TIDMHCM
Hutchmed (China) Limited
10 January 2022
Press Release
HUTCHMED Initiates Phase I Study of BTK Inhibitor HMPL-760 in
Patients with Previously Treated B-Cell Non-Hodgkin Lymphoma in
China
- HMPL-760 is the eleventh innovative potential oncology drug
candidate discovered in-house by HUTCHMED -
- HMPL-760 is HUTCHMED's fifth candidate in clinical development
for hematological malignancies, including amdizalisib and HMPL-523
that also target the B-cell receptor ("BCR") signaling pathway, and
tazemetostat and HMPL-306 -
Hong Kong, Shanghai & Florham Park, NJ - Monday, January 10,
2022: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM;
HKEX:13) has initiated a Phase I study in China of HMPL-760, a
highly potent, selective, and reversible inhibitor with long target
engagement against Bruton's tyrosine kinase ("BTK"), including
wild-type and C481S-mutated BTK. The first patient received their
first dose on January 4, 2022.
The clinical study is a multi-center, open-label study to
evaluate the safety, tolerability, pharmacokinetics (PK),
pharmacodynamics (PD) and preliminary efficacy profile of HMPL-760.
The study is enrolling patients with previously treated chronic
lymphocytic leukemia/ small lymphocytic lymphoma (CLL/SLL) or other
types of Non-Hodgkin Lymphoma ("NHL"), including patients treated
with a prior regimen containing a BTK inhibitor, whose disease
carries either wild-type BTK or acquired resistance to first
generation BTK inhibitors due to additional muta-tions to BTK.
An initial dose escalation stage to determine the maximum
tolerated dose (MTD) and/or the recommended Phase II dose ("RP2D")
is planned, to be followed by a dose expansion phase where patients
will receive HMPL -- 760 to further evaluate the safety,
tolerability, and clinical activity at the RP2D. Approximately 100
patients are expected to be enrolled.
HMPL-760 is HUTCHMED's fifth investigational drug candidate
targeting hematological malig-nan-cies in clinical development.
Amdizalisib (HMPL-689, targeting the delta isoform of
phospho-inositide 3-kinase or PI3K delta) and HMPL-523 (targeting
spleen tyrosine kinase or Syk) are also being studied in several
Phase II trials against B-cell dominant malignancies. Phase II
registration studies are underway in China for amdizalisib in
patients with follicular lymphoma (FL), for which it has been
granted Break-through Therapy Desig-nation in China, and marginal
zone lymphoma (MZL).
In addition to the three BCR inhibitors, for hema-to-logical
malignancies HUTCHMED is also develop-ing its in-house discovered
drug candidate HMPL-306, a dual-inhibitor of mutant isocitrate
dehydro-genase 1 and 2, and tazemetostat, a methyl-trans-ferase
inhibitor of EZH2 (being devel-oped in Greater China by HUTCHMED
pursuant to a strategic collab-oration with Epizyme).
About BTK and Non-Hodgkin Lymphoma
BTK is a key component of the B-cell receptor signaling pathway
and is an important regulator of cell prolif-era-tion and cell
survival in various lymphomas. The abnormal activation of B-cell
receptor signaling is closely related to the develop-ment of B-cell
type hemato-logical cancers, which represent approximately 85% of
all NHL cases.[1] BTK is considered a validated target for drugs
that aim to treat certain hemato-logical cancers, however C481S
mutation of BTK is a known resistance mechanism for first and
second generation BTK inhibitors. In 2020, approximately 93,000 new
cases of NHL are estimated to have been diagnosed in China. [2]
About HMPL-760
HMPL-760 is an investigational, highly selective, non-covalent,
third-generation inhibitor of BTK, both wild-type and C481S mutant
enzymes, with pre-clinical data suggesting high target specificity
and higher potency versus first generation BTK inhib-itors. BTK
C481S mutation plays an important role in resistance to certain BTK
inhibitors.[3](,[4])
HMPL-760 is HUTCHMED's eleventh innovative potential oncology
drug candidate to enter clinical develop-ment. HUTCHMED currently
retains all rights to HMPL-760 worldwide.
