China's First Nectin-4 Targeted ADC 9MW2821 Clinical Progress Released

2023-04-10

抗体药物偶联物临床结果

Mabwell (688062.SH), an innovative biopharmaceutical company with the whole industry chain layout, announced its Nectin-4 targeted site-specific ADC asset (R&D code: 9MW2821) demonstrated promising clinical data. The preliminary data show positive therapeutic signals in solid tumors, and good safety profile at the recommended phase II dose (RP2D).

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.

About Mabwell

Mabwell (688062.SH), an innovation-driven biopharmaceutical company, has the whole industrial chain of R&D, manufacturing, and commercialization. We provide more effective and accessible therapy and innovative medicines to fulfill global medical needs. Since 2017, an advanced R&D system which covers target discovery, early discovery, druggability, preclinical, clinical research and manufacturing transformation was established. Mabwell has 17 pipeline products in different R&D stages based on a world-class and state-of-the-art R&D engine, including 13 novel drug candidates and 4 biosimilars. We focus on the therapeutic areas of auto-immune diseases, oncology, metabolic disorders, ophthalmologic diseases and infectious diseases, etc. Of these, 2 products have been approved and commercialized, 1 product has been filed for MA approval, 3 products are in pivotal trials. We have also undertaken 1 national major scientific and technological special project for "Significant New Drugs Development", 2 projects for National Key R&D Programmes, and several provincial and municipal science and technological innovation projects. Mabwell's Taizhou factory possesses robust in-house manufacturing capability compliant with international GMP standards regulated by the NMPA, FDA and EMA, and has passed the EU QP Audit. The large-scale manufacturing base located in Shanghai is under construction. Our mission is "Explore Life, Benefit Health" and our vision is "Innovation, from ideas to reality". For more information, please visit www.mabwell.com.

SOURCE: Mabwell

机构

Mabwell Therapeutics, Inc.

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