I-Mab Biopharma and MorphoSys Announce First Patient Dosed in Phase 3 Clinical Study of TJ202/MOR202 in Multiple Myeloma
SHANGHAI and MUNICH, April 29, 2019 /PRNewswire/ -- I-Mab Biopharma (I-Mab), a China-based clinical stage biopharmaceutical company exclusively focused on the development of innovative biologics in immuno-oncology and autoimmune diseases, and MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ: MOR), announced today that the first patient has been dosed in a phase 3 randomized and multi-center clinical study in Taiwan to evaluate MorphoSys's investigational human CD38 antibody TJ202/MOR202 in combination with lenalidomide in patients with relapsed or refractory multiple myeloma. I-Mab has the exclusive rights for development and commercialization of TJ202/MOR202 in mainland China, Taiwan, Hong Kong and Macao.
"The initiation of our first phase 3 trial represents another important milestone in advancing TJ202/MOR202 towards registration with the hope of providing more therapeutic options for MM patients globally. With planned enrollment of 291 patients, this will be a broad trial of this second most common blood cancer worldwide," said Dr. Joan Shen, M.D., Head of R&D at I-Mab. "In parallel with our pivotal phase 2 trial of TJ202/MOR202 in combination with dexamethasone, the phase 3 study will further assess the efficacy of TJ202/MOR202 as a potential second line treatment in MM."
Under I-Mab's fast-to-market development strategy, the phase 3 study, if successful, could lead to a biologics license application (BLA) in Greater China. The randomized, open-label, parallel-controlled, multicenter study will be conducted in mainland China and Taiwan to evaluate 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. The primary endpoint is to evaluate the progression-free survival (PFS) comparing the efficacy of TJ202/MOR202 plus LEN/DEX versus LEN/DEX.
The dosing of the first patient triggers a milestone payment of USD 3 million to MorphoSys.
"We are delighted that our partner I-Mab has started a phase 3 trial of TJ202/MOR202 in combination with lenalidomide in Asia in addition to the ongoing phase 2 trial of MOR202 in combination with dexamethasone. We see a high medical need for the treatment of patients with multiple myeloma in the Chinese region and look forward to supporting I-Mab in developing this investigational compound for these patients," said Dr. Malte Peters, Chief Development Officer of MorphoSys AG.
With MorphoSys's support through a licensing agreement in November 2017, I-Mab is currently leading the clinical development of TJ202/MOR202 in Greater China, including mainland China, Hong Kong, Macao and Taiwan. In addition to Taiwan, I-Mab has filed an investigational new drug (IND) application to China's National Medical Products Administration in August 2018. Previously on March 20, 2019, I-Mab and MorphoSys announced the first patient dosing of TJ202/MOR202 in a phase 2 multi-center clinical study in Taiwan in patients with relapsed or refractory multiple myeloma.
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 research suggest that an anti-CD38 antibody may have therapeutic potential also in other cancers as well as autoimmune diseases. Based on an exclusive regional licensing agreement signed in late 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 Biopharma
I-Mab is a dynamic and fast-growing global player exclusively focused on developing first-in-class and best-in-class biologics in the areas of immuno-oncology and autoimmune diseases through internal R&D capabilities and global partnerships. I-Mab's pipeline is driven by the company's development strategy to address unmet needs in China and to bring innovative assets to the world. The company is prepared to submit additional INDs in order to initiate clinical trials in China and the U.S., including multiple Phase 2 and Phase 3 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 markets by successfully raising approximately USD 370 million within 12 months, with the recent USD 220 million Series C financing representing one of the largest amounts ever raised by an innovative biotech company in China. www.i-mabbiopharma.com.
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, 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 330 employees. More information at 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, Inc.
This communication contains certain forward-looking statements concerning the MorphoSys group of companies, including expectations regarding the initiation of a phase 3 clinical study to evaluate MorphoSys's investigational CD38 antibody TJ202/MOR202 in combination with lenalidomide in patients with relapsed or refractory multiple myeloma in Taiwan 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 fling for TJ202/MOR202 and expectations around the submission of an IND application to China's National Medical Products Administration 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 initiation of a phase 2 clinical study to evaluate MorphoSys's investigational CD38 antibody TJ202/MOR202 in combination with lenalidomide in patients with relapsed or refractory multiple myeloma in Taiwan 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 fling 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.
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SOURCE I-Mab Biopharma