BioInvent: Positive results from the BI-505 phase I study in multiple myeloma

  BioInvent: Positive results from the BI-505 phase I study in multiple

Business Wire

LUND, Sweden -- January 24, 2013

BioInvent International (OMXS:BINV) announced today the first results from the
BI-505 phase I study in patients with multiple myeloma. The study has reached
a final stage and the preliminary analysis shows that BI-505 has an
advantageous safety profile. In cohorts where extended therapy was available,
24 % of the patients had stable disease for at least two months, indicating
effect of BI-505. The final conclusions of the study will be available at a
later time-point. The optimal dose has been defined according to the study
protocol and will be used in the next clinical trial which is approved by the
health authorities.

Cristina Glad, CEO of BioInvent, commented: “We are delighted that this phase
I trial has shown that BI-505 has an advantageous safety profile and that
stable disease is observed in a significant number of patients. Although this
is still early stage data, the results are encouraging and add to our
excitement about the potential of this therapy to significantly improve the
treatment of patients with multiple myeloma. We look forward to progress with
BI-505 into further development.”

“These results are of significant clinical interest. I am very encouraged by
the safety profile of BI-505 and by the factthat in this heavily pretreated
population, we were noticing patients with stable disease for quite some
time.” said the Coordinating Investigator of the BI-505 study, Guido Tricot,
M.D., at the University of Iowa in Iowa City. “We look forward to further
clinical trials with this antibody to determine its full potential, with the
goal of ultimately improving outcomes for myeloma patients.”

BI-505 is a human antibody selected from the n-CoDeR^®-library and fully owned
by BioInvent. It is directed against the ICAM-1 adhesion protein, which is
highly expressed on multiple myeloma cells. BI-505 has demonstrated
significant anti-tumor activity in several relevant models of multiple

Thirty-five patients with relapsed or refractory disease after at least two
previous regimens with other drugs are included in the phase I, dose
escalation study. The primary objective is to determine the safety and
tolerability of BI-505 in patients with advanced disease. Pharmacokinetics and
pharmacodynamic variables including relevant biomarkers for tumor response are
also being evaluated in order to determine the optimal dose for further
clinical development. The study is being conducted at seven sites in the US
and Europe.

Groups of patients are treated with increasing doses of BI-505 (0,0004 – 20
mg/kg; eleven dose levels) every second week over a four-week period, with a
possibility of extended therapy every two weeks until disease progression for
patients at dose level six and onwards.

The preliminary assessment demonstrates that BI-505 has a favorable safety
profile with a low number of reported adverse events. Temporary
infusion-related reactions were observed when the first dose was given which
is commonly seen. Despite advanced disease, 7 of the 29 patients on extended
therapy (at dose level six and onwards) had stable disease for at least two
months. A dosing regimen of 10 mg/kg every second week resulted in complete
saturation of the ICAM-1 epitopes on the patient´s bone marrow myeloma cells.
The 10 mg/kg dose will thus be used in the next clinical trial which has
already been approved by the health authorities.

                                   -- END –

To the editors:

About BioInvent

BioInvent International AB, listed on the NASDAQ OMX Stockholm (BINV), is a
research-based pharmaceutical company that focuses on developing antibody
drugs. The Company's pipeline currently includes three product candidates for
the treatment of cancer. The Company has signed various strategic alliances to
strengthen the product pipeline and increase the likelihood of success. These
partners include Genentech, Human Genome Sciences and ThromboGenics.

The company's competitive position is underpinned by n-CoDeR®, a proprietary
antibody development platform. The scope and strength of this platform is also
utilised by partners, such as Bayer HealthCare, Daiichi Sankyo, Mitsubishi
Tanabe and Servier. More information is available at

BioInvent International AB (publ)

Co. reg. No. 556537-7263,

Visiting address: Sölvegatan 41

Mailing address: SE-223 70 LUND

Phone: +46 (0)46 286 85 50

Legal disclaimer

The press release contains statements about the future, consisting of
subjective assumptