SAN FRANCISCO, Jan. 28, 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 cleared the Company’s first Investigational New Drug (IND) application, enabling the initiation of its first-in-human clinical trial. With this clearance, Siren officially advances to a clinical-stage biotechnology company.
The IND clearance supports the evaluation of Siren’s lead investigational program in adult patients with recurrent high-grade glioma and represents a significant regulatory milestone for the Company. Siren believes this marks the first FDA-cleared IND for an adeno-associated virus (AAV)-based therapy in an oncology indication, underscoring the growing potential of gene therapy approaches in cancer.
“This IND clearance represents a defining moment for Siren as we transition from a preclinical-stage company into the clinic,” said Nicole K. Paulk, PhD, Founder, CEO, and President of Siren Biotechnology. “Reaching this milestone reflects years of focused platform development, rigorous translational work, and close engagement with regulators, and it positions us to begin evaluating our approach in patients.”
Siren plans to initiate a first-in-human clinical study in adult patients with recurrent high-grade glioma. This advancement builds on the Company’s broader Universal AAV Immuno-Gene Therapy platform, which is designed to enable localized and durable delivery of immune-modulating payloads directly within tumors.
The IND clearance follows the FDA’s prior granting of Orphan Drug and Rare Pediatric Disease designations for the program and reflects the completion of the nonclinical and CMC activities required to support clinical evaluation.
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)
CIRM was created by the people of California to fund stem cell and gene therapy research with the goal of accelerating treatments for patients with unmet medical needs. With $8.5 billion in funding allocated through both Proposition 71 in 2004 and Proposition 14 in 2020, CIRM supports stem cell and gene therapy discoveries from inception through clinical trials, trains a workforce in California to fill jobs in the state’s thriving biotech and biomedical research industry, and creates infrastructure to make clinical trials accessible for people throughout California. All of CIRM’s research, workforce development, and infrastructure programs are designed to benefit the people of California, whose vision created the agency. 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.