Healios K.K. to bring its novel regenerative pluripotent stem cell treatments to market through accelerated Japanese approvals process.
The company, which is Japan’s leading clinical stage biotech company, is focused on harnessing the power of stem cells for regenerative therapies which include organ regeneration .
Longevity.Technology: Healios is using cutting edge stem cell technology to address a range of serious conditions. Time is of the essence and they clearly believe that getting these treatments to market as quickly as possible has the potential to accelerate commercialisation.
The company’s CFO Richard Kincaid will use the biotech conference, being held between the 13th and 16th January, to present the company’s strategy in regenerative medicine. The therapy combines near-term and potentially accelerated commercialisation of Somatic Stem Cell (SSC) based treatments with the development of next generation therapies thanks to its induced Pluripotent Stem Cell technology platform.
Healios is currently in a pivotal second/third stage trial in Japan in Ischemia stroke which offers the potential for effective treatment.
In addition, it is also in the middle of a Phase 2 trial in acute respiratory distress syndrome (ARDS) in Japan and hopes to deliver the world’s first approved therapeutic drug.
Assuming these studies are completed successfully, Healios intends to accelerate along the path to approval and commercialisation thanks to Japan’s highly favourable regulatory framework, the Conditional and Time Limited Authorisation System, or SAKIGAKE in Japanese .
The strategy was conceived by the ministry of health to accelerate the development of innovative medicines and, where possible, accelerate the practical application of off label life saving medications to the wider audience.
Alongside this, Healios is developing a proprietary gene modified iPSC Platform of non-immunogenic, off-the-shelf (allogenic) ‘Universal Donor Cells’ for applications in next-generation therapies in ophthalmology, organ regeneration, and immuno-oncology.
This includes the development of iPSC derived gene-modified natural killer cells, which can offer long-lasting effects while still avoiding the need for immunosuppressive drug treatment.