On March 23, 2026 Siren Biotechnology reported that the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application submitted by the University of California, San Francisco to initiate a Phase 1 clinical study evaluating the safety and biologic activity of SRN-101 in adult patients with recurrent high-grade glioma. 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.
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"This IND clearance allows us to begin evaluating this novel investigational approach in patients with recurrent high-grade glioma," said Dr. Butowski. "This early-phase study will provide important safety and translational data to help inform future clinical development."
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.
"We are honored to support Dr. Butowski and the UCSF team in advancing this investigator-initiated study," said Nicole K. Paulk, PhD, Founder, CEO, and President of Siren Biotechnology. "UCSF has long been a leader in neuro-oncology research, and we are excited to contribute to this important effort on behalf of patients with recurrent high-grade glioma."
This research was additionally made possible by funding from the California Institute for Regenerative Medicine (CIRM), a state of California Agency that funds regenerative medicine, stem cell, gene therapy research and clinical trials (Grant number: TRAN1-15325).
"People with recurrent high-grade glioma urgently need more effective treatment options," said Ross Okamura, PhD, Research Fellow in Preclinical Development at CIRM. "The launch of this trial at UCSF is a major step toward identifying new options and providing hope for people with this deadly condition."
About Recurrent High-Grade Gliomas
Recurrent high-grade gliomas are among the most aggressive and lethal brain tumors. Current treatments can include surgery, radiation, and chemotherapy, all of which offer limited benefit. Novel therapeutic approaches are urgently needed.
(Press release, Siren Biotechnology, MAR 23, 2026, View Source [SID1234663848])