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SGS is supporting Selecta Biosciences and Asklepios BioPharmaceutical with the Phase I dose-escalation trial of SEL-3999, an AAV8 vector capsid containing no transgene with ImmTOR.
SGS is supporting Selecta Biosciences and Asklepios BioPharmaceutical with the Phase I dose-escalation trial of SEL-3999, an adeno-associated viral serotype 8 (AAV8) vector capsid containing no transgene with ImmTOR. The company announced the news in a March 30, 2021 press release.
The first-in-human trial will be conducted at the SGS Clinical Pharmacology Unit (CPU) in Antwerp, Belgium, and SGS will provide a full scope of services, including regulatory support, healthy participant recruitment, project management, pharmacovigilance, and handling of unblinding data. A unique set of qualifications must be managed for the study, for instance, to accommodate for the requirement of all study subjects being AAV8 antibody negative, SGS CPU will create a specific database to enable accelerated recruitment of study participants.
In the trial, Selecta and AskBio are seeking to determine whether the administration of ImmTOR will prevent the generation of antibodies to the AAV8 vector. If it does prevent AAV8 antibody generation then it will enable redosing of the gene therapy in a patient, which could help overcome a common obstacle with gene therapies.
“Here at SGS, we are delighted to be conducting this Phase I trial. The study medication that we are testing is incredibly innovative and may have important implications in the treatment of genetic disorders,” said Jonathan van Gucht, clinical research physician at SGS, in the press release.