ROCKVILLE, Md., June 17, 2019 /PRNewswire/ -- CASI
Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical
company that is focusing on developing and accelerating the launch
of innovative therapeutics and pharmaceutical products in
China, the U.S., and throughout
the world, announces the signing of a license agreement for
exclusive worldwide license and commercialization rights to an
autologous anti-CD19 T-cell therapy product (CNCT19) from
Juventas Cell Therapy Ltd., a China-based domestic company located in
Tianjin City, China. Juventas will continue to develop
CNCT19 with CASI's participation on the program's steering
committee. CASI will be responsible for payment of certain
future development milestones and sales royalties.
In connection with the license, CASI Pharmaceuticals (Wuxi) Co.,
Ltd., a joint venture in which CASI owns 80% of the registered
capital, will invest RMB 80 million
(approximately 11.6 million) in Juventas through a wholly owned
Chinese subsidiary in lieu of the upfront payment for the
license.
CNCT19 targets CD19, a B-cell surface protein widely expressed
during all phases of B-cell development and a validated target for
B-cell driven hematological malignancies. CD19-targeted CAR
constructs from several different institutions have demonstrated
consistently high antitumor efficacy in children and adults with
relapsed B-cell acute lymphoblastic leukemia (B-ALL), chronic
lymphocytic leukemia (CLL), and B-cell non-Hodgkin lymphoma
(B-NHL). CD19 antigen is the most frequently used biomarker in
the CAR-T cell therapy clinical trials for hematological malignant
diseases such as leukemia and lymphoma. Juventas has
previously submitted two INDs to the NMPA for Acute Lymphoblastic
Leukemia (ALL) and Non-Hodgkin Lymphoma (NHL) indications;
approvals of which are expected in late 2019.
Larry Zhang, President of CASI
(Beijing) Pharmaceuticals Co.,
Ltd., a wholly owned subsidiary of CASI, commented, "We are
extremely excited by this partnership and are encouraged by the
preliminary data which showed promising results that may offer the
potential to be the best in class anti-CD19 CAR-T product for
Non-Hodgkin lymphoma (NHL) and B-cell acute lymphoblastic leukemia
(B-ALL). We are excited about our role to help drive
innovation in this exciting therapeutic area and remain committed
to providing a range of solutions to patients with hematological
malignancies. We look forward to working with Juventas to advance
the clinical development of this therapy and for CASI to begin
commercial planning."
Alexander Zukiwski, M.D., CASI's
Chief Medical Officer commented, "Juventas has made significant
strides thus far with regulatory filings in two treatment areas,
B-cell acute lymphoblastic leukemia (B-ALL) and Non-Hodgkin
lymphoma (NHL), and have identified sites for both Phase 1 and
Phase 2 studies in China. We look forward to reviewing the
data from the Phase 1 and 2 studies once they are available."
About CASI Pharmaceuticals
CASI Pharmaceuticals is a U.S. biopharmaceutical company focused
on developing and accelerating the launch of pharmaceutical
products and innovative therapeutics in China, the U.S., and throughout the
world. CASI's product pipeline features (i) an autologous
anti-CD19 t-cell therapy product (CNCT19) being developed for the
treatment of B-ALL and NHL; (ii) an anti-CD38 monoclonal antibody
being developed for the treatment of multiple myeloma and other
CD38 positive hematological cancers (CID-103); (iii) China rights to three U.S. Food and Drug
Administration (FDA)-approved drugs (EVOMELA® (melphalan
hydrochloride for injection) approved by China's National Medical Products
Administration (NMPA) for marketing, ZEVALIN®
(ibritumomab tiuxetan) and MARQIBO® (vincristine sulfate
LIPOSOME injection) approved by NMPA for registration confirmatory
trials in China; and (iv) a
portfolio of FDA-approved and pending abbreviated new drug
applications (ANDAs). CASI has offices in Rockville, Maryland and a wholly owned
subsidiary in Beijing, China.
More information on CASI is available at
www.casipharmaceuticals.com.
About Juventas
Juventas Cell Therapy is a China-based domestic company located in
Tianjin City, China engaged in cell therapy. The
company's lead product, CNCT19, devolved from the CD19 CAR-T, was
originally created at the Institute of Hematology, Chinese Academy
of Medical Sciences, one of the top hematology centers in
China. CD19 CAR-T is used to treat
cancer patients with acute lymphoblastic leukemia and relapsed
non-Hodgkin lymphoma. Through its commercial collaboration with
CASI, Juventas intends to be the first domestic company to launch a
CD19 CAR-T in China. Wei-Wu He Ph.D. is the chairman and a
founding shareholder of Juventas. A committee of independent
directors of CASI negotiated the terms of the investment and
license agreements and recommended that the board of directors
approve the transaction. Dr. He did not participate in the
committee's deliberations or the board of directors' approval of
the transaction.
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, 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 no duty to
update forward-looking statements is assumed. Actual results
could differ materially from those currently anticipated due to a
number of factors, including: the difficulty of executing our
business strategy 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 FDA, NMPA, 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 volatility in the market price of our
common stock; risks relating to the need for additional capital and
the uncertainty of securing additional funding on favorable terms;
risks associated with CID-103,
CNCT19, and our product candidates; risks associated with CID-103,
CNCT19, and our other early-stage products under development;
risks that results in preclinical and early clinical models are not
necessarily indicative of later clinical results; uncertainties
relating to preclinical and clinical trials, including delays to
the commencement of such trials; the lack of success in the
clinical development of any of our products; and our dependence on
third parties. Such factors, among others, could have a
material adverse effect upon our business, results of operations
and financial condition. We caution readers not to place
undue reliance on any forward-looking statements, which only speak
as of the date made. Additional information about the factors and
risks that could affect our business, financial condition and
results of operations, are contained in our filings with the U.S.
Securities and Exchange Commission, which are available at
www.sec.gov.
EVOMELA®, Marqibo®
and Zevalin® are
proprietary to Acrotech Biopharma LLC and its affiliates.
COMPANY
CONTACT:
CASI
Pharmaceuticals, Inc.
240.864.2643
ir@casipharmaceuticals.com
|
INVESTOR
CONTACT:
Solebury
Trout
Jennifer
Porcelli
646.378.2962
jporcelli@troutgroup.com
Brennan
Doyle
617.221.9005
BDoyle@troutgroup.com
|
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SOURCE CASI Pharmaceuticals, Inc.