Siren Biotech Lands $8M for Brain Cancer Gene Therapy

Siren Biotechnology has secured a significant $8 million non-dilutive grant from the California Institute for Regenerative Medicine (CIRM). This crucial funding will accelerate the clinical development of SRN-101, an investigational immuno-gene therapy targeting aggressive brain cancers, specifically high-grade gliomas. The award marks a pivotal step for the San Francisco-based company, moving its lead candidate from translational research into human trials.

The grant follows closely on the heels of the U.S. Food and Drug Administration (FDA) granting Investigational New Drug (IND) application clearance for SRN-101 earlier this year. This regulatory milestone greenlit Siren's entry into its first Phase 1/2 clinical trial, designed to assess the therapy's safety and efficacy in adult patients battling recurrent high-grade glioma. The CIRM funding is earmarked to support the operational execution and evaluation of this critical trial.

SRN-101 is engineered on Siren's proprietary Universal AAV Immuno-Gene Therapy platform. This innovative approach aims to deliver immune-stimulating agents directly to tumor sites, promoting localized and sustained anti-cancer immune responses. The therapy has already garnered attention from the FDA, receiving Fast Track, Orphan Drug, and Rare Pediatric Disease designations, underscoring its potential to address significant unmet medical needs in oncology. Notably, CIRM previously provided $4 million in TRAN1 grant funding to support the earlier, translational stages of this program.

High-grade gliomas, including glioblastoma, represent some of the most challenging and lethal forms of primary brain tumors. Current treatment paradigms, often involving surgery, radiation, and chemotherapy, offer limited long-term survival benefits, highlighting the urgent need for novel therapeutic strategies. The market for innovative oncology treatments, particularly those targeting difficult-to-treat brain cancers, continues to see substantial investment and research focus, driven by the high mortality rates and patient suffering associated with these diseases.

“We are profoundly grateful to CIRM, who backed this science at its earliest stage and is now standing with us as we enter the clinic,” stated Nicole K. Paulk, PhD, Founder, CEO, and President of Siren Biotechnology. “High-grade gliomas remain among the hardest cancers to treat, and the patients who live with them cannot wait. This funding propels SRN-101 toward the patients who need it, made possible by the vision of the people of California.”

The California Institute for Regenerative Medicine, established by California voters, plays a vital role in funding cutting-edge regenerative medicine and gene therapy research. With substantial funding allocated through state propositions, CIRM supports research from discovery through clinical trials, fostering a robust biotech ecosystem within California. This latest award to Siren Biotechnology exemplifies CIRM's commitment to advancing promising therapies for devastating diseases.