South Korea’s Ministry of Food and Drug Safety has approved a Maryland-based regenerative medicine company’s drug candidate aimed to treat osteoarthritis.

Maryland-based TissueGene, whose Korean licensee, Kolon Life Sciences has developed Invossa-K Inj, a drug which 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 in order to minimize patient immune response to the injected cells and are then 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.

The companies claim the drug to be first-in-class cell-mediated gene therapy designed to treat moderate (Kellgren and Lawrence grade 3) knee osteoarthritis through regeneration of cartilage.

Invossa is now being assessed in a Phase III trial in the U.S. after having shown to ease the symptoms of about 84% of patients in Phase III trials in Korea.

With the ministry’s approval, Invossa becomes 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.

Kolon has also inked an exclusive licensing and development agreement with Mitsubishi Tanabe Pharma to market the drug in Japan. In terms of the deal, Mitsubishi Tanabe pays approximately $24 million upfront plus up to $410 million in payments tied to achieving development, regulatory, and commercial milestones, plus double-digit sales royalties.

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