Medicilon assisted Hangzhou DAC Biotech in approval of clinical study of ADC drug DAC-002

On July 20, 2020, DAC Biotech’s new ADC drug development, TROP2-ADC—DAC-002 was approved of clinical study by NMPA. for the indication of solid malignant tumor. Medicilon completed preclinical pharmacokinetic and toxicological studies in this project, accelerating the development process.

DAC-002 is an ADC anti-Trop2 monoclonal antibody conjugated by an intelligent ligand against Tubulysin B analogue. It is used to treat Trop2 triple negative breast cancer, small cell lung cancer, non-small cell lung cancer and pancreatic cancer.Trop2 can promote the proliferation, invasion, metastasis and diffusion of tumor cells, and its high expression is closely related to the shortening of survival time and poor prognosis of tumor patients. Therefore, it is of great significance to study anti-tumor drugs targeted by Trop2.

Medicilon helped DAC Biotech complete the pharmacokinetic and toxicological study of DAC-002. There is no fixed research scheme for ADC drug research. Due to the differentiation of conjugating mode and drug structure, the preclinical research of each ADC drug has different challenges and problems. Medicilon is committed to providing its customers with mature tumor models that evaluate the efficacy of ADC in vivo, complete the modeling and feeding of model animals in AAALAC certified environment, and complete relevant pharmacodynamics evaluation tests at the high standard of GLP-like. Medicilon provides a variety of high-quality test methods for ADC component analytes in vivo, providing customers with reliable and high-quality PK data by analyzing plasma/serum samples collected from animals.

Up to now，Medicilon has completed 7 sets of holistic preclinical studies. Among them, 5 sets have been approved for NMPA clinical trials, and 1 set has been approved for both NMPA and FDA clinical trials. There are several ADC projects under development in collaboration with Medicilon, which will take advantage of its service platform to accelerate the preclinical development and application process of innovative drugs.

Medicilon congratulates DAC Biotech on the periodic success of DAC-002 project, and hopes that other ADC prDojects under development can also be carried out smoothly and declare success as soon as possible.