translational medication neurosciences, and, earlier than that, 4 years as director, CNS ache and translational medication at Johnson & Johnson.
At Apic, he’ll assist lead the corporate’s R&D efforts, which embody its lead program, an adeno-associated virus-based gene remedy for the remedy of copper zinc superoxide dismutase 1 (SOD1) ALS, a genetic type of the illness, in addition to for uncommon, undertreated neurological and liver illnesses.
The IND for its ALS try is deliberate for this 12 months.
“We’re excited to welcome Jorge to Apic throughout this essential interval for the corporate and our pipeline. His intensive experience within the scientific and regulatory growth of gene therapies for uncommon illnesses will help the development of each our SOD1 amyotrophic lateral sclerosis (ALS) and alpha-1 antitrypsin deficiency (Alpha-1) applications,” mentioned John Reilly, co-founder and CEO of Apic.
“As CMO, Jorge will even lead the event and construct out of our early-stage gene remedy applications derived from our THRIVE platform. We sit up for working with Jorge throughout this subsequent chapter for Apic as we quickly advance our therapies into the clinic on behalf of sufferers and households in want.”