Hutchmed (China) Limited HUTCHMED Initiates Phase I Trial of HMPL-A83
15 Juillet 2022 - 10:30AM
RNS Non-Regulatory
TIDMHCM
Hutchmed (China) Limited
15 July 2022
Press Release
HUTCHMED Initiates Phase I Trial of Anti-CD47 Monoclonal
Antibody HMPL-A83 in Patients with Advanced Malignant Neoplasms in
China
- HMPL-A83 is the thirteenth innovative oncology drug candidate
discovered in-house by HUTCHMED and its second large molecule drug
candidate to enter clinical studies-
Hong Kong, Shanghai & Florham Park, NJ - Friday, July 15,
2022: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM;
HKEX:13) today announces that it has initiated a Phase I trial in
China of HMPL-A83, an investigational novel IgG4-type humanized
anti-CD47 monoclonal antibody. The first patient received their
first dose on July 15, 2022.
The Phase I trial is a multicenter, open-label study to evaluate
the safety, tolerability, pharmacokinetics and preliminary efficacy
of HMPL-A83 in patients with advanced malignant neoplasms. The
primary endpoints are dose-limiting toxicity (DLT), safety,
tolerability, recommended phase II dose (RP2D) and maximum
tolerated dose (MTD). The secondary endpoints include
pharmacokinetics, pharmacodynamics, immunogenicity and preliminary
efficacy profile. The lead principal investigators are Dr Ye Guo of
Shanghai East Hospital and Dr Yuping Sun of Shandong Cancer
Hospital. Additional details may be found at clinicaltrials.gov,
using identifier NCT05429008.
Dr Weiguo Su, Chief Executive Officer and Chief Scientific
Officer of HUTCHMED, said: "HMPL-A83 marks a new chapter in our
large molecule and immunotherapy exploration. It is our thirteenth
oncology drug candidate to emerge from our innovative in-house
discovery platform and it has significant potential to offer new
combination therapy opportunities with our existing small molecule
portfolio. This approach forms a key part of our multi-pronged
strategy to treat cancer and immunological diseases and we are very
excited to advance HMPL-A83's development."
About HMPL-A83 and CD47
CD47 is a cell surface transmembrane protein that is
ubiquitously expressed on virtually all human cells. The
overexpression of CD47 is reported in a variety of tumors and is
believed to be associated with immune escape from
macrophage-mediated phagocytosis.
HMPL-A83 is an investigational IgG4-type humanized anti-CD47
monoclonal antibody that exhibits high affinity for CD47. HMPL-A83
blocks CD47 binding to Signal regulatory protein (SIRP)
<ALPHA> and disrupts the "do not eat me" signal that cancer
cells use to shield themselves from the immune system.
In preclinical studies, HMPL-A83 demonstrated weak affinity for
red blood cells and no induction of hemagglutination, implying low
risk of anemia. HMPL-A83 also demonstrated a high affinity for CD47
antigen on tumor cells and strong phagocytosis induction of
multiple tumor cells. HMPL-A83 has also demonstrated strong
anti-tumor activity in multiple animal models.
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 4,900 personnel
across all its companies, at the center of which is a team of about
1,800 in oncology/immunology. Since inception it has advanced 13
cancer drug candidates from in-house discovery into clinical
studies around the world, with its first three oncology drugs now
approved and marketed. 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-A83 for patients, its expectations as to whether
any studies on HMPL-A83 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 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-A83, including as a
combination therapy, to meet the primary or secondary endpoint of a
study, to obtain regulatory approval in different jurisdictions and
to gain commercial acceptance after obtaining regulatory approval;
the potential market of HMPL-A83 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
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