The root cause of autoimmune disease starts in the gut. So do we.
At Tolagen, we are pioneering oral tolerogenic therapies designed to restore immune homeostasis in the gut, targeting the root cause of chronic inflammatory and autoimmune diseases. Our biomimetic platform retrains the immune system to self-regulate — offering a path to durable, potentially preventative treatment beyond today’s standard of care.
We go where the problem starts — the gut.
Tolagen’s dual-polymer nanoparticles are purpose-built to be recognized and phagocytosed by antigen presenting cells (APCs) in the gut — an outer enteric coating protects the payload through the stomach, while the particle’s size and shape are precisely tuned for APC uptake. Once inside APCs, the therapy is released exclusively within the cell — never entering general circulation — retraining it to restore the body’s natural immune tolerance and calm inflammation at its source, instead of suppressing the immune system as a whole. Our approach is designed to be:
Andreas Vogt, PhD
PhD in Pharmaceutical Chemistry
Kevin Mollen, MD
Chief, Division of Pediatric Surgery
Mark Schurdak, PhD
Research Associate Professor
Jon Piganelli, PhD
Professor of Medicine
Backed by Science, Powered by Innovation
Tolagen’s team has secured $1.5M in NIH Phase I STTR and SBIR funding from NIDDK and NIAID to support platform validation and early proof-of-concept studies across our three lead programs. We are now raising a $1–3M pre-seed round to generate the animal efficacy data needed to select a lead indication, advance manufacturability planning, and reach an FDA Pre-IND milestone — positioning Tolagen for Series A financing and strategic partnerships.
Be Part of the Future of Immune Health
We are on track to initiate Phase 1 trials by 2029, setting the stage for strategic partnerships, further funding rounds, and a path toward IPO.
Why Tolagen?
A Game-Changing Approach
Our orally administered, APC-targeting nanomedicines are designed for greater safety, better patient compliance, and lower costs than biologics or cell therapies.
High-Value Market Potential
With Celiac Disease, Inflammatory Bowel Disease, and Type 1 Diabetes as initial targets, our pipeline addresses a combined $70B+ market opportunity in autoimmune care.
Strong Early-Stage Support
Backed by $1.5M in NIH STTR and SBIR funding, we are advancing platform validation across three disease models toward an FDA Pre-IND milestone.
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2026
Tolagen – All rights reserved