Disease Modifying Status Targeted As Kolon's Novel OA Therapy Enters US Phase III
With the removal of an FDA clinical hold, Kolon TissueGene is set to begin a US Phase III trial for Invossa, its first-in-class cell and gene therapy, for osteoarthritis of the knee. The planned study, which is larger and longer than the product's Korean Phase III program, will be under the spotlight as it will determine whether Invossa can be designated as the world's first disease-modifying drug in osteoarthritis, and is being designed accordingly.
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South Korea’s first approved gene therapy has been suspended from sale in the country, while recruitment in an ongoing US Phase III program has been temporarily halted, after findings that an active cell component may differ from the data submitted at the time of approval. While both manufacturer and regulator see no safety risk, results from an official Korean probe are due in mid-April.
Kolon Life Science has reached a sizable license deal with Mundipharma for the development in Japan of the South Korean company’s first-in-class cell and gene therapy for osteoarthritis of the knee, easing uncertainties after an agreement with Mitsubishi Tanabe for the product collapsed last year.
Mitsubish Tanabe has sought to cancel the license agreement for Kolon Life Science's Invossa, clouding the South Korean firm’s global ambitions for the allogeneic cell mediated gene therapy. However, analysts don’t anticipate a big hit for Kolon even if the deal falls through given that the cancellation demand is not linked to Invossa’s efficacy.