World’s First Cell and Gene Therapy for Knee Osteoarthritis Gets Approval
The Korea Ministry of Food and Drug Safety (MFDS) has granted approval to the world's first cell and gene therapy for knee osteoarthritis, known as Invossa-K Inj.
Kolon Life Science, the manufacturer of this therapy, holds the exclusive license for Asia, including Korea.
Invossa is a pioneering cell-mediated gene therapy specifically designed to address moderate knee osteoarthritis (Kellgren and Lawrence grade 3) by promoting cartilage regeneration.
The therapy utilizes allogeneic human cartilage cells that have been genetically engineered to express transforming growth factor TGF-ß1. TissueGene's platform technology involves introducing TGF-ß1 into the cells using a retroviral vector, ensuring the expression occurs at the appropriate therapeutic level and duration.
The modified cell lines undergo selection and screening to minimize the likelihood of an immune response in patients receiving the injected cells. These modified cells are combined with unmodified cells to enable cartilage regeneration, as well as the potential for bone, disc, and nerve regeneration through the company's other product candidates.
Invossa-K Inj. involves a single injection directly into the knee joint, allowing the cells to secrete therapeutic growth factors that stimulate tissue repair and regeneration.
The approval by the MFDS is a significant milestone, marking the first step towards a global launch of this groundbreaking cell and gene therapy technology. It addresses a critical unmet medical need faced by millions of individuals worldwide who suffer from osteoarthritis.
Phase III clinical trials conducted at 12 major university hospitals in Korea provided evidence of the therapy's efficacy, demonstrating pain relief, improved mobility, and potentially transformative enhancements in joint structure. Clinical trials in Korea have been completed, while ongoing trials are being conducted in the United States.
This first-of-its-kind cell and gene therapy for knee osteoarthritis offers substantial relief and convenience for patients who would otherwise require surgery to address their osteoarthritis symptoms.
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.
