The funding will be used to develop Aurion Biotech’s first candidate, AURN001, a cell therapy aiming to treat corneal edema.
Aurion Biotech is a clinical-stage biotech firm that is aiming to “restore vision to millions of patients” with its regenerative therapies. According to the firm, the raised funds will be used to file an IND to the US Food and Drug Administration (FDA) in order to begin clinical trials.
Additionally, Aurion wants to submit an NDA to the Japan Pharmaceuticals and Medical Devices Agency (PMDA).
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“Funds will be used to advance the clinical development of our cell therapy for corneal edema [AURN001], secondary to corneal endothelial disease,” Judith McGarry, vice president marketing at Aurion told BioProcess Insider.
“The endothelium is a single layer of cells in the human cornea; it regulates hydration of the cornea. When those cells degrade or die (due to disease or surgical trauma), they do not regenerate. Once those cells are gone, the cornea become swollen and cloudy, ultimately causing loss of vision.”
The cell therapy was developed by Shigeru Kinoshita and his colleagues at Kyoto Prefecture University of Medicine (KPUM) in Japan. Aurion acquired this technology in 2020 and is preparing to submit a Japanese new drug application (J-NDA).
“First, our inventor was able to figure out how to get human corneal endothelial cells (HCECs) to replicate in the lab (keep in mind, they do not replicate in the body). With this patented process, the cells from a single donor can be manufactured to treat up to 100 eyes,” said McGarry.
She continued: “This alone is a significant benefit since there is a global shortage of donor corneas available for transplant. Second, the cell therapy procedure itself is relatively straightforward, and can be performed in an outpatient setting, in approximately 15 minutes. The ophthalmologist makes an incision into the anterior chamber of the patient’s eye, and ‘polishes’ off the diseased endothelial cells. Then, via another incision, the ophthalmologist injects HCECs in solution into the anterior chamber. The cells quickly settle into place, along the stroma of the cornea [and] the patient lies face down for a couple of hours, to facilitate adhesion.”
The $120 million financing was led by Deerfield Management, and included current investors Flying L Partners, Falcon Vision, KKR, Visionary Ventures, and Petrichor Healthcare Capital Management. Furthermore, funds will be paid out to Aurion based on specific achievements of clinical and operational milestones.