08.08.2018
MorphoSys AG DE0006632003
DGAP-News: MorphoSys and I-Mab Biopharma Announce China IND Submission of TJ202/MOR202
DGAP-News: MorphoSys AG / Key word(s): Research Update
MorphoSys and I-Mab Biopharma Announce China IND Submission of TJ202/MOR202
(news with additional features)
08.08.2018 / 03:01
The issuer is solely responsible for the content of this announcement.
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MorphoSys and I-Mab Biopharma Announce China IND Submission of TJ202/MOR202
German biopharma company MorphoSys AG (FSE: MOR; Prime Standard Segment,
TecDAX; NASDAQ: MOR) and I-Mab Biopharma ("I-Mab"), a Shanghai-based biotech
company focused on innovative biologics in oncology and autoimmune diseases,
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
also 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 1/2a trial in patients with relapsed/refractory multiple myeloma 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(R) (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(R), HuCAL GOLD(R), HuCAL PLATINUM(R), CysDisplay(R), RapMAT(R),
arYla(R),
Ylanthia(R), 100 billion high potentials(R), Slonomics(R), Lanthio Pharma(R)
and LanthioPep(R) are registered trademarks of the MorphoSys Group.
Tremfya(R)
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
[email protected]
I-Mab Biopharma
Raven Lin, Vice President of Corporate Development
[email protected]
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Additional features:
Document: http://n.eqs.com/c/fncls.ssp?u=MPNSJSENFW
Document title: Press Release
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08.08.2018 Dissemination of a Corporate News, transmitted by DGAP - a
service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
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Financial/Corporate News and Press Releases.
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Language: English
Company: MorphoSys AG
Semmelweisstr. 7
82152 Planegg
Germany
Phone: +49 (0)89 899 27-0
Fax: +49 (0)89 899 27-222
E-mail: [email protected]
Internet: www.morphosys.com
ISIN: DE0006632003
WKN: 663200
Indices: TecDAX
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated
Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover,
Munich, Stuttgart, Tradegate Exchange
End of News DGAP News Service
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