Siren Biotech Unveils FDA-Designated SRN-101 for High-Grade Gliomas

On November 18, 2024, Siren Biotechnology, a trailblazer in AAV immuno-gene therapy for cancer, introduced its primary asset, SRN-101, aimed at treating high-grade gliomas. The FDA has granted SRN-101 both Orphan Drug and Rare Pediatric Disease designations, facilitating its development as a novel treatment for patients suffering from high-grade gliomas and pediatric-type diffuse high-grade gliomas. These designations underscore the drug's potential to address some of the most aggressive brain cancers, which currently have limited treatment options. This recognition represents a significant milestone for Siren Biotechnology as it strives to meet the urgent needs of both adult and pediatric patients suffering from these malignant tumors.

Dr. Nicholas Butowski, a renowned Neuro-Oncologist and Director of Translational Research in Neuro-Oncology at the University of California, San Francisco, expressed optimism about SRN-101. He highlighted the therapy's potential to fill a critical gap in effective treatments for high-grade gliomas by utilizing the body’s immune response in a novel and targeted manner. According to Dr. Butowski, this innovative approach could revolutionize the treatment of one of the most fatal brain cancers and bring new hope to patients.

SRN-101 is based on a recombinant adeno-associated viral (AAV) vector that expresses a specially engineered cytokine. Siren Biotechnology, which is supported by venture capital, was launched last year with preclinical data showcasing the potent anti-tumor effects of their universal AAV immuno-gene therapies in preclinical models of brain cancer. The company also received a $4 million CIRM TRAN1 grant to advance the development of these therapies. SRN-101 is the first product and indication unveiled from Siren Biotechnology’s universal AAV immuno-gene therapy platform, with additional technological innovations and other solid tumor indications currently under development.

Dr. Nicole K. Paulk, the CEO and Founder of Siren Biotechnology, expressed enthusiasm about announcing SRN-101 as the leading asset in their AAV immuno-gene therapy platform. She emphasized the extensive efforts of the team to develop an approach that shows exceptional promise not only for treating high-grade gliomas but also for its transformative potential in other indications.

Siren Biotechnology, headquartered in San Francisco, California, is dedicated to combating cancer. The company is a pioneer in Universal AAV Immuno-Gene Therapy, which merges the capabilities of AAV gene therapy and cytokine immunotherapy into a single treatment modality. This innovative approach aims to redefine cancer treatment by effectively destroying tumor cells and inducing anti-tumor immunity. Siren Biotechnology envisions its Universal AAV Immuno-Gene Therapy becoming the standard of care for various solid tumor cancers, revolutionizing how these diseases are treated.

With SRN-101, Siren Biotechnology is making strides in the field of cancer therapy, aiming to provide new hope to patients battling high-grade gliomas and potentially other solid tumors in the future. The company’s innovative approach and dedication to advancing cancer treatment highlight its commitment to addressing some of the most pressing medical challenges.