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

DGAP-News: Biotest AG / Key word(s): Research Update
Biotest AG: Biotest AG initiates clinical study with Indatuximab
Ravtansine (BT-062) in solid tumors

27.03.2014 / 15:00

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PRESS RELEASE

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