29 December, 2023, Lepu Biopharma Co., Ltd. (Stock Code: 02157.HK) is pleased to announce that, our drug candidate MRG003, an antibody drug conjugate (“ADC”) drug candidate targeting epidermal growth factor receptor (“EGFR”) and a core product of the Company, has successfully completed the enrollment of all patients in the Pivotal Phase IIb clinical trial for the treatment of recurrent or metastatic nasopharyngeal cancer (“R/M NPC”) recently.
This trial is a randomized, open-label, multicenter Pivotal Phase IIb clinical study, which started patient enrollment in April 2023, in respect of which 173 participants have successfully completed enrollment as of the date of this announcement.
Previously, MRG003 has been granted the breakthrough therapy designation by the Center for Drug Evaluation of the National Medical Products Administration of the People’s Republic of China (the “PRC”), the Orphan-drug Designation by the Food and Drug Administration of the United States (the “FDA”) for the treatment of R/M NPC and the Fast Track Designation by the FDA.
The Pivotal Phase IIb clinical trial of MRG003 in China aims to research and evaluate the safety, preliminary efficacy and optimal dosing strategy of MRG003 for the treatment of R/M NPC, and to accumulate more data to comprehensively evaluate the risks and benefits of later clinical trials in order to accelerate the global development process of the product.
MRG003 is an ADC comprised of an EGFR-targeted monoclonal antibody conjugated with the potent microtubulin inhibiting payload monomethyl auristatin E via a valine-citrulline linker. It binds specifically with high affinity to EGFR on the surface of tumor cells, releases the potent payload upon internalization and lysosomal protease cleavage of the linker and results in tumor cell death.
EGFR is highly expressed in colorectal cancer, lung cancer, head and neck cancer and other malignant solid tumors, and is expressed in 89% advanced NPC. Therefore, EGFR is an important target for cancer treatment.