Hutchmed (China) Limited HUTCHMED Initiates Phase I Trials of HMPL-295
July 06 2021 - 03:30AM
RNS Non-Regulatory
TIDMHCM
Hutchmed (China) Limited
06 July 2021
Press Release
HUTCHMED Initiates Phase I Trials of novel ERK inhibitor
HMPL--295 in Patients with Advanced Solid Tumors in China
Hong Kong, Shanghai and Florham Park, NJ - Tuesday, July 6,
2021: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM; HKEX:
13) has initiated a Phase I study of HMPL--295, its investigative
and highly selective oral inhibitor of ERK, which is a downstream
component of the RAS-MAPK[1] pathway signaling cascade. HMPL-295
has the potential to address intrinsic or acquired resistance from
upstream mechanisms such as RAS, RAF and MEK. This is our first of
multiple candidates in discovery addressing the RAS-MAPK pathway.
The first patient was dosed on July 2, 2021.
The clinical trial is a multi-center, open-label study to
evaluate safety, tolerability, pharmacokinetics and preliminary
efficacy pro file of HMPL- 295, and to determine the maximum
tolerated dose and recommended Phase II dose ("RP2D") in patients
with advanced malignant solid tumors. Following the initial dose
escalation stage, another 10 to 15 patients will be enrolled at the
RP2D to further evaluate its safety and the preliminary efficacy of
HMPL-295. An exploratory study on the pharmacokinetic biomarkers of
HMPL-295 is also planned. Additional details may be found at
clinicaltrials.gov, using identifier NCT04908046.
We currently retain all rights to HMPL-295 worldwide.
About ERK and the RAS-MAPK pathway
The RAS-MAPK pathway is dysregulated in human diseases,
particularly cancer, in which mutations or nongenetic events
hyperactivate the pathway in more than 50% of cancers. Activating
mutations in RAS genes occur in more than 30% of cancers. RAS and
RAF predict worse clinical prognosis in a wide variety of tumor
types, mediate resistance to targeted therapies, and decrease the
response to the approved standards of care, namely, targeted
therapy and immunotherapy. On the RAS-MAPK pathway, KRAS inhibitors
are under clinical evaluation, and acquired resistance develops for
RAF/MEK targeted therapies. ERK inhibition has the potential to
overcome or avoid the intrinsic or acquired resistance from
upstream mechanisms such as these.
About HUTCHMED
HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) (formerly Hutchison China
MediTech) is an innovative, commercial-stage, biopharmaceutical
company. It is committed to the discovery and global development
and commercialization of targeted therapies and immunotherapies for
the treatment of cancer and immunological diseases. A dedicated
organization of over 1,300 personnel has advanced ten cancer drug
candidates from in-house discovery into clinical studies around the
world, with its first three oncology drugs now approved. For more
information, 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, including its expectations regarding the therapeutic
potential of HMPL-295, the further clinical development for
HMPL-295, its expectations as to whether such studies 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 uncertainties include, among other
things, assumptions regarding enrollment rates, 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-295, including as a combination therapy, to meet the primary
or secondary endpoint of a study, to obtain regulatory approval in
different jurisdictions, to gain commercial acceptance after
obtaining regulatory approval, the potential market of HMPL-295 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, on AIM and The Stock Exchange of Hong Kong
Limited. 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 - Joseph Chi Lo / Zhou Yi, +852 9850 5033 (Mobile) / +852 97 83 6894 (Mobile)
Brunswick HUTCHMED@brunswickgroup.com
Nominated Advisor
Atholl Tweedie / Freddy Crossley,
Panmure Gordon (UK) Limited +44 (20) 7886 2500
[1] Mitogen -- activated protein kinase, MAPK.
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