On January 12, 2022 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 had been dosed in its China phase 2 study (NCT05145907) of efineptakin alfa (also known as TJ107) in combination with pembrolizumab (Keytruda) in patients with advanced solid tumors (Press release, I-Mab Biopharma, JAN 12, 2022, View Source [SID1234598647]). The study will follow a "basket" trial design to include selected tumor types, including triple-negative breast cancer (TNBC) and squamous cell cancer of the head and neck (SCCHN).

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Efineptakin alfa, the world’s first and only long-acting recombinant human interleukin-7 (rhIL-7) developed as a T lymphocyte-booster for cancer-related immunotherapy, has distinct advantages over other cytokines such as human IL-2. Efineptakin alfa combined with immune checkpoint inhibitors, such as PD-(L)1 therapies, has a synergistic effect as it increases the number of circulating anti-tumor T cells for tumor suppression. It has been tested as monotherapy and in combination with checkpoint inhibitors to treat advanced solid tumors in the U.S., South Korea and China, with encouraging clinical results.

"As the majority of cancer patients either do not respond or respond poorly to current PD-(L)1 therapies, there are intense attempts to identify an effective agent that can work synergistically with PD-(L)1 antibodies to increase the probability of treatment success," said Professor Ye Guo, Deputy Director of Department of Oncology at Shanghai East Hospital and the principal investigator of the study. "Studies have shown that efineptakin alfa has the potential to address this unmet need. We look forward to further validating the safety and efficacy profile of efineptakin alfa in patients with solid tumors."

"The initiation of efineptakin alfa’s phase 2 study is another example that I-Mab’s pipeline is not only innovative but also mature with a majority of clinical programs being in the advanced clinical development stage," said Dr. Andrew Zhu, President of I-Mab. "Efineptakin alfa is the world’s first rhIL-7 designed to cater to the therapeutic needs of cancer patients, so we are mindful of the importance of this therapy and are committed to expediting the clinical development of a potentially transformative solution for patients in need."

I-Mab is also evaluating efineptakin alfa in another phase 2 clinical trial (NCT04600817) in lymphopenic patients with newly diagnosed glioblastoma multiforme (GBM) who have received standard concurrent chemoradiotherapy. By leveraging the two ongoing clinical studies, the Company aims to rapidly advance the clinical development of efineptakin alfa for approval in Greater China.

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.