San Diego, CA — Allele Biotechnology & Pharmaceuticals, Inc. (Allele), a San Diego-based biotechnology company specializing in induced pluripotent stem cell (iPSC) technologies and regenerative medicine, today announced the issuance of U.S. Patent No. 12,338,462 by the United States Patent and Trademark Office (USPTO). The patent, titled “Induction of Pancreatic β-Cells by Stem Cell Differentiation with RNA,” expands Allele’s robust intellectual property portfolio and reinforces its leadership in diabetes research and regenerative medicine.
Granted on June 24, 2025, the patent covers proprietary methods for directing human pluripotent stem cells to differentiate into sugar-sensing, insulin-secreting pancreatic β-cells. These cells form islet-like spheroids capable of withstanding cryopreservation and maintaining long-term functional survival post-transplantation.
“While other technologies have advanced the field—such as the Vertex program nearing the first approved type 1 diabetes cell therapy—our mRNA-based differentiation and manufacturing methods offer exceptionally high efficiency and lower costs, particularly for cGMP manufacturing,” said Dr. Jiwu Wang, founder and CEO of Allele Biotechnology and co-inventor of the patent. “This patent protects our innovation in scalable, reliable β-cell differentiation and supports both our internal development and strategic partnerships.”
This new patent builds upon Allele’s broader stem cell portfolio, which includes mRNA reprogramming and differentiation of pluripotent stem cells into various cell types such as neuroprogenitor cells, hepatocytes, cardiomyocytes, and lung epithelial cells. Notably, last week our Allele Reagents branch launched the first-ever mRNA-directed iPSC differentiation kit, enabling drug developers to generate consistent, functional human hepatocytes based on Allele’s patented technologies.
About Allele Biotechnology & Pharmaceuticals, Inc.
Founded in 1999, Allele Biotechnology & Pharmaceuticals, Inc. is a privately held company based in San Diego, California. The company is a recognized leader in stem cell innovation, nanobody development, and fluorescent protein engineering, with a focus on enabling technologies for cell therapy, synthetic biology, and drug discovery.