About HUTCHMED
HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) is an innovative,
commercial-stage, biopharma-ceutical company. It is committed to
the discovery and global develop-ment and commercial-ization of
targeted therapies and immuno-therapies for the treatment of cancer
and immuno-logical diseases. It has more than 4,500 personnel
across all its companies, at the center of which is a team of over
1,400 in oncology/ immunology. Since inception it has advanced 11
cancer drug candidates from in-house discovery into clinical
studies around the world, with its first three oncology drugs now
approved and marketed in China. For more informa-tion, please
visit: www.hutch-med.com or follow us on LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the "safe harbor" provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These forward-looking
statements reflect HUTCHMED's current expectations regarding future
events, includ-ing its expectations regarding the thera-peutic
potential of HMPL-760, amdizalisib, HMPL-523, HMPL-306 and
tazemetostat for patients, its expectations as to whether any
studies on HMPL-760, amdizalisib, HMPL-523, HMPL-306 and
tazemetostat would meet their primary or secondary endpoints, and
its expectations as to the timing of the completion and the release
of results from such studies. Forward-looking statements involve
risks and uncertainties. Such risks and uncer-tainties include,
among other things, assumptions regarding enrollment rates and the
timing and availability of subjects meeting a study's inclusion and
exclusion criteria; changes to clinical protocols or regulatory
requirements; unexpected adverse events or safety issues; the
ability of HMPL-760, amdizalisib, HMPL-523, HMPL-306 and
tazemetostat, including as a combination therapy, to meet the
primary or secondary endpoint of a study, to obtain regulatory
approval in different jurisdic-tions and to gain commercial
acceptance after obtaining regulatory approval; the potential
market of HMPL-760, amdizalisib, HMPL-523, HMPL-306 and
tazemetostat for a targeted indication; the sufficiency of funding;
and the impact of the COVID-19 pandemic on general economic,
regulatory and political conditions. Existing and prospective
investors are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof.
For further discussion of these and other risks, see HUTCHMED's
filings with the U.S. Securities and Exchange Commission, The Stock
Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no
obligation to update or revise the information contained in this
press release, whether as a result of new information, future
events or circumstances or otherwise.
CONTACTS
Investor Enquiries
Mark Lee, Senior Vice President +852 2121 8200
Annie Cheng, Vice President +1 (973) 567 3786
Media Enquiries
Americas - Brad Miles, +1 (917) 570 7340 (Mobile)
Solebury Trout bmiles@troutgroup.com
Europe - Ben Atwell / Alex Shaw, +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)
FTI Consulting HUTCHMED@fticonsulting.com
Asia - Zhou Yi, +852 97 83 6894 (Mobile)
Brunswick HUTCHMED@brunswickgroup.com
Nominated Advisor
Atholl Tweedie / Freddy Crossley,
Panmure Gordon (UK) Limited +44 (20) 7886 2500
[1] American Cancer Society (2019, January 29). Types of B-cell
Lymphoma.
https://www.cancer.org/cancer/non-hodgkin-lymphoma/about/b-cell-lymphoma.html.
Accessed January 5, 2022.
[2] The Global Cancer Observatory, China fact sheet.
https://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf.
Accessed November 17, 2021.
[3] Woyach JA, Ruppert AS, Guinn D, et al. BTKC(481S) -Mediated
Resistance to Ibrutinib in Chronic Lymphocytic Leukemia. J Clin
Oncol. 2017;35(13):1437-1443. doi:10.1200/JCO.2016.70.2282.
[4] Woyach JA, Huang Y, Rogers K, et al. Resistance to
Acalabrutinib in CLL is Mediated Primarily by BTK Mutations. Blood.
2019;134 (Supplement_1): 504. doi:10.1182/blood-2019-127674.
This information is provided by Reach, the non-regulatory press
release distribution service of RNS, part of the London Stock
Exchange. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
Reach is a non-regulatory news service. By using this service an
issuer is confirming that the information contained within this
announcement is of a non-regulatory nature. Reach announcements are
identified with an orange label and the word "Reach" in the source
column of the News Explorer pages of London Stock Exchange's
website so that they are distinguished from the RNS UK regulatory
service. Other vendors subscribing for Reach press releases may use
a different method to distinguish Reach announcements from UK
regulatory news.
RNS may use your IP address to confirm compliance with the terms
and conditions, to analyse how you engage with the information
contained in this communication, and to share such analysis on an
anonymised basis with others as part of our commercial services.
For further information about how RNS and the London Stock Exchange
use the personal data you provide us, please see our Privacy
Policy.
END
NRASSLFDWEESEFF
(END) Dow Jones Newswires
January 10, 2022 02:00 ET (07:00 GMT)
Hutchison China Meditech (LSE:0J7G)
Graphique Historique de l'Action
De Juin 2024 à Juil 2024
Hutchison China Meditech (LSE:0J7G)
Graphique Historique de l'Action
De Juil 2023 à Juil 2024