On December 07, 2015 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) reported that it has published safety and efficacy data on its proprietary drug candidate MOR202, a fully human HuCAL antibody targeting CD38, a highly expressed and validated target in multiple myeloma (MM) (Press release, MorphoSys, DEC 6, 2015, View Source [SID:1234508443]). The data are from a phase 1/2a clinical study in 52 heavily pretreated patients with relapsed/refractory multiple myeloma. The data, which were presented on Sunday, December 6, 2015, at the 2015 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (ASH) (Free ASH Whitepaper), show that MOR202 was safe and well tolerated with a 2-hour infusion time. The incidence of infusion-related reactions (IRR) was very low and mainly limited to the first infusion. In this heavily pre-treated patient population, MOR202 demonstrated encouraging responses with a best-in-class tolerability profile.

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"We are very pleased with the updated clinical results for MOR202. The clinically relevant dose regimens show encouraging clinical efficacy combined with a very good safety profile," commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG. "The clinical study will continue as planned, focusing on combination cohorts, as we see the highest potential for MOR202 in combination therapy."

The ongoing phase 1/2a, open-label, multi-center, dose-escalation study is being conducted in several centers in Germany and Austria. The study is evaluating the safety and preliminary efficacy of MOR202 as monotherapy and in combination with the immunomodulatory drugs (IMiDs) pomalidomide (POM) and lenalidomide (LEN) plus dexamethasone (Dex) in patients with relapsed/refractory multiple myeloma. The primary endpoints of the trial are the safety, tolerability and recommended dose of MOR202 alone and in combination with the IMiDs. Secondary outcome measures are pharmacokinetics and preliminary efficacy based on overall response rate, duration of response, time-to-progression, and progression-free survival.

The data presented at ASH (Free ASH Whitepaper) show that MOR202 can be safely administered as a 2-hour infusion and is well tolerated. Infusion-related reactions occurred in only 1 patient (6%) in the cohorts treated with the clinically relevant dose regimens. Patients received a median of 4 prior therapies. The maximum tolerated dose (MTD) has not been reached. In the monotherapy group, comprising patients treated with the clinically relevant dose regimens, 3 out of 9 patients (33%) achieved an objective response rate, with the other 6 patients showing stable disease. In the early combination cohorts at 8 mg/kg MOR202 with IMiDs (n=6), 1 very good partial response (VGPR; to be confirmed in next response assessment), 2 partial responses (PR) and 1 minimal response (MR) were reported. In upcoming cohorts, patients will receive 16 mg/kg MOR202 in combination with pomalidomide (POM) and lenalidomide (LEN) plus dexamethasone. In addition, confirmatory cohorts are planned to validate the recommended dose of MOR202 as monotherapy and in combination with POM/Dex and LEN/Dex.

MorphoSys also presented promising preclinical data demonstrating synergy of MOR202 in combination with different compounds representative of drug classes commonly used in the treatment of multiple myeloma. Another set of pre-clinical data focused on MOR202’s ability to kill targeted cells via ADCC. While MOR202 showed a level of killing of multiple myeloma cells equivalent to that of surrogates of daratumumab and isatuximab, it exhibited significantly reduced killing of NK cells. These results suggest that MOR202 may show a more durable clinical response than other compounds of its class, by sparing the NK cells needed for ADCC.

MorphoSys will hold today, December 7, 2015, at 8:00pm EST (December 8, 2015: 1:00am GMT, 2:00am MEZ) an Investor & Analyst Event at the 2015 ASH (Free ASH Whitepaper) Annual Meeting. Two KOLs will present the new clinical data for MOR208 and MOR202.