SHANGHAI, May 24, 2024
/PRNewswire/ -- Mabwell (688062.SH), an innovation-driven
biopharmaceutical company, announced the data and latest progress
of the Phase I/II clinical study of 9MW2821, a novel
Nectin-4-targeting ADC for multiple advanced solid tumors, which
will be reported as an oral presentation at the 2024 American
Society of Clinical Oncology (ASCO) Annual Meeting.
As of April 1, 2024, among 240
patients in the 1.25 mg/kg dose group in the Phase II clinical
trial:
>> Urothelial Carcinoma (UC)
Of the 37 patients evaluable for efficacy assessment, the objective
response rate (ORR) and disease control rate (DCR) were 62.2% and
91.9%, respectively, with median progression-free survival (mPFS)
was 8.8 months and median overall survival (mOS) was 14.2
months.
>> Cervical Cancer (CC)
Of the 53 patients evaluable for efficacy assessment, 51% were
previously treated with
platinum-based doublet chemotherapy and bevacizumab,
and 58% received platinum-based doublet chemotherapy and
immune checkpoint inhibitor, with ORR and DCR were 35.8% and 81.1%,
respectively. The mPFS was 3.9 months, with mOS not reached. Of the
patients with Nectin-4 tumor cell staining intensity 3+, the ORR
was 43.6% among the 39 evaluable patients.
>> Esophageal Cancer (EC)
Of the 39 patients evaluable for efficacy assessment, ORR and DCR
were 23.1% and 69.2%, respectively, with mPFS of 3.9 months and mOS
of 8.2 months; 37 of them were treated with platinum-based
chemotherapy and immunotherapy previously.
>> Triple-negative Breast Cancer (TNBC)
Of the 20 patients with locally advanced or metastatic
triple-negative breast cancer and evaluable for efficacy
assessment, the ORR and DCR were 50.0% and 80.0% respectively. The
mPFS was 5.9 months, and the mOS was not yet reached, with one
patient achieved complete response (CR) and had been in CR for 20
months and is currently sustained to be CR.
>> Safety Profile
To date, the most common treatment-related adverse events (all
grade, ≥grade 3) in the 240 patients in the 1.25 mg/kg dose group
were white blood cell count decreased (50.8%, 23.3%), neutrophil
count decreased (46.3%, 27.9%), anemia (43.8%, 8.3%), aspartate
aminotransferase increased (42.1%, 2.9%), alanine aminotransferase
increased (35.4%, 2.1%), asthenia (32.1%, 2.9%), rash (30.0%,
5.0%), decreased appetite (28.8%, 1.3%), nausea (26.7%, 0%),
hyperglycemia (25.4%, 2.1%), platelet count decreased (24.2%,
4.6%), alopecia (24.2%, 0%), hypoaesthesia (22.5%, 1.7%),
constipation (21.3%, 0%), vomiting (20.9%, 1.3%),
hypertriglyceridemia (20.4%, 2.1%), and gamma glutamyl
aminotransferase increased (15.8%, 5.4%). The data suggest that
9MW2821 has a manageable safety profile.
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