BEIJING and LUND,
Sweden, March 5, 2024 /PRNewswire/ -- CASI
Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company
specializing in the development and commercialization of innovative
therapeutic and pharmaceutical products, and BioInvent
International AB ("BioInvent") (Nasdaq Stockholm: BINV), a biotech
company focused on the discovery and development of novel and
first-in-class immune-modulatory antibodies for cancer
immunotherapy, today announced preliminary encouraging efficacy
data for BI-1206 in combination with rituximab in patients with
relapsed/refractory (R/R) indolent Non-Hodgkin's Lymphoma (iNHL) in
the ongoing development program in China.
BI-1206 is a first-in-class fully human monoclonal antibody
(mAb) that targets FcγRIIB. It is being evaluated in combination
with rituximab in patients with R/R iNHL. The Phase 1 study is
designed to assess the safety, tolerability, pharmacology, and
clinical activity of BI-1206, administered though intravenous (IV)
infusion.
The Phase 1 dose-escalation study showed impressive signs of
clinical efficacy, with 4 partial responses (PR) and 1 complete
response (CR) out of 8 evaluable patients. The results are
consistent with the clinical data that have been previously
reported by BioInvent. Among the responders in the study being
conducted in China, one patient
with relapsed Marginal Zone Lymphoma (MZL) patient who achieved CR
has maintained a durable complete remission for 20+ weeks. The
preliminary results demonstrated a manageable safety profile across
all patients.
Dr. Wei-Wu He, CEO of CASI, said
"These initial BI-1206 data showed promising response for patients
with difficult-to-treat disease. The data are especially notable as
they demonstrated strong and durable responses at lower dose
levels. We believe these results represent important steps toward
validating BI-1206 as a potential treatment as well as de-risk our
plan for future development."
Dr. He continued, "Further developing BI-1206 to help treat more
patients with iNHL is an important goal we share with our partner
BioInvent. The interim results further strengthen our confidence in
progressing BI-1206 into the next stage of clinical development as
a potential treatment option for patients with R/R iNHL."
Dr. Martin Welschof, CEO of BioInvent commented, "We are
encouraged by the promising new interim Phase 1 data reported today
by our partner, CASI. BI-1206 is being developed to re-establish
the clinical efficacy of cancer therapies such as rituximab by
addressing fundamental resistance mechanisms to cancer treatments.
The clinical efficacy results reported today, including a
long-lasting complete response, reinforce previously reported data.
We continue to be enthusiastic about the development of BI-1206 in
NHL and look forward to reporting data from additional studies in
the first half of 2024."
About BI-1206 (Anti-FcyRIIB antibody)
The National Medical Products Administration (NMPA) granted the
BI-1206 Clinical Trial Application (CTA) approval in December 2021. Ethics committee approval from a
leading investigational site was granted in January 2022. BI-1206 is currently being
evaluated in the US, the EU, Brazil and China in three Phase 1/2 trials. Two studies
are evaluating BI-1206 in combination with rituximab for the
treatment of indolent non-Hodgkin lymphoma (NHL), which includes
patients with follicular lymphoma (FL), mantle cell lymphoma (MCL),
and MZL who have relapsed or are refractory to rituximab. The third
Phase 1/2 trial is investigating BI-1206 in combination with the
anti-PD1 therapy KEYTRUDA® (pembrolizumab) in solid
tumors. The U.S. Food and Drug Administration (FDA) has granted
Orphan Drug Designation for BI-1206 for the treatment of follicular
lymphoma, the most common form of slow-growing non-Hodgkin
lymphoma. BioInvent has licensed the rights for BI-1206 to CASI for
China, Hong Kong, Macau, and Taiwan.
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.
About BioInvent International AB
BioInvent International AB (Nasdaq Stockholm: BINV) is a
clinical-stage biotech company that discovers and develops novel
and first-in-class immuno-modulatory antibodies for cancer therapy,
with currently five drug candidates in six ongoing clinical
programs in Phase 1/2 trials for the treatment of hematological
cancer and solid tumors. The Company's validated, proprietary
F.I.R.S.T™ technology platform identifies both targets and the
antibodies that bind to them, generating many promising new
immune-modulatory candidates to fuel the Company's own clinical
development pipeline and providing licensing and partnering
opportunities.
The Company generates revenues from research collaborations and
license agreements with multiple top-tier pharmaceutical companies,
as well as from producing antibodies for third parties in the
Company's fully integrated manufacturing unit. More information is
available at www.bioinvent.com. Follow on the social media platform
X: @BioInvent.
CASI 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.
BioInvent disclaimer: The press release contains
statements about the future, consisting of subjective assumptions
and forecasts for future scenarios. Predictions for the future only
apply as the date they are made and are, by their very nature, in
the same way as research and development work in the biotech
segment, associated with risk and uncertainty. With this in mind,
the actual outcome may deviate significantly from the scenarios
described in this press release. This press release is published in
Swedish and English. In the event of any difference between the
English version and the Swedish original, the Swedish version shall
prevail. For a more detailed description of risk factors, see
section "Risks and Risk Management," page 47, in the Company's
annual report 2022.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co. LLC, Rahway, NJ, USA.
COMPANY CONTACT:
Rui Zhang
CASI Pharmaceuticals, Inc.
240.864.2643
ir@casipharmaceuticals.com
For further information, please contact:
Cecilia Hofvander, Senior Director
Investor Relations
Phone: +46 (0)46 286 85 50
Email: cecilia.hofvander@bioinvent.com
BioInvent International AB (publ)
Co. Reg. No. Org nr: 556537-7263
Visiting address: Ideongatan 1
Mailing address: 223 70 LUND
Phone: +46 (0)46 286 85 50
www.bioinvent.com
This information is information that BioInvent International is
obliged to make public pursuant to the EU Market Abuse Regulation.
The information was submitted for publication, through the agency
of the contact persons set out above, at 2024 03-05 at 13:00 CET.
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