Astellas Institute for Regenerative Medicine

Regenerative medicine company that is a subsidiary of Astellas Pharma focused on development and commercialization of stem cell and regenerative medicine therapies.

In 2018 Astellas Institute for Regenerative Medicine (AIRM) became the new name of Ocata Therapeutics, which had previously been called Advanced Cell Technology. Ocata Therapeutics was acquired by Astellas Pharma in late 2015. Robert Lanza is Head of Astellas Global Regenerative Medicine and Chief Scientific Officer at the Astellas Institute for Regenerative Medicine.

AIRM developed a retinal pigment epithelium-based therapy for treatment of degenerative retinal diseases, a myoblast stem cell therapy for treatment of chronic heart failure and a hemangioblast platform for treatment of blood and cardiovascular diseases.

Technologies developed at AIRM are planned to combine with those of Universal Cell, acquired by Astellas in 2018. The focus of AIRM was initially ophthalmology but Astellas plans to invest in manufacturing facilities at AIRM and expand their therapeutic products beyond ophthalmology. The collaboration with Universal Cell aims to overcome immunological rejection of transplanted cells by using genome editing to prevent expression of human leukocyte antigen (HLA) molecules which may be mismatched and cause immune reactions.

AIRM began a small early-stage clinical trial of embryonic stem cell-derived transplants in 2019 to treat the dry form of macular degeneration which is a major cause of blindness. As of 2019 there were 10 potential stem cell-derived therapies in their pipeline. Six of those originated from Ocata and were lead by Robert Lanza.

When the company was under its former name, Advanced Cell Technology, it pioneered the first clinical investigation using human embryonic stem cell derived Retinal Pigment Epithelium (RPE) to treat retinal diseases including Stargardts Macular Degeneration (SMD) and Geographic Atrophy (GA), secondary to Age-related Macular Degeneration (AMD). The cell line is named MA09-hRPE. In Phase 1/2 clinical trials MA09-hRPE cells were administered in suspension form beginning in April 2011 and completed in 2017 in eye centers in the United States, United Kingdom and South Korea (Clinicaltrial.gov identifiers: UK-SMD: NCT01469832; US-SMD: NCT01345006; US-AMD: NCT01344993).

Astellas entered into a licensing agreement through AIRM with San Diego company Allele Biotechnology to expand access to Allele’s induced pluripotent stem cell (iPSC) technologies. Allele’s iPSC technologies involve reprogramming somatic cells into iPSCs.

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Robert Lanza

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Yoshitsugu Shitaka

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