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TVAX Biomedical awarded US FDA Fast Track Designation for brain cancer treatment.

M2 PHARMA-June 8, 2020-TVAX Biomedical awarded US FDA Fast Track Designation for brain cancer treatment


Immunotherapy company TVAX Biomedical announced on Friday that it has received Fast Track Designation from the US Food and Drug Administration (FDA) to accelerate marketing approval of its vaccine-enhanced adoptive T cell therapy (VACT) for treating glioblastoma multiforme (GBM).

The company said it has completed Phase 1 and 2a studies in multiple cancers, including GBM, a deadly form of brain cancer. Significant benefit was demonstrated in GBM patients using TVAX's patented VACT in those studies. The 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.

Unlike other forms of immunotherapy effective against a limited number of cancer types, the company stated that its 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 objective clinical responses in treated patients.

In addition, the company said it intends to launch a Phase 2b study in newly diagnosed GBM patients in 2020 as well as seeking investors and corporate alliances to support the development.

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Publication:M2 Pharma
Date:Jun 8, 2020
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