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MorphoSys Presents Interim Safety, Pharmacokinetic and Efficacy Data for MOR202 in Multiple Myeloma at ASH Meeting

  • MOR202 produced encouraging response rates as single agent and in first combination cohorts with immunomodulatory drugs (IMiDs).
  • MOR202 is well tolerated and can be safely administered as a 2-hour intravenous infusion with a very low incidence of infusion-related reactions.
  • The phase 1/2a trial is ongoing; dose escalation to 16 mg/kg MOR202 combined with pomalidomide or lenalidomide plus dexamethasone will continue.
  • Confirmatory cohorts are planned to validate the recommended dose of MOR202 monotherapy and in combination with IMiDs.
  • In preclinical models, MOR202 showed a level of antibody-dependent cellular cytotoxicity (ADCC) against multiple myeloma cells equivalent to that of daratumumab and isatuximab surrogates, while sparing the natural killer (NK) cells that are essential for the activity of the antibody.

MARTINSRIED / MUNICH, Germany, Dec. 7, 2015 (GLOBE NEWSWIRE) -- MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) 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). 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 Annual Meeting (ASH), 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.

"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 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 Annual Meeting. Two KOLs will present the new clinical data for MOR208 and MOR202.

A replay and the presentation will be made available at http://www.morphosys.com.

Live-Webcast: http://morphosys.equisolvewebcast.com/analyst-event-12-7-15

The ASH posters can be downloaded from the Company's website:

Poster #3035
M. Raab et al: Phase I/IIa Study of the Human Anti-CD38 Antibody MOR202 (MOR03087) in Relapsed or Refractory Multiple Myeloma

Poster #3015
R. Boxhammer et al: MOR202, a Human Anti-CD38 Monoclonal Antibody, Mediates Potent Tumoricidal Activity In Vivo and Shows Synergistic Efficacy in Combination with Different Antineoplastic Compounds

Poster # 2203
H. Bruns et al: Lenalidomide Enhances MOR202 Dependent Macrophage-Mediated Effector Functions Via the Vitamin D Pathway

About MorphoSys:

MorphoSys developed HuCAL, the most successful antibody library technology in the pharmaceutical industry. By successfully applying this and other patented technologies, MorphoSys has become a leader in the field of therapeutic antibodies, one of the fastest-growing drug classes in human healthcare.

Together with its pharmaceutical partners, MorphoSys has built a therapeutic pipeline of more than 100 human antibody drug candidates for the treatment of cancer, rheumatoid arthritis, and Alzheimer's disease, to name just a few. With its ongoing commitment to new antibody technology and drug development, MorphoSys is focused on making the healthcare products of tomorrow. MorphoSys is listed on the Frankfurt Stock Exchange under the symbol MOR. For regular updates about MorphoSys, visit http://www.morphosys.com.

HuCAL®, HuCAL GOLD®, HuCAL PLATINUM®, CysDisplay®, RapMAT®, arYla®, Ylanthia®, 100 billion high potentials®, Slonomics®, Lanthio Pharma® and LanthioPep® are registered trademarks of the MorphoSys Group.

This communication contains certain forward-looking statements concerning the MorphoSys group of companies, The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve risks and uncertainties, Should actual conditions differ from the Company's assumptions, actual results and actions may differ from those anticipated, MorphoSys does not intend to update any of these forward-looking statements as far as the wording of the relevant press release is concerned.

For more information, please contact:
MorphoSys AG
Dr. Claudia Gutjahr-Löser
Head of Corporate Communications & IR

Alexandra Goller
Manager Corporate Communications & IR

Jochen Orlowski
Associate Director Corporate Communications & IR

Tel: +49 (0) 89 / 899 27-404
investors@morphosys.com

Media Release (PDF) http://hugin.info/130295/R/1971627/720975.pdf

HUG#1971627

Source:MorphoSys AG