Planegg / Munich, Germany, and Shanghai, China (Press Release) – MorphoSys AG (FSE:MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ:MOR) and I-Mab Bio­pharma­ (I-Mab) announced today that I-Mab has received Inves­ti­ga­tional New Drug (IND) clear­ances from the National Medical Products Admin­istra­tion (NMPA) of China to ex­pand the ongoing phase 2 and 3 clin­i­cal trials of MOR202 / TJ202, MorphoSys's human mono­clonal anti-CD38 anti­body for the treat­ment of multiple myeloma (MM), also to mainland China. I-Mab, a China-based clin­i­cal stage bio­pharma­ceu­tical com­pany exclusively focused on the discovery and devel­op­ment of novel or highly dif­fer­en­ti­ated …

Shanghai, China (Press Release) – I-Mab Bio­pharma­ ("I-Mab"), a China and U.S.-based clin­i­cal stage bio­pharma­ceu­tical com­pany exclusively focused on the discovery and devel­op­ment of novel or highly dif­fer­en­ti­ated biologics in immuno-oncology and auto­immune dis­eases and German biopharma com­pany MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX;Nasdaq: MOR), today announced that I-Mab has received Inves­ti­ga­tional New Drug (IND) clear­ances from the National Medical Products Admin­istra­tion (NMPA) of China to ex­pand the ongoing phase II and III clin­i­cal trials of TJ202 / MOR202, MorphoSys's human mono­clonal anti-CD38 anti­body for the treat­ment of multiple …

A team of Dutch researchers has published results of a small study in­ves­ti­gat­ing the impact of Darzalex treat­ment on immuno­glob­u­lin levels in multiple myeloma patients.

In their study, the researchers focus in particular on how the levels of a patient’s un­in­volve­d immuno­glob­u­lins are affected by treat­ment with Darzalex.

Uninvolved immuno­glob­u­lins in myeloma patients are immuno­glob­u­lins that have a type dif­fer­en­t from any mono­clonal immuno­glob­u­lin made by a patient’s myeloma cells.

Someone with IgG multiple myeloma, for example, has myeloma plasma cells that produce mono­clonal immuno­glob­u­lin G (IgG). For this myeloma patient, the …

As researchers search for new treat­ments for multiple myeloma, they are particularly interested in uncovering ther­a­pies that address the dis­ease in new ways. Survival and the chance for a cure are likely to be im­proved the most by new treat­ments that are noticeably dif­fer­en­t from other myeloma ther­a­pies.

One of the reasons Darzalex (dara­tu­mu­mab), for example, has been such an im­por­tant new treat­ment for multiple myeloma is because it rep­re­sents a new way of treating the dis­ease. Darzalex was not just another immuno­modu­la­tory agent, like Revlimid (lena­lido­mide) or thalido­mide, and not just …

Silver Spring, MD (Approval & Safety Notification) – On Sep­tem­ber 26, 2019, the Food and Drug Admin­istra­tion approved dara­tu­mu­mab (DARZALEX, Janssen) for adult patients with multiple myeloma in com­bi­na­tion with bor­tez­o­mib, thalido­mide, and dexa­meth­a­sone in newly diag­nosed patients who are eli­gible for au­tol­o­gous stem cell trans­plant (ASCT).

Efficacy was in­ves­ti­gated in CASSIOPEIA (NCT02541383), an open-label, ran­dom­ized, active-controlled phase 3 study com­par­ing induction and con­sol­i­da­tion treat­ment with dara­tu­mu­mab 16 mg/kg in com­bi­na­tion with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone (DVTd) to treat­ment with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone (VTd) in patients with newly diag­nosed multiple myeloma eli­gible for …

• DARZALEX (dara­tu­mu­mab) approved by U.S. FDA in com­bi­na­tion with bor­tez­o­mib, thalido­mide (an immuno­modu­la­tory agent) and dexa­meth­a­sone as treat­ment for patients newly diag­nosed with multiple myeloma who are eli­gible for au­tol­o­gous stem cell trans­plant
• Approval based on Phase III CASSIOPEIA study

Copenhagen, Denmark (Company Announcement) – Genmab A/S (Nasdaq: GMAB) announced today that the U.S. Food and Drug Admin­istra­tion (U.S. FDA) has approved the use of DARZALEX® (dara­tu­mu­mab) in com­bi­na­tion with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone (VTd) as treat­ment for patients newly diag­nosed with multiple myeloma who are eli­gible for au­tol­o­gous stem cell trans­plant (ASCT). The supple­mental Biologics License Application (sBLA) for this indi­ca­tion was sub­mitted by Genmab’s licensing partner, Janssen Biotech, Inc. (Janssen) in March 2019. The U.S. FDA sub­se­quently granted priority review to the sBLA, …

• Phase III CANDOR study of dara­tu­mu­mab in com­bi­na­tion with car­filz­o­mib and dexa­meth­a­sone in re­lapsed or re­frac­tory mul­ti­ple myeloma met the pri­mary end­point of im­prove­ment in pro­gres­sion free sur­vival
• Data to be discussed with health author­i­ties in preparation for regu­la­tory sub­missions

Copenhagen, Denmark (Company Announcement) – Genmab A/S (Nasdaq: GMAB) an­nounced to­day top­line re­­sults from the Phase III CANDOR study, sponsored by Amgen, of dara­tu­mu­mab in com­bi­na­tion with car­filz­o­mib and dexa­meth­a­sone (Kd) versus Kd alone in patients with mul­ti­ple myeloma who have re­lapsed after one to three prior ther­a­pies. The study met the pri­mary end­point of im­prov­ing pro­gres­sion free sur­vival (PFS). The regi­men re­­sulted in a 37% re­duc­tion in the risk of pro­gres­sion or death in patients with re­lapsed or re­frac­tory mul­ti­ple myeloma treated with …