I-Mab and Genexine Announce China NMPA Clearance for Phase 2 Clinical Trial of TJ107/HyLeukin-7™ in Glioblastoma Multiforme
SHANGHAI, GAITHERSBURG, Md. and SEOUL,
The affirmation was provided by NMPA in response to a pre-IND request to support the clinical development plans for TJ107/HyLeukin-7™ as a potential treatment for GBM. Per the clearance, I-Mab and Genexine are able to initiate a phase 2 clinical study in
"There's a critical need to bring innovative therapies for patients suffering from GBM, an aggressive brain cancer with a particularly grim prognosis. I-Mab and Genexine appreciate the NMPA's accelerated assessment and giving the greenlight to initiate a Phase 2 clinical trial of TJ107/Hyleukin-7 for GBM," said Dr.
Under the terms of the expanded collaboration,
"Standard of care in treating GBM induces long-lasting lymphopenia in most patients. As a potential treatment for patients suffering from this devastating cancer, TJ107/HyLeukin-7™ has demonstrated to effectively induce T cells, especially naïve and memory T cells, and correct lymphopenia in patients with late stage solid tumors," said Dr.
The restoring ability of T cell deficiency of TJ107/HyLeukin-7™ in a Phase 1b study (NCT03478995) by Genexine was presented at the
By leveraging the results of Genexine's ongoing clinical trials in South Korea, I-Mab is currently conducting a Phase 1b trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and determine recommended Phase 2 dose (RP2D) of TJ107/HyLeukin-7™ in Chinese subjects with advanced solid tumors (NCT04001075).
According to the data released by GLOBOCAN 2018 by
 Ostrom Q T, Gittleman H, Liao P, et al. CBTRUS statistical report: primary brain and other central nervous system tumors diagnosed in
TJ107/HyLeukin-7™ (Efineptakin alfa) 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/ HyLeukin™ in Greater China. TJ107/HyLeukin-7™ 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/HyLeukin-7™ has also been shown to synergize with a PD-1 antibody in various tumor animal models potentially through increased T-lymphocyte activation and proliferation.
About Genexine, Inc.
Genexine, Inc., listed on KOSDAQ (095700) since 2009, is a leading biotherapeutics company focused on immuno-oncology and orphan disease. Genexine's goal is to bring out innovative biotherapeutics to save the lives of patients with serious diseases. Genexine has a robust pipeline of products in the clinical stage, e.g. Hyleukin-7™(GX-I7), HyTropin (GX-H9), Papitrol (GX-188E), etc. based on long-acting Fc fusion technology and DNA vaccine technology.Hyleukin-7™ is under Phase 1b or Phase 2 trials in several cancer types for monotherapy or combination therapy. Papitrol, a therapeutic DNA vaccine for HPV-associated diseases is under Phase 2 trial in combination with Keytruda (Merck) for advanced recurred cervical cancer. Genexine has completed multinational phase 2 trials of HyTropin (long-acting human growth hormone, hGH-hyFc) in PGHD and AGHD. Founded in 1999, Genexine has over 160 employees, and half of them are scientists with MSc, or Ph.D. Genexine is located in
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