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Biotest AG: Further preclinical studies emphasise the potential of Indatuximab Ravtansine (BT-062) in solid tumours


Biotest AG / Key word(s): Research Update

24.10.2014 / 10:30


/
PRESS RELEASE

Further preclinical studies emphasise the potential of Indatuximab Ravtansine (BT-062) in solid tumours

- Antibody-drug conjugate shows high efficacy in an animal model in the treatment of bladder, breast, pancreatic and other tumours.

- Complete remission achieved in some treatment-refractory tumours.

- Presentation of the results at the World ADC specialist conference in San Diego.

Dreieich, 24 October 2014. Biotest has further results from preclinical studies of Indatuximab Ravtansine (BT-062) in various solid tumours. The studies were undertaken by Oncotest GmbH in Freiburg, an independent research laboratory. They exhibit efficacy that can be "classified as unusually good", according to a statement by the director, Prof. Dr. Heinz-Herbert Fiebig. "I have personally never yet seen such an outstanding effect on this scale," Prof. Fiebig continued.

Indatuximab Ravtansine was tested in vivo on human carcinomas of the bladder, breast, lung, prostate and pancreas and on head and neck tumours. A mouse model specially developed by Oncotest was used.
The tumour size diminished markedly under the therapy. 9 out of 14 tumours completely disappeared, some of which had not responded previously to standard therapy. These new studies, which concluded recently, confirm the results of previous preclinical studies published in 2012 and emphasise the high potential of Indatuximab Ravtansine.

"As an independent research institute with over 30 years' experience, Oncotest has a very good overview of current development projects in haematology and oncology. Classifying the test results with Indatuximab Ravtansine as extraordinarily good is therefore a particular confirmation for us to push ahead with development in these tumour indications", says Prof. Gregor Schulz, CEO of Biotest AG. Biotest will present the recent results at the World ADC conference, which takes place in San Diego from 26 to 29 October.

In March 2014 Biotest started a clinical phase I/IIa study in which the safety and anti-tumour activity of Indatuximab Ravtansine are being investigated in patients with triple receptor-negative metastatic breast cancer and patients with metastatic bladder cancer, who have the CD138 receptor on the surface of their tumour. In this monotherapy study, the maximum tolerable dosage must be determined again, regardless of the studies previously conducted in multiple myeloma. Biotest will have results regarding efficacy in the first half of next year. After the conclusion of the study, as usual in oncology, further studies in combination with other treatment modalities are planned. In multiple myeloma, the lead indication of Indatuximab Ravtansine, clinical trials have already shown good tolerability and very good efficacy in combination with lenalidomide. Current data will be presented at the beginning of December 2014 at the American Society of Hematology conference.

About Indatuximab Ravtansine (BT-062):
Indatuximab Ravtansine (BT-062) is an antibody-drug conjugate, consisting of a monoclonal antibody to which a highly active cytotoxic maytansin derivative (DM4) has been coupled. The technology developed by ImmunoGen, Inc. is used for toxin conjugation. The antibody is directed against the CD138 receptor, which is over-expressed on multiple myeloma cells and on other cells of various cancers.
After the conjugate is absorbed into the target cell, DM4 is released and exerts its cytotoxic activity so that the tumour cell is killed. This combination of high effectiveness and specificity with low systemic toxicity distinguishes BT-062 from most therapies currently used in oncology.

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 2.000 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

About Oncotest

Oncotest is a CRO dedicated to the preclinical profiling of novel anti-cancer molecules, facilitating the optimal planning of clinical trials. Promising indications, novel combinations of anti-cancer molecules and potential biomarkers are identified using a combination of in vitro and in vivo tests with Oncotest's extensively characterized collection of more than 400 unique patient-derived tumor xenografts (PDX) propagated in nude mice. PDX are known to replicate patient tumor responses to anti-cancer drugs to a high degree. Ex vivo 3D assays are an important component of Oncotest's assay portfolio and standard panels of to up 200 PDX are offered for 3D assay campaigns. Clients benefit from Oncotest's industry leading experience.
Oncotest, based in Freiburg, Germany, was founded in 1993 by Prof. Heiner Fiebig, a clinical oncologist who pioneered the use of PDX for anti-cancer drug discovery and development. The company is focused on preclinical pharmacology of anti-cancer agents and works with large pharmaceutical and biotech companies. www.oncotest.com





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