I-Mab (NASDAQ: IMAB), a clinical stage biopharmaceutical company
committed to the discovery, development and commercialization of
novel or highly differentiated biologics to treat diseases with
significant unmet medical needs, and MorphoSys AG (FSE: MOR; Prime
Standard Segment, MDAX & TecDAX; NASDAQ: MOR), today jointly
announced that the first patient has been dosed in a phase 3
clinical study in mainland China to evaluate MorphoSys’
investigational human CD38 antibody TJ202/MOR202 in combination
with lenalidomide plus dexamethasone in patients with relapsed or
refractory multiple myeloma (r/r MM). Under a licensing agreement
with MorphoSys, I-Mab has exclusive rights for development and
commercialization of TJ202/MOR202 in mainland China, Taiwan, Hong
Kong and Macao.
The clinical trial (NCT03952091) in mainland
China is a randomized, open-label, parallel-controlled,
multi-center study to evaluate the efficacy and safety of the
combination of TJ202/MOR202, lenalidomide and dexamethasone versus
the combination of lenalidomide and dexamethasone in patients with
r/r MM who received at least one prior line of treatment. This
multi-center study has already started at sites in Taiwan in April
2019 and now officially started in mainland China as part of the
coordinated effort to accelerate the study.
“TJ202/MOR202 is a front-runner candidate that
adequately demonstrates our fast-to-market development strategy,
representing a highly differentiated clinical development approach
to provide new treatment options for unmet medical needs,” said Dr.
Joan Shen, CEO of I-Mab. “The phase 3 study is the second
registrational trial of TJ202 as a potential second line treatment
option for patients with multiple myeloma in Greater China.”
“We are delighted that our partner I-Mab has
dosed the first patient in the ongoing phase 3 study for
TJ202/MOR202 in mainland China, which marks an important step in
the development of this compound,” commented Dr. Malte Peters,
Chief Research & Development Officer of MorphoSys. “There is a
high need for the treatment of patients with r/r multiple myeloma
in the Greater China area and we look forward to the further
development of TJ202/MOR202 by our partner I-Mab in this
indication.”
In addition to the phase 3 trial, I-Mab is
conducting a pivotal phase 2 study (NCT03860038) to evaluate the
efficacy and safety of TJ202/MOR202 in combination with
dexamethasone in subjects with r/r MM who received at least 2 prior
lines of treatment.
About TJ202/MOR202
MOR202/TJ202 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 research 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 MOR202/TJ202 in mainland
China, Taiwan, Hong Kong and Macao.
About I-Mab
I-Mab (NASDAQ: IMAB) is a dynamic, global
biotech company exclusively focused on developing novel or highly
differentiated biologics 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 pre-clinical and clinical development expertise, and
world-class GMP manufacturing capabilities. I-Mab has offices in
China and the United States. For more information, please visit
http://ir.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, 27 of which are currently in clinical
development. In 2017, Tremfya®, marketed by Janssen for the
treatment of plaque psoriasis, became the first drug based on
MorphoSys’ antibody technology to receive regulatory approval.
MorphoSys’ most advanced proprietary product candidate, tafasitamab
(MOR208), is in late-stage clinical development for the treatment
of patients with relapsed/refractory diffuse large B-cell lymphoma
(r/r DLBCL). Headquartered near Munich, Germany, the MorphoSys
group, including the fully owned U.S. subsidiary MorphoSys US Inc.,
has over 400 employees. More information at www.morphosys.com
HuCAL®, HuCAL GOLD®, HuCAL PLATINUM®,
CysDisplay®, RapMAT®, arYla®, Ylanthia®, 100 billion high
potentials®, Slonomics®, Lanthio Pharma®, LanthioPep® and
ENFORCERTM are trademarks of the MorphoSys Group. Tremfya® is a
trademark of Janssen Biotech, Inc. XmAb® is a trademark of Xencor,
Inc.
I-Mab forward looking
statements
This press release includes certain disclosures
which contain “forward-looking statements.” You can identify
forward-looking statements because they contain words such as
“anticipate” and “expected.” Forward-looking statements are based
on I-Mab’s current expectations and assumptions. Because
forward-looking statements relate to the future, they are subject
to inherent uncertainties, risks and changes in circumstances that
may differ materially from those contemplated by the
forward-looking statements, which are neither statements of
historical fact nor guarantees or assurances of future performance.
Important factors that could cause actual results to differ
materially from those in the forward-looking statements are set
forth in filings with the U.S. Securities and Exchange Commission.
I-Mab undertakes no obligation to publicly update or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise, except as may be required by law.
MorphoSys forward looking
statements
This communication contains certain
forward-looking statements concerning the MorphoSys group of
companies, including the expectations regarding the expansion of
the ongoing phase 2 and phase 3 clinical studies to evaluate
MorphoSys’ investigational CD38 antibody MOR202/TJ202 in
combination with lenalidomide in patients with relapsed or
refractory multiple myeloma to mainland China as well as the size
and scope of these studies, expectations in connection with
MOR202/TJ202 and expectations regarding the further development of
MOR202/TJ202 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 MOR202/TJ202. 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 expansion of the ongoing
phase 2 and phase 3 clinical studies to evaluate MorphoSys’
investigational CD38 antibody MOR202/TJ202 in combination with
lenalidomide in patients with relapsed or refractory multiple
myeloma to mainland China as well as the size and scope of this
studies, expectations in connection with MOR202/TJ202 and
expectations regarding the further development of MOR202/TJ202 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 MOR202/TJ202,
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’
Annual Report on Form 20-F 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 Jielun Zhu, CFO E-mail:
jielun.zhu@i-mabbiopharma.com Office line: +86 21 6057 8000
Gigi Feng, Vice President of Corporate CommunicationsE-mail:
gigi.feng@i-mabbiopharma.comOffice line: +86 21 6057 8000
Investor Inquiries:
Burns McClellan, Inc. (Americas and Europe) Steve Klass E-mail:
sklass@burnsmc.com Office line: +1 212 213 0006
The Piacente Group, Inc. (Asia) Emilie Wu E-mail:
emilie@thepiacentegroup.com Office line: + 86 21 6039 8363
MorphoSys AGInvestor
Contact:
Dr. Julia NeugebauerDirector Corporate Communications &
IRTel: +49 (0) 89 / 899 27-179Julia.Neugebauer@morphosys.com
Media Contact:
Dr. Anca AlexandruAssociate Director Corporate Communications
& IRTel: +49 (0) 89 / 899
27-26738Anca.Alexandru@morphosys.com
Dr. Verena KupasAssociate Director Corporate Communications
& IRTel: +49 (0) 89 / 899
27-26814Verena.Kupas@morphosys.com
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