Siren Biotechnology Receives FDA Fast Track Designation for SRN-101 for the Treatment of Recurrent High-Grade Glioma

SAN FRANCISCO, Feb. 24, 2026 (GLOBE NEWSWIRE) -- Siren Biotechnology, pioneers of Universal AAV Immuno-Gene Therapy for cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to SRN-101, the Company’s lead AAV-based immuno-gene therapy for recurrent high-grade glioma (HGG). This designation is intended to facilitate the expedited development and review of SRN-101, recognizing its potential to address a serious condition with significant unmet medical need.

Siren recently announced FDA clearance of its first Investigational New Drug (IND) filing for SRN-101, enabling first-in-human clinical evaluation in patients with recurrent high-grade glioma. SRN-101 is a recombinant AAV vector expressing an engineered immunomodulatory cytokine designed to locally stimulate a potent anti-tumor immune response within the tumor microenvironment. SRN-101 is built on Siren’s Universal AAV Immuno-Gene Therapy platform, a modality that aims to overcome the long-standing limitations of traditional immunotherapy approaches in solid tumors.

“Fast Track Designation underscores the urgency of bringing new therapeutic options to patients with recurrent high-grade glioma,” said Nicole K. Paulk, PhD, Founder, CEO, and President of Siren Biotechnology. “We believe SRN-101 represents a fundamentally new approach to treating solid tumors, and this designation reinforces the FDA’s recognition of its potential to make a meaningful difference for patients facing this devastating disease.”

This research was additionally made possible by funding from the California Institute for Regenerative Medicine (CIRM), a state of California Agency that funds regenerative medicine, stem cell, and gene therapy research (Grant number: TRAN1-15325).

About High-Grade Glioma
High-grade gliomas, including glioblastoma, are among the most aggressive and lethal primary brain tumors. Current treatments include surgery, radiation, and chemotherapy, all of which offer limited benefit. Novel therapeutic approaches are urgently needed.

About the California Institute for Regenerative Medicine (CIRM)
The California Institute for Regenerative Medicine (CIRM) is a state agency created by California voters to accelerate stem cell and gene therapies for people with unmet medical needs. Since 2004, Californians have entrusted CIRM with $8.5 billion to accelerate promising discoveries through clinical trials, train a regenerative medicine workforce, strengthen the state’s biotechnology economy, and expand access to transformative treatments. Today, CIRM is pioneering new models of therapy development and accelerating medical breakthroughs that change lives — in California and around the world. For more information, visit www.cirm.ca.gov.

About Siren Biotechnology
Headquartered in San Francisco, California, Siren Biotechnology is sounding the alarm against cancer. The Company is pioneering Universal AAV Immuno-Gene Therapy, a novel therapeutic modality that combines the precision and durability of AAV gene therapy with the immune-modulating potential of cytokine-based approaches. Siren’s platform is designed to support localized, sustained immune activation across solid tumors.

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

Universal AAV Immuno-Gene Therapy for Cancer. It’s Here.

Forward-Looking Statements
This press release contains forward-looking statements, including statements related to the initiation, timing, and conduct of clinical trials, the development of investigational therapies, and Siren Biotechnology’s future plans and objectives. These statements are based on current expectations and assumptions and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied. Such risks and uncertainties include, but are not limited to, regulatory review and approval processes, clinical trial execution and outcomes, and other factors beyond the Company’s control. Siren Biotechnology undertakes no obligation to update these forward-looking statements except as required by law.

Contact
Dr. Akela Kuwahara
press@sirenbiotechnology.com

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