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GX-I7, 중국에서 면역항암제 병용 임상 2상 IND승인


GX-I7, 중국에서 면역항암제 병용 임상 2상 IND승인 

중국 IMAB biopharma (나스닥: IMAB) 는 제넥신의 면역항암제 신약후보물질 GX-I7을 라이선스-인 하고 중국 식약처인 NMPA로부터 임상2상의 IND 승인을 받아 

뉴스를 통해 알렸습니다. 앞으로도 제넥신과 IMAB은 양사의 역량을 집중하여 시너지를 창출할 수 있는 전략적 파트너십을 이어나갈 것입니다.



I-Mab Announces IND Acceptance for Phase 2 Clinical Trial of Efineptakin Alfa in Combination with PD-1 Therapy in China

- Efineptakin alfa in combination with pembrolizumab induced 27.8% ORR in metastatic TNBC patients in a phase 1b/2 trial in South Korea

- Efineptakin alfa in patients with GBM showed a 83.3% survival ratio over one year in a phase 1 trial in the U.S.

SHANGHAI, China and GAITHERSBURG, MD. – July 28, 2021 – I-Mab (the “Company”) (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced that an IND application for the initiation of a phase 2 clinical trial of efineptakin alfa (also known as TJ107/GX-I7/NT-I7) in combination with anti-PD-1 antibody in patients with advanced solid tumors, including triple-negative breast cancer (TNBC) and head and neck cancers (HNC), has been accepted by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA). 

Efineptakin alfa is the world’s first and only long-acting recombinant human interleukin-7 (“rhIL-7”) being developed as a T lymphocyte-booster for cancer-related immunotherapy. Efineptakin alfa is expected to show a therapeutic effect as a combination therapy with immune checkpoint inhibitors due to its inherent properties to increase T-cells that are critical for tumor suppression. Its T-cell properties comes with unique selectivity that only stimulates tumor-fighting lymphocytes and spares tumor-protecting Treg cells, differentiating it from other cytokines such as human IL-2.

The IND submission leverages accumulative clinical data from multiple previous studies of efineptakin alfa as monotherapy and in combination with checkpoint inhibitors in the treatment of advanced solid tumors, conducted by I-Mab in China and Genexine and NeoImmuneTech in South Korea and the U.S., respectively. Data from the phase 1b/2 Keynote-899 study, presented at SITC 2020, have shown that simultaneuous treatment of efineptakin alfa at 1200μg/kg with pembrolizumab (Keytruda®) induced 27.8% ORR in patients with  metastatic TNBC. According to the data from NIT-110 dose escalation presented at ASCO 2021, the combination treatment was safe and well-tolerated in the study. In addition, interim results from the phase 1 trial (NCT03687957) in newly diagnosed patients with high-grade gliomas that have undergone chemoradiotherapy showed that absolute lymphocyte count (ALC) increased by 1.3 – 4.1 fold at week 4 in a dose-dependent manner and lasted up to 12 weeks after injection, with a one-year survival rate of 83.3% being observed so far.[1] Furthermore, a phase 1b trial (NCT04001075) in China is about to complete to facilitate the further development of efineptakin alfa.

“Current clinical data suggest that efineptakin alfa has the great potential to revolutionize the treatment in particularly difficult-to-treat cancers,” said Dr. Joan Shen, CEO of I-Mab. “We have already initiated a phase 2 trial in lymphopenic patients with newly-diagnosed glioblastoma multiforme earlier this year. With these additional studies, we hope to fast-track the clinical development of efineptakin alfa in China and bring this potentially very valuable treatment to a large population of cancer patients.”


About Efineptakin alfa

Efineptakin alfa, also known as TJ107/GX-I7/NT-I7, 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 the discovering of long-acting biologics.  I-Mab has acquired exclusive rights from Genexine to develop and commercialize efineptakin alfa in Greater China. Efineptakin alfa 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. Efineptakin alfa has also been shown to synergize with a PD-1 antibody in various tumor animal models potentially through increased T-lymphocyte activation and proliferation.