Siren Biotechnology Reveals SRN-101 as Lead Asset for High-Grade Gliomas with Both Orphan Drug and Rare Pediatric Disease Designations from the FDA

SAN FRANCISCO, Nov. 18, 2024 (GLOBE NEWSWIRE) — Siren Biotechnology, pioneer of AAV immuno-gene therapy for cancer, today revealed its lead asset, SRN-101, for the treatment of high-grade gliomas. The FDA granted both Orphan Drug and Rare Pediatric Disease designations to SRN-101, supporting its development as a new therapy for patients with high-grade gliomas and pediatric-type diffuse high-grade gliomas, respectively, some of the most aggressive brain cancers with few therapeutic options. This marks a significant milestone for the company as it advances efforts to address the urgent unmet needs of adult and pediatric patients with high-grade gliomas.

Siren Biotechnology’s Approach Could Transform the High-Grade Glioma Therapy Landscape

“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,” said Dr. Nicholas Butowski, MD, Neuro-Oncologist and Director of Translational Research in Neuro-Oncology at the University of California, San Francisco. “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.”

SRN-101 is a recombinant adeno-associated viral (AAV) vector expressing an engineered cytokine. Last year, Siren Biotechnology, a VC-backed company, launched with preclinical data demonstrating that their universal AAV immuno-gene therapies exhibited potent anti-tumor effects in preclinical models of brain cancer [read more], and was additionally awarded a $4M CIRM TRAN1 grant to support the development of these therapies [read more]. SRN-101 for high-grade gliomas is the first asset and indication to be revealed from Siren Biotechnology’s universal AAV immuno-gene therapy platform, with additional technology innovations and other solid tumor indications in development.

“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 Siren Biotechnology
Headquartered in San Francisco, CA, Siren Biotechnology is sounding the alarm against cancer. We are the pioneers of Universal AAV Immuno-Gene Therapy, which combines the promise of two transformative therapeutic technologies, AAV gene therapy and cytokine immunotherapy, into a single modality which we believe will redefine how we destroy tumor cells and elicit anti-tumor immunity. Our vision is for Universal AAV Immuno-Gene Therapy to become the standard of care for any solid tumor cancer.

To learn more, visit sirenbiotechnology.com, and follow us on LinkedIn and Twitter.

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