RCS - Hutchmed China Ltd - HUTCHMED to Present Clinical Data at ASH

HUTCHMED (China)Announcement

08/11/2021 07:05

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RNS Number : 5336R  Hutchmed (China) Limited  08 November 2021

Press Release

 

HUTCHMED Highlights HMPL-523 Clinical Data to be Presented at the 2021 ASH Annual Meeting

 

 

Hong Kong, Shanghai & Florham Park, NJ - Monday, November 8, 2021:
HUTCHMED (China) Limited ("HUTCHMED (https://www.hutch-med.com/) ")
(Nasdaq/AIM:HCM; HKEX:13) today announces that new analyses and updates on the
ongoing studies of HMPL-523 and HMPL-306 will be presented at the upcoming
63(rd) American Society for Hematology's (ASH) Annual Meeting and Exposition,
taking place on December 11-14, 2021. The meeting will be held virtually and
in person at the Georgia World Congress Center in Atlanta, Georgia US.

 

Further details of the presentations are as follows:

 

HMPL-523 Clinical Data Presentations

 

 Title:            Safety, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Adult
                   Patients with Primary Immune Thrombocytopenia: A Randomized, Double-Blind and
                   Placebo-Controlled Phase Ib Study
 Presenter:        Renchi Yang, MD, Hematology Hospital of the Chinese Academy of Medical
                   Sciences
 Session:          311. Disorders of Platelet Number or Function: Clinical and Epidemiological:
                   Treatment of Immune Thrombocytopenia
 Abstract No.:     149895 (https://ash.confex.com/ash/2021/webprogram/Paper149895.html)
 Date & Time:      Saturday, December 11, 2021 9:30am - 11am ET
 Location:         Georgia World Congress Center, C101 Auditorium and virtually

 

 

 Title:            Preliminary Results from a Phase I Study of HMPL-523, a Selective, Oral Syk
                   Inhibitor, in Patients with Relapsed or Refractory Lymphoma
 Presenter:        Paolo Strati, MD, The University of Texas MD Anderson Cancer Center
 Session:          623. Mantle Cell, Follicular, and Other Indolent B Cell Lymphomas: Clinical
                   and Epidemio-logical: Poster II
 Abstract No.:     2432 (https://ash.confex.com/ash/2021/webprogram/Paper145641.html)
 Date & Time:      Sunday, December 12, 2021 6:00pm - 8:00pm ET
 Location:         Georgia World Congress Center, Hall B5 and virtually

 

 

HMPL-306 (Trial in Progress)

 

 Title:           A Phase I, Open-Label, Multicenter Study of HMPL-306 in Advanced Hematological
                  Malignancies with Isocitrate Dehydrogenase (IDH) Mutations
 Lead Author:     Anu Doraiswamy, MD, Rutgers Cancer Institute of New Jersey
 Session:         616. Acute Myeloid Leukemias: Investigational Therapies, Excluding
                  Transplantation and Cellular Immunotherapies
 Abstract No.:    4438
 Date available:  November supplemental issue of 'Blood'

 

 

About HMPL-523

 

HMPL-523 is a novel, investigational, selective small molecule inhibitor for
oral administration targeting spleen tyrosine kinase, also known as Syk. Syk
is a major component in B-cell receptor signaling and is an established target
for the treatment of multiple subtypes of B-cell lymphomas and autoimmune
disorders.

 

HUTCHMED currently retains all rights to HMPL-523 worldwide. The ESLIM-01
Phase III trial is underway to evaluate the efficacy and safety of HMPL-523 in
treating adult patients with primary immune thrombocytopenia (ITP), an
autoimmune disorder that can lead to increased risk of bleeding. Additional
details may be found at clinicaltrials.gov, using identifier NCT05029635
(https://clinicaltrials.gov/ct2/show/NCT05029635) . HMPL-523 is also being
studied in indolent non-Hodgkin's lymphoma and multiple subtypes of B-cell
malignancies in China (NCT02857998
(https://clinicaltrials.gov/ct2/show/NCT02857998) ), the U.S. and Europe
(NCT03779113 (https://clinicaltrials.gov/ct2/show/NCT03779113) ). A trial to
study HMPL-523 in patients with warm autoimmune hemolytic anemia (wAIHA),
another autoimmune disorder, is also planned.

 

About HMPL-306

 

HMPL-306 is an investigative and selective small molecule inhibitor of IDH1
and IDH2, and the company's sixth novel oncology candidate to enter global
clinical development. IDH1 and IDH2 mutations have been implicated as drivers
of certain hematological malignancies, gliomas and solid tumors, particularly
among acute myeloid leukemia patients. Cytoplasmic mutant IDH1 and
mitochondrial mutant IDH2 have been known to switch to the other form when
targeted by an inhibitor of IDH1 mutant alone or IDH2 mutant alone. Targeting
both IDH1 and IDH2 mutations could potentially provide therapeutic benefits in
cancer patients harboring either IDH mutation, and may address acquired
resistance to IDH inhibition through isoform switching.

 

HUTCHMED currently retains all rights to HMPL-306 worldwide. Phase I studies
have been initiated in patients with hematological malignancies in China
(NCT04272957 (https://clinicaltrials.gov/ct2/show/NCT04272957) ) and the U.S.
and Europe (NCT04764474 (https://clinicaltrials.gov/ct2/show/NCT04764474) ),
and in patients with solid tumors in the U.S. and Europe (NCT04762602
(https://clinicaltrials.gov/ct2/show/NCT04762602) ).

 

About HUTCHMED

 

HUTCHMED (Nasdaq/AIM: HCM; HKEX:13) 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. 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 eleven 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 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-523 and HMPL-306 for patients, its expectations
as to whether any studies on HMPL-523 and HMPL-306 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-523 and HMPL-306, 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-523 and HMPL-306 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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