ASLAN Pharmaceuticals’ Varlitinib Selected by Leading Korean Gastric Cancer Group for Study in Second-Line Gastric Cancer
10 Mai 2019 - 10:15AM
ASLAN Pharmaceuticals (Nasdaq:ASLN, TPEx:6497), a clinical-stage
oncology and immunology focused biopharma company, today
announced that it has signed an agreement with the Korean
Cancer Diagnosis & Treatment Enterprise (K-MASTER) to
investigate varlitinib in a phase 1b/2 multi-centre umbrella study
to evaluate the safety and efficacy of varlitinib in combination
with weekly paclitaxel as a second-line treatment in HER1/HER2
co-expressing advanced or metastatic gastric cancer patients.
K-MASTER, operated by Korea University, is funded by the South
Korean government to support three key goals: genomic sequencing of
cancers, clinical trials for South Korean cancer patients, and the
development of a cancer genomics database. K-MASTER is already
involved in 16 clinical trials, which include testing new drugs
targeted at specific cancer mutations.
The two-part, phase 1b/2, open label, multi-centre study will
recruit approximately 400 patients, divided between four
experimental arms and a common control arm based on biomarker
profiling. Patients that are HER1/HER2 co-expressing will receive
varlitinib in combination with weekly paclitaxel. Other arms will
test PD1 and PI3K-beta inhibitors. The study, led by Professor Sun
Young Rha of the Yonsei Cancer Center, will be conducted in up to
10 sites in South Korea.
The primary objective of the phase 1b study is to determine the
maximum tolerated dose and the recommended phase 2 dose of the
varlitinib and paclitaxel combination. The phase 2 part of the
study will evaluate the treatment effect of the varlitinib and
paclitaxel combination on progression free survival (PFS) in
subjects with HER1 and HER2 co-expression in advanced or metastatic
gastric cancer. ASLAN has previously conducted studies of
varlitinib in first-line gastric cancer patients where there was a
trend towards a clinical benefit in patients treated with
varlitinib.
Dr Chih-Yi Hsieh, Chief Medical Officer of ASLAN
Pharmaceuticals, said: “The current prognosis of
patients with advanced gastric cancer remains poor, even in
countries like Korea where screening is widely performed. There is
a clear need for new therapeutic agents to improve treatment
outcomes and the survival of patients. Varlitinib is a potent
inhibitor of HER1 and HER2, which are often over-expressed in
gastric cancer, and we are delighted that it has been identified by
the prestigious K-MASTER group as a promising new treatment for
second-line gastric cancer in this ground breaking study.”
Gastric cancer is the fifth most common cancer worldwide.
Gastric cancer is especially prevalent in Asia, with Asia making up
74.5% of gastric cancer incidences worldwide1. Korea has the
highest age standardised rates in the world2.
Media and IR contacts
Emma
ThompsonSpurwing CommunicationsTel: +65 6340 7287Email:
ASLAN@spurwingcomms.com |
Robert
UhlWestwicke PartnersTel: +1 858 356 5932Email:
robert.uhl@westwicke.com |
About varlitinib (ASLAN001)
Varlitinib (ASLAN001) is a highly potent, oral, reversible,
small molecule pan-HER inhibitor that targets the human epidermal
growth factor receptors HER1, HER2 and HER4. These receptors can be
mutated or overexpressed in many tumours, which can cause excessive
proliferative activity and uncontrolled growth. Therefore, by
inhibiting the activation of the HER receptors, varlitinib could
inhibit proliferation and control tumour growth. Varlitinib has
been granted orphan drug designation in the United States for
gastric cancer and cholangiocarcinoma, a sub-type of biliary tract
cancer, and was awarded orphan drug designation for the treatment
of biliary tract cancer by the Ministry of Food and Drug Safety in
South Korea.
About ASLAN Pharmaceuticals
ASLAN Pharmaceuticals (Nasdaq:ASLN, TPEx:6497) is a
clinical-stage oncology and immunology focused biopharma company
targeting cancers that are both highly prevalent in Asia and orphan
indications in the United States and Europe. ASLAN targets diseases
that are both highly prevalent in Asia and orphan indications in
the United States and Europe. Led by a senior management team with
extensive experience in global and regional development and
commercialisation, ASLAN is headquartered in Singapore and has
offices in Taiwan and China. ASLAN’s clinical portfolio is
comprised of three product candidates which target validated growth
pathways applied to new patient segments, novel immune checkpoints
and novel cancer metabolic pathways. ASLAN’s partners include Array
BioPharma, Bristol-Myers Squibb, Almirall and CSL. For additional
information please visit www.aslanpharma.com.
Forward looking statements
This release and the accompanying financial information, if any,
contains forward-looking statements. These statements are based on
the current beliefs and expectations of the management of ASLAN
Pharmaceuticals Limited and/or its affiliates (the "Company").
These forward-looking statements may include, but are not limited
to, statements regarding the timing, scope, progress and outcome of
the phase 1b/2 umbrella study testing varlitinib as a second-line
treatment in HER1/HER2 co-expressing advanced or metastatic gastric
cancer patients, the Company’s business strategy, the Company’s
plans to develop and commercialise its product candidates, the
safety and efficacy of the Company’s product candidates, the
Company’s plans and expected timing with respect to regulatory
filings and approvals, and the size and growth potential of the
markets for the Company’s product candidates. The Company’s
estimates, projections and other forward-looking statements are
based on management's current assumptions and expectations of
future events and trends, which affect or may affect the Company’s
business, strategy, operations or financial performance, and
inherently involve significant known and unknown risks and
uncertainties. Actual results and the timing of events could differ
materially from those anticipated in such forward-looking
statements as a result of these risks and uncertainties, which
include, without limitation the risk factors described in the
Company’s US Securities and Exchange Commission filings and reports
(Commission File No. 001-38475), including the Company’s Annual
Report on Form 20-F for the year ended December 31, 2018 filed with
the US Securities and Exchange Commission on April 29,
2019.
All statements other than statements of historical fact are
forward-looking statements. The words “believe,” “may,” “might,”
“could,” “will,” “aim,” “estimate,” “continue,” “anticipate,”
“intend,” “expect,” “plan,” or the negative of those terms, and
similar expressions that convey uncertainty of future events or
outcomes are intended to identify estimates, projections and other
forward-looking statements. Estimates, projections and other
forward-looking statements speak only as of the date they were
made, and, except to the extent required by law, the Company
undertakes no obligation to update or review any estimate,
projection or forward-looking statement.
___________________________________1
http://gco.iarc.fr/today/data/factsheets/cancers/7-Stomach-fact-sheet.pdf2
http://gco.iarc.fr/today/online-analysis-table?v=2018&mode=population&mode_population=countries&population=900&populations=900&key=asr&sex=0&cancer=7&type=0&statistic=5&prevalence=0&population_group=0&ages_group%5B%5D=0&ages_group%5B%5D=17&nb_items=5&group_cancer=1&include_nmsc=1&include_nmsc_other=1
ASLAN Pharmaceuticals (NASDAQ:ASLN)
Historical Stock Chart
Von Jun 2024 bis Jul 2024
ASLAN Pharmaceuticals (NASDAQ:ASLN)
Historical Stock Chart
Von Jul 2023 bis Jul 2024