SHANGHAI, July 15,
2024 /PRNewswire/ -- Mabwell (688062.SH), an
innovative biopharmaceutical company with entire industry chain,
announced its novel Nectin-4 targeting ADC (R&D code: 9MW2821)
has been approved by the NMPA to enter Phase II clinical trial as
monotherapy or in combination with a PD-1 inhibitor for the
treatment of triple-negative breast cancer (TNBC).
The Phase II clinical trial recently approved aims to evaluate
the efficacy and safety of 9MW2821 as monotherapy or in combination
with a PD-1 inhibitor in patients with locally advanced or
metastatic TNBC. The study includes two cohorts: Cohort A will
enroll patients with locally advanced or metastatic TNBC who have
previously received taxane/anthracycline-based chemotherapy and
topoisomerase inhibitor based antibody-drug conjugate treatment,
and will receive 9MW2821 monotherapy; Cohort B will enroll patients
with locally advanced or metastatic TNBC who have not previously
received systemic therapy, and will receive a combination treatment
of 9MW2821 and a PD-1 inhibitor.
Clinical results previously presented at the 2024 ASCO Annual
Meeting showed that among the 20 patients with locally advanced or
metastatic TNBC treated by 9MW2821 and evaluable for efficacy
assessment, the objective response rate (ORR) and disease control
rate (DCR) were 50.0% and 80.0% respectively. The median
progression-free survival (mPFS) was 5.9 months, and the median
overall survival (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. Additionally, 9MW2821 has
recently been granted Fast Track Designation (FTD) by the U.S. Food
and Drug Administration (FDA) for the treatment of locally advanced
or metastatic Nectin-4 positive TNBC.
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 (CC),
esophageal cancer (EC) and breast cancer. 9MW2821 has been granted
FTD by FDA for the treatment of advanced, recurrent, or metastatic
esophageal squamous cell carcinoma (ESCC) in Feb. 2024, and also respectively granted Orphan
Drug Designation (ODD) and FTD for the treatment of EC and
recurrent or metastatic CC progressed on or following prior
treatment with a platinum-based chemotherapy regimen in
May 2024. Then, it has been granted
FTD for the treatment of locally advanced or metastatic Nectin-4
positive TNBC in July, 2024.
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 in
Shanghai and the ADC
commercialized manufacturing base in Taizhou are 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.
Forward-Looking Statements
This press release contains forward-looking statements
including, but not limited to, the potential safety, efficacy,
regulatory review or approval and commercial success of our product
candidates and those relating to the Company's product development,
clinical studies, clinical and regulatory milestones and timelines,
market opportunity, competitive position, possible or assumed
future results of operations, business strategies, potential growth
opportunities and other statements that are predictive in nature.
"Forward-looking statements" are statements that are not historical
facts and involve a number of risks and uncertainties, which may
cause actual results to be materially different from any future
results expressed or implied in the forward-looking statements.
These statements may be identified by the use of forward-looking
expressions, including, but not limited to, "expect," "anticipate,"
"intend," "plan," "believe," "estimate," "potential," "predict,"
"project," "should," "would", and similar expressions and the
negatives of those terms.
Forward-looking statements are based on the Company's current
expectations and assumptions. Forward-looking statements are
subject to a number of risks, uncertainties, and other factors,
many of which are beyond the Company's control, including, but not
limited to: environment; politic; economy; society; legislation;
our dependence on our product candidates, most of which are still
in preclinical or various stages of clinical development; our
reliance on third-party vendors, such as contract research
organizations and contract manufacturing organizations; the
uncertainties inherent in clinical testing; our ability to complete
required clinical trials for our product candidates and obtain
approval from regulatory authorities for our product candidates;
our ability to protect our intellectual property; the potential
impact of COVID-19; the loss of any executive officers or key
personnel. In case one or more of these risks or uncertainties
deteriorate, or any assumptions are incorrect, the actual results
may be seriously inconsistent with the stated results.
The Company cautions all the persons not to place undue reliance
on any such forward-looking statements, which speaks only as of the
date of this press release. The Company disclaims any obligation,
except as specifically required by law and the rules of the
applicable Stock authority to publicly update or revise any such
statements to reflect any change in expectations or in events,
conditions, or circumstances on which any such statements may be
based, or that may affect the likelihood that actual results will
differ from those set forth in the forward-looking statements. All
forward-looking descriptions, figures and assumptions in this press
release are applicable to this statement.
View original
content:https://www.prnewswire.com/news-releases/mabwell-receives-nmpa-approval-for-clinical-trial-of-novel-nectin-4-targeting-adc-in-tnbc-302196758.html
SOURCE Mabwell