Sinovant Sciences Announces Approval of Derazantinib’s Clinical Trial Application by the China National Medical Products Ad...
April 30 2019 - 4:01PM
Business Wire
Chinese registrational clinical trial for
derazantinib to begin in 2H 2019
ArQule, Inc.’s (Nasdaq: ARQL) partner, Sinovant Sciences,
announced that its Clinical Trial Application (CTA) for
derazantinib has been accepted by the Center for Drug Evaluation at
the China National Medical Products Administration (NMPA), enabling
the initiation of a registrational clinical trial in patients with
second-line intrahepatic cholangiocarcinoma (iCCA) in the second
half of 2019.
“This is an important step forward for derazantinib in China,
where the unmet need in iCCA is particularly acute,” said Peter
Lawrence, President and COO of ArQule. “We are very pleased with
the operational and regulatory progress our partner has made in
this region and look forward to further clinical updates.”
To read the full Sinovant Sciences press release announcing the
approval, click here.
In 2018, ArQule and Sinovant Sciences, entered into a licensing
agreement for derazantinib in China. Under the terms of the
agreement, ArQule granted Sinovant Sciences, a subsidiary of
Roivant Sciences, an exclusive license to develop and commercialize
derazantinib in the People's Republic of China, Hong Kong, Macau
and Taiwan (greater China). In addition to the $3 million upfront
payment and $2.5 million developmental milestone it has already
received, ArQule is eligible for regulatory and commercial
milestones and royalties on future sales of derazantinib in Greater
China.
About ArQuleArQule is a biopharmaceutical company engaged
in the research and development of targeted therapeutics to treat
cancers and rare diseases. ArQule’s mission is to discover, develop
and commercialize novel small molecule drugs in areas of high unmet
need that will dramatically extend and improve the lives of our
patients. Our clinical-stage pipeline consists of four drug
candidates, all of which are in targeted, biomarker-defined patient
populations, making ArQule a leader among companies our size in
precision medicine. ArQule’s pipeline includes: ARQ 531, an orally
bioavailable, potent and reversible dual inhibitor of both wild
type and C481S-mutant BTK, in phase 1 for patients with B-cell
malignancies refractory to other therapeutic options; miransertib
(ARQ 092), a potent and selective inhibitor of the AKT
serine/threonine kinase, planned to initiate registrational trial
cohorts in Proteus syndrome and PROS in 2019, and in phase 1b in
combination with the hormonal therapy, anastrozole, in patients
with advanced endometrial cancer; ARQ 751, a next generation highly
potent and selective AKT inhibitor, in phase 1 for patients with
AKT1 and PI3K mutations; and derazantinib, a multi-kinase inhibitor
designed to preferentially inhibit the fibroblast growth factor
receptor (FGFR) family, in a registrational trial for iCCA in
collaboration with Basilea and Sinovant. ArQule’s current discovery
efforts are focused on the identification and development of novel
kinase inhibitors, leveraging the Company’s proprietary library of
compounds.
About DerazantinibDerazantinib is a potent, orally
administered inhibitor of the fibroblast growth factor receptor
(FGFR) family, a key driver of cell proliferation, differentiation,
and migration. In a phase 1/2 study in patients with iCCA harboring
FGFR2 gene fusions, treatment with derazantinib resulted in an
objective response rate of 21%, nearly 3 times higher than
standard-of-care chemotherapy.
About Intrahepatic CholangiocarcinomaCholangiocarcinoma
(CCA) is the most common biliary malignancy and the second most
common malignancy in the liver after hepatocellular carcinoma
(HCC).1 Depending on the anatomic location, CCA is classified as
intrahepatic (iCCA), perihilar (pCCA), and extrahepatic (eCCA).
iCCA originates from the intrahepatic biliary ductal system and
forms an intrahepatic mass. iCCA is an aggressive cancer, with a
median 5-year survival rate of only 15% for patients diagnosed with
early-stage disease.2 Reports show that in China's most populous
cities the incidence of cholangiocarcinoma is more than 7 cases per
100,000 people, and a majority of cases are intrahepatic.3
About SinovantSinovant is a Chinese biopharmaceutical
company dedicated to conducting globally innovative biomedical
R&D in China to meet the needs of patients in Greater China and
around the world. Sinovant's mission is to develop and
commercialize new medicines that address the most pressing public
health challenges in China while simultaneously advancing Chinese
biopharmaceutical research abroad. For further information, please
visit www.sinovant.com.
Forward Looking StatementsThis press release contains
forward-looking statements regarding clinical trials with
derazantinib under the Company’s license agreement with Sinovant
Sciences. These statements are based on the Company’s current
beliefs and expectations and are subject to risks and uncertainties
that could cause actual results to differ materially. Positive
information from early stage clinical trials does not ensure that
later stage or larger scale clinical trials will be successful. The
results achieved in later stage trials may not be sufficient to
meet applicable regulatory standards or to justify further
development. In addition, derazantinib may not demonstrate an
acceptable safety profile in current or later stage or larger scale
clinical trials as a result of known or as yet unanticipated side
effects. Problems or delays may arise during clinical trials or in
the course of developing, testing or manufacturing derazantinib
that could lead the Company or Sinovant Sciences to delay or
discontinue its development. Even if later stage clinical trials
are successful, unexpected concerns may arise from subsequent
analysis of data or from additional data. Regulatory authorities
may disagree with the Company’s or Sinovant Sciences’ view of the
data or require additional data or information or additional
studies. If derazantinib is not successfully developed and as a
result of any of the foregoing or other issues, risks or
uncertainties, the Company may not receive future
milestones or royalties under the license agreement. For more
detailed information on the risks and uncertainties associated with
the Company’s drug development and other activities, see the
Company’s periodic reports filed with the Securities and
Exchange Commission. The Company does not undertake any obligation
to publicly update any forward-looking statements.
1 Welzel TM, et al. Impact of classification of hilar
cholangiocarcinomas (Klatskin tumors) on the incidence of intra-
and extrahepatic cholangiocarcinoma in the United States. Journal
of the National Cancer Institute 2006; 98(12), 873-875.2American
Cancer Society3 Banales JM, et al. Cholangiocarcinoma: current
knowledge and future perspectives consensus statement from the
European Network for the Study of Cholangiocarcinoma (ENS-CCA).
Nature Reviews: Gastroenterology & Hepatology 2016; 13,
261-280.
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version on businesswire.com: https://www.businesswire.com/news/home/20190430006164/en/
Corporate Contact:Kathleen FarrenInvestor Relations
&Executive Assistant to the CFOir@arqule.com
Media Contact:Cait Williamson, Ph.D.LifeSci Public
Relations(646) 751-4366cait@lifescipublicrelations.com
www.ArQule.com
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