The world’s first cell and gene therapy for knee osteoarthritis (Invossa-K Inj.) gets approval from the Korea Ministry of Food and Drug Safety (MFDS).
This therapy was manufactured by Kolon Life Science and it has received exclusive licensee for Asia, including Korea.
Invossa is a first-in-class cell-mediated gene therapy designed to treat moderate (Kellgren and Lawrence grade 3) knee osteoarthritis through regeneration of cartilage.
Invossa uses allogeneic human cartilage cells engineered to express transforming growth factor TGF-ß1. TissueGene’s platform technology involves transducing the cells with a retroviral vector engineered to express TGF-ß1 at a specific therapeutic level and duration of time.
The modified cell lines are further selected and screened for cellular expression characteristics intended to minimize patient immune response to the injected cell.
They are mixed with unmodified cells to create cartilage regeneration via Invossa, as well as bone, disc, and nerve regeneration through the company’s other product candidates.
It has been designed for a single injection directly into the knee joint, allowing the cells to induce repair and regeneration of tissue by secreting therapeutic growth factors.
Invossa-K Inj. was tested based on efficacy results from its Phase III clinical trials conducted at 12 major university hospitals in Korea.
This approval by MFDS is the first clinical step towards a global launch for this initiative, novel cell and gene therapy technology that will address one of the most pressing unmet medical need affecting millions of people suffering from osteoarthritis worldwide.
Clinical trials completed in Korea and on-going in the US have stated pain relief, increased mobility, and potentially game-changing improvements in joint structure.
The first cell and gene therapy for knee osteoarthritis offers substantial relief and convenience for osteoarthritis patients who would otherwise be in need of surgery.
With the Korean drug ministry’s approval, Invossa became the 29th South Korean-developed novel therapy approved by the country’s drug regulatory agency and one of only four cell gene therapies to have ever been approved globally.