06.12.2016
Biotest AG DE0005227235
DGAP-News: Biotest AG: Encouraging data of Indatuximab Ravtansine (BT-062) in combination therapy in advanced Multiple Myeloma
DGAP-News: Biotest AG / Key word(s): Research Update
Biotest AG: Encouraging data of Indatuximab Ravtansine (BT-062) in
combination therapy in advanced Multiple Myeloma
06.12.2016 / 07:00
The issuer is solely responsible for the content of this announcement.
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PRESS RELEASE
Encouraging data of Indatuximab Ravtansine (BT-062) in combination therapy
in advanced Multiple Myeloma
- New data from BT-062 in combination therapy presented at 58th annual
conference of the American Society of Hematology
- Clinical benefit seen in large majority of patients with advanced
multiple myeloma
- Very good response achieved in patients who did not respond adequately
to prior therapies
Dreieich, 6 December 2016. Biotest presented new clinical data derived from
an ongoing combination study with BT-062 at the 58th annual meeting of the
American Society of Hematology (ASH) in San Diego. The Phase I/IIa study
(Study 983) is investigating the safety and efficacy of BT-062 in
combination with lenalidomide or pomalidomide and dexamethasone in patients
with multiple myeloma who have not been responding (any more) to previous
treatments. Multiple myeloma is an incurable malignant hematologic disease
and despite new treatment options patients finally relapse.
In the study, a total of 64 patients were treated with BT-062, used in
combination with lenalidomide and dexamethasone (47 patients) or
pomalidomide and dexamethasone (17 patients). Enrollment into the study is
completed. Patients are treated until progression of multiple myeloma or
intolerance. 11 of the 64 heavily pretreated patients enrolled are
currently still on treatment, partly for up to 42 months.
Currently available efficacy data were evaluated from 43 patients treated
with BT-062 in combination with lenalidomide and dexamethasone, who had
received at least two complete treatment cycles. 77% of these heavily
pretreated patients had an objective response, achieving a partial response
or better. Even in 13 patients previously treated with both lenalidomide
and bortezomib and who did not respond adequately to the last therapy, an
objective response rate of 54% was obtained. This patient population, known
to usually have a poor response to treatment, was selected for a treatment
with BT-062 in combination with pomalidomide and dexamethasone. Among 14
patients having completed at least 2 treatment cycles, 11 patients achieved
a partial or very good partial response, resulting in an objective response
rate of 79%.
The available data indicates that BT-062 at doses up to 100 mg/m² is well
tolerated in both combination regimens.
Data from the study suggests that BT-062 in combination with lenalidomide
and dexamethasone or pomalidomide and dexamethasone may provide additional
treatment options for patients with advanced multiple myeloma. BT-062 in
combination with pomalidomide and dexamethasone seems particularly suitable
for patients usually known to have a poor outcome. These encouraging data
support further investigation in larger clinical studies. Biotest is
currently looking for a partner for further development of this promising
compound, which is also being investigated in a clinical study in solid
tumors.
Further information is available on the Biotest website: http://
www.biotest.de/ww/en/pub/biotherapeutics/publications.cfm
About BT-062
BT-062 (indatuximab ravtansine) is an antibody-drug conjugate (ADC)
consisting of a monoclonal antibody and a highly potent cytotoxic
maytansine derivative (DM4) using the ADC technology developed by
ImmunoGen, Inc. The antibody binds specifically to the antigen CD138, which
is over-expressed on multiple myeloma cells and a variety of solid tumors.
Once the conjugate is internalized into the target cell, the DM4 is
released from the targeting molecule, thereby releasing it in its fully-
potent state. This combination of high efficacy and specificity with low
systemic toxicity sets BT-062 apart from most therapies currently used to
treat multiple myeloma.
About Biotest
Biotest is a provider of plasma proteins and biological drugs. With a value
added chain that extends from pre-clinical and clinical development to
worldwide sales, Biotest has specialised primarily in the areas of clinical
immunology, haematology and intensive medicine. Biotest develops and
markets immunoglobulins, coagulation factors and albumins based on human
blood plasma. These are used for diseases of the immune and haematopoietic
systems. In addition Biotest develops monoclonal antibodies in the
indications of cancer of plasma cells and systemic lupus erythematosus
which are produced by recombinant technologies. Biotest has more than 2,500
employees worldwide. The preference shares of Biotest AG are listed in the
SDAX on the Frankfurt stock exchange.
IR contact
Dr. Monika Buttkereit
phone: +49-6103-801-4406
email: [email protected]
PR contact
Dirk Neumüller
phone: +49-6103-801-269
email: [email protected]
Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.de
Ordinary shares: securities' ID No. 522720; ISIN DE0005227201
Preference shares: securities' ID No. 522723; ISIN DE0005227235
Listing: Prime Standard
Open Market: Berlin-Bremen, Düsseldorf, Frankfurt, Hamburg, Hanover,
Munich, Stuttgart
Disclaimer
This document contains forward-looking statements on overall economic
development as well as on the business, earnings, financial and assets
position of Biotest AG and its subsidiaries. These statements are based on
current plans, estimates, forecasts and expectations of the company and are
thus subject to risks and elements of uncertainty that could result in
significant deviation of actual developments from expected developments.
The forward-looking statements are only valid at the time of publication.
Biotest does not intend to update the forward-looking statements and
assumes no obligation to do so.
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06.12.2016 Dissemination of a Corporate News, transmitted by DGAP - a
service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
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Language: English
Company: Biotest AG
Landsteinerstraße 5
63303 Dreieich
Germany
Phone: 0 61 03 - 8 01-0
Fax: 0 61 03 - 8 01-150
E-mail: [email protected]
Internet: http://www.biotest.de
ISIN: DE0005227235, DE0005227201
WKN: 522723, 522720
Indices: SDAX
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated
Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover,
Munich, Stuttgart, Tradegate Exchange
End of News DGAP News Service
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