~ NMPA approved CB-5339 CTA for Multiple
Myeloma indication ~
~ Expected enrollment to begin in 2023
~
ROCKVILLE, Md. and BEIJING, Jan. 6, 2023
/PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S.
biopharmaceutical company focused on developing and commercializing
innovative therapeutics and pharmaceutical products, announces that
the China National Medical Products Administration (NMPA) has
approved the Company's Clinical Trial Application (CTA) for
CB-5339, a first-in-class VCP/p97 inhibitor from Cleave
Therapeutics. CASI is planning a Phase 1 development program in
China of CB-5339 as a single agent
to evaluate the PK/safety profile, select the Recommended Phase 2
Dose, and assess early signs of clinical efficacy. The Phase 1
development program is expected to start in 2023.
Wei-Wu He, Ph.D., CASI's
Chairman, and Chief Executive Officer, commented, "This is exciting
news for CASI, as we are now a step closer to make CB-5339
available to patients and healthcare providers across Greater China. CB-5339 represents a promising
new agent for selectively targeting VCP/p97 in cancers and is a
complementary addition to our growing portfolio of approved and
investigational therapies for hematology oncology indications. CASI
is responsible for the conduct of the clinical trials in
China and will initiate the
studies as soon as possible."
About CB-5339 (VCP/p97 inhibitor)
CB-5339 is an oral second-generation, small molecule VCP/p97
inhibitor, and is currently being evaluated by Cleave Therapeutics
in a Phase 1 clinical trial in patients with acute myeloid leukemia
(AML), myelodysplastic syndrome (MDS) and myeloproliferative
neoplasms (NCT04402541).
VCP/p97 inhibitors exploit molecular features that define cancer
cell growth and metabolism. VCP/p97 plays a critical role in
protein homeostasis processes such as endoplasmic reticulum
associated degradation (ERAD) and chromatin-associated degradation
(CAD), as well as the DNA damage response (DDR). These key cellular
stress pathways are known to represent sensitivities critical to
cancer cell survival. Cellular stress provides an attractive means
of targeting non-oncogene addiction as a way to combat tumor
heterogeneity and emerging resistance to targeted therapies. Such
an approach has the added benefit of broad applicability, not
dependent on a single driver mutation and potential efficacy across
cancer types.
About Cleave
Therapeutics
Cleave Therapeutics is a clinical-stage biopharmaceutical
company focused on VCP/p97 as a novel target in protein homeostasis
and cellular stress pathways for therapeutic use in cancer. The
privately held company, based in San
Francisco, is studying CB-5339, its second-generation, small
molecule VCP/p97 inhibitor, in a Phase 1 clinical trial in patients
with acute myeloid leukemia, myelodysplastic syndrome and
myeloproliferative neoplasms. Cleave investors include 5AM Ventures, Bristol-Myers Squibb, Orbimed, U.S.
Venture Partners (USVP), Arcus Ventures, Astellas Venture
Management, and Osage University Partners. For additional
information, visit www.cleavetherapeutics.com.
About CASI
Pharmaceuticals
CASI Pharmaceuticals, Inc. is a U.S. 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. The
Company has built a commercial team of more than 100 hematology and
oncology sales and marketing specialists based in China. More information on CASI is available
at www.casipharmaceuticals.com.
Forward-Looking
Statements
This news release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act with
respect to the outlook for expectations for future financial or
business performance, revenue growth, strategies, expectations, and
goals. Forward-looking statements are subject to numerous
assumptions, risks, and uncertainties, which change over time.
Forward-looking statements speak only as of the date they are made,
and we assume no duty to update forward-looking statements. New
factors emerge from time to time, and it is not possible for us to
predict which factors will arise. In addition, we cannot assess the
impact of each factor on our business or the extent to which any
factor, or combination of factors, may cause actual results to
differ materially from those contained in any forward-looking
statements. Actual results could differ materially from those
currently anticipated due to a number of factors.
COMPANY CONTACT:
Rui Zhang
CASI Pharmaceuticals, Inc.
Phone: 240.864.2643
Email: ir@casipharmaceuticals.com
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SOURCE CASI Pharmaceuticals, Inc.