Shanghai, China and Rockville, MD (Press Release) – 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 cur­rent 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.

Source: I‑Mab.