Shanghai, China and Munich, Germany (Press Release) – 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.

About TJ202 / MOR202

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.

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, 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.

Cautions Concerning Forward-Looking State­ments

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.

Source: I-Mab Bio­pharma.