RCS - Hutchmed China Ltd - HUTCHMED Initiates Phase I Trial of HMPL-A83

HUTCHMED (China)Announcement

15/07/2022 09:30

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RNS Number : 6350S  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 (https://www.hutch-med.com/) ") (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
(https://clinicaltrials.gov/ct2/show/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) α 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 (https://www.hutch-med.com/) or
follow us on LinkedIn (https://www.linkedin.com/company/hutchmed/) .

 

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 (mailto:bmiles@troutgroup.com)
 Europe - Ben Atwell / Alex Shaw,   +44 20 3727 1030 / +44 7771 913 902 (Mobile) /

FTI Consulting                    +44 7779 545 055 (Mobile)
                                    HUTCHMED@fticonsulting.com (mailto:HUTCHMED@fticonsulting.com)
 Asia - Zhou Yi,                    +852 9783 6894 (Mobile)

Brunswick                         HUTCHMED@brunswickgroup.com (mailto:HUTCHMED@brunswickgroup.com)

 Nominated Advisor
 Atholl Tweedie / Freddy Crossley,  +44 (20) 7886 2500

Panmure Gordon (UK) Limited

 

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