Biopharmaceutical firm Mabwell has announced that the preliminary data of the ongoing clinical studies of its Nectin-4 targeted site-specific ADC asset (9MW2821) showed promising signs.
9MW2821 is claimed to be the first Nectin-4 targeted ADC to receive approval for clinical trials in China and the second globally.
Its pharmacokinetics, tolerability, preliminary anti-tumour activity, and safety are being evaluated in multiple ongoing clinical studies which include more than ten different solid tumours.
At the recommended phase II dose (RP2D), the drug candidate demonstrated positive therapeutic signals in solid tumours as well as good safety profile, according to the preliminary data.
The findings showed that 50% objective response rate (ORR) and 100% disease control rate (DCR) was observed among six patients with cervical carcinoma, and among 12 urothelial carcinoma (UC) patients, 50% ORR and 100% DCR was observed.
Currently, the company is promoting enrolment of multiple cohorts of non-small cell lung cancer, HER-2 negative breast cancer, UC, CC, and prostate cancer.
Mabwell said that the National Medical Products Administration (NMPA) accepted the clinical trial application for Trop-2 targeted ADC (9MW2921).
It intends to submit the clinical trial application for B7-H3 targeted ADC (7MW3711) soon.
By next year, the company expects to have three to five ADC products in clinical stage.
Last month, NMPA accepted the clinical trial application for the company’s 9MW3811 for advanced malignancies and idiopathic pulmonary fibrosis indications.
9MW3811 is an independently developed humanised monoclonal antibody against human interleukin-11 (IL-11).