NovAccess Global Lead Scientist Published in High-Profile Medical Journal for Cancer Vaccine Advancements - Seite 2

Oncogene is a weekly international journal publishing top peer-reviewed research in cancer science on the basis of its originality, importance, interest to the cancer field, timeliness, accessibility, and conclusions. Please see the entire published report on the potential role of IDH1 in the treatment of glioblastoma at https://www.nature.com/articles/s41388-023-02713-7.pdf.

Later this month, Dr. Wheeler and Dr. Irvin will speak on the Company's groundbreaking technology at the World Orphan Drug Congress near Washington, DC. NovAccess Global received approval of its application with the U.S. Food and Drug Administration (FDA) for Orphan Drug Designation (ODD) for TLR-AD1, a vaccine immunotherapy for the treatment of aggressive brain cancers, including glioblastoma and other high-grade gliomas. This approval was accompanied by the FDA expanding the scope of the Company's submission, which underscores the promise of NovAccess Global's platform technology. The special status afforded to the Company through the ODD is expected to enable an acceleration of the development of its therapies for new treatment options for a wide range of glioblastoma patients.

The FDA's Office of Orphan Products Development grants orphan designation status to investigational drugs and therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the United States. Orphan drug designation provides benefits to drug developers which may include assistance in the drug development process, financial incentives to support clinical development, tax credits for clinical costs, exemptions from certain FDA fees and the potential for seven years of post-approval marketing exclusivity.

NovAccess Global's participation and presentation at the World Orphan Drug Congress will allow the Company to disseminate and leverage its groundbreaking work to provide support for clinical development, accelerate time to market, and increase the reach of its therapeutic technology platform. Considered to be the world's most important orphan drug and rare disease event, the World Orphan Drug Congress brings together leading pharmaceutical and biotech companies, government and regulatory authorities, patient advocacy groups, payers, investors and solution providers. The conference is a place to meet and brainstorm on ways to advance orphan drug development and improve access to life-saving therapies.