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DGAP-Adhoc: MorphoSys AG: Ad hoc: Primary Endpoint of L-MIND, a Combination Study of Tafasitamab (MOR208) and Lenalidomide, has been met, Confirming Previously Published Activity

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DGAP-Ad-hoc: MorphoSys AG / Key word(s): Study results
MorphoSys AG: Ad hoc: Primary Endpoint of L-MIND, a Combination Study of
Tafasitamab (MOR208) and Lenalidomide, has been met, Confirming Previously
Published Activity

16-May-2019 / 21:13 CET/CEST
Disclosure of an inside information acc. to Article 17 MAR of the Regulation
(EU) No 596/2014, transmitted by DGAP - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

*Ad hoc release according to article 17 MAR*
Planegg/Munich, Germany, May 16, 2019

*Ad hoc: Primary Endpoint of L-MIND, a Combination Study of Tafasitamab
(MOR208) and Lenalidomide, has been met, Confirming Previously Published
Activity*

MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; Nasdaq: MOR)
today announced results from the primary analysis (cut-off date November 30,
2018) of the ongoing single-arm phase 2 clinical trial known as L-MIND. The
results overall confirm earlier reported interim data from this trial.
L-MIND is designed to investigate the antibody tafasitamab (MOR208) in
combination with lenalidomide in patients with relapsed or refractory
diffuse large B cell lymphoma (r/r DLBCL) who are ineligible for high-dose
chemotherapy and autologous stem cell transplantation. Tafasitamab is an
investigational humanized Fc-enhanced monoclonal antibody directed against
CD19 and is currently in clinical development in blood cancer indications.

The data reported today included 80 patients enrolled into the trial who had
received tafasitamab and lenalidomide and had been followed-up as per
protocol for at least one year. Efficacy results in this update are based on
response rates assessed by an independent review committee for all 80
patients.

The primary endpoint, defined as best objective response rate (ORR) compared
to published data on the respective monotherapies, has been met. The ORR was
60% (48 out of 80 patients), and the complete response (CR) rate was 43% (34
out of 80 patients). The median progression free survival (mPFS) was 12.1
months with a median follow-up of 17.3 months. The medium duration of
response (mDoR) was 21.7 months. These results provide overall confirmation
of the strong L-MIND data previously published at ASH in December 2018.
These data showed an ORR of 58% with a CR rate of 33%; the mPFS was 16.2
months; data was assessed by the investigators.

*END OF AD HOC RELEASE*

Information and Explanation of the Issuer to this News:

About CD19 and tafasitamab (MOR208)
CD19 is broadly and homogeneously expressed across different B cell
malignancies including DLBCL and CLL. CD19 has been reported to enhance B
cell receptor (BCR) signaling, which is assumed important for B cell
survival, making CD19 a potential target in B cell malignancies.
Tafasitamab (MOR208) is an investigational humanized Fc-engineered
monoclonal antibody directed against CD19. Fc-modification of tafasitamab is
intended to lead to a significant potentiation of antibody-dependent
cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular
phagocytosis (ADCP), thus aiming to improve a key mechanism of tumor cell
killing. Tafasitamab has been observed in preclinical models to induce
direct apoptosis by binding to CD19, which is assumed to be involved in B
cell receptor (BCR) signaling.
MorphoSys is clinically investigating tafasitamab as a therapeutic option in
B cell malignancies in a number of ongoing combination trials. An open-label
phase 2 combination trial (L-MIND study) is investigating the safety and
efficacy of tafasitamab in combination with lenalidomide in patients with
relapsed/refractory DLBCL who are not eligible for high-dose chemotherapy
(HDC) and autologous stem cell transplantation (ASCT). Based on interim data
from L-MIND, in October 2017 the U.S. FDA granted Breakthrough Therapy
Designation for tafasitamab plus lenalidomide in this patient population.
The pivotal phase 2/3 B-MIND study is designed to investigate tafasitamab in
combination with the chemotherapeutic agent bendamustine in patients with
relapsed/refractory DLBCL who are not eligible for high-dose chemotherapy
(HDC) and autologous stem cell transplantation (ASCT) in comparison to the
combination of the anti-CD20 antibody rituximab plus bendamustine. In
addition, tafasitamab is currently being investigated in patients with
relapsed/refractory CLL/SLL after discontinuation of a prior Bruton tyrosine
kinase (BTK) inhibitor therapy (e.g. ibrutinib) in combination with
idelalisib or venetoclax.

