Immuno-gene therapy for brain cancer tumors now on FDA fast track
SRN-101 uses modified viruses to signal immune system to attack glioma cells
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An “immuno-gene” therapy that turns a virus into a cancer-fighting agent has received a fast-track designation from the U.S. Food and Drug Administration (FDA). The experimental treatment, known as SRN-101, is being developed for recurrent high-grade glioma, an aggressive form of brain cancer that has returned after initial treatment and currently has few effective options.
The FDA’s fast-track program is reserved for therapies that address serious unmet medical needs. This designation provides the developer, Siren Biotechnology, with frequent access to the FDA to expedite the drug’s development and review process, potentially bringing it to patients sooner.
“Fast Track Designation underscores the urgency of bringing new therapeutic options to patients with recurrent high-grade glioma,” Nicole K. Paulk, PhD, founder, CEO, and president of Siren, said in a company press release.
Harnessing AAV for cancer therapy
Glioma is a form of brain cancer that arises from the uncontrolled growth of glia, cells that normally help protect the brain against damage and support the health of nerve cells. SRN-101 aims to treat aggressive gliomas using a modified adeno-associated virus (AAV).
AAV is a virus that naturally infects people, but it doesn’t usually cause serious infection. Like other viruses, AAV is very good at getting genetic material into cells. This combination of traits has made AAV a popular platform for gene therapies targeting rare genetic diseases. The basic idea is that AAV can be modified to deliver a healthy version of a mutated gene to cells, thereby addressing the root cause of genetic disorders. Several gene therapies based on AAV have been FDA-approved for various rare genetic diseases over the last decade.
SRN-101 uses the same general strategy, but with a twist: instead of delivering a healthy version of a mutated gene, the virus is designed to deliver a gene encoding a cytokine — that is, a signaling molecule that tells the immune system to go on the attack. The goal is to increase cytokine levels in the tumor, thereby triggering the immune system to better attack and eradicate the cancer.
“We believe SRN-101 represents a fundamentally new approach to treating solid tumors,” Paulk said, adding that the FDA’s decision to give the therapy fast-track designation “reinforces the FDA’s recognition of its potential to make a meaningful difference for patients facing this devastating disease.”
The new designation comes a few weeks after the FDA cleared Siren’s investigational new drug application, granting the company the green light to begin a clinical trial testing SRN-101 in people for the first time. According to Siren, this marks the first AAV-based cancer therapy to enter clinical testing.
