• 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, Germany I October 24, 2014 I 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.

SOURCE: Biotest