BEIJING, July 20,
2023 /PRNewswire/ -- CASI Pharmaceuticals, Inc.
(Nasdaq: CASI), a biopharmaceutical company focused on developing
and commercializing innovative therapeutics and pharmaceutical
products, today announced the execution of the Assignment Agreement
(the "Agreement") with Cleave Therapeutics, Inc. ("Cleave"),
pursuant to which CASI obtained all rights and global intellectual
property rights related to CB-5339, a novel VCP/p97 inhibitor, as
well as all remaining CB-5339 drug substance and drug product.
Additionally, CASI will assume responsibility of the United States ("US") CB-5339
Investigational New Drug ("IND") application.
CB-5339 is an oral, second-generation, small molecule
valosin-containing protein (VCP)/p97 inhibitor, designed to disrupt
protein homeostasis, DNA damage response and other cellular stress
pathways. In a Phase 1 clinical trial in patients with acute
myeloid leukemia and myelodysplastic syndrome, the drug was well
tolerated in 55 patients and demonstrated signs of clinical
activity. Two patients remain on CB-5339 under compassionate use
protocols at two leading US cancer centers.
Wei-Wu He, Ph.D., CASI's Chairman
and Chief Executive Officer, commented, "CB-5339 is a first in
class small molecule drug candidate that represents a promising
opportunity to selectively target VCP/p97 in various malignancies.
We are encouraged by the early clinical data in the phase 1 study
of CB-5339 in patients with AML and MDS. CB-5339 is a complementary
addition to our growing portfolio of approved and investigational
therapies in oncology."
About Cleave Therapeutics
Cleave was founded in 2011 with scientific co-founders
Raymond Deshaies, PhD, Seth Cohen, PhD, and Francesco Parlati,
PhD. The company has focused on novel biological mechanisms and
pathways in the AAA (ATPases Associated with diverse cellular
Activities) family of ATPases to address unmet needs in oncology
and neurodegeneration. Cleave investors include 5AM Ventures, Bristol-Myers Squibb, Orbimed, U.S.
Venture Partners, Arcus Ventures, Astellas Venture Management, and
Osage University Partners.
About CASI Pharmaceuticals
CASI Pharmaceuticals, Inc. is a biopharmaceutical company
focused on developing and commercializing innovative therapeutics
and pharmaceutical products in China, the United
States, and throughout the world. The Company is focused on
acquiring, developing, and commercializing products that augment
its hematology oncology therapeutic focus as well as other areas of
unmet medical need. The Company intends to execute its plan to
become a leader by launching medicines in the Greater China market, leveraging the Company's
China-based regulatory and
commercial competencies and its global drug development expertise.
The Company's operations in China
are conducted through its wholly owned subsidiary, CASI
Pharmaceuticals (China) Co., Ltd.,
located in Beijing, China. More
information on CASI is available at
www.casipharmaceuticals.com.
Forward-Looking Statements
This announcement contains forward-looking statements. These
statements are made under the "safe harbor" provisions of the U.S.
Private Securities Litigation Reform Act of 1995. These
forward-looking statements can be identified by terminology such as
"will," "expects," "anticipates," "future," "intends," "plans,"
"believes," "estimates," "confident" and similar statements. Among
other things, the business outlook and quotations from management
in this announcement, as well as the Company's strategic and
operational plans, contain forward- looking statements.
The Company may also make written or oral forward-looking
statements in its periodic reports to the U.S. Securities and
Exchange Commission (the "SEC"), in in its annual report to
shareholders, in press releases and other written materials and in
oral statements made by its officers, directors or employees to
third parties. Statements that are not historical facts, including
statements about the Company's beliefs and expectations, are
forward-looking statements.
Forward-looking statements involve inherent risks and
uncertainties. A number of factors could cause actual results to
differ materially from those contained in any forward-looking
statement, including but not limited to the following: the risk
that we may be unable to continue as a going concern as a result of
our inability to raise sufficient capital for our operational
needs; the possibility that we may be delisted from trading on The
Nasdaq Capital Market if we fail to satisfy applicable continued
listing standards; the volatility in the market price of our
ordinary shares; the risk of substantial dilution of existing
shareholders in future share issuances; the difficulty of executing
our business strategy on a global basis including China; our inability to enter into strategic
partnerships for the development, commercialization, manufacturing
and distribution of our proposed product candidates or future
candidates; legal or regulatory developments in China that adversely affect our ability to
operate in China, our lack of
experience in manufacturing products and uncertainty about our
resources and capabilities to do so on a clinical or commercial
scale; risks relating to the commercialization, if any, of our
products and proposed products (such as marketing, safety,
regulatory, patent, product liability, supply, competition and
other risks); our inability to predict when or if our product
candidates will be approved for marketing by the U.S. Food and Drug
Administration, European Medicines Agency, PRC National Medical
Products Administration, or other regulatory authorities; our
inability to enter into strategic partnerships for the development,
commercialization, manufacturing and distribution of our proposed
product candidates or future candidates; the risks relating to the
need for additional capital and the uncertainty of securing
additional funding on favorable terms; the risks associated with
our product candidates, and the risks associated with our other
early-stage products under development; the risk that result in
preclinical and clinical models are not necessarily indicative of
clinical results; uncertainties relating to preclinical and
clinical trials, including delays to the commencement of such
trials; our ability to protect our intellectual property rights;
the lack of success in the clinical development of any of our
products; and our dependence on third parties; the risks related to
our dependence on Juventas to conduct the clinical development of
CNCT19 and to partner with us to co-market CNCT19; risks related to
our dependence on Juventas to ensure the patent protection and
prosecution for CNCT19; risks relating to the commercialization, if
any, of our proposed products (such as marketing, safety,
regulatory, patent, product liability, supply, competition and
other risks); risks relating to interests of our largest
shareholder and our Chairman and CEO that differ from our other
shareholders; and risks related to the development of a new
manufacturing facility by CASI Pharmaceuticals (Wuxi) Co., Ltd.
Further information regarding these and other risks is included in
the Company's filings with the SEC. All information provided herein
is as of the date of this announcement, and the Company undertakes
no obligation to update any forward-looking statement, except as
required under applicable law.
Additional Information and Where to Find it
CASI will furnish to the SEC a current report on Form 6-K with
respect to the Agreement and other matter in relation thereto. All
of those materials (and any other documents filed with the SEC)
will be available at no charge on the SEC's website
at www.sec.gov.
COMPANY CONTACT:
Rui Zhang
CASI Pharmaceuticals, Inc.
240.864.2643
ir@casipharmaceuticals.com
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SOURCE CASI Pharmaceuticals, Inc.