This milestone of Doer Biologics, the large-molecule biopharma, also represents the first humanized VHH-Fc based anti-Claudin 18.2 monoclonal antibody entering the clinical stage in the globe.
Doer Biologics (Chinese: 道尔生物), the subsidiary of Huadong Medicine (Chinese: 华东医药, 000963) recently announced that Phase I clinical trial of the novel drug DR30303 achieved first-patient-in (FPI).
The Phase I clinical trial of DR30303 for injection, led by Pan Hongming, the dean of Sir Run Run Shaw Hospital, is aimed to evaluate the safety, tolerability, pharmacokinetics and initial efficacy of DR30303 in treating patients with advanced solid tumors.
Doer Biologics submitted the Investigational New Drug (IND) application for the authorization of Phase I clinical trial for DR30303 in November 2021 and was granted《Notice of Drug Clinical Trial Approval》(notice number: 2022LP00075) by the national medical products administration (NMPA) on January 18, 2021.
DR30303 for injection is a humanized anti-Claudin (CLDN) 18.2 heavy chain antibody Fc fusion protein (VHH-Fc) generated via Doer Biologics’ proprietary SMART-VHHBody platform, belonging to Class 1 biologicals.
Claudins are transmembrane proteins with extracellular loops and an integral component of tight junction.
Claudin 18.2, an isoform of claudins, is commonly expressed in multiple cancers such as gastric cancer and pancreatic cancer and does not exist in healthy tissues with the exception of gastric mucosa. Therefore, it is one of the promising targets for treating cancer.
DR30303 exhibits strong and highly selective binding to CLDN18.2 according to its pre-clinical experimental data. Additionally, it also possesses a smaller size, enhanced ADCC activity and low immunogenicity risk, resulting in a strong competitive advantage and differentiation compared with other anti-CLDN18.2 antibodies in the market.
Doer Biologics, founded in 2014, focuses on the discovery of protein drugs for metabolic, ophthalmic diseases and cancers, and owns proprietary intellectual property rights of three protein drug discovery platforms.