Full Press Release Details
I-Mab and MorphoSys Announce First Patient Dosed in Phase 3 Clinical
Trial of TJ202/MOR202
in r/r Multiple Myeloma in Mainland China
SHANGHAI, China, and ROCKVILLE, MD., and Munich, Germany, April 27, 2020 (GLOBE NEWSWIRE) 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.
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.
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
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
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:
E-mail: jielun.zhu@i-mabbiopharma.com
Office line: +86 21 6057 8000
Gigi Feng, Vice President of
Corporate Communications
E-mail: gigi.feng@i-mabbiopharma.com
Office line: +86 21 6057 8000
Burns McClellan, Inc. (Americas and Europe)
E-mail: sklass@burnsmc.com
Office line: +1 212 213 0006
The Piacente Group, Inc. (Asia)
E-mail: emilie@thepiacentegroup.com
Office line: + 86 21 6039 8363
Dr. Julia Neugebauer
Director Corporate Communications & IR
Associate Director Corporate Communications & IR
+49 (0) 89 / 899 27-26738
Associate Director Corporate Communications & IR
+49 (0) 89 / 899 27-26814