FDA Clears IND for AAV-Based Gene Therapy Targeting High-Grade Glioma

February 2026 — Global Biotech News

San Francisco, CA / USA — The U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application for SRN-101, an AAV-based immuno-gene therapy developed by Siren Biotechnology, enabling the initiation of the company’s first-in-human clinical trial in patients with recurrent high-grade glioma — an aggressive and hard-to-treat form of brain cancer. This marks the first time the FDA has cleared an IND for an adeno-associated virus (AAV)-based therapy in an oncology indication, underscoring a significant regulatory milestone for gene therapy approaches in cancer.

SRN-101 employs a recombinant AAV vector to deliver an engineered immune-modulating payload directly into the tumor microenvironment with the goal of stimulating a sustained anti-tumor immune response. According to Siren Biotechnology, preclinical data indicated potent anti-tumor activity in models of brain cancer, supporting the transition into clinical investigation.

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Nicole K. Paulk, PhD, founder, chief executive officer, and president of Siren Biotechnology, described the IND clearance as “a defining moment” for the company’s evolution from preclinical research into the clinical stage, reflecting years of platform development and regulatory engagement.

The upcoming first-in-human study will evaluate SRN-101 among adults with recurrent high-grade glioma, a patient population with limited therapeutic options and generally poor outcomes under existing standard treatments such as surgery, radiation, and chemotherapy. The trial will focus on safety, tolerability, and early signals of clinical benefit.

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Industry observers say the clearance represents a broader shift in the gene therapy field, as researchers and regulators increasingly explore AAV-based platforms in solid tumor oncology, an area that previously faced challenges related to vector delivery, immune response, and clinical translation.

Source: FDA Clears IND for Investigational Program in Recurrent High-Grade Glioma — Cancer Network / Siren Biotechnology press releases linked via Reuters reporting (January 29–28, 2026)