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Siren Biotechnology's SRN-101 Receives FDA Designations for High-Grade Gliomas

• Siren Biotechnology's SRN-101, an AAV immuno-gene therapy, has been granted Orphan Drug and Rare Pediatric Disease designations by the FDA for high-grade gliomas. • SRN-101 leverages the body’s immune response in a targeted manner, potentially addressing a critical gap in effective high-grade glioma therapies. • Siren Biotechnology's platform aims to redefine tumor cell destruction and elicit anti-tumor immunity, marking SRN-101 as the lead asset. • SRN-101 represents a significant advancement for both adult and pediatric patients facing these aggressive brain cancers with limited therapeutic options.

Siren Biotechnology has announced that its lead asset, SRN-101, an adeno-associated viral (AAV) immuno-gene therapy, has received both Orphan Drug and Rare Pediatric Disease designations from the FDA for the treatment of high-grade gliomas, including pediatric-type diffuse high-grade gliomas.

SRN-101: A Novel Approach to High-Grade Glioma Treatment

SRN-101 is designed to harness the body's immune response to target and destroy tumor cells. The therapy utilizes a recombinant AAV vector to express an engineered cytokine. Preclinical data has demonstrated potent anti-tumor effects in brain cancer models.
According to Dr. Nicholas Butowski, MD, Neuro-Oncologist and Director of Translational Research in Neuro-Oncology at the University of California, San Francisco, SRN-101 has the potential to address a critical gap in effective high-grade glioma therapies by leveraging the body’s immune response in a targeted, innovative way. He added that this approach could represent a major breakthrough in how we treat one of the most devastating brain cancers and offers a new path of hope for patients.

Siren Biotechnology's Universal AAV Immuno-Gene Therapy Platform

SRN-101 is the first asset and indication to be revealed from Siren Biotechnology’s universal AAV immuno-gene therapy platform. The company is also developing additional technology innovations and exploring other solid tumor indications.
"We are excited to announce SRN-101 as the lead universal AAV immuno-gene therapy asset in our platform’s pipeline," said Dr. Nicole K. Paulk, PhD, Siren Biotechnology’s CEO and Founder. "Our team has worked tirelessly to develop an approach that demonstrates remarkable promise for the treatment of high-grade gliomas but also has transformative potential for use in additional indications."

About High-Grade Gliomas

High-grade gliomas are aggressive brain cancers with limited therapeutic options, representing a significant unmet medical need in both adult and pediatric populations. The FDA designations for SRN-101 underscore the urgent need for new therapies to address these challenging cancers.
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Reference News

[1]
Siren Biotechnology Reveals SRN-101 as Lead Asset for - GlobeNewswire
globenewswire.com · Nov 18, 2024

Siren Biotechnology unveiled SRN-101, an AAV immuno-gene therapy for high-grade gliomas, receiving FDA's Orphan Drug and...

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