Nosis Bio, an AI-native biotechnology company pioneering cell-targeted gene silencing, today announced the nomination of its first development candidate (DC) for fibrosis. The milestone marks the company’s transition into IND-enabling studies and the advancement of its proprietary targeted delivery and drug design platform into clinical-stage development.

Fibrosis affects over 100 million people globally and remains a high-burden, underserved condition that causes progressive scarring of critical organs such as the lungs, kidneys, and heart. Despite its prevalence, the field has seen limited progress, with existing treatments offering only modest efficacy and being constrained by systemic toxicity and poor tolerability.

Nosis Bio has designed a new option for patients: a cell-targeted therapeutic that selectively silences fibrotic drivers only in the pathogenic cells responsible for disease. This precision approach enables superior efficacy, a clean safety profile with minimal off-target effects, and a broad therapeutic index that unlocks the potential for long-term treatment and meaningful clinical impact in an area with significant patient need.

Key data supporting the DC nomination include:

• Superior efficacy compared to standard-of-care therapeutics in head-to-head preclinical studies
• A clean safety profile at 100-fold the anticipated therapeutic dose, with no dose-limiting toxicities observed
• Demonstrated repeat dosing with no immunogenicity or anti-drug antibody (ADA) generation observed

“This milestone reflects our belief that the future of medicine lies in delivering potent therapeutics precisely to the cells that need them,” said Jim Martineau, CEO and Co-Founder of Nosis Bio. “Unlike viral or lipid-based approaches, our cell-targeted platform avoids systemic toxicity and immunogenicity, simplifies manufacturing, and expands delivery to tissues and cell types that were previously out of reach. With our lead candidate nominated and a world-class team in place, we’re focused on advancing rapidly to the clinic to bring safer, more effective treatments to patients.”

Nosis Bio’s lead candidate was developed using the company’s Connexa platform, an AI-native system designed to overcome key challenges with targeted delivery and drug design. In particular, Connexa has enabled cell-targeted delivery across seven tissues including the lung, kidney, heart, brain, muscle, small intestine, and key immune cell populations.

In addition to its program in fibrosis, Nosis is advancing a pipeline of cell-targeted therapeutics in immunology and inflammatory disease and is collaborating with leading pharmaceutical companies to apply its platform broadly across high-value indications.

About Nosis Bio

Nosis Bio is an AI-native biotechnology company pioneering cell-targeted gene silencing through its proprietary Connexa platform. By integrating physics-informed deep learning, drug design, and a seamlessly connected wet lab platform, Nosis designs medicines to silence disease-causing genes in precise cell types. The approach enables highly specific, safe, redosable, efficacious, and cost-effective therapeutics for diseases with high unmet need. Nosis is backed by leading institutional investors and has ongoing therapeutic collaborations with major pharmaceutical partners. For more information, visit www.nosisbio.com.

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