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.
Glioblastoma is an aggressive type of cancer that can occur in the brain or spinal cord. Glioblastoma forms from cells called astrocytes that support nerve cells. Glioblastoma can occur at any age, but tends to occur more often in older adults. It can cause worsening headaches, nausea, vomiting and seizures.
The company expects to submit an Investigational New Drug application for TLR-AD1 in the first half of 2023.
NovAccess Global, Inc. operates as a medical equipment company. The Company discovers, develops, and brings to market novel medicines and medical devices to improve the quality of care for cancer and neurological patients. Novaccess Global serves customers worldwide. Founded: 1997, headquarters: Ohio, United States, subsidiary: StemVax, LLC.
October 27, 2022