UPDATE : Monday, August 3, 2020
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Chinese regulator OKs Genexine's P2 trial of glioblastoma treatment
  • By Lee Han-soo
  • Published 2020.05.22 17:23
  • Updated 2020.05.25 13:35
  • comments 0

Genexine said that China's National Medical Products Administration has given the go-ahead to conduct phase 2 clinical trials for GX-I7, an immunotherapeutic drug candidate, for treating glioblastoma.

Genexine's GX-I7 is a fusion of cytokine interleukin-7, which plays an essential role in the proliferation of T cells in the body

The company plans to conduct the trial with I-Mab Biopharma. This Chinese biopharmaceutical company acquired the rights for the drug in China. I-Mab signed a $548 million worth technology transfer agreement for GX-I7 from Genexine, noting on GX-I7's value as an immunotherapy drug in 2017, and has since been conducting clinical trials to treat end-stage cancer patients.

Glioblastoma is a malignant brain tumor with rapid growth and metastasis rates that are very difficult to treat and has a significantly lower survival rate than other cancers. The standard treatment for the patients includes chemotherapy followed by surgery.

However, most glioblastoma patients fall into T cell deficiency during chemotherapy, and these T cell deficiency patients have lower survival after treatment than patients that maintain T cell levels.

GX-I7 normalizes T cell levels in brain tumor patients, exerting strong therapeutic synergy when used in combination with adjuvant chemotherapy. The company expects that the treatment will become an innovative alternative that can increase the survival of glioblastoma patients who are difficult to treat.

"Glioblastoma is a malignant brain tumor," Genexine CEO Sung Young-chul said. "Despite being a rare cancer, the number of new glioblastoma patients in China is so large that the company expects to quickly verify the combination therapy that uses GX-I7 through rapid recruitment."

Based on a strong partnership and excellent expertise established over many years with I-Mab Biopharma, the company hopes that it will make a successful outcome in this co-clinical study, Sung added.


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