SRN-101 / Siren Biotech - LARVOL DELTA

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