BeiGene Initiates First-in-Human Phase 1 Clinical Trial of Investigational TYK2 Inhibitor BGB-23339
November 22 2021 - 07:00AM
Business Wire
Expanding portfolio with first internally
discovered asset in Inflammation and Immunology with internally
discovered asset
A highly selective, allosteric TYK2 inhibitor
that has shown potent inhibition against pro-inflammatory cytokines
in preclinical studies
BeiGene (NASDAQ: BGNE; HKEX: 06160), a global, science-driven
biotechnology company focused on developing innovative and
affordable medicines, today announced that the first patient has
been dosed in a Phase 1 clinical trial of BGB-23339, a potent,
allosteric investigational tyrosine kinase 2 (TYK2) inhibitor
internally developed by BeiGene scientists.
TYK2 is a member of the JAK family and functions as a critical
mediator in cytokine signaling pathways implicated in multiple
immune-mediated disorders, such as psoriasis and inflammatory bowel
disease. BGB-23339 is a potent, highly selective, investigational
TYK2 inhibitor targeting the regulatory pseudokinase (JH2)
domain.
“Discovered and developed by BeiGene, BGB-23339 is a highly
selective, potent, allosteric TYK2 inhibitor that has shown
promising activity in preclinical evaluation,” commented Lai Wang,
Ph.D., Global Head of R&D at BeiGene. “Building on our proven
track record in oncology, BeiGene is expanding its clinical focus
to discover new modalities and platforms in areas of high unmet
need, including inflammation and immunology, to bring innovative,
impactful medicines to patients.”
The first-in-human Phase 1 trial (NCT05093270) is designed to
evaluate the safety, tolerability, pharmacokinetics, and
preliminary activity of BGB-23339. The trial is expected to enroll
up to 115 healthy volunteers in Australia and/or China.
In addition to its broad portfolio focused on hematological
malignancies and solid tumors, BeiGene is applying its research
excellence and clinical expertise to address inflammation and
immunology, an area of high unmet medical need. BeiGene’s
internally developed, highly selective next-generation BTK
inhibitor BRUKINSA® (zanubrutinib) is currently being evaluated in
a Phase 2 trial in patients with active proliferative lupus
nephritis.
About BGB-23339
BGB-23339 is a potent, highly selective, allosteric,
investigational tyrosine kinase 2 (TYK2) inhibitor discovered and
being developed by BeiGene. TYK2 is a member of the JAK family and
functions as a critical mediator in cytokine signaling pathways
implicated in multiple immune-mediated disorders. Designed to
target the regulatory pseudokinase (JH2) domain on TYK2, BGB-23339
has demonstrated strong selectivity in preclinical studies with
potent inhibition of interleukin (IL)-12, IL-23, and Type 1
interferons (IFNs)—pro-inflammatory cytokines that play a
determinant role in the induction of inflammation. BGB-23339 is
currently being evaluated in a Phase 1 clinical study.
About BeiGene
BeiGene is a global, science-driven biotechnology company
focused on developing innovative and affordable medicines to
improve treatment outcomes and access for patients worldwide. With
a broad portfolio of more than 40 clinical candidates, we are
expediting development of our diverse pipeline of novel
therapeutics through our own capabilities and collaborations. We
are committed to radically improving access to medicines for two
billion more people by 2030. BeiGene has a growing global team of
over 7,700 colleagues across five continents. To learn more about
BeiGene, please visit www.beigene.com and follow us on Twitter at
@BeiGeneGlobal.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
and other federal securities laws, including statements regarding
plans for the Phase 1 trial and development of BGB-23339, the
potential for BGB-23339 to address unmet medical needs, BeiGene’s
plan to expand its clinical focus to discover new modalities and
platforms in areas of high unmet need, including inflammation and
immunology, and BeiGene’s plans, commitments, aspirations and goals
under “About BeiGene”. Actual results may differ materially from
those indicated in the forward-looking statements as a result of
various important factors, including BeiGene's ability to
demonstrate the efficacy and safety of its drug candidates; the
clinical results for its drug candidates, which may not support
further development or marketing approval; actions of regulatory
agencies, which may affect the initiation, timing and progress of
clinical trials and marketing approval; BeiGene's ability to
achieve commercial success for its marketed medicines and drug
candidates, if approved; BeiGene's ability to obtain and maintain
protection of intellectual property for its medicines and
technology; BeiGene's reliance on third parties to conduct drug
development, manufacturing and other services; BeiGene’s limited
experience in obtaining regulatory approvals and commercializing
pharmaceutical products and its ability to obtain additional
funding for operations and to complete the development and
commercialization of its drug candidates and achieve and maintain
profitability; the impact of the COVID-19 pandemic on the BeiGene’s
clinical development, regulatory, commercial, and other operations,
as well as those risks more fully discussed in the section entitled
“Risk Factors” in BeiGene’s most recent quarterly report on Form
10-Q as well as discussions of potential risks, uncertainties, and
other important factors in BeiGene's subsequent filings with the
U.S. Securities and Exchange Commission. All information in this
press release is as of the date of this press release, and BeiGene
undertakes no duty to update such information unless required by
law.
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version on businesswire.com: https://www.businesswire.com/news/home/20211122005809/en/
BeiGene Investor Contact Gabrielle Zhou +86
10-5895-8058 or +1 857-302-5189 ir@beigene.com
Media Contact Vivian Ni +1 857-302-7596
media@beigene.com
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