C&R Research Signs CRO Contract for APB-A001 Anticancer Drug with APIT Bio

[Asia Economy Reporter Chunhee Lee] Clinical Research Organization (CRO) C&R Research has signed a contract to conduct Phase 1 clinical trials for APIT Bio, an antibody new drug platform company, for its treatment of refractory solid tumors, 'APB-A001.'

Through this contract, C&R Research will carry out overall tasks for Phase 1, including protocol development for the APB-A001 pipeline, preparation of Investigational New Drug (IND) application, and clinical trial outsourcing.

Regarding this clinical trial, C&R Research plans to utilize OncoTrialBoard, an oncology-specific IT solution from Trial Informatics, to standardize global clinical data based on CDISC from the early stages of the trial.

A representative from C&R Research stated, “We plan to effectively conduct the domestic Phase 1 clinical trial of APB-A001 by applying the clinical expertise accumulated through numerous oncology trials in Korea. Especially in this trial, as clinical data management for oncology trials in preparation for the U.S. Food and Drug Administration (FDA) has become globally important, we will more effectively support clinical data standardization based on CDISC.”

APIT Bio’s lead pipeline, APB-A001, is a monoclonal antibody therapeutic that has demonstrated excellent efficacy in various cancer types such as pancreatic cancer and cholangiocarcinoma through animal efficacy tests. It targets L1CAM (CD171), which is known to be overexpressed in progressive, metastatic, and refractory solid tumors, promoting cancer progression and metastasis, inducing drug resistance, and facilitating immune evasion of cancer.

The two companies plan to obtain IND approval from the Ministry of Food and Drug Safety (MFDS) for APB-A001 early next year and initiate Phase 1 clinical trials to assess the candidate drug’s tolerability and pharmacokinetic properties.