SRN-101 / Siren Biotech - LARVOL DELTA

A Phase 1 Study of SRN-101 Administered Prior to Surgical Resection in Adults With Recurrent High-Grade Glioma. (clinicaltrials.gov) - P1 | N=6 | Not yet recruiting | Sponsor: Nicholas Butowski

First-in-human • New P1 trial • Brain Cancer • Glioblastoma • Glioma • High Grade Glioma • Oligodendroglioma • Oncology • Solid Tumor

Siren Biotechnology Awarded $8M in Non-Dilutive Grant Funding from the California Institute for Regenerative Medicine (CIRM) to Support Clinical Development of SRN-101 in High-Grade Glioma (GlobeNewswire) - "The award follows the U.S. Food and Drug Administration's (FDA) clearance of Siren's first Investigational New Drug (IND) application earlier this year, which advanced the Company to clinical stage and enabled a Phase 1/2 trial in adult patients with recurrent high-grade glioma. CIRM's transformative CLIN2 funding will support the conduct of that trial and the activities required to evaluate SRN-101 in patients."

Financing • Glioma

End-to-end device compatibility and in-use stability assessment of an AAV gene therapy delivered by convection-enhanced delivery (ASGCT 2026) - "Conclusion This comprehensive device compatibility and in-use stability study demonstrated that SRN-101 maintains critical quality attributes following exposure to a CED delivery device under clinically relevant and worst-case conditions. The results support the suitability of the selected delivery system for Phase 1/2 clinical administration and provide a practical, end-to-end framework for evaluating device compatibility of AAV gene therapies requiring specialized delivery approaches."

Gene therapy • Gene Therapies • IFNB1

MRI-Guided Convection-Enhanced Delivery of an AAV-hIFNβ Vector Achieves Targeted Brain Retention and Durable Transgene Expression in a Large-Animal Model (ASGCT 2026) - "Conclusion MRI-guided CED enabled controlled, localized delivery of SRN-101 to the brain with durable transgene expression and limited peripheral exposure in a large-animal model. These findings support the clinical translation of SRN-101 for targeted intratumoral delivery in patients with brain tumors."

Preclinical • Brain Cancer • Solid Tumor • IFNB1

AAV immuno-gene therapy platform delivering vectorized cytokines defines a new modality for high-grade glioma treatment. (PubMed, Mol Ther Oncol) - "To enable clinical translation, we developed SRN-101, a clinical-grade AAV-hIFNβ construct with optimized potency and manufacturability, which achieved superior expression and in vivo efficacy vs. the research-grade vector. These findings establish AAV-vectorized cytokines as a durable, locally delivered immuno-gene therapy platform for high-grade gliomas."

IO biomarker • Journal • Brain Cancer • Gene Therapies • Glioblastoma • Glioma • High Grade Glioma • Oncology • Solid Tumor • IFNA1 • IFNB1 • IFNG

Siren Biotechnology Announces FDA Clearance of Investigator-Initiated IND to Advance Phase 1 Study in Recurrent High-Grade Glioma (GlobeNewswire) - "The IND clearance enables the launch of a single-center, investigator-initiated Phase 1 study led by Nicholas Butowski, MD, Professor of Neurological Surgery and Neuro-Oncology at UCSF....SRN-101 is an investigational gene therapy developed by Siren Biotechnology. Siren is providing study drug and collaborating with UCSF in support of the trial."

IND • P1 data • Glioma

Siren Biotechnology Receives FDA Fast Track Designation for SRN-101 for the Treatment of Recurrent High-Grade Glioma (GlobeNewswire) - "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."

Fast track • High Grade Glioma

Siren Biotechnology Announces FDA Clearance of First IND, Advancing Company to Clinical Stage (The Manila Times) - "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 plans to initiate a first-in-human clinical study in adult patients with recurrent high-grade glioma."

First-in-human • IND • New trial • Glioma

SRN-101 universal AAV gene therapy for solid tumors (ASGCT 2025) - "Supported by the Translational Science Committee"

Gene therapy • Gene Therapies • Oncology • Solid Tumor

Siren Biotechnology to Present Universal AAV Immuno-Gene Therapy Data at the 2025 American Society of Gene and Cell Therapy (ASGCT) Annual Meeting (GlobeNewswire) - "Siren Biotechnology Inc...announced that it will present new scientific data at the 2025 American Society of Gene and Cell Therapy (ASGCT) Annual Meeting, taking place May 13–17 in New Orleans, LA."

Clinical data • Glioma • Solid Tumor

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

FDA event • Orphan drug • Glioma