RCS - Hutchmed China Ltd - HUTCHMED Initiates Phase I Study of HMPL-760

HUTCHMED (China)Announcement

10/01/2022 07:05

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RNS Number : 8159X  Hutchmed (China) Limited  10 January 2022

Press Release

 

HUTCHMED Initiates Phase I Study of BTK Inhibitor HMPL-760 in Patients with Previously Treated B-Cell Non-Hodgkin Lymphoma in China

 

- HMPL-760 is the eleventh innovative potential oncology drug candidate
discovered in-house by HUTCHMED -

 

- HMPL-760 is HUTCHMED's fifth candidate in clinical development for
hematological malignancies, including amdizalisib and HMPL-523 that also
target the B-cell receptor ("BCR") signaling pathway, and tazemetostat and
HMPL-306 -

 

Hong Kong, Shanghai & Florham Park, NJ - Monday, January 10, 2022:
HUTCHMED (China) Limited ("HUTCHMED (https://www.hutch-med.com/) ")
(Nasdaq/AIM:HCM; HKEX:13) has initiated a Phase I study in China of HMPL-760,
a highly potent, selective, and reversible inhibitor with long target
engagement against Bruton's tyrosine kinase ("BTK"), including wild-type and
C481S-mutated BTK. The first patient received their first dose on January 4,
2022.

 

The clinical study is a multi-center, open-label study to evaluate the safety,
tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary
efficacy profile of HMPL-760. The study is enrolling patients with previously
treated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) or
other types of Non-Hodgkin Lymphoma ("NHL"), including patients treated with a
prior regimen containing a BTK inhibitor, whose disease carries either
wild-type BTK or acquired resistance to first generation BTK inhibitors due to
additional muta-tions to BTK.

 

An initial dose escalation stage to determine the maximum tolerated dose (MTD)
and/or the recommended Phase II dose ("RP2D") is planned, to be followed by a
dose expansion phase where patients will receive HMPL‑760 to further
evaluate the safety, tolerability, and clinical activity at the RP2D.
Approximately 100 patients are expected to be enrolled.

 

HMPL-760 is HUTCHMED's fifth investigational drug candidate targeting
hematological malig-nan-cies in clinical development. Amdizalisib (HMPL-689,
targeting the delta isoform of phospho-inositide 3-kinase or PI3K delta) and
HMPL-523 (targeting spleen tyrosine kinase or Syk) are also being studied in
several Phase II trials against B-cell dominant malignancies. Phase II
registration studies are underway in China for amdizalisib in patients with
follicular lymphoma (FL), for which it has been granted Break-through Therapy
Desig-nation in China, and marginal zone lymphoma (MZL).

 

In addition to the three BCR inhibitors, for hema-to-logical malignancies
HUTCHMED is also develop-ing its in-house discovered drug candidate HMPL-306,
a dual-inhibitor of mutant isocitrate dehydro-genase 1 and 2, and
tazemetostat, a methyl-trans-ferase inhibitor of EZH2 (being devel-oped in
Greater China by HUTCHMED pursuant to a strategic collab-oration with
Epizyme).

 

 

About BTK and Non-Hodgkin Lymphoma

 

BTK is a key component of the B-cell receptor signaling pathway and is an
important regulator of cell prolif-era-tion and cell survival in various
lymphomas. The abnormal activation of B-cell receptor signaling is closely
related to the develop-ment of B-cell type hemato-logical cancers, which
represent approximately 85% of all NHL cases. 1  BTK is considered a validated
target for drugs that aim to treat certain hemato-logical cancers, however
C481S mutation of BTK is a known resistance mechanism for first and second
generation BTK inhibitors. In 2020, approximately 93,000 new cases of NHL are
estimated to have been diagnosed in China.[ (#_edn2) 2] (#_edn2)

 

 

About HMPL-760

 

HMPL-760 is an investigational, highly selective, non-covalent,
third-generation inhibitor of BTK, both wild-type and C481S mutant enzymes,
with pre-clinical data suggesting high target specificity and higher potency
versus first generation BTK inhib-itors. BTK C481S mutation plays an important
role in resistance to certain BTK inhibitors. 3 (, 4 )

 

HMPL-760 is HUTCHMED's eleventh innovative potential oncology drug candidate
to enter clinical develop-ment. HUTCHMED currently retains all rights to
HMPL-760 worldwide.

 

 

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
4,500 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 11 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 informa-tion, 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, includ-ing its expectations regarding
the thera-peutic potential of HMPL-760, amdizalisib, HMPL-523, HMPL-306 and
tazemetostat for patients, its expectations as to whether any studies on
HMPL-760, amdizalisib, HMPL-523, HMPL-306 and tazemetostat 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 uncer-tainties
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-760, amdizalisib,
HMPL-523, HMPL-306 and tazemetostat, including as a combination therapy, to
meet the primary or secondary endpoint of a study, to obtain regulatory
approval in different jurisdic-tions and to gain commercial acceptance after
obtaining regulatory approval; the potential market of HMPL-760, amdizalisib,
HMPL-523, HMPL-306 and tazemetostat  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

 

 

 1   American Cancer Society (2019, January 29). Types of B-cell Lymphoma.
https://www.cancer.org/cancer/non-hodgkin-lymphoma/about/b-cell-lymphoma.html
(https://www.cancer.org/cancer/non-hodgkin-lymphoma/about/b-cell-lymphoma.html)
. Accessed January 5, 2022.

 2  The Global Cancer Observatory, China fact sheet.
https://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf
(https://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf)
.  Accessed November 17, 2021.

 3   Woyach JA, Ruppert AS, Guinn D, et al. BTKC(481S)-Mediated Resistance to
Ibrutinib in Chronic Lymphocytic Leukemia. J Clin Oncol.
2017;35(13):1437-1443. doi:10.1200/JCO.2016.70.2282
(https://doi.org/10.1200/jco.2016.70.2282) .

 4   Woyach JA, Huang Y, Rogers K, et al.  Resistance to Acalabrutinib in
CLL is Mediated Primarily by BTK Mutations. Blood.  2019;134 (Supplement_1):
504.  doi:10.1182/blood-2019-127674
(https://doi.org/10.1182/blood-2019-127674) .

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