I-Mab, Genexine win Phase II nod for TJ107/HyLeukin-7 in GBM in China



Shanghai-based I-Mab (Nasdaq.IMAB) and South Korea’s Genexine Incorporated announced clinical trial approval from the National Medical Products Administration (NMPA) to initiate a Phase II study for novel long-acting recombinant human interleukin-7 (rhIL-7) TJ107/HyLeukin-7 (efineptakin alfa) in lymphogenic patients with newly-diagnosed glioblastoma multiforme (GBM). Meanwhile, the two expanded their partnership to include development of TJ107/HyLeukin-7 for said indication, specifics not disclosed.

TJ107/HyLeukin-7 is the world's first and only long-acting recombinant human interleukin-7 (rhIL-7), known to boost T lymphocytes by increasing their number and functions. I-Mab penned a USD 548 million licensing deal with Genexine in December 2017, taking exclusive development and commercialization rights for Greater China. The drug obtained clinical approval in December 2018 in China in advanced solid tumors and completed first patient dosing in a Phase Ib/II study in March 2019. Genexine published Phase Ib study results at the Society for Immunotherapy of Cancer (SITC) 34th annual meeting in 2019, which showed TJ107 was well tolerated in 21 advanced solid tumor cases, with no dose-limiting toxicity or cytokine release syndrome (CRS), while absolute lymphocyte counts and T cell subsets (non-regulatory T cells) increased in a dose-dependent manner. TJ107 can be combined with radiotherapy, chemotherapy, cancer vaccines and immune checkpoint inhibitors for a synergistic anti-tumor effect.

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