SHANGHAI, May 13, 2024
/PRNewswire/ -- Mabwell (688062.SH), an innovation-driven
biopharmaceutical company with entire industry chain, announced the
progress of the clinical study of its novel Nectin-4-targeting
ADC (R&D code: 9MW2821) for triple-negative breast
cancer.
Based on 9MW2821's current ongoing monotherapy clinical data, in
20 subjects with locally advanced or metastatic triple-negative
breast cancer treated with the 1.25 mg/kg dose and evaluable for
tumor assessment, the objective response rate (ORR) and disease
control rate (DCR) were 50% and 80%, respectively, with one patient
achieved CR and had been in complete response (CR) for 20 months
and is currently sustained to be CR. Investigational new drug
application of 9MW2821 in combination with immune checkpoint
inhibitor for the treatment of triple-negative breast cancer has
been accepted by the China National Medical Products Administration
(NMPA).
9MW2821 is currently undergoing clinical studies across multiple
indications. Phase III monotherapy study of locally
advanced/metastatic urothelial carcinoma on patients previously
treated with platinum-based chemotherapy and PD-(L)1 inhibitor has
formally initiated; A Phase I/II study evaluating first-line
combination therapy options with a PD-1 inhibitor has also begun.
The first patient enrollment for the two studies were both
completed. For cervical cancer and esophageal cancer, Mabwell is
actively seeking for Phase III clinical trial approval, and
additionally conducting scientific assessments of front-line
combination regimens, with clinical trial application expected to
be submitted soon. 9MW2821 has been granted Fast Track Designation
(FTD) and Orphan Drug Designation (ODD) by the U.S. Food and Drug
Administration for the treatment of advanced, recurrent, or
metastatic esophageal squamous cell carcinoma and esophageal
cancer, respectively.
About 9MW2821
9MW2821 is the first site-specific conjugated novel
Nectin-4-targeting ADC developed by Mabwell using ADC platform and
automated high-throughput hybridoma antibody molecular discovery
platform, and is the first drug candidate to enter clinical study
among the Nectin-4-targeting ADCs developed by Chinese companies,
and the first therapeutic drug candidate targeting Nectin-4 in the
world to reveal clinical efficacy data of cervical cancer,
esophageal cancer and breast cancer. 9MW2821 has been granted Fast
Track Designation (FTD) and Orphan Drug Designation (ODD) by the
U.S. Food and Drug Administration for the treatment of advanced,
recurrent, or metastatic esophageal squamous cell carcinoma and
esophageal cancer in Feb. 2024 and
May 2024, respectively.
9MW2821 achieves site-specific modification of antibody through
proprietary conjugate technology linkers and optimized ADC
conjugation process. After injection, 9MW2821 can specifically bind
to Nectin-4 on the cell membrane surface, be internalized and
release cytotoxic drug, and induce the apoptosis of tumor
cells.
About Mabwell
Mabwell (688062.SH) is an innovation-driven biopharmaceutical
company with the entire value chain of the pharmaceutical industry.
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 14 pipeline products in
different stages based on a world-class and state-of-the-art
R&D engine, including 10 novel drug candidates and 4
biosimilars. We focus on the therapeutic areas of oncology,
auto-immune diseases, metabolic disorders, ophthalmologic diseases
and infectious diseases, etc. Of these, 3 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 multiple 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/en.
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SOURCE Mabwell