TIDMHCM
Hutchison China Meditech Limited
03 September 2020
Press Release
Chi-Med Initiates a Phase II Trial of HMPL-453 in Patients with
Advanced Intrahepatic Cholangiocarcinoma in China
Hong Kong, Shanghai, & Florham Park, NJ: Thursday, September
3, 2020: Hutchison China MediTech Limited ("Chi-Med") (Nasdaq/AIM:
HCM) has initiated a Phase II study of HMPL-453, its novel small
molecule inhibitor targeting fibroblast growth factor receptors
("FGFR"), in patients with advanced intrahepatic cholangiocarcinoma
("IHCC"), which is a type of liver cancer.
The clinical study is a single-arm, multi-center, open-label
study, evaluating the efficacy, safety and pharmacokinetics of
HMPL-453 in patients with advanced IHCC with FGFR2 fusion that had
failed at least one line of systemic therapy.
The primary outcome measure is objective response rate (ORR).
Secondary outcome evaluations include preliminary efficacy
measures, such as disease control rate (DCR), time to response
(TTR), duration of response (DoR), progression-free survival (PFS),
and overall survival (OS). Additional details may be found at
clinicaltrials.gov, using identifier NCT04353375.
About IHCC
IHCC is a cancer that develops in the cells within the bile
ducts[1]. With over 390,000 new cases every year, China accounted
almost 50% of the world's annual incidence of liver cancer in
2018.[2](,[3]) After hepatocellular carcinoma ("HCC"), IHCC is the
second most common primary hepatic malignancy accounting for 10% to
20% of newly diagnosed liver cancers[4]. Approximately 10-15% of
IHCC patients have tumors that harbor FGFR2 fusion[5](,[6]) .
Long-term survival for patients with IHCC is worse than for HCC,
which may be related to a high propensity for regional and distant
metastases as well as the lack of effective systemic therapy
options(2) .
About FGFR
FGFRs are a sub--family of receptor tyrosine kinases. Activation
of FGFR signaling pathways is central to several biological
processes. In normal physiology, FGF/FGFR signaling is involved in
embryonic development (organogenesis and morphogenesis), tissue
repair, angiogenesis, neuroendocrine and metabolism homeostasis.
Given its complexity and critical role in a number of important
physiological processes, aberrant FGFR signaling has been found to
be a driving force in tumor growth, promotion of angiogenesis, as
well as conferring resistance to anti--tumor therapies.
About HMPL--453
HMPL--453 is a novel, highly selective and potent small molecule
inhibitor targeting FGFR 1, 2 and 3. In pre--clinical studies,
HMPL--453 demonstrated superior potency and better kinase
selectivity as compared to other drugs in the same class, as well
as a favorable safety profile. Enrollment has been completed for
the dose escalation of the Phase I study of HMPL-453 in China
(clinicaltrials.gov identifier NCT03160833). Enrollment of a Phase
II study is ongoing in patients with advanced malignant
mesothelioma in China (clinicaltrials.gov identifier
NCT04290325).
About Chi-Med
Chi-Med (Nasdaq/AIM: HCM) is an innovative, commercial-stage,
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 clinical development of
HMPL-453, including plans to initiate clinical studies for
HMPL-453, its expectations as to whether such studies 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, 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-453 to meet the primary or secondary endpoint of a
study, to obtain regulatory approval in different jurisdictions, to
gain commercial acceptance after obtaining regulatory approval, the
potential market of HMPL-453 for a targeted indication and the
sufficiency of funding. 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] NIH. Genetic & Rare Diseases Information Center. rarediseases.info.nih.gov/diseases/6042/intrahepatic-cholangiocarcinoma.
[2] Global Cancer Observatory. China Fact Sheet. gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf.
[3] Global Cancer Observatory. Liver Cancer Fact Sheet. gco.iarc.fr/today/data/factsheets/cancers/11-Liver-fact-sheet.pdf.
[4] Epidemiology of Hepatocellular Carcinoma and Intrahepatic Cholangiocarcinoma. Cancer Control. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5937247.
[5] Lowery et al. Comprehensive Molecular Profiling of
Intrahepatic and Extrahepatic Cholangiocarcinomas: Potential
Targets for Intervention. Clin Cancer Res September 1 2018 (24)
(17) 4154-4161. DOI: 10.1158/1078-0432.CCR-18-0078.
[6] Cleary et al. Therapeutic targeting of extracellular FGFR2
activating deletions in intrahepatic cholangiocarcinoma. J Clin
Oncol 38, 2020 (suppl 4; abstr 567). DOI:
10.1200/JCO.2020.38.4_suppl.567.
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