On September 23, 2015 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) reported updated safety and preliminary efficacy data on its proprietary drug candidate MOR202 from an ongoing phase 1/2a study (Press release, MorphoSys, SEP 22, 2015, View Source [SID:1234507519]). MOR202 is a fully human HuCAL antibody targeting CD38, a highly expressed and validated target in multiple myeloma. The clinical data, which will be presented at the 15th International Myeloma Workshop in Rome, Italy, September 23th-26th, confirm the very good overall safety profile previously reported at this year’s ASCO (Free ASCO Whitepaper) meeting. The update also includes promising first results from the highest dose escalation cohort of 16 mg/kg of MOR202 weekly plus dexamethasone and from the recently initiated combination arms with the immunomodulatory drugs (IMiDs) pomalidomide and lenalidomide.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

As of August 24, 2015, 50 heavily pretreated patients with relapsed/refractory multiple myeloma had received MOR202 with and without dexamethasone and in a few cases in combination with pomalidomide or lenalidomide as part of a recently initiated second part of the study. MOR202 continued to demonstrate long-lasting tumor control, as well as signs of activity. In addition to the earlier reported very good partial response (VGPR) in a cohort dosed weekly with 4 mg/kg of MOR202 plus dexamethasone, a minor response (MR) in the 8 mg/kg MOR202 weekly plus dexamethasone cohort further improved into a partial response (PR). A first MR was observed in one patient in an ongoing cohort at the highest dose level, of 16 mg/kg MOR202 plus dexamethasone. The first evaluable patient in the ongoing combination cohort of 8 mg/kg MOR202 plus pomalidomide and dexamethasone achieved a PR already after the first cycle. In the ongoing combination cohort of 8 mg/kg MOR202 plus lenalidomide and dexamethasone, one patient showed a MR after the first cycle. In total, the data shows one VGPR, two PRs and two MRs so far.

"The MOR202 data have matured nicely since we presented the program at this year’s ASCO (Free ASCO Whitepaper) conference and we expect an even more comprehensive picture as the trial progresses. First results from the combination cohorts with lenalidomide and pomalidomide confirm the synergistic potential we have demonstrated in preclinical studies using our antibody together with these two IMiDs. This bodes well for the future development of MOR202," commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG.

The data to be presented at the International Myeloma Workshop 2015 show that MOR202 was safe and tolerable and could be administered as a 2-hour infusion. Infusion-related reactions occurred in 15 patients (30%). Only one out of these 15 patients received dexamethasone as co-medication and experienced an infusion-related reaction (grade 1). In the absence of dexamethasone, all infusion reactions were grade 1-2 except for one patient with grade 3, mainly limited to the first infusion. The maximum tolerated dose has not been reached.

"The antibody continues to show a balanced safety and tolerability profile and the preliminary efficacy seen so far with MOR202 as single agent and in combinations is promising. Considering the low rate of infusion reactions, even in cohorts without dexamethasone, the short infusion time and other aspects, MOR202 may turn out to be an excellent choice in terms of safety and tolerability," commented Dr. Marc-Steffen Raab, Group Leader Experimental Therapies for Hematologic Malignancies at the Heidelberg University Hospital and the German Cancer Research Center DKFZ.

The study is ongoing and MorphoSys plans to provide a further update at a medical conference later this year.

The IMW poster can be downloaded from the Company’s website:

Poster #0156

Raab et al.: A phase I/IIa study of the human CD38 antibody MOR202 (MOR03087) in relapsed or refractory multiple myeloma

The poster presentation will take place on Friday Sep 25th, 6:40pm to 7:40pm CEST.