SHANGHAI, Oct. 14, 2019 /PRNewswire/ -- I-Mab Biopharma
("I-Mab"), a China and U.S.-based
clinical stage biopharmaceutical company exclusively focused on the
discovery and development of novel or highly differentiated
biologics in immuno-oncology and autoimmune diseases and German
biopharma company MorphoSys AG (FSE: MOR; Prime Standard Segment,
MDAX & TecDAX; Nasdaq: MOR), today announced that I-Mab has
received Investigational New Drug (IND) clearances from the
National Medical Products Administration (NMPA) of China to expand the ongoing phase II and III
clinical trials of TJ202/MOR202, MorphoSys's human monoclonal
anti-CD38 antibody for the treatment of multiple myeloma (MM), also
to mainland China. I-Mab owns the
exclusive rights for development and commercialization of
TJ202/MOR202 in China,
Taiwan, Hong Kong and Macao.
I-Mab is currently conducting two clinical trials with
TJ202/MOR202 in Taiwan. The phase
II study, which was initiated in March
2019, is designed to evaluate the efficacy and safety of
TJ202/MOR202 as third-line treatment in patients with relapsed or
refractory MM. The phase III study, initiated in April 2019, assesses the efficacy and safety of
the combination of TJ202/MOR202 plus lenalidomide (LEN) and
dexamethasone (DEX) versus the combination of LEN and DEX in
patients with relapsed or refractory MM who received at least one
prior line of treatment. Under the fast-to-market development
strategy, I-Mab will now be expanding these trials into mainland
China.
"Receiving two IND clearances for TJ202/MOR202 from the China
NMPA marks an important milestone for us and demonstrates I-Mab's
capability and commitment to the advancement of immunological
technology for the market. We will move forward with the clinical
development of TJ202/MOR202 in China to bring it to the market as efficiently
as possible. I-Mab will continue to expand our portfolio in
innovative therapeutics to benefit patients in need," commented Dr.
Jingwu Zang, MD., PhD., Founder and
Chairman of I-Mab Biopharma.
"We are very pleased that our partner I-Mab now also received
the IND clearances for TJ202/MOR202 for China, allowing the expansion of the clinical
development of TJ202/MOR202 in multiple myeloma to mainland
China," commented Dr. Malte Peters, Chief Development Officer of
MorphoSys AG. "There is a high need for alternative treatment
options for patients with multiple myeloma in the Chinese region
and we look forward to the further development of TJ202/MOR202 by
our partner I-Mab in this indication."
About TJ202/MOR202
TJ202/MOR202 is an investigational human monoclonal antibody
derived from MorphoSys's HuCAL antibody technology. The antibody is
directed against CD38 on the surface of multiple myeloma cells,
which has been characterized as one of the most strongly and
uniformly expressed antigens on the surface of malignant plasma
cells. According to its suggested mode of action, the antibody
recruits cells of the body's immune system to kill the tumor
through antibody-dependent cellular cytotoxicity (ADCC) and
antibody-dependent cellular phagocytosis (ADCP). The antibody does
not involve complement dependent cytotoxicity, or CDC, an
additional immune mechanism involved in tumor cell killing.
Scientific researche suggests that an anti-CD38 antibody may have
therapeutic potential also in other cancers as well as autoimmune
diseases. Based on a licensing agreement between MorphoSys and
I-Mab signed in November 2017, I-Mab
owns the exclusive rights for development and commercialization of
TJ202/MOR202 in mainland China,
Taiwan, Hong Kong and Macao.
About I-Mab:
I-Mab is a dynamic and fast-growing global biotech company
exclusively focused on developing biologics of novel or highly
differentiated in the therapeutic areas of immuno-oncology and
autoimmune diseases. I-Mab's mission is to bring transformational
medicines to patients through innovation. I-Mab's innovative
pipeline of more than 10 clinical and pre-clinical stage drug
candidates is driven by the Company's Fast-to-PoC
(Proof-of-Concept) and Fast-to-Market development strategies
through internal R&D and global partnerships. The Company is on
track to become a fully integrated end-to-end global
biopharmaceutical company with cutting-edge discovery platforms,
proven preclinical and clinical development expertise, and
world-class GMP manufacturing capabilities. I-Mab is
well-recognized by capital markets to have successfully raised over
US $400 million in equity financing
since its establishment in 2016. Its recent US $200 million Series C financing represents one of
the largest amounts ever raised by a biotech company in
China.
For more information, please see the Company's website at
www.i-mabbiopharma.com
About MorphoSys:
MorphoSys (FSE & NASDAQ: MOR) is a clinical-stage
biopharmaceutical company dedicated to the discovery, development
and commercialization of exceptional, innovative therapies for
patients suffering from serious diseases. The focus is on cancer.
