February 18, 2021 -- Selecta Biosciences and Asklepios BioPharmaceutical (AskBio) have initiated a phase I clinical trial to evaluate the safety and preliminary efficacy of ImmTor in gene therapy.
The dose-escalation trial of SEL-399, an adeno-associated viral serotype 8 (AAV8) empty vector capsid (EMC-101) containing no DNA, has been combined with ImmTor. The trial will investigate the optimal dose of ImmTor to mitigate the formation of antibodies to AAV8 capsids in gene therapies.
The study is being conducted in healthy volunteers at the SGS Life Sciences Clinical Pharmacology Unit in Antwerp, Belgium and will enroll up to 45 subjects to investigate increasing doses of ImmTor and EMC-101. Subjects will be randomized in a three to one ratio of ImmTor plus empty AAV8 capsid to empty capsid alone. Preliminary efficacy will be measured by assessing levels of AAV8-specific neutralizing antibodies.
"By determining the dose at which ImmTor is able to inhibit the formation of AAV-specific antibodies, this study could be a significant first step toward overcoming some of the unwanted immune responses associated with gene therapies, said Jude Samulski, PhD, chief scientific officer and co-founder of AskBio.