SHANGHAI, Aug. 7, 2018 /PRNewswire/ -- On August 8, 2018
Beijing time I-Mab Biopharma ("I-Mab"), a Shanghai-based biotech company focused on
innovative biologics in oncology and autoimmune disease, and German
biopharma company MorphoSys AG (FSE: MOR; Prime Standard Segment,
TecDAX; NASDAQ: MOR) announced today that I-Mab has Submitted an
investigational new drug (IND) application to China National Drug
Administration (CNDA) for TJ202/MOR202, a human monoclonal antibody
directed against CD38 for the treatment of multiple myeloma.
Multiple myeloma is the second most common blood cancer
worldwide. The patient number has gradually increased in
China in recent years due to an
increasingly aging population. Yet there are no effective biologics
approved in China for this
indication and current therapies have been associated with serious
side effects and limited treatment efficacy.
TJ202/MOR202 is a monoclonal antibody derived from MorphoSys's
HuCAL antibody technology. The antibody is directed against CD38 on
the surface of multiple myeloma cells, and, according to its
suggested mode of action, recruits cells of the body's immune
system to kill the tumor. Scientific research suggest that an
anti-CD38 antibody may have therapeutic potential in other cancers,
as well as autoimmune diseases.
China recently issued a new
round of reform initiatives to accelerate clinical trial approval
for new drugs, especially in oncology. "The IND submission was done
after a successful pre-submission consultation meeting with Center
for Drug Evaluation (CDE) of CNDA, which is required under
China's new drug regulation,
unless waived," said Dr. Joan Shen,
Head of R&D at I-Mab.
"CNDA has endorsed the overall clinical and regulatory strategy,
as well as the study designs, which should lead to the biologics
license application (BLA)," said Dr. Joan
Shen.Through a licensing agreement with MorphoSys AG in
November 2017, I-Mab gained exclusive
rights to develop and commercialize TJ202/MOR202 in Greater China territory, including mainland
China, Hong Kong, Macau and Taiwan.
After observing patient responses in an interim analysis from an
ongoing Phase I/IIa trial in patients with relapsed/refractory MM
in Germany and Austria, MorphoSys decided to support I-Mab to
lead clinical development of TJ202/MOR202 in Greater China. MorphoSys will continue to
evaluate additional other suitable indications for further global
development of TJ202/MOR202.
Dr. Malte Peters, Chief
Development Officer of MorphoSys AG commented: "We are delighted
that our partner I-Mab has taken this important step in advancing
TJ202/MOR202 into clinical development in China. We look forward to supporting I-Mab in
developing this investigational compound with the goal of helping
Chinese patients in multiple myeloma, an indication with a high
unmet medical need".
"With a fast-to-market strategy under the new drug regulation,
we hope to bring this innovative treatment to patients as soon as
possible," Dr. Shen commented. "MorphoSys and I-Mab plan to
continuously evaluate the potential and further development of
TJ202 in other indications."
About I-Mab Biopharma
Having built a world-class R&D capability and highly
experienced team, I-Mab focuses on discovery and development of
First-in-Class and Best-in-Class biologics in the areas of
immuno-oncology and immuno-inflammation. The company has already
submitted several IND applications and is prepared to submit
additional INDs in order to initiate clinical trials in
China and the US, including
multiple Phase II and Phase III studies. I-Mab is on a fast track
toward becoming an end-to-end fully integrated biopharma company.
The company has been well recognized by capital market by
successfully raising US $330 million
within two years, the recent Series C financing was representing
one of the largest amounts ever in C round by an innovative biotech
company in China.
http://www.i-mabbiopharma.com
About MorphoSys:
MorphoSys is a late-stage, biopharmaceutical company devoted to
the development of innovative and differentiated therapies for
patients suffering from serious diseases. Based on its
technological leadership in generating antibodies, 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. This broad pipeline spans
MorphoSys's two business segments: Proprietary Development, in
which MorphoSys invests in product candidates for its own account,
and Partnered Discovery, in which product candidates are developed
exclusively for a variety of Pharma and Biotech partners. In 2017,
Tremfya® (guselkumab), marketed by Janssen, became the
first therapeutic antibody based on MorphoSys's proprietary
technology to receive marketing approval for the treatment of
moderate to severe plaque psoriasis in the United States, the European Union and
Canada. MorphoSys is listed on the
Frankfurt Stock Exchange and on the U.S. stock exchange Nasdaq
under the symbol MOR. For regular updates about MorphoSys, visit
https://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.
This communication contains certain forward-looking
statements concerning the MorphoSys group of companies, including
the partnering expectations in connection with MOR202 and
expectations regarding the further development of MOR202 in
multiple myeloma in Greater China,
including the intended targeting of CD38, potential additional
indications such as autoimmune diseases and systemic lupus
erythematosus, potential future payments to be made to MorphoSys
under the licensing agreement for MOR202, assumptions regarding the
submission of an IND application to China National Drug
Administration (CNDA) for MOR202 as well as expectations regarding
the current clinical phase 1/2a development in multiple myeloma by
MorphoSys. 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 MorphoSys' expectations regarding the partnering expectations
in connection with MOR202 and expectations regarding the further
development of MOR202 in multiple myeloma in Greater China, including the intended
targeting of CD38, potential additional indications such as
autoimmune diseases and systemic lupus erythematosus, potential
future payments to be made to MorphoSys under a licensing agreement
for MOR202, assumptions regarding the submission of an IND
application to China National Drug Administration (CNDA) for MOR202
as well as expectations regarding the current clinical phase 1/2a
development in multiple myeloma by MorphoSys, MorphoSys' 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:
MorphoSys AG
Alexandra Goller
Associate Director Corporate Communications & IR
Jochen Orlowski
Associate Director Corporate Communications & IR
Dr. Claudia Gutjahr-Löser
Investor Relations Officer
Tel: +49 (0) 89 / 899
27-404
investors@morphosys.com
I-Mab Biopharma
Raven Lin, Vice President of
Corporate Development
raven.lin@i-mabbiopharma.com
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SOURCE I-Mab Biopharma