Clinical Trials

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.

* On March 27, 2014, Biotest has announced that the first patient has been treated in a phase I/IIa study (Study 989) that 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.

Tolerability and clinical activity of indatuximab ravtansine  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).

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

* On December 10, 2013. Biotest has announced that the company has submitted a phase I/IIa study (Study 989) in solid tumors to the European authorities. Triple negative metastatic breast and metastatic urinary bladder cancer were selected based on the convincing preclinical data and a comprehensive medical need analysis. The recruitment of patients into the study is planned for beginning of 2014.

* On March 22, 2012, Biotest has announced pre-clinical data showing the efficacy of the immunoconjugate BT-062 against several types of solid tumors. These data indicate that the immunoconjugate might have a significant potential in the treatment of certain solid tumor types for which there is currently no adequate treatment option.

In addition to multiple myeloma, many solid tumors over-express CD138, the target antigen (target on the tumor, to which BT-062 binds) of BT-062. Biotest therefore initiated pre-clinical studies to investigate the potential of BT-062 to treat such solid tumors. Within this context, mice implanted with patient derived tumors were treated with BT-062. For the study , Biotest used primary tumors of human origin to obtain the most relevant data on the anti-tumor activity of BT-062. The investigations were performed using human breast, pancreas, bladder, and lung carcinoma material. The mice received BT-062 once weekly at alternative study doses (between 2 mg/kg to 13 mg/kg). BT-062 caused complete elimination of the tumors in all animals, with no recurrence of the tumors throughout the follow up periods. Especially striking results were obtained for triple negative breast cancer. These tumors do not respond to treatment with estrogen-, progesterone-, or HER2 (Herceptin2)-targeted therapies thus leaving few treatment options. In triple negative breast cancer models, BT-062 completely eradicated the tumor burden in all animals at doses starting well below of the maximum tolerated dose established in the multiple myeloma clinical trials. These results suggest effective treatment of such tumors can be achieved at doses that can be used in patients . Similar responses in comparable tumor model are rarely observed with other compounds, highlighting the potential of BT-062 for the treatment of malignancies with a high medical need. Biotest will continue to focus its resources on the development of BT-062 in the lead indication multiple myeloma. For the clinical development in solid tumor indications Biotest intends to collaborate with a strategic partner.