Siren Biotechnology Secures FDA Fast Track Designation For SRN-101, Its Lead Universal AAV Immuno-Gene Therapy For Recurrent High-Grade Glioma After Recent IND Clearance By The U.S. Food & Drug Administration (FDA)

Siren Biotechnology, known for developing universal AAV immuno-gene therapies for cancer, has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to SRN-101, its lead investigational therapy for recurrent high-grade glioma (HGG). Fast Track Designation is given to treatments that have the potential to address serious illnesses where current options are limited, and it is designed to speed up both development and review.

This announcement comes shortly after the company received FDA clearance for its first Investigational New Drug (IND) application for SRN-101. With this clearance, the therapy can move into first-in-human clinical trials involving patients with recurrent high-grade glioma, an aggressive brain cancer with historically poor outcomes and few effective treatment options.

SRN-101 is a recombinant AAV vector engineered to deliver an immunomodulatory cytokine directly into the tumor microenvironment. By doing so, it is designed to activate a strong and localized anti-tumor immune response. The therapy is built on Siren’s Universal AAV Immuno-Gene Therapy platform, which aims to overcome the major challenges that have limited traditional immunotherapies in solid tumors, such as restricted immune access, limited durability, and insufficient activation within the tumor site.

Nicole K. Paulk, PhD, Founder, CEO, and President of Siren Biotechnology, said that the Fast Track Designation reinforces the critical need for new treatment approaches for recurrent high-grade glioma. She noted that SRN-101 represents a fundamentally different strategy for treating solid tumors by using gene therapy to reprogram the immune response directly at the tumor location. According to her, the designation reflects the FDA’s acknowledgement of its potential to provide meaningful benefits for patients facing an especially devastating and difficult-to-treat cancer.

The development of SRN-101 has also been supported through funding from the California Institute for Regenerative Medicine (CIRM), a state agency that invests in regenerative medicine, stem cell research, and gene therapy. The program received support through Grant TRAN1-15325, which helped advance the work leading up to the IND clearance and Fast Track recognition.