Siren Biotechnology Clears Its First IND and Enters the Clinic
Scottsdale, AZ — January 28, 2026 · KMAK Capital
The FDA has cleared the first Investigational New Drug application from portfolio company Siren Biotechnology, enabling a first-in-human clinical trial and moving the company to clinical stage.
The clearance supports evaluation of Siren’s lead program in adult patients with recurrent high-grade glioma. The company believes this represents the first FDA-cleared IND for an AAV-based therapy in an oncology indication.
“This IND clearance represents a defining moment for Siren as we transition from a preclinical-stage company into the clinic. 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.”
The program is built on Siren’s Universal AAV Immuno-Gene Therapy platform, designed for localized, durable delivery of immune-modulating payloads within tumors. The clearance follows prior FDA grants of Orphan Drug and Rare Pediatric Disease designations. The California Institute for Regenerative Medicine provided funding support through grant TRAN1-15325.
Recurrent high-grade glioma is an unforgiving setting for a first-in-human study, which is part of why the clearance carries weight.