Siren Biotechnology Receives FDA Fast Track Designation for SRN-101 for Recurrent High-Grade Glioma
Wednesday, February 25, 2026
Siren Biotechnology has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for SRN-101, its lead AAV-based immuno-gene therapy for the treatment of recurrent high-grade glioma (HGG).
The Fast Track status is granted to support the quicker development and review of medicines that treat serious conditions and address unmet medical needs. Recurrent high-grade glioma is an aggressive brain tumour with limited treatment options.
The company recently secured FDA clearance for its first Investigational New Drug (IND) application for SRN-101. This approval allows the therapy to move into first-in-human clinical trials in patients with recurrent HGG.
SRN-101 is a recombinant AAV vector that delivers an engineered immunomodulatory cytokine directly into the tumour. It is designed to activate a strong anti-tumour immune response within the tumour environment. The therapy is developed using Siren’s Universal AAV Immuno-Gene Therapy platform, which aims to overcome the limitations of traditional immunotherapy in solid tumours.
The development of SRN-101 has also been supported by funding from the California Institute for Regenerative Medicine (CIRM), a state agency that funds research in regenerative medicine, stem cell science and gene therapy.
Source: globenewswire.com
