On February 4, 2021 I-Mab (the "Company") (NASDAQ: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported that the first patient has been dosed in a phase 2 clinical trial (NCT04600817) of TJ107 (efineptakin alpha), a novel long-acting recombinant human interleukin-7 (rhIL-7), in patients with glioblastoma multiforme (GBM) in China (Press release, I-Mab Biopharma, FEB 4, 2021, View Source [SID1234574653]).
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The phase 2 trial is a randomized, single-blind, placebo-controlled study to evaluate the efficacy and safety of TJ107 in lymphopenic patients with newly diagnosed GBM who have been treated with standard concurrent chemoradiotherapy. The study’s goal is to determine the proportion of patients with an increase in the absolute lymphocyte counts and associated clinical response after the administration of the first TJ107 dose.
There is increasing evidence that lymphopenia induced by radiotherapy and chemotherapy is associated with poor survival in cancer patients. In case of GBM, standard treatments induce long-lasting lymphopenia in most patients, and currently there are no definitive therapies for it. A phase 1b study conducted by Genexine Inc. (KOSDAQ: 095700) demonstrated that TJ107 rapidly increased absolute lymphocyte counts and restored T cell counts especially in the naïve and memory subsets but not the regulatory T cells in terminally ill patients with solid tumors. TJ107 was well tolerated with no dose-limiting toxicity or cytokine release syndrome observed.
"Despite advances in standard therapy, GBM is associated with poor clinical outcomes and survival rates," said Professor Wenbin Li, Director of Department of Neuro-Oncology at Beijing Tiantan Hospital of Capital Medical University and the leading principal investigator of the clinical trial. "Based on its preclinical and clinical data, TJ107 promises to improve tolerance to the standard therapy, quality of life and prognosis in patients with GBM, and we look forward to making this drug accessible to our patients."
"TJ107 is the first and only long-acting rhIL-7 in the clinical stage globally and early studies have shown its potential to treat patients with GBM whose prognosis is still poor," said Dr. Joan Shen, Chief Executive Officer of I-Mab. "The initiation of the phase 2 trial brings us one step closer to delivering a highly innovative therapy to treat patients with one of the most life-threatening forms of cancer."
GBM is the most aggressive type of glial cancer which can arise in the brain de novo or evolve from existing tumors. GBM accounts for 17% of new brain and nervous system cancers in China, according to data from the World Health Organization in 2018.[1]
[1] Ostrom Q T, Gittleman H, Liao P, et al. CBTRUS statistical report: primary brain and other central nervous system tumors diagnosed in the United States in 2010–2014[J]. Neuro-oncology, 2017, 19(suppl_5): v1-v88.
About TJ107/GX-I7
TJ107/GX-I7 (efineptakin alpha) 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. It emerged from Genexine’s proprietary hyFc platform for discovering of long-acting biologics. I-Mab has acquired exclusive rights from Genexine to develop and commercialize TJ107/GX-I7 in Greater China. TJ107/GX-I7 may have utility in cancer treatment-related lymphopenia (low blood lymphocyte levels), a common condition that occurs in cancer patients who have received chemotherapy or radiation therapy, for which there is no approved treatment. TJ107/ GX-I7 has also been shown to synergize with a PD-1 antibody in various tumor animal models potentially through increased T-lymphocyte activation and proliferation.