On October 18, 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 Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has approved the IND submission for the initiation of phase 2 clinical trial of efineptakin alfa (also known as TJ107/GX-I7/NT-I7) in combination with PD-1 antibody in patients with advanced solid tumors, including triple-negative breast cancer (TNBC) as well as head and neck cancers (Press release, I-Mab Biopharma, OCT 18, 2021, View Source [SID1234591477]).

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Efineptakin alfa is the world’s first and only long-acting recombinant human interleukin-7 (rhIL-7) developed as a T lymphocyte-booster for cancer-related immunotherapy. Efineptakin alfa is expected to show 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. Treatment with efineptakin alfa has distinct advantages over other cytokines such as human IL-2 that have a narrow therapeutic window and cause serious adverse effects.

Efineptakin alfa has been tested as monotherapy and in combination with checkpoint inhibitors to treat advanced solid tumors in the U.S., South Korea and China. According to the data from the NIT-110 dose-escalation study presented at ASCO (Free ASCO Whitepaper) 2021, the combination of efineptakin alfa and pembrolizumab is safe and well-tolerated in patients with advanced solid tumors. It significantly increased T cell numbers in both the tumor microenviroment and the peripheral blood. At the SITC (Free SITC Whitepaper) 2020, data from the phase 1b/2 Keynote-899 study (NCT03752723) have shown that simultaneuous treatment of efineptakin alfa at 1200μg/kg with pembrolizumab (Keytruda) induced 27.8% ORR in patients with metastatic TNBC. In addition, interim results from the phase 1 trial (NCT03687957) in high-grade gliomas unresponsive to chemoradiotherapy showed a 1.3 – 4.1 fold increase in the absolute lymphocyte count (ALC) with a one-year survival rate of 83.3%.[1] Further, a China phase 1b trial (NCT04001075) in patients with advanced solid tumors will soon complete to facilitate further development of efineptakin alfa.

"Efineptakin alfa is the first rhIL-7 for cancer treatment and underscores I-Mab’s commitment to innovation. Oriented by patients’ needs, we look forward to initiating this important trial to accelerate the clinical development and deliver a potentially transformative solution to patients," said Dr. Joan Shen, CEO of I-Mab.

Efineptakin alfa is also being studied in another phase 2 clinical trial (NCT04600817) to evaluate its efficacy and safety in lymphopenic patients with newly diagnosed glioblastoma multiforme (GBM) who have been treated with standard concurrent chemoradiotherapy. The study is currently advancing rapidly with the first patient dosed in February 2021.

[1] Data can be viewed in NeoImmuneTech’s poster presentation at 2021 ASCO (Free ASCO Whitepaper) Annual Meeting at the following link: View Source;fname=AX_7356756659.pdf&orifname=nit_ir%20presentation_asco2021_e.pdf

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.