Date: 2014-10-24
Type of information: Results
phase: preclinical
Announcement: results
Company: Biotest (Germany)
Product: indatuximab ravtansine (BT-062)
Action
mechanism: antibody drug conjugate (ADC). Indatuximab ravtansine (BT-062) is an antibody drug conjugate consisting of a monoclonal antibody and a highly potent cytotoxic maytansine derivative (DM4) using the Targeted Antibody Payload (TAP) technology developed by ImmunoGen. 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 restoring its original cytotoxic potency.
Disease: various solid tumours (human carcinomas of the bladder, breast, lung, prostate and pancreas and on head and neck tumours)
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On October 24, 2014, Biotest has announced 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. 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. 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, 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.
