Shanghai, China (Press Release) – I-Mab Bio­pharma­ ("I-Mab"), a global bio­pharma­ceu­tical com­pany based in China and the United States and focused on the discovery and devel­op­ment of novel or highly dif­fer­en­ti­ated biologics in immuno-oncology and auto­immune dis­eases today announced the dosing of the first patient in mainland China in its reg­is­tra­tional study eval­u­ating its human CD38 anti­body (TJ202/MOR202) in patients with re­lapsed or re­frac­tory multiple myeloma (MM).

I-Mab ini­ti­ated two reg­is­tra­tional trials with TJ202 / MOR202 in re­lapsed or re­frac­tory MM in Taiwan in early 2019 and ex­panded these trials into mainland China in late 2019, after re­ceiv­ing IND clear­ance from the National Medical Products Admin­istra­tion (NMPA). The first trial (NCT03860038), a Phase 2 trial, is designed to eval­u­ate the efficacy and safety of TJ202 / MOR202 as a third-line treat­ment in patients with re­lapsed or re­frac­tory MM, while the second trial (NCT03952091) is assessing 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. Site preparations in China have proceeded well with the first patient being dosed on schedule in the Phase 2 study. Under I-Mab's fast-to-market devel­op­ment strat­e­gy, both studies have been designed as pivotal trials, which, if suc­cess­ful, could pave the way for new drug appli­ca­tions (NDA) for TJ202 / MOR202 in Greater China.

"We are pleased that the first patient has been suc­cess­fully dosed in mainland China," said Jingwu Zang, MD., PhD., Founder and Honorary Chairman of I-Mab Bio­pharma­. "The initiation of enrollment in China of TJ202 / MOR202 is an im­por­tant mile­stone. We look for­ward to accelerating TJ202 / MOR202 clin­i­cal pro­gram sig­nif­i­cantly to­wards reg­is­tra­tion, which will benefit the patients with multiple myeloma in China," added Dr. Zang.

TJ202/MOR202 is a dif­fer­en­ti­ated anti­body originally devel­oped by MorphoSys AG that has shown prom­ise in pre­clin­i­cal animal studies and early human clin­i­cal trials. I-Mab licensed the prod­uct from MorphoSys and owns the ex­clu­sive rights for its devel­op­ment and com­mer­cial­iza­tion in mainland China, Hong Kong, Macao and Taiwan. I-Mab is devel­op­ing this prod­uct in multiple myeloma and in cer­tain auto­immune dis­eases, in­clud­ing sys­temic lupus erythematosus.

About TJ202 / MOR202

TJ202/MOR202 is an inves­ti­ga­tional fully human mono­clonal anti­body derived from the MorphoSys 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 mech­a­nism 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 anti-CD38 anti­bodies may have thera­peutic poten­tial in other cancers and auto­immune dis­eases. Based on a license agree­ment be­tween MorphoSys and I-Mab signed in No­vem­ber 2017, I-Mab owns the ex­clu­sive rights for the devel­op­ment and com­mer­cial­iza­tion of TJ202 / MOR202 in mainland China, Taiwan, Hong Kong and Macao.

About I-Mab

I-Mab is a dynamic, global bio­tech com­pany ex­clu­sively focused on devel­op­ing biologics of novel or highly dif­fer­en­ti­ated 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 pre­clin­i­cal and clin­i­cal devel­op­ment ex­per­tise, and world-class GMP manu­fac­tur­ing capabilities. I-Mab is a private bio­pharma­ceu­tical com­pany with offices in China and the United States and has raised over US$400 million in equity financing since its estab­lish­ment in 2016.

For more in­for­ma­tion, please see the Com­pany's website at www.i-mabbiopharma.com

Source: I-Mab Bio­pharma­.