Hutchison China Meditech Limited Chi-Med Initiates HMPL-306 Phase I Trial in China
July 24 2020 - 2:00AM
RNS Non-Regulatory
TIDMHCM
Hutchison China Meditech Limited
24 July 2020
Press Release
Chi-Med Initiates a Phase I Trial of IDH1/2 Dual Inhibitor in
Patients with Hematological Malignancies in China
- HMPL-306 is the ninth innovative oncology drug candidate
discovered in house by Chi-Med -
Hong Kong, Shanghai & Florham Park, NJ: Friday, July 24,
2020: Hutchison China MediTech Limited ("Chi-Med") (Nasdaq/AIM:
HCM) has initiated a Phase I study of HMPL-306, its novel selective
small molecule dual inhibitor of isocitrate dehydrogenase ("IDH") 1
and 2 mutations, in patients with hematological malignancies in
China. The first patient was dosed today .
This is a multi-center study to evaluate the safety,
pharmacokinetics, pharmacodynamics and efficacy of HMPL--306 in
patients of relapsed or refractory hematological malignancies with
an IDH1 and/or IDH2 mutation. The first stage of the study is a
dose escalation phase where cohorts of patients will receive
ascending oral doses of HMPL--306 to determine the maximum
tolerated dose and/or the recommended Phase II dose ("RP2D"). The
second stage of the study is a dose expansion phase where three
cohorts of patients will receive HMPL--306 to further evaluate the
safety, tolerability, and clinical activity at the RP2D. Additional
details may be found at clinicaltrials.gov, using identifier
NCT04272957.
HMPL-306 is Chi-Med's ninth innovative oncology asset discovered
in house. 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. By targeting
both IDH1 and IDH2 mutations, this drug candidate may provide
therapeutic benefits in cancer patients harboring IDH mutations,
and may address acquired resistance to IDH inhibition through
isoform switching.
About IDH and Hematological Malignancies
IDHs are critical metabolic enzymes that help to break down
nutrients and generate energy for cells. When mutated, IDH creates
a molecule that alters the cell's genetic programming and prevents
cells from maturing. IDH1 or IDH2 mutations are common genetic
alterations in various types of blood and solid tumors, including
acute myeloid leukemia ("AML") with approximately 20% of patients
having mutant IDH genes, myelodysplastic syndrome (MDS),
myeloproliferative neoplasms (MPNs), low-grade glioma and
intrahepatic cholangiocarcinoma. Mutant IDH isoform switching,
either from cytoplasmic mutant IDH1 to mitochondrial mutant IDH2,
or vice versa, is a mechanism of acquired resistance to IDH
inhibition in AML and cholangiocarcinoma.[1](,[2],[3])
According to the National Cancer Institute (NCI), there will be
approximately 20,000 new cases of AML in the U.S. in 2020 and the
five-year relative survival rate is 28.7%[4]. Currently, the U.S.
Food and Drug Administration (FDA) has approved one drug for IDH1
mutation and one drug for IDH2 mutation, but no dual inhibitor
targeting both IDH1 and IDH2 mutants has been approved. There were
an estimated 19,700 new cases of AML in China in 2018 and is
estimated to reach 24,200 in China in 2030.[5] In China no IDH
inhibitor has been approved.
About Chi-Med
Chi-Med (Nasdaq/AIM: HCM) is an innovative biopharmaceutical
company committed, over the past twenty years, to the discovery and
global development of targeted therapies and immunotherapies for
the treatment of cancer and immunological diseases. It has a
portfolio of nine cancer drug candidates currently in clinical
studies around the world and extensive commercial infrastructure in
its home market of China. For more information, please visit:
www.chi-med.com.
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 Chi-Med's current expectations regarding future
events, including its expectations for the initiation of clinical
development of HMPL-306 and the potential benefits of HMPL-306 in
patients harboring IDH mutation s. Forward-looking statements
involve risks and uncertainties. Such risks and uncertainties
include, among other things, assumptions regarding clinical trial
enrollment rates, 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 drug candidate HMPL-306 as a
monotherapy or in combinations 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 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 Chi-Med's filings with the U.S. Securities and
Exchange Commission and on AIM. Chi-Med 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 Trout +1 (917) 570 7340 (Mobile)
bmiles@troutgroup.com
Europe - Ben Atwell / Alex Shaw, FTI Consulting +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779
545 055 (Mobile)
Chi-Med@fticonsulting.com
Asia - Joseph Chi Lo / Zhou Yi, Brunswick +852 9850 5033 (Mobile), jlo@brunswickgroup.com / +852 97
83 6894 (Mobile), y zhou@brunswickgroup.com
Nominated Advisor
Freddy Crossley / Atholl Tweedie, Panmure Gordon (UK)
Limited +44 (20) 7886 2500
[1] S Choe S et al. Blood 2019;134(Supplement_1):545. doi:10.1182/blood-2019-122671.
[2] Harding JJ et al. Isoform Switching as a Mechanism of
Acquired Resistance to Mutant Isocitrate Dehydrogenase Inhibition.
Cancer Discov. 2018;8(12):1540-1547.
doi:10.1158/2159-8290.CD-18-0877.
[3] Delahousse J et al. Circulating oncometabolite
D-2-hydroxyglutarate enantiomer is a surrogate marker of isocitrate
dehydrogenase-mutated intrahepatic cholangiocarcinomas. Eur J
Cancer. 2018;90:83-91. doi:10.1016/j.ejca.2017.11.024.
[4] Source: National Cancer Institute - seer.cancer.gov/statfacts/html/amyl.html.
[5] Lin J et al. IDH1 and IDH2 mutation analysis in Chinese
patients with acute myeloid leukemia and myelodysplastic syndrome.
Ann Hematol. 2012;91(4):519-525. doi:10.1007/s00277-011-1352-7.
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END
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