AimPharm's CCR8 Antagonist IPG7236 Administers First Dose to Cancer Patient in U.S.

On January 6, 2022, Nanjing Aimeifei Biomedical Technology Co., Ltd. (hereinafter referred to as “Aimeifei Pharma”) administered the first dose of its CCR8 antagonist, IPG7236, to a subject in the United States, with no drug-related adverse events observed. The Phase I clinical trial of IPG7236 (IPG7236-001) is an open-label, multicenter, dose-escalation and dose-expansion study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of IPG7236 as a monotherapy in patients with advanced solid tumors. The Principal Investigator (PI) for this clinical study is Dr. Andrae Vandross from Next Oncology in Austin, Texas, USA.

IPG7236, independently developed by Nanjing Aimeifei Biomedical Technology Co., Ltd., is the world’s first small-molecule antagonist targeting the chemokine receptor CCR8 to enter clinical development. It received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) in August 2021 and from China’s National Medical Products Administration (NMPA) in early December 2021. CCR8 is a chemokine receptor highly expressed on tumor-associated regulatory T cells (Tregs), while its expression is very low or absent on non-tumor-associated Tregs. CCR8 is also expressed on various types of tumor cells. IPG7236 efficiently blocks the migration of tumor-associated Tregs into tumor tissues, inhibits their expansion within the tumor microenvironment, and reverses Treg-mediated suppression of effector T cells. This enhances the quantity and activity of CD8+ T cells in the tumor microenvironment, thereby inhibiting tumor growth and metastasis. Additionally, IPG7236 significantly suppresses tumor metastasis in cancers with high CCR8 expression. Preclinical studies have demonstrated that IPG7236 markedly inhibits the growth of multiple tumor types (with tumor inhibition rates exceeding 70%), indicating broad-spectrum antitumor activity. Furthermore, it exhibits synergistic effects with PD-1 antibodies, highlighting its promising potential for combination therapy with immune checkpoint inhibitors. Nanjing Aimeifei Biomedical Technology Co., Ltd. is systematically preparing for Phase II clinical trials, continuously expanding the drug’s clinical indications, and accelerating its research, development, and commercialization to benefit patients as soon as possible.

Mechanism of Action of IPG7236

Aimeifei Pharmaceuticals is a clinical-stage innovative drug development company founded by senior medical experts with overseas experience. Its core management team hails from globally renowned multinational pharmaceutical companies such as GSK and Novartis, as well as prestigious academic institutions including Harvard University and the Chinese Academy of Sciences. Since its establishment in 2016, the company has been dedicated to developing global innovative drugs and has achieved a global footprint with operations in Nanjing, Shanghai, Sydney, and San Francisco. Among Aimeifei’s first-tier pipeline candidates, in addition to IPG7236, which has received clinical trial approvals from both the U.S. FDA and China’s CDE, IPG1094 is the world’s first MIF small-molecule inhibitor to enter clinical trials. It has obtained five clinical trial approvals in China and the United States for indications including multiple myeloma, solid tumors, multiple sclerosis, systemic lupus erythematosus, and psoriasis. Efforts to expand the clinical indications for this drug are proceeding in an orderly manner, with multiple new indications (including ALS and AD) expected to receive IND approvals in both China and the United States by mid-2022. Aimeifei Pharmaceuticals has evolved into an innovative drug R&D company equipped with dual platforms for small-molecule and large-molecule therapeutics, boasting a pipeline of over 15 candidates (all first-in-class) covering oncology, autoimmune diseases, neurodegenerative disorders, and other fields.

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