RCS - Hutchmed China Ltd - Presentations at AACR Annual Meeting 2023

HUTCHMED (China)Announcement

12/04/2023 07:00

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RNS Number : 8540V  Hutchmed (China) Limited  12 April 2023

Press Release

 

HUTCHMED Highlights Presentations at American Association for Cancer Research Annual Meeting 2023

 

Hong Kong, Shanghai & Florham Park, NJ - Wednesday, April 12, 2023:
HUTCHMED (China) Limited ("HUTCHMED (https://www.hutch-med.com/) ")
(Nasdaq/AIM: HCM, HKEX: 13) today announces that new and updated clinical and
non-clinical data related to five HUTCHMED investigational drug candidates
will be presented during the American Association for Cancer Research Annual
Meeting 2023 (AACR 2023), which will take place from April 14 to 19, 2023 in
Orlando, Florida.

 

Savolitinib
 Title:           A multicenter Phase II study of savolitinib in patients with MET-amplified
                  gastroesophageal junction adenocarcinomas or gastric cancer
 Lead Author:     Lin Shen, MD, Peking University Cancer Hospital & Institute
 Type:            Poster presentation
 Session Number:  PO.CT02.01 - Phase II Clinical Trials 1
 Abstract Link:   https://www.abstractsonline.com/pp8/#!/10828/presentation/10376
                  (https://www.abstractsonline.com/pp8/#!/10828/presentation/10376)

 Title:           Baseline and on-treatment plasma-based genomics as a predictor of outcome in
                  SAVANNAH: Savolitinib + osimertinib in EGFRm MET overexpressed/amplified NSCLC
                  post-osimertinib
 Lead Author:     Ryan J Hartmaier, Ph.D, AstraZeneca
 Type:            Poster presentation
 Session Number:  LB294/7
 Abstract Link:   https://www.abstractsonline.com/pp8/#!/10828/presentation/9996
                  (https://www.abstractsonline.com/pp8/#!/10828/presentation/9996)

 

Mesenchymal epithelial transition factor ("MET") gene amplification is
associated with poor prognosis in gastric cancer ("GC") and gastroesophageal
junction adenocarcinomas ("GEJ"). Savolitinib is a potent and highly selective
oral MET tyrosine-kinase inhibitor.

 

Here we reported the preliminary efficacy and safety data from a Phase II
trial of savolitinib monotherapy in patients with MET-amplified advanced or
metastatic GC/GEJ (NCT04923932
(https://clinicaltrials.gov/ct2/show/NCT04923932) ). Additionally, utility of
plasma-based genomics was investigated in the SAVANNAH Phase II trial of
savolitinib in addition to osimertinib in epidermal growth factor receptor
(EGFR) mutated, MET overexpressed/amplified non-small cell lung cancer
("NSCLC") post osimertinib. First presentation of the SAVANNAH results
occurred at the International Association for the Study of Lung Cancer (IASLC)
2022 World Conference on Lung Cancer (WCLC) in August 2022
(https://www.hutch-med.com/savannah-study-wclc2022/) .

 

Surufatinib
 Title:           Surufatinib plus toripalimab for first-line treatment of advanced non-small
                  cell lung cancer (NSCLC) with PD-L1 positive expression: A multicenter,
                  single-arm phase 2 study
 Lead Author:     Ying Cheng, MD, Jilin Cancer Hospital
 Type:            Poster presentation
 Session Number:  PO.CT02.02 - Phase II Clinical Trials 2
 Abstract Link:   https://www.abstractsonline.com/pp8/#!/10828/presentation/10405
                  (https://www.abstractsonline.com/pp8/#!/10828/presentation/10405)

 

Surufatinib (a small-molecule inhibitor of vascular endothelial growth factor
receptor ("VEGFR") 1-3, fibroblast growth factor receptor ("FGFR") 1 and
colony-stimulating factor 1 receptor ("CSF-1R")) plus toripalimab (an
anti-programmed cell death protein-1 ("PD-1") antibody) showed encouraging
antitumor activity in solid tumors. Programmed death ligand 1 ("PD-L1")
expression is the established biomarker for first-line immune checkpoint
inhibitors therapy in advanced NSCLC. We conducted an open-label,
multi-cohort, single-arm Phase II study to evaluate the safety and efficacy of
surufatinib plus toripalimab in patients with advanced solid tumors. Here, we
reported the results of advanced NSCLC with PD-L1 positive expression cohort
(NCT04169672 (https://www.clinicaltrials.gov/ct2/show/NCT04169672) ).

