Overcoming the Barriers to Beta Cell Replacement
Over 9 million people worldwide live with type 1 diabetes (T1D). Current insulin-based treatments, including pumps and CGMs, remain burdensome. They cannot replicate the precise glycemic control of endogenous beta cells, leaving patients vulnerable to debilitating acute and long‑term complications. Islet transplantation demonstrates that beta cell replacement can restore normal glucose regulation and insulin independence, but this approach is limited by scarce donor tissue and the need for lifelong immunosuppression with significant side effects.
Our Solution: Off-the-shelf, iPSC-Derived Islet-Like Clusters (ILCs)
Off-the-shelf iPSC derived islet-like clusters (ILCs) that replace natural islet function and are genetically shielded from immune rejection. A scalable therapy to achieve full, durable normoglycemia without insulin injections or immunosuppression, designed as a once-and-done treatment.
Long‑Term Glycemic Control and In Vivo Safety of our High‑Quality ILCs
- Highly pure iPSC-derived endocrine cells with an optimized beta cell fraction >60%
- Full glycemic control in predictive diabetes animal model maintained for 1 year
- No unwanted cell growth observed after 1 year in vivo
- Gene‑edited ILCs perform equivalently to non‑edited controls and donor islets
Streamlined, GMP‑compatible iPSC Gene Engineering for Maximal Durability & Safety
- Immunosuppression-free therapy enabled by IP-protected, multifaceted shielding against innate and adaptive immunity, validated in vitro
- Drug-inducible kill-switch for enhanced patient safety, validated in vitro and in vivo
- Precise, site-directed CRISPR gene editing paired with stringent genetic QC guided by FDA/EMA
- Optimized editing strategy to maximize effectiveness while minimizing complexity
Robust, Scalable and GMP-Compatible ILC Manufacturing
- Unlimited iPSC‑based cell supply
- IP‑protected, GMP‑compatible ILC differentiation in multi‑liter bioreactors
- Modular process enabling flexible manufacturing planning
- Shipment of drug product in implantation‑ready medium
- Manufacturing process and control strategy aligned with regulatory authorities
Contact us
We are currently seeking strategic partners to accelerate our iShield.Beta program toward the clinic. For detailed pre-clinical data packages or to discuss investment opportunities, please contact us via the form below.
