FDA Grants Fast Track Designation to TVAC Biomedical’s Vaccine-Enhanced Adoptive T-Cell Therapy for Treatment of Glioblastoma Multiforme

OLATHE, Kan., June 4, 2020 /PRNewswire/ — TVAX Biomedical announced today receipt of Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the use of its vaccine-enhanced adoptive T cell therapy (VACT) for treatment of glioblastoma multiforme, a deadly form of brain cancer. 

“We are very pleased to receive Fast Track Designation by the FDA for glioblastoma multiforme (GBM),” stated Dr. Wayne Carter, Chief Executive Officer. “Glioblastoma is a devastating disease for which there are limited treatment options.”

FDA Fast Track Designation is designed to accelerate marketing approval of therapies aimed at treating serious and life-threatening diseases. The Designation creates an opportunity for close and regular communication between TVAX Biomedical and the FDA in order to improve the efficiency of product development. Additionally, it provides a pathway for accelerated approval and rolling review of completed Biological Licensing Application sections by the FDA.

TVAX Biomedical has completed Phase 1 and 2a studies in multiple cancers, including GBM. Significant benefit was demonstrated in GBM patients using TVAX’s patented VACT in those studies. TVAX’s currently planned studies will evaluate VACT in newly diagnosed GBM patients who have healthy immune systems and minimal disease at a time when VACT would be anticipated to generate maximal efficacy.

About TVAX Biomedical

TVAX Biomedical is a clinical stage development company advancing its targeted T cell-based immunotherapy for the treatment of cancer. The company’s proprietary therapeutic approach offers the promise of improved clinical outcomes, low toxicity and the potential for fundamentally changing the way cancer is treated. Unlike other forms of immunotherapy that are effective against a limited number of cancer types, VACT is a unique personalized T cell treatment that has demonstrated the potential to effectively treat a wide range of cancers. T cells present a powerful new opportunity with their demonstrated ability to kill cancer cells, including cancer stem cells, and produce significant numbers of objective clinical responses in treated patients.

The company’s lead candidate focuses on treating brain cancer and is supported by positive Phase 2 clinical data, as well as extensive preclinical and Phase 1 safety studies. TVAX plans to initiate a Phase 2b study in newly diagnosed GBM patients in 2020. As part of its ongoing strategy, the company is seeking investors and corporate alliances to support the development.

For more information, please visit: www.tvaxbiomedical.com

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