Immunotherapy for Glioblastoma Preps For Clinical Trials

NovAccess Global Inc. recently announced the approval of its application with the U.S. Food and Drug Administration (FDA) for Orphan Drug Designation for TLR-AD1, a vaccine immunotherapy for the treatment of aggressive brain cancers, including glioblastoma and other high-grade gliomas.

Glioblastoma is a form of aggressive brain cancer that annually impacts approximately 250,000 people globally.

TLR-AD1 is designed to activate anti-tumor immune responses against these brain tumors using immune-activating dendritic cells combined with the patient’s tumor proteins.

The resulting dendritic cell vaccines are matured with a proprietary combination of Toll-like receptor (TLR) adjuvants to boost their immune-activating potency beyond current vaccine preparations.

“Orphan Drug Designation is yet another timely milestone achieved by NovAccess Global as we prepare an Investigative New Drug (IND) application for FDA approval to start human clinical trials. We expect to submit the IND in the first half of 2023,” said the Company’s CEO, Dr. Dwain K. Irvin, in a press release on October 26, 2022.

“The designation represents a critical step forward as we address an important and unmet healthcare challenge in treating brain cancers.”

NovAccess Global expects to submit an IND application to the FDA for TLR-AD1 in the first half of 2023.

In advance of the IND filing, the Company expects to announce a partnership with a clinical manufacturing organization for vaccine testing and production readiness for phase I-II clinical trials of TLR-AD1.