On April 6, 2023 Mabwell (688062.SH), an innovative biopharmaceutical company with the whole industry chain layout, reported its Nectin-4 targeted site-specific ADC asset (R&D code: 9MW2821) demonstrated promising clinical data (Press release, Mabwell Biotech, APR 6, 2023, View Source [SID1234629888]). The preliminary data show positive therapeutic signals in solid tumors, and good safety profile at the recommended phase II dose (RP2D).
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Developed with site specific conjugate technology, 9MW2821 is China’s first, global second Nectin-4 targeted ADC approved for clinical study. The multiple ongoing clinical studies include more than 10 different solid tumors, evaluate safety, tolerability, pharmacokinetics, and preliminary antitumor activity. The preliminary data show that under RP2D, among 12 UC (Urothelial Carcinoma) patients the ORR (Objective Response Rate) was 50% and DCR (Disease Control Rate) was 100%, and among 6 CC (Cervical Carcinoma) patients, the ORR was 50% and DCR was 100%. Mabwell is promoting the enrollment of multiple cohorts of UC, CC, prostate cancer, HER-2 negative breast cancer, and non-small cell lung cancer. Details will be published in upcoming academic meetings.
Mabwell has also achieved several breakthroughs in new ADC technology platform, optimizing ADC platform by developing IDDC, a new generation ADC site-specific conjugate technology platform, which is composed of multiple systematized core patented technologies including site-specific conjugate process DARfinity, special designed linker IDconnect, novel payload Mtoxin, and conditional release structure LysOnly. Developed Based on mentioned systematic patent technologies, the next generation ADCs have better structural homogeneity, quality stability, pharmacodynamics and tolerability, as well as dominant advantage of differentiation.
At present, the advantage of IDDC platform has been validated in several products under development. Clinical trial application for Trop-2 targeted ADC (R&D code: 9MW2921) has been accepted by NMPA. Clinical trial application for B7-H3 targeted ADC (R&D code: 7MW3711) is expected to be submitted soon. By continuously advancing development of multiple ADC candidates, it is expected that Mabwell will have 3 to 5 ADC products in clinical stage by 2024.
Mabwell has established complete industry chain for ADC, including early discovery, pre-clinical development and pilot scale production. The large-scale commercialized site is expected to be ready for production trial run at Q2, 2023.