MorphoSys announces updated clinical data on its proprietary drug candidate MOR208

Matured Data Set Shows Six Complete Remissions with Durable Responses in Diffuse Large B-cell Lymphoma and Follicular Lymphoma

MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) today announced updated clinical data on its proprietary drug candidate MOR208. MOR208 is a potent anti-CD19 antibody with a proprietary modification to the Fc portion that is being developed to treat B-cell malignancies. The data, which were presented today at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting, are from an ongoing phase 2a study of patients with four different subtypes of relapsed or refractory Non-Hodgkin's Lymphoma (NHL). The clinical data show that MOR208 is well tolerated with a low level of infusion reactions and demonstrates encouraging single-agent activity. Based on these encouraging results, MorphoSys plans to advance MOR208 into two combination trials in DLBCL.

"The results for MOR208 have matured significantly since we presented the program at ASH 2014 with two additional complete remissions reported and first-published results for the duration of response. It is worth noting that MOR208 was used as monotherapy in this trial, and the good tolerability we observed supports our plans to test combinations with other drugs," commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG. "The results we've seen in the clinic justify our ambitious program for this exciting drug candidate, which include two subsequent studies evaluating MOR208 in combination with lenalidomide and bendamustine to treat DLBCL."

The preliminary data presented today at ASCO summarize efficacy and safety results for 92 heavily pre-treated patients. The overall response rate was 28% across all four subtypes of NHL and reached 36% in the DLBCL subgroup (both based on evaluable patients). At the time of the analysis, the majority of responders - 16 out of 21 - had an ongoing response to the treatment. The longest response duration observed so far exceeded 14.2 months in DLBCL, 15.4 months in FL and 10.8 months in other iNHL.

The open-label, phase 2a, multicenter study was designed to assess the activity and safety of single-agent MOR208 in patients with diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), and other indolent NHL (iNHL), who had received at least one prior rituximab-containing therapy. Patients were initially treated with a total of eight weekly doses of 12 mg/kg MOR208. Those with at least stable disease stayed on MOR208 treatment for an additional four weeks. After completion of these twelve weekly doses of treatment, responding patients, who demonstrated at least partial response received maintenance therapy until disease progression or unacceptable toxicity.

Investigator assessed response in the NHL subtype specific cohorts

Best overall response NHL subtypes (patients per cohort)
DLBCL (35) FL (34) iNHL (11) MCL (12) Overall (92)
Complete responses 2 2 2 0 6
Partial responses 7 7 1 0 15
Stable disease 5 17 4 6 32
Progressive disease 11 4 3 5 23
Not evaluable 10 4 1 1 16
ORR per cohort 26% 26% 27% 0% 23%
ORR (evaluable patients) 36% 30% 30% 0% 28%

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