 

HMPL-760
 Title:           HMPL-760 is a highly potent and selective reversible BTK inhibitor, targeting
                  BTK and BTK(C481S) in B-cell malignancies
 Lead Author:     Linfang Wang, HUTCHMED
 Type:            Poster presentation
 Session Number:  PO.ET09.07 - Tyrosine Kinase and Phosphatase Inhibitors 1
 Abstract Link:   https://www.abstractsonline.com/pp8/#!/10828/presentation/6728

                (https://www.abstractsonline.com/pp8/#!/10828/presentation/6728)

Bruton's tyrosine kinase ("BTK"), a member of the Tec family, plays a crucial
role in signaling through B-cell receptor ("BCR"). BTK inhibition blocks BCR
signals and prevents B-cell activation and growth. First-generation BTK
inhibitors such as ibrutinib covalently binds to a cysteine residue ("C481")
of BTK. Their most frequent acquired resistance is the development of a serine
mutation in the binding site ("C481S"). Next generation BTK inhibitors such as
HMPL-760 aim to overcome this resistance to first-generation inhibitors.

 

The poster outlined preclinical data showing HMPL-760 is a reversible,
selective, highly potent BTK inhibitor targeting both BTK(WT) and BTK(C481S).
The first-in-human Phase I clinical trials of HMPL-760 are under way in
patients with relapsed/refractory B-Cell Non-Hodgkin's Lymphoma (NCT05190068
(https://clinicaltrials.gov/ct2/show/NCT05190068) ).

 

HMPL-306
 Title:           Preclinical characteristic of HMPL-306, a CNS-penetrable dual inhibitor of
                  mutant IDH1 and IDH2
 Lead Author:     Na Yang, HUTCHMED
 Type:            Poster presentation
 Session Number:  PO.ET01.01 - Oncogenes and Tumor Suppressor Genes as Targets for Therapy 1
 Abstract Link:   https://www.abstractsonline.com/pp8/#!/10828/presentation/8579

                (https://www.abstractsonline.com/pp8/#!/10828/presentation/8579)

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 ("mIDHs") cause accumulated
2-hydroxyglutarate, leading to blockage of cell differentiation, thereby
inducing malignant transformation. Rare cases were identified carrying
co-existing mutations in IDH1 and IDH2. mIDH 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. Thus,
simultaneous inhibition on both mIDH1 and mIDH2 may be a promising strategy to
overcome resistance and improve clinical efficacy. HMPL-306, a dual inhibitor
of mIDH1/mIDH2, developed by HUTCHMED, 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) ).

 

The poster outlines preclinical data that shows that HMPL-306 is a potent,
durable, dual inhibitor of IDH1/2 mutation that crosses the blood brain
barrier and demonstrated effect on pharmacodynamic markers that lead to the
differentiation of immature malignant cells to mature normal cells. The strong
activity and favorable pharmacokinetics profiles support further clinical
evaluation.

 

HMPL-453
 Title:           HMPL-453, a highly selective inhibitor of fibroblast growth factor receptors
                  1, 2, and 3, displays potent activity in FGFR-altered tumor models
 Lead Author:     Jia Hu, HUTCHMED
 Type:            Poster presentation
 Session Number:  PO.ET01.07 - Growth Factor Receptors as Therapeutic Targets
 Abstract Link:   https://www.abstractsonline.com/pp8/#!/10828/presentation/8706

                (https://www.abstractsonline.com/pp8/#!/10828/presentation/8706)

 

Fibroblast growth factors ("FGFs") and their receptors ("FGFRs") regulate
numerous cellular processes. Dysregulation of FGFR signaling due to receptor
fusion, mutation or amplification is observed across multiple cancer types,
making activated FGFRs an important therapeutic target. Herein, we presented
the preclinical characterization of HMPL-453, a highly potent and selective
inhibitor of FGFR1, 2, and 3, discovered and being currently developed in
Phase II clinical trial (NCT04353375
(https://clinicaltrials.gov/ct2/show/NCT04353375) ) by HUTCHMED.

 

The presentation outlines preclinical data that shows that HMPL-453 is a
highly potent and selective inhibitor of FGFR 1, 2, and 3 with strong activity
against FGFR-deregulated tumors in preclinical models, supporting continued
investigation in patients with FGFR alterations (such as fusion and mutation)
either as a single agent or in combination with PD-1 blockade.

 

About Savolitinib (ORPATHYS(®) in China)

Savolitinib is an oral, potent and highly selective MET tyrosine kinase
inhibitor that has demonstrated clinical activity in advanced solid tumors.
Іt blocks atypical activation of the MET receptor tyrosine kinase pathway
that occurs because of mutations (such as exon 14 skipping alterations or
other point mutations), gene amplification or protein overexpression.

 

Іn 2011, AstraZeneca and HUTCHMED entered a global licensing and
collaboration agreement to jointly develop and commercialize savolitinib.
Joint development of savolitinib in China is led by HUTCHMED, while
AstraZeneca leads development outside of China. HUTCHMED is responsible for
the marketing authorization, manufacturing and supply of savolitinib in China.
AstraZeneca is responsible for the commercialization of savolitinib in China
and worldwide. Sales of savolitinib are recognized by AstraZeneca.

 

About Surufatinib (SULANDA(®) in China)

Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively
inhibits the tyrosine kinase activity associated with VEGFR and FGFR, which
both inhibit angiogenesis, and CSF-1R, which regulates tumor-associated
macrophages, promoting the body's immune response against tumor cells. Its
unique dual mechanism of action may be very suitable for possible combinations
with other immunotherapies, where there may be synergistic anti-tumor effects.

 

HUTCHMED currently retains all rights to surufatinib worldwide.

 

About HMPL-760

HMPL-760 is an investigational, non-covalent, third-generation BTK inhibitor.
It is a highly potent, selective, and reversible inhibitor against both
wild-type and C481S-mutated BTK.

 

HUTCHMED currently retains all rights to HMPL-760 worldwide.

 

About HMPL-306

HMPL-306 is a novel dual-inhibitor of ꞮDH1 and ꞮDH2 enzymes. ꞮDH1 and
ꞮDH2 mutations have been implicated as drivers of certain hematological
malignancies, gliomas and solid tumors, particularly among acute myeloid
leukemia patients.

 

HUTCHMED currently retains all rights to HMPL-306 worldwide.

 

About HMPL-453

HMPL‑453 is a novel, highly selective and potent inhibitor targeting FGFR 1,
2 and 3. Aberrant FGFR signaling has been found to be a driving force in
tumor growth (through tissue growth and repair), promotion of angiogenesis and
resistance to anti-tumor therapies.  Abnormal FGFR gene alterations are
believed to be the drivers of tumor cell proliferation in several solid tumor
settings.

 

HUTCHMED currently retains all rights to HMPL-453 worldwide.

 

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 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 (http://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, includ-ing its expectations regarding
the thera-peutic potential of savolitinib, surufatinib, HMPL-760, HMPL-306 and
HMPL-453, the further clinical develop-ment for savolitinib, surufatinib,
HMPL-760, HMPL-306 and HMPL-453, its expectations as to whether any studies on
savolitinib and HMPL-453 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 savolitinib, surufatinib, HMPL-760, HMPL-306 and HMPL-453,
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 savolitinib, surufatinib, HMPL-760, HMPL-306 and HMPL-453 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,                             +1 (917) 570 7340 (Mobile)

Solebury Strategic Communications                 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,                                    +852 9783 6894 (Mobile)

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

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

 

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