The USPTO approved a patent for Axiogenesis AG for the invention of its in vitro assay to screen pharmaceutical drug candidates for effectiveness and safety in treating Hypertrophic Cardiomyopathy (HCM).
The assay, which has previously received patents in Europe and Japan, is based on induced pluripotent stem (iPS) cell technology. Axiogenesis has developed the ability to induce HCM in iPS cell-derived cardiomyocytes, creating an in vitro model of the disease that can be used to evaluate drug candidates and molecular targets.
Hypertrophic Cardiomyopathy, also known as cardiac hypertrophy, is a potentially fatal disease that can develop in as many as 5 in 1,000 people worldwide.
"There is a great unmet need for better treatments of HCM; however, development of new therapies within pharmaceutical companies requires an enormous amount of time and expense", said Axiogenesis' CEO, Dr. Heribert Bohlen, MD. "We estimate that this new technology will help pharma companies bring innovative treatments of HCM to the market in nearly half the time, and with huge cost savings."
The patent is far-reaching and broadly covers mechanisms for inducing cardiac hypertrophy in any stem cell-derived cardiomyocytes, including Axiogenesis' Cor.4U® human iPS cell-derived cardiomyocytes and Cor.At® murine stem cell-derived cardiomyocytes.
Axiogenesis' in vitro differentiated iPSC-derived cell lines, Cor.4U® and Cor.At®, were developed using the Nobel Prize-winning Yamanaka protocol and Axiogenesis' proprietary cell production and purification technology. Axiogenesis' stem cell lines are used in many other applications, such as toxicology and safety pharmacology.
"iPSC-derived cells have superior benefits over other cellular systems," commented Felix von Haniel, Director of Business Development for Axiogenesis. "Primary human cells are highly variable, and both animal models and human embryonic stem cells are controversial for use in pharma companies."
The United States patent is the latest demonstration of Axiogenesis' commitment to the U.S. market. Since October, the company also recently invested in a US-based representative as well as a U.S. storage and logistics partner to support the launch of the Cor.4U® human iPSC-derived cardiomyocytes. This past summer, Axiogenesis also announced a collaboration agreement with Sigma Life Sciences covering the U.S. and beyond.
Axiogenesis is currently evaluating collaboration and licensing arrangements to further expand the use of the HCM assay technology.