Helixsmith said Wednesday that it has acquired a patent for its technology of new plasmid deoxyribonucleic acid (DNA) therapy in China.
With the newly registered patent, the company secured exclusive rights of therapeutic techniques for treating patients with peripheral artery disease using a combination of hepatocyte growth factor (HGF) and stromal cell-derived factor 1 (SDF-1α) until 2035.
The combination drug delivers HGD by Engensis (VM202) and SDF-1α through pIKO.
pIKO is a new gene therapy candidate developed by Helixmith’s research team. It can significantly increase the biological activity of Engensis and help expand the indications for more diseases.
The drug candidate was developed by discovering a gene that could induce a synergetic effect in the angiogenesis process through interaction with the HGF gene loaded in Engensis.
Helixmith screened for genes that could additionally or synergistically raise angiogenic activity when used with HGF. The company found SDF-1α during the study and made pIKO that expresses the gene.
In an animal model of critical limb ischemia (CLI), the treatment was more effective when administered with pIKO than in Engensis monotherapy, indicating that the combined therapy of Engensys and pIKO could be used for various types of peripheral arterial disease, the company said.
The technology was registered in Korea in 2017, Japan in 2019, and the EU in 2020. China became the fourth country to grant exclusive rights to Helixmith’s technology.
The number of patients with peripheral arterial diseases was estimated to be about 40 million in China in 2017. Peripheral arterial diseases have a wide range of illnesses, including diabetic vascular disease, CLI, claudication, and diabetic foot.
A significant proportion of patients with peripheral arterial patients also have diabetes as high blood glucose levels can narrow or block blood vessels. About 100 million people in China have diabetes, and the number rises to 10 percent of the entire population if pre-symptomatic patients are included.
The company is conducting phase 3 clinical trials with a local partner in China for CLI, the most extreme form of peripheral artery disease.
“We have secured various next-generation plasmid DNA pipelines centered on Engensis. pIKO, one of the genetic therapy candidates, can help expand the Engensis market as it can increase the activity of Engensis in treating peripheral artery disease,” Helixmith CEO Yu Seung-shin said. “The recently acquired patent provided us an opportunity to block the appearance of biosimilars fundamentally.”