TIDMHCM
Hutchmed (China) Limited
10 October 2022
Press Release
HUTCHMED Initiates a Phase II/III Trial of Sovleplenib for Warm
Antibody Autoimmune Hemolytic Anemia in China
Hong Kong, Shanghai & Florham Park, NJ - Monday, October 10,
2022: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM;
HKEX:13) today announces that it has initiated a Phase II/III trial
of sovleplenib in adult patients with warm antibody autoimmune
hemolytic anemia ("wAIHA") in China. wAIHA is an autoimmune
disorder that can lead to anemia and has limited treatment options.
The first patient received the first dose on September 30,
2022.
This is a randomized, double blind, placebo-controlled clinical
trial. The Phase II stage of the study is to evaluate the safety
and preliminary efficacy of sovleplenib in adult patients with
wAIHA. If results of the Phase II stage are positive, the Phase III
stage will be initiated to confirm such efficacy and safety. The
primary endpoint for the Phase II study is the proportion of
patients with overall hemoglobin ("Hb") response by Week 24,
whereas the primary endpoint for the Phase III study would be the
proportion of patients who achieve a durable Hb response by Week
24. Approximately 110 patients are expected to be enrolled. The
lead principal investigators are Dr. Liansheng Zhang of Lanzhou
University Second Hospital, Dr. Fengkui Zhang of Chinese Academy of
Medical Sciences Blood Diseases Hospital and Dr. Bing Han of
Chinese Academy of Medical Sciences Peking Union Medical College
Hospital. Additional details may be found at clinicaltrials.gov,
using identifier NCT05535933.
About Sovleplenib
Sovleplenib is a novel, investigational, selective small
molecule inhibitor for oral administration targeting the spleen
tyrosine kinase, also known as Syk. Syk is a major component in
B-cell receptor and Fc 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 sovleplenib worldwide.
In addition to wAIHA, sovleplenib is also being studied in immune
thrombocytopenia (NCT05029635), indolent non-Hodgkin's lymphoma and
multiple subtypes of B-cell malignancies in China, the U.S. and
Europe (NCT02857998; NCT03779113).
About wAIHA and Syk
AIHA is an autoimmune disorder characterized by the destruction
of red blood cells ("RBCs") due to the production of antibodies
against RBC. The incidence of AIHA is estimated to be
0.8-3.0/100,000 adults per year with an estimated prevalence of 17
per 100,000 adults and a death rate of 8%-11%. [1] [2] wAIHA is the
most common of the autoimmune hemolytic diseases, [3] accounting
for about 75-80% of all adult AIHA cases. [4]
The accelerated clearance of antibody-coated RBCs by
immunoglobulin Fc receptor ("FcR") bearing macrophages is thought
to be the pathogenic mechanism in wAIHA. [5] Activation of the FcR
is associated with a signaling subunit, FcR<GAMMA>, whose
phosphorylation subsequent to receptor binding results in the
recruitment and activation of Syk. [6] Activated Syk mediates
downstream signaling of the activated FcRs in phagocytic cells,
resulting in phagocytosis of RBCs. [7] In addition, activation of
Syk through the B-cell receptor mediates activation and
differentiation of B-lymphocytes into antibody secreting plasma
cells. [8] Therefore, inhibition of Syk may have potential effects
in the treatment of wAIHA through inhibition of phagocytosis and
reduction of antibody production.
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 4,900 personnel across all
its companies, at the center of which is a team of over 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 in China. For more information, please visit:
www.hutch-med.com or follow us on LinkedIn.
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 sovleplenib for patients for the treatment of wAIHA
and other indications, its expectations as to whether any studies
on sovleplenib 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 sovleplenib, 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 sovleplenib 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, Solebury +1 (917) 570 7340 (Mobile)
bmiles@s oleburystrat .com
Europe - Ben Atwell / Alex Shaw, FTI Consulting +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055
(Mobile)
HUTCHMED@fticonsulting.com
Asia - Zhou Yi, Brunswick +852 97 83 6894 (Mobile)
HUTCHMED@brunswickgroup.com
Nominated Advisor
Atholl Tweedie / Freddy Crossley, Panmure Gordon +44 (20) 7886 2500
[1] Eaton WW, Rose NR, Kalaydjian A, Pedersen MG, Mortensen PB.
Epidemiology of autoimmune diseases in Denmark. J Autoimmun. 2007;
29 (1):1-9.
[2] Roumier M, Loustau V, Guillaud C, et al. Characteristics and
outcome of warm autoimmune hemolytic anemia in adults: new insights
based on a single-center experience with 60 patients. Am J Hematol.
2014; 89 (9):E150-5.
[3] Cotran Ramzi S, Kumar Vinay, Fausto Nelson, Nelso Fausto,
Robbins Stanley L, Abbas Abul K. Robbins and Cotran pathologic
basis of disease. St. Louis, Mo: Elsevier Saunders; 2005. p.
637.
[4] Gehrs BC, Friedberg RC. Autoimmune haemolytic anemia. Am J
Hematol. 2002; 69:258-271. doi: 10.1002/ajh.10062.
[5] Barros MM, Blajchman MA, Bordin JO. Warm autoimmune
hemolytic anemia: recent progress in understanding the
immunobiology and the treatment. Transfus Med Rev. 2010;
24(3):195--210. doi: 10.1016/j.tmrv.2010.03.002.
[6] Braselmann S, Taylor V, Zhao H, et al. R406, an orally
available spleen tyrosine kinase inhibitor blocks fc receptor
signaling and reduces immune complex--mediated inflammation. J
Pharmacol Exp Ther. 2006; 319(3):998--1008. doi:
10.1124/jpet.106.109058.
[7] Barcellini W, Fattizzo B, Zaninoni A. Current and emerging
treatment options for autoimmune hemolytic anemia. Expert Rev Clin
Immunol. 2018; 14(10):857--872. doi:
10.1080/1744666x.2018.1521722.
[8] Davidzohn N, Biram A, Stoler--Barak L, Grenov A, Dassa B,
Shulman Z. SYK degradation restrains plasma cell formation and
promotes zonal transitions in germinal centers. J Exp Med. 2020;
217(3):e20191043. doi: 10.1084/jem.20191043.
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