NovAccess Global Gains Orphan Drug Status for Brain Cancer Drug Candidate

The FDA has granted an Orphan Drug designation to NovAccess Global’s for an investigational immunotherapy for aggressive brain cancers such as glioblastoma.

The drug candidate, TLR-AD1, is designed to activate antitumor responses by using immune-activating dendritic cells combined with the patient’s own tumor proteins. The combination produces a vaccine that is then matured with a proprietary combination of Toll-like receptor adjuvants to boost the immune-activating potency.

The company expects to submit an Investigational New Drug application for TLR-AD1 in the first half of 2023.