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Biotest AG initiates clinical study with Indatuximab Ravtansine (BT-062) in solid tumors

- First patient treated in phase I/IIa study (no. 989) in patients with triple-negative metastatic breast cancer or metastatic urinary bladder cancer

Dreieich, 27 March 2014. Biotest AG, pursuing an innovative technology using the antibody-drug conjugate indatuximab ravtansine (BT-062) for targeted anti-cancer therapy, today announced that the first patient has been treated in a phase I/IIa study.

The phase I/IIa study (no. 989) evaluates safety and anticancer activity of indatuximab ravtansine (BT-062) in patients with triple-negative metastatic breast cancer or metastatic urinary bladder cancer expressing the receptor CD138.

The indications of the first trial in solid tumors were selected based on convincing preclinical data and a comprehensive medical need analysis. Only few treatment options are available for these patients. Specific treatments that are available in the market against other types of breast cancer, as hormonal or HER 2-directed therapies, are not efficacious in triple-negative breast cancer. Moreover for 2nd line urinary bladder cancer, only one drug is currently approved.

Tolerability and clinical activity of indatuximab ravtansine (BT-062) as single agent was demonstrated in two clinical trials in patients suffering from relapsed (recurring) or relapsed/refractory (resistant) multiple myeloma. Preliminary data indicates that indatuximab ravtansine (BT-062) is also well tolerated in this patient population when administered in combination with Lenalidomide and Dexamethasone at doses leading to partial or even complete tumor remission (reduction/ decrease).

About study no. 989:

This phase I/IIa trial is designed to evaluate indatuximab ravtansine (BT-062) (administered days 1, 8 and 15, every 4 weeks cycle) when used as monotherapy to treat patients with CD138-expressing triple-negative metastatic breast or metastatic urinary bladder cancer. To qualify for enrollment, patients with breast cancer must have failed at least two treatment regimen, patients with urinary bladder cancer at least one prior treatment regimen.

In the phase I part of the trial, cohorts of at least three patients will be assigned to increasing doses of indatuximab ravtansine (BT-062) to determine its maximum tolerated dose (MTD) in solid tumor indications. In the Phase IIa part, indatuximab ravtansine (BT-062) is being administered at its MTD to further assess its safety and efficacy in the mentioned indications.

The study is funded by Cluster for Individualized ImmunIntervention (Ci3) Mainz, Germany.

About indatuximab ravtansine (BT-062):
Indatuximab ravtansine (BT-062) is an antibody drug conjugate consisting of a monoclonal antibody and a highly potent cytotoxic maytansine derivative (DM4) using the antibody-drug conjugate (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 internalised into the target cell, the cytotoxic agent DM4 is released from the targeting molecule by lysosomal degradation. Thus, the conjugation of DM4 to the antibody keeps the cytotoxic moiety inactive until it is released within the CD138 expressing target cell. This combination of high efficacy and specificity with low systemic toxicity sets indatuximab ravtansine (BT-062) apart from most therapies currently used to treat malignancies.

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 biotherapeutic 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 about 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

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