Award

NIH Reporter #5R44NS141514-02

Treatment of GM1 gangliosidosis CNS manifestations by AAV systemic expression of lectin-enhanced enzyme

Recipient

BIOSTRATEGIES, LC

Award Amount

$1,500,000.00

Ceiling

$1,500,000.00

Awarded

September 14, 2026

Identifier

5R44NS141514-02

This award funds the development of BIOS-GM1, a gene therapy for GM1 gangliosidosis that uses AAV vectors to deliver enzyme replacement systemically, crossing the blood-brain barrier to treat CNS manifestations, aiming to provide the first effective treatment for this neurodegenerative disease.

Description

BioStrategies LC proposes to complete IND-enabling studies to develop BIOS-GM1, a novel gene therapy for GM1 gangliosidosis. The therapy combines delivery-enhanced enzyme replacement with gene therapy to treat CNS and other organ pathologies. The approach involves using AAV-based vectors to deliver genes to produce functional acid β-galactosidase, crossing the blood-brain barrier without intrathecal or intraventricular administration. Successful development could provide the first effective treatment for GM1, addressing a critical unmet medical need.

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