RCS - Hutchmed China Ltd - HUTCHMED Highlights Presentations at EHA and ICML

HUTCHMED (China)Announcement

09/06/2023 10:30

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RNS Number : 2466C  Hutchmed (China) Limited  09 June 2023

Press Release

 

HUTCHMED Highlights Presentations for Hematological Malignancy Programs at the 2023 EHA and ICML Meetings

 

Hong Kong, Shanghai & Florham Park, NJ - Friday, June 9, 2023: HUTCHMED
(China) Limited ("HUTCHMED (https://www.hutch-med.com/) ") (Nasdaq/AIM:HCM;
HKEX:13) today announces that new and updated clinical data related to two
novel investigational hematological malignancy therapies, HMPL-306 and
amdizalisib, will be presented at the upcoming European Hematology Association
("EHA") Annual Meeting, taking place June 8-11, 2023 in Frankfurt, and the
17(th) International Conference on Malignant Lymphoma ("ICML") taking place
June 13-17, 2023 in Lugano.

 

HMPL-306: first in human results
 Title:                  A phase 1 study of HMPL-306, a dual inhibitor of mutant isocitrate
                         dehydrogenase (IDH) 1 and 2, in pts with relapsed/refractory myeloid
                         hematological malignancies harboring IDH1 and/or 2 mutations
 Lead Author:            Lijuan Hu, MD, Peking University People's Hospital
 Meeting:                EHA poster presentation
 Session:                Myeloproliferative neoplasms - Clinical
 Abstract # & Link:      Abstract #P539
                         (https://library.ehaweb.org/eha/2023/eha2023-congress/386368/lijuan.hu.a.phase.1.study.of.hmpl-306.a.dual.inhibitor.of.mutant.isocitrate.html?f=listing%3D0%2Abrowseby%3D8%2Asortby%3D1%2Ac_id%3D386368)

 

Mutations in isocitrate dehydrogenase ("IDH") 1/2 are frequently identified in
various cancers, such as acute myeloid leukemia ("AML"), cholangiocarcinoma,
chondrosarcoma and glioma. Mutant IDHs cause accumulated 2-hydroxyglutarate,
leading to blockage of cell differentiation, thereby inducing malignant
transformation. Mutant IDH isoform switching, from mutant IDH1 to mutant IDH2
and vice versa, have been reported as a mechanism of acquired resistance to
IDH inhibition in AML and cholangiocarcinoma, as well as cases initially
carrying co-existing mutations.

 

Preclinical data
(https://www.abstractsonline.com/pp8/#!/10828/presentation/8579) presented at
the American Association for Cancer Research Annual Meeting 2023 (AACR 2023)
demonstrated that HMPL-306 is a potent, durable, dual inhibitor of IDH1/2
mutation that crosses the blood brain barrier and affects pharmacodynamic
("PD") markers that lead to the differentiation of immature malignant cells to
mature normal cells. It is being evaluated in clinical trials (NCT04272957
(https://clinicaltrials.gov/ct2/show/NCT04272957) , NCT04762602
(https://clinicaltrials.gov/ct2/show/NCT04762602) , NCT04764474
(https://clinicaltrials.gov/ct2/show/NCT04764474) ).

 

This first-in-human, dose-escalation study data presents HMPL-306 in patients
with relapsed/refractory myeloid hematological malignancies harboring IDH1
and/or IDH2 mutations. Based on PD, pharmaco-kinetic ("PK"), and preliminary
clinical findings, a recommended Phase II dose was nominated for the dose
expansion phase of the study.

 

Amdizalisib: updates from Phase Ib
 Title:        Updated results from a phase 1b study of amdizalisib, a novel inhibitor of
               phospho-inositide 3-kinase-delta (PI3Kδ), in patients with relapsed or
               refractory lymphoma
 Lead Author:  Junning Cao, MD, Fudan University Shanghai Cancer Center
 Meeting:      ICML Publication
 Session:      Phase I-II trials
 Abstract #:   Abstract #653
               (https://www.icml.ch/icml/17th-icml-redirect/general-information-on-site.html)

 

Amdizalisib (HMPL-689) is a novel, selective and potent oral inhibitor
targeting the isoform PI3Kδ. Amdizalisib's PK properties are favorable with
good oral absorption, moderate tissue distribution and low clearance in
preclinical PK studies, suggesting a low risk of drug accumulation and
drug-to-drug interaction. Because of its high target selectivity and optimal
PK profile, amdizalisib has the potential to demonstrate an optimal
benefit-risk profile in this class.  Amdizalisib is currently being evaluated
in a Phase II registration trial in relapsed or refractory follicular lymphoma
("FL") and marginal zone lymphoma ("MZL") as a single agent (NCT04849351
(https://clinicaltrials.gov/ct2/show/NCT04849351) ), as well as in combination
with tazemetostat (a methyl-trans-ferase inhibitor of EZH2) in patients with
relapsed or refractory lymphoma in a Phase II study in China (NCT05713110
(https://clinicaltrials.gov/ct2/show/NCT05713110) ).

 

Here we report updated results from a Phase Ib study of amdizalisib in
patients with various subtypes of non‑Hodgkin's lymphoma ("NHL"). In this
update, more mature data were available from the FL cohorts, at median
follow-up duration of 22.1 months. Median duration of response ("DoR") and
progression free survival ("PFS") were not reached for the 26 efficacy
evaluable patients in the FL cohort. PFS and DoR from the MZL cohort were
presented for the first time, at median follow-up duration of 20.3 months.
Median DoR was not reached and median PFS was 26.8 months for the 16 efficacy
evaluable patients in the MZL cohort. Safety data were reported from 153
patients with median exposure duration of 8.7 months. The most common
treatment emergent adverse events (TEAEs) of Grade ≥3 (≥5%) were pneumonia
(15.7%), neutrophil count decreased (12.4%), lipase increased (7.8%), and rash
(5.9%). The treatment discontinuation rate due to adverse events was 11.8%.

 

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 approximately
5,000 personnel across all its companies, at the center of which is a team of
about 1,800 in oncology/immunology. Since inception it has focused on bringing
cancer drug candidates from in-house discovery to patients 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-306 and amdizalisib, the further clinical
development for HMPL-306 and amdizalisib, its expectations as to whether any
studies on HMPL-306 and amdizalisib 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-306 and amdizalisib, 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-306 and amdizalisib 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) 306 4490

 Media Enquiries
 Americas - Brad Miles, Solebury Strategic Communications         +1 (917) 570 7340 (Mobile) / bmiles@s (mailto:bmiles@soleburystrat.com)
                                                                  oleburystrat (mailto:bmiles@soleburystrat.com) .com
                                                                  (mailto:bmiles@soleburystrat.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, Brunswick                                        +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
                                                                  (mailto:HUTCHMED@brunswickgroup.com)

 Nominated Advisor
 Atholl Tweedie / Freddy Crossley / Daphne Zhang, Panmure Gordon  +44 (20) 7886 2500

 

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