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PRESS RELEASE

New data from Biotest's monoclonal antibody-drug-conjugate (ADC) BT-062 in the therapy of solid tumors

- Good tolerability and signs of efficacy in phase I/IIa clinical study

- Very good effectiveness when combined with chemotherapeutic agent in preclinical studies on difficult to treat breast cancer

- Biotest is seeking investors for further development of BT-062

Dreieich, 3 May 2018. Biotest announced data from a phase I/IIa study with the antibody-drug conjugate Indatuximab Ravtansine (BT-062) in patients with solid tumors.

Study (no. 989) examined the safety and antitumor activity of BT-062 in patients with triple-negative metastatic breast cancer and patients with metastatic bladder cancer, both types of tumor bearing the receptor CD138 on their surface. The study confirms the good safety profile of BT-062 and shows initial encouraging signs of efficacy in these critically ill patients for whom options for further treatment are largely exhausted.

Furthermore, BT-062 in combination with chemotherapy showed very good efficacy in a tumor model for triple-negative breast cancer, a type of tumor that is particularly difficult to treat. In mice loaded with human tumors, very good efficacy was already shown at low doses of BT-062 monotherapy and was further improved when BT-062 was given in combination with the cytostatic drug docetaxel. Preclinical data on the mode of action of BT-062 have been published in two full papers (links for download given below).

The clinical and preclinical results presented here underline the promising potential and support further development of BT-062 as combination therapy for CD138-positive solid tumors.

The combination therapy approach is supported by evidence obtained with
BT-062 in the treatment of multiple myeloma, a malignant disease of the bone marrow also involving CD138-positive cells. In this indication a combination of BT-062 with appropriate agents lead to a considerable increase in efficacy:

Safety and early signs of efficacy of BT-062 monotherapy were reported in two clinical trials (no. 969 and no. 975) in patients with relapsed/recurrent or refractory multiple myeloma.

Data from combination therapy of BT-062 with lenalidomide or pomalidomide and dexamethasone in multiple myeloma (clinical phase I/IIa study no. 983) are now available over a period of almost six years. They show that in this patient population, treatment with BT-062 in combination with lenalidomide or pomalidomide and dexamethasone can lead to partial or complete response. The study continues as some patients have been benefitting from the combination treatment for over four years.

These results support that combination therapy with appropriate chemotherapeutic or immune-oncological drugs may further enhance efficacy of BT-062 in the solid tumors studied, similar to the effects observed in multiple myeloma.

Since Biotest is going to focus on the development of plasma products in the future, the company plans to sell off or further develop their portfolio of promising antibody-based drug candidates in a separate company.

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 has been 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.

About Study no. 989
This phase I/IIa trial was designed to evaluate Indatuximab Ravtansine (BT-062) (administered days 1, 8 and 15, every 4 weeks) 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 regimens, patients with urinary bladder cancer at least one prior treatment regimen. In the phase I part of the trial, the maximum tolerated dose (MTD) of Indatuximab Ravtansine (BT-062) in solid tumor indications was determined. In the Phase IIa part, Indatuximab Ravtansine (BT-062) was administered at this dose to further assess its safety and efficacy in the mentioned indications.
The study was funded by the Cluster for Individualized ImmunIntervention (Ci3) Mainz, Germany.

About the preclinical investigations with BT-062
The publications can be downloaded following the links:
https://rdcu.be/LQKN
https://doi.org/10.1371/journal.pone.0195823

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 1,600 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: investor.relations@biotest.de

PR contact
Dirk Neumüller
phone: +49-6103-801-269
email: pr@biotest.com

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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.