SAN FRANCISCO, CA, March 23, 2026
Siren Biotechnology has announced that the U.S. Food and Drug Administration (FDA) has granted clearance for an Investigational New Drug (IND) application, enabling the initiation of a Phase 1 clinical trial for its investigational gene therapy SRN-101 in patients with recurrent high-grade glioma. This milestone represents a critical regulatory advancement in the development of innovative therapies targeting one of the most aggressive and treatment-resistant brain cancers, with the study being conducted in collaboration with the University of California, San Francisco (UCSF).
FDA IND Clearance Enables First-in-Human Study
The FDA IND clearance allows Siren Biotechnology and UCSF to proceed with a single-center, investigator-initiated Phase 1 clinical trial designed to evaluate the safety and biological activity of SRN-101 in adult patients suffering from recurrent high-grade glioma. This early-stage clinical study is a key step in translating preclinical innovation into human trials, adhering to strict Good Clinical Practice (GCP) standards and regulatory oversight.
The trial will be led by neuro-oncology expert Dr. Nicholas Butowski, with Siren providing the investigational therapy and supporting clinical development efforts. Importantly, this study aims to generate critical safety data and translational insights, which will inform subsequent phases of development and potential regulatory submissions. The IND clearance underscores the FDA’s confidence in the preclinical data package, enabling the advancement of a novel therapeutic modality into clinical evaluation.
SRN-101: Advancing Gene Therapy for Brain Cancer
Advertisement
SRN-101 is an investigational gene therapy developed using Siren Biotechnology’s Universal AAV Immuno-Gene Therapy platform, which combines the precision of adeno-associated virus (AAV) delivery systems with immune-modulating cytokine approaches. This innovative platform is designed to achieve localized and sustained immune activation within tumors, potentially enhancing therapeutic efficacy while minimizing systemic toxicity.
The therapy targets recurrent high-grade glioma, a condition characterized by rapid progression and limited treatment options. Current standard-of-care treatments, including surgery, radiation, and chemotherapy, often provide only temporary benefit, highlighting the urgent need for novel therapeutic strategies. By leveraging gene therapy technology, SRN-101 aims to introduce a new paradigm in oncology treatment, particularly for patients with unmet medical needs.
Addressing Unmet Need in Recurrent High-Grade Glioma
Recurrent high-grade gliomas are among the most lethal brain tumors, with poor prognosis and limited survival outcomes despite aggressive treatment. The initiation of this Phase 1 clinical trial represents a significant step forward in addressing this unmet need, offering hope for patients who have exhausted conventional therapies.
The study is further supported by funding from the California Institute for Regenerative Medicine (CIRM), highlighting the importance of public-private collaboration in advancing cutting-edge therapies. Experts emphasize that the launch of this trial is a major milestone in identifying new treatment options and accelerating progress in the field of neuro-oncology.
As Siren Biotechnology continues to advance its pipeline, the successful execution of this trial could pave the way for future clinical development and potential regulatory approval, reinforcing the growing role of gene therapies in modern medicine. The company’s collaboration with leading academic institutions like UCSF further strengthens its position in the biopharmaceutical innovation ecosystem.
Source: Siren Biotechnology press release