Based on its leading expertise in antibody, protein and peptide
technologies, MorphoSys, together with its partners, has developed
and contributed to the development of more than 100 product
candidates, of which 29 are currently in clinical development. In
2017, Tremfya®, marketed by Janssen for the treatment of
plaque psoriasis, became the first drug based on MorphoSys's
antibody technology to receive regulatory approval. The Company's
most advanced proprietary product candidate, tafasitamab (MOR208),
has been granted U.S. FDA breakthrough therapy designation for the
treatment of patients with relapsed/refractory diffuse large B-cell
lymphoma (DLBCL). Headquartered near Munich, Germany, the MorphoSys group,
including the fully owned U.S. subsidiary MorphoSys US Inc., has
approximately 370 employees. More information at
www.morphosys.com.
HuCAL®, HuCAL GOLD®, HuCAL PLATINUM®, CysDisplay®, RapMAT®,
arYla®, Ylanthia®, 100 billion high potentials®, Slonomics®,
Lanthio Pharma® and LanthioPep® are registered trademarks of the
MorphoSys Group. Tremfya® is a trademark of Janssen Biotech,
Inc.
This communication contains certain forward-looking statements
concerning the MorphoSys group of companies, including expectations
regarding the expansion of the ongoing phase 2 and phase 3 clinical
studies to evaluate MorphoSys's investigational CD38 antibody
TJ202/MOR202 in combination with lenalidomide in patients with
relapsed or refractory multiple myeloma to mainland China as well as the size and scope of this
study, expectations in connection with TJ202/MOR202 and
expectations regarding the further development of TJ202/MOR202 in
multiple myeloma in Greater China,
including the intended targeting of CD38 and the suggested mode of
action, potential additional indications such as autoimmune
diseases, as well as expectations regarding a potential future
regulatory filing for TJ202/MOR202. The forward-looking statements
contained herein represent the judgment of MorphoSys as of the date
of this release and involve known and unknown risks and
uncertainties, which might cause the actual results, financial
condition and liquidity, performance or achievements of MorphoSys,
or industry results, to be materially different from any historic
or future results, financial conditions and liquidity, performance
or achievements expressed or implied by such forward-looking
statements. In addition, even if MorphoSys' results, performance,
financial condition and liquidity, and the development of the
industry in which it operates are consistent with such
forward-looking statements, they may not be predictive of results
or developments in future periods. Among the factors that may
result in differences are that MorphoSys's expectations regarding
the expansion of the ongoing phase 2 and phase 3 clinical studies
to evaluate MorphoSys's investigational CD38 antibody TJ202/MOR202
in combination with lenalidomide in patients with relapsed or
refractory multiple myeloma to mainland China as well as the size and scope of this
study, expectations in connection with TJ202/MOR202 and
expectations regarding the further development of TJ202/MOR202 in
multiple myeloma in Greater China,
including the intended targeting of CD38 and the suggested mode of
action, potential additional indications such as autoimmune
diseases, as well as expectations regarding a potential future
regulatory filing for TJ202/MOR202 and expectations around the
submission of an IND application to China's National Medical Products
Administration for TJ202/MOR202 are false, MorphoSys's reliance on
collaborations with third parties, estimating the commercial
potential of its development programs and other risks indicated in
the risk factors included in MorphoSys's Registration Statement on
Form F-1 and other filings with the US Securities and Exchange
Commission. Given these uncertainties, the reader is advised not to
place any undue reliance on such forward-looking statements. These
forward-looking statements speak only as of the date of publication
of this document. MorphoSys expressly disclaims any obligation to
update any such forward-looking statements in this document to
reflect any change in its expectations with regard thereto or any
change in events, conditions or circumstances on which any such
statement is based or that may affect the likelihood that actual
results will differ from those set forth in the forward-looking
statements, unless specifically required by law or regulation.
For more information, please contact:
I-Mab Biopharma
Raven Lin Vice President of
Corporate Development
raven.lin@i-mabbiopharma.com
Jielun Zhu CFO
jielun.zhu@i-mabbiopharma.com
Amanda Dai Associate Director of Public Relation
zhenhua.dai@i-mabbiopharma.com
MorphoSys AG
Dr. Sarah
Fakih
Head of Corporate
Communications & IR
Tel: +49 (0) 89 / 899 27-26663
Sarah.Fakih@morphosys.com
|
Dr. Julia
Neugebauer
Director Corporate
Communications & IR
Tel: +49 (0) 89 / 899 27-179
Julia.Neugebauer@morphosys.com
|
Dr. Verena
Kupas
Manager Corporate
Communications & IR
Tel: +49 (0) 89 / 899 27-26814
Verena.Kupas@morphosys.com
|
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