Press Detail

Biotest AG: Encouraging Efficacy of Indatuximab Ravtansine (BT-062) in Multiple Myeloma in combination with Lenalidomide and Dexamethasone

Biotest AG / Key word(s): Research Update

09.12.2014 / 05:00

/
PRESS RELEASE

Encouraging Efficacy of Indatuximab Ravtansine (BT-062) in Multiple Myeloma in combination with Lenalidomide and Dexamethasone

- New data from combination therapy study presented at 56^th annual conference of the American Society of Hematology

- Clinical benefit seen in all evaluable patients with advanced Multiple Myeloma

- Complete remissions observed in individual patients

- Good response achieved in patients who did not respond adequately to other therapies

Dreieich, 9 December 2014. Biotest presented new clinical data derived from an ongoing combination study with BT-062 at the 56^th annual meeting of the American Society of Hematology (ASH) in San Francisco. The Phase I/IIa study (Study 983) in multiple myeloma is investigating the safety and efficacy of BT-062 in combination with lenalidomide and dexamethasone in patients who have not been responding (any more) to previous treatments.

In the study, a total of 47 patients were treated with three different dosages up to maximum of 120 mg/m² BT-062, used in combination with lenalidomide and dexamethasone. Patients were treated until progression of the underlying disease or occurrence of unacceptable toxicities. 25 of the 47 patients enrolled are currently still on treatment, partly for up to 23 months.

Currently available efficacy data were evaluated from those 41 patients who had at least two efficacy assessments since the start of the treatment. All of these heavily pretreated patients showed clinical benefit from the therapy, achieving a stable disease or better. 78% of these patients had an objective response which ranges from a partial response to stringent complete response. Up to now 10% of the patients had a complete remission. Even in patients previously treated with both lenalidomide and bortezomib, an objective response rate of 68% was obtained.

The available data indicate that BT-062 is well tolerated in this combination regimen up to doses of 100 mg/m².

Among the patients treated with the maximal tolerated dose (100 mg/m²), even 83% had an objective response.

Based on these encouraging data, it is planned to also evaluate safety and efficacy of BT-062 in combination with pomalidomide and dexamethasone in patients already exposed to lenalidomide and bortezomib.
Besides the multiple myeloma cells also many solid tumors express high levels of the CD 138 receptor. Biotest is conducting a monotherapy phase I/IIa study (Study 989) in triple negative metastatic breast cancer and metastatic urinary bladder cancer in Belgium and Germany.

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 ImmunoGen, Inc.
ImmunoGen, Inc. develops targeted anticancer therapeutics. The Company's ADC technology uses tumor-targeting antibodies to deliver ImmunoGen cell-killing agent specifically to cancer cells; the Company has also developed antibodies with anticancer activity of their own. The first product with ImmunoGen's ADC technology is Roche's Kadcyla^(R). ImmunoGen has three product candidates in clinical testing and additional compounds in clinical testing through the Company's partnerships with Amgen, Bayer HealthCare, Biotest and Sanofi.

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.

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 rheumatoid arthritis and cancer of plasma cells, which are produced by recombinant technologies. Biotest has more than 2.100 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.

Biotest AG, Landsteinerstr. 5, 63303 Dreieich, www.biotest.de
Dr. Monika Buttkereit
tel.: +49 (0) 6103 801-4406,
e-mail: investor_relations@biotest.de
fax: +49 (0) 6103 801-347

Securities' ID No., ISIN ordinary shares: 522720, DE0005227201
Securities' ID No., ISIN preference shares: 522723, DE0005227235
Listing: Prime Standard
Open Market: Berlin-Bremen, Düsseldorf, Frankfurt, Hamburg, Hannover, München, Stuttgart

09.12.2014 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.
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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:	investor_relations@biotest.de
Internet:	http://www.biotest.de
ISIN:	DE0005227235, DE0005227201
WKN:	522723, 522720
Indices:	SDAX
Listed:	Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr in Berlin, Düsseldorf, Hamburg, Stuttgart


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