Celltrion announced on the 12th that it has confirmed the potential to expand indications to various solid tumors for its next-generation multi-specific antibody new drug “CT-P72 (ABP-102),” based on its excellent efficacy and tolerability. The research results were unveiled on the 11th at the “World Bispecific & T-Cell Engager Summit South Korea” through a presentation titled “HER2 TCE CT-P72/ABP-102 with Excellent Therapeutic Index (TI).”

CT-P72 is an immuno-oncology therapy that Celltrion is co-developing with the U.S.-based biotech company Abpro Holdings. As it is a co-development project, it has two development code names. It received approval from the U.S. Food and Drug Administration (FDA) last December to initiate a Phase 1 clinical trial and is currently in the patient screening stage for full-scale clinical implementation. The company also plans to apply for FDA Fast Track designation within the year.

According to the newly presented study results, CT-P72 (ABP-102) demonstrated strong anticancer activity against tumors with high expression of human epidermal growth factor receptor 2 (HER2) in in vitro cytotoxicity assays. In contrast, its cytotoxic activity against HER2 low-expression cells was markedly reduced, indicating a highly selective response toward cancer cells. HER2 is a protein (receptor) located on the cell membrane that regulates cell growth, differentiation, and repair. It is present in normal cells but is also known as a receptor that is produced in excessively high amounts compared with normal levels in certain cancer cells, such as those in breast and gastric cancers.

In addition, non-clinical pharmacokinetic (PK) and toxicity studies in non-human primates for CT-P72 reportedly confirmed excellent tolerability at high doses of up to 80 mg/kg. In animal models transplanted with gastric cancer that had developed resistance to existing therapies, Celltrion reported observing potent anticancer effects that exceeded the efficacy of conventional drugs.

In particular, the company verified strong anticancer effects in other HER2 high-expression cancers, including bladder cancer, biliary tract cancer, and breast cancer, suggesting the potential for broad indication expansion as a treatment for HER2 high-expression solid tumors.

In breast cancer, powerful anticancer activity, including T-cell infiltration by immune cells, was confirmed in a microphysiological system (MPS) utilizing organoids. MPS is a tool that examines drug responses in an artificially created environment that closely mimics actual patients. Celltrion uses MPS, in addition to traditional animal testing, to secure predictive reliability of therapeutic effects before administering the drug to patients.

Based on these research findings, Celltrion plans to accelerate the pivotal clinical development of CT-P72. The company intends to develop it as a “Best-in-Class” new drug that overcomes resistance and tolerability limitations of the existing HER2 high-expression therapy Enhertu (ingredient name: trastuzumab deruxtecan) and addresses unmet medical needs. In parallel, development of antibody-drug conjugate (ADC)-based new drugs is progressing smoothly. Three anticancer drug candidates (CT-P70, CT-P71, CT-P73) that have entered Phase 1 clinical trials are currently being administered to patients.

A Celltrion official stated, “Through preclinical studies, the multi-specific antibody anticancer drug CT-P72 has demonstrated high anticancer efficacy and excellent tolerability against HER2 high-expression targets,” adding, “Having also confirmed its therapeutic potential against various solid tumors, the company will continue to make every effort to successfully conduct clinical trials and develop it into a new drug superior to existing therapies.”

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