About MorphoSys:
MorphoSys (FSE & NASDAQ: MOR) is a clinical-stage biopharmaceutical company
dedicated to the discovery, development and commercialization of
exceptional, innovative therapies for patients suffering from serious
diseases. The focus is on cancer. Based on its leading expertise in
antibody, protein and peptide technologies, MorphoSys, together with its
partners, has developed and contributed to the development of more than 100
product candidates, of which 29 are currently in clinical development. In
2017, Tremfya(R), marketed by Janssen for the treatment of plaque psoriasis,
became the first drug based on MorphoSys's antibody technology to receive
regulatory approval. The Company's most advanced proprietary product
candidate, tafasitamab, has been granted U.S. FDA breakthrough therapy
designation for the treatment of patients with relapsed/refractory diffuse
large B-cell lymphoma (DLBCL). Headquartered near Munich, Germany, the
MorphoSys group, including the fully owned U.S. subsidiary MorphoSys US
Inc., has approximately 330 employees. More information at
https://www.morphosys.com [1].

HuCAL(R), HuCAL GOLD(R), HuCAL PLATINUM(R), CysDisplay(R), RapMAT(R),
arYla(R), Ylanthia(R), 100 billion high potentials(R), Slonomics(R), Lanthio
Pharma(R) and LanthioPep(R) are registered trademarks of the MorphoSys
Group. Tremfya(R) is a trademark of Janssen Biotech, Inc.

MorphoSys forward looking statements
This communication contains certain forward-looking statements concerning
the MorphoSys group of companies, including the clinical development of
tafasitamab in combination with lenalidomide in the L-MIND study in r/r
DLBCL, the clinical development of tafasitamab in combination with
bendamustine versus rituximab and bendamustine in the B-MIND study in r/r
DLBCL,the further clinical development of tafasitamab as well as
interactions with regulatory authorities and expectations regarding
regulatory filings and possible approvals for tafasitamab. The
forward-looking statements contained herein represent the judgment of
MorphoSys as of the date of this release and involve known and unknown risks
and uncertainties, which might cause the actual results, financial condition
and liquidity, performance or achievements of MorphoSys, or industry
results, to be materially different from any historic or future results,
financial conditions and liquidity, performance or achievements expressed or
implied by such forward-looking statements. In addition, even if MorphoSys'
results, performance, financial condition and liquidity, and the development
of the industry in which it operates are consistent with such
forward-looking statements, they may not be predictive of results or
developments in future periods. Among the factors that may result in
differences are MorphoSys' expectations the clinical development of
tafasitamab in combination with lenalidomide in the L-MIND study in r/r
DLBCL, the clinical development of tafasitamab in combination with
bendamustine versus rituximab and bendamustine in the B-MIND study in r/r
DLBCL, the further clinical development of tafasitamab as well as
interactions with regulatory authorities and expectations regarding
regulatory filings and possible approvals for tafasitamab, MorphoSys'
reliance on collaborations with third parties, estimating the commercial
potential of its development programs and other risks indicated in the risk
factors included in MorphoSys's Annual Report on Form 20-F and other filings
with the US Securities and Exchange Commission. Given these uncertainties,
the reader is advised not to place any undue reliance on such
forward-looking statements. These forward-looking statements speak only as
of the date of publication of this document. MorphoSys expressly disclaims
any obligation to update any such forward-looking statements in this
document to reflect any change in its expectations with regard thereto or
any change in events, conditions or circumstances on which any such
statement is based or that may affect the likelihood that actual results
will differ from those set forth in the forward-looking statements, unless
specifically required by law or regulation.

*For more information, please contact:*

*MorphoSys AG*
Dr. Sarah Fakih
Head of Corporate Communications & IR

Alexandra Goller
Director Corporate Communications & IR

Dr. Julia Neugebauer
Director Corporate Communications & IR

Dr. Verena Kupas
Manager Corporate Communications & IR

*Tel: +49 (0) 89 / 899 27-404*
_investors@morphosys.com_

16-May-2019 CET/CEST The DGAP Distribution Services include Regulatory
Announcements, Financial/Corporate News and Press Releases.
Archive at www.dgap.de
Language: English
Company: MorphoSys AG
Semmelweisstr. 7
82152 Planegg
Germany
Phone: +49 (0)89 899 27-0
Fax: +49 (0)89 899 27-222
E-mail: investors@morphosys.com
Internet: www.morphosys.com
ISIN: DE0006632003
WKN: 663200
Indices: MDAX, TecDAX
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated
Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover,
Munich, Stuttgart, Tradegate Exchange; Nasdaq
EQS News ID: 812717

End of Announcement DGAP News Service

812717 16-May-2019 CET/CEST


1: https://link.cockpit.eqs.com/cgi-bin/fncls.ssp?fn=redirect&url=3e1886fbba4d35045db9993a27da4719&application_id=812717&site_id=vwd&application_name=news


(END) Dow Jones Newswires

May 16, 2019 15:14 ET ( 19:14 GMT)
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