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
[1] Ostrom Q T, Gittleman H, Liao P, et al. CBTRUS statistical report: primary brain and other central nervous system tumors diagnosed in |
About TJ107/HyLeukin-7™
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
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
This press release includes certain disclosures which contain "forward-looking statements." You can identify forward-looking statements because they contain words such as "anticipate" and "expected." Forward-looking statements are based on
For more information, please contact:
Jielun Zhu, CFO
E-mail: jielun.zhu@i-mabbiopharma.com
Office line: +86 21 6057 8000
Email: gigi.feng@i-mabbiopharma.com
Office line: +86 21 6057 8000
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Genexine, Inc.
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E-mail: ir@genexine.com
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