MorphoSys Presents First Safety, Pharmacokinetic and Efficacy Data for MOR202 in Multiple Myeloma at ASCO Meeting
(Thomson Reuters ONE) -
MorphoSys AG /
MorphoSys Presents First Safety, Pharmacokinetic and Efficacy Data for MOR202 in
Multiple Myeloma at ASCO Meeting
. Processed and transmitted by NASDAQ OMX Corporate Solutions.
The issuer is solely responsible for the content of this announcement.
Clinical Activity and Long-lasting Tumor Control Already Observed at Low Doses
* MOR202 is safe and tolerable in weekly and biweekly doses
* MOR202 showed early signs of clinical activity with cases of long-lasting
tumor control
* MOR202 demonstrated best-in-class infusion tolerability as consistent 2-hour
infusion with no infusion reaction in combination with dexamethasone
* Overall, the first clinical MOR202 data hint towards a balanced and
potentially best-in-class safety/efficacy profile
* Preclinical data demonstrate synergistic potential of MOR202 and
pomalidomide, an established immunomodulatory agent in relapsed/refractory
multiple myeloma therapy
* Dose escalation to 16 mg/kg weekly plus dexamethasone is ongoing;
combination with pomalidomide and lenalidomide plus dexamethasone to start
shortly
MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) today
published first safety and efficacy data on its proprietary drug candidate
MOR202. The data are from a phase 1/2a study in 42 heavily pretreated patients
with relapsed/refractory multiple myeloma. MOR202 is a fully human monoclonal
HuCAL antibody targeting CD38, a highly expressed and validated target in
multiple myeloma. The preliminary clinical data, which were presented today at
the 2015 American Society of Clinical Oncology Annual Meeting (ASCO), show that
MOR202 was safe and well tolerated with a best-in-class infusion tolerability as
a 2-hour infusion. Infusion reactions in patients receiving MOR202 without
dexamethasone were mostly mild to moderate and mainly limited to the first
infusion. In patients receiving MOR202 in combination with dexamethasone, no
infusion reactions were observed. MOR202 demonstrated promising early signs of
activity, and cases of long-lasting tumor control were already observed in early
cohorts.
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
pomalidomide and lenalidomide plus dexamethasone 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 immunomodulatory drugs (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 today at the ASCO 2015 meeting show that MOR202 was safe and
tolerable and could be administered as a 2-hour infusion. Infusion-related
reactions occurred in 13 patients (37%) receiving MOR202 without dexamethasone,
mainly limited to the first infusion. All infusion reactions were grade 1-2
except for one patient with grade 3. No infusion reactions occurred in patients
who received dexamethasone. The maximum tolerated dose (MTD) has not been
reached. The best response to date, a very good partial response (VGPR), was
achieved in the 4.0 mg/kg weekly dose cohort plus dexamethasone. Additionally,
one minimal response (MR) and ten cases of stable disease (SD) in other dose
groups starting as low as 1.5 mg/kg biweekly were reported. The preliminary
pharmacokinetic data indicate the potential for full target occupancy with a
dose of 16 mg/kg administered weekly.
The study is ongoing and the higher doses of MOR202 are being evaluated in
combination with dexamethasone. Further cohorts in which patients will
receive MOR202 up to 16 mg/kg weekly in combination with the IMiDs pomalidomide
and lenalidomide plus dexamethasone will commence shortly.
"MOR202 has shown clinical activity, which is already very promising. The safety
and tolerability profile, especially regarding infusion reactions, opens up the
clear potential to differentiate our compound from other anti-CD38 therapies
currently in development," commented Dr. Arndt Schottelius, Chief Development
Officer of MorphoSys AG. "We are pleased with this first snapshot of MOR202's
clinical potential. The data will mature over the coming months and we will
provide updates at future medical conferences."
MorphoSys additionally presented today promising preclinical data demonstrating
the synergistic potential of MOR202 and pomalidomide, an established
immunomodulatory agent in relapsed/refractory multiple myeloma therapy.
This synergistic benefit was between 1.2-fold and 3.1-fold above the theoretical
benefit of combining the drugs and resulted from multiple mechanisms, namely
direct cytotoxicity, CD38 up-regulation and activation of effector cells.
Dr. Schottelius added: "We believe MOR202 is a very attractive combination
partner in multiple myeloma. The data presented today support the rationale of
combining MOR202 with established multiple myeloma drugs such as lenalidomide
and pomalidomide in cohorts which will commence shortly in the ongoing study."
The ASCO posters can be downloaded from the Company's website:
Poster #8574
A phase 1/2a study of the human anti-CD38 antibody MOR202 (MOR03087) in relapsed
or refractory multiple myeloma (rrMM).
Poster #8588
Effect of IMiD compounds on CD38 expression on multiple myeloma cells: MOR202, a
human CD38 antibody in combination with pomalidomide.
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 90 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(®) and 100 billion high potentials(®) are registered trademarks of
MorphoSys AG.
Slonomics(®) is a registered trademark of Sloning BioTechnology GmbH, a
subsidiary of MorphoSys AG.
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
Mario Brkulj
Associate Director Corporate Communications & IR
Alexandra Goller
Manager Corporate Communications & IR
Jessica Rush
Manager Corporate Communications & IR
Tel: +49 (0) 89 / 899 27-404
investors(at)morphosys.com
Media Release (PDF):
http://hugin.info/130295/R/1925029/690614.pdf
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: MorphoSys AG via GlobeNewswire
[HUG#1925029]
Unternehmensinformation / Kurzprofil:
Datum: 31.05.2015 - 15:01 Uhr
Sprache: Deutsch
News-ID 396966
Anzahl Zeichen: 9632
contact information:
Town:
Martinsried / Munich
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 236 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"MorphoSys Presents First Safety, Pharmacokinetic and Efficacy Data for MOR202 in Multiple Myeloma at ASCO Meeting"
steht unter der journalistisch-redaktionellen Verantwortung von
MorphoSys AG (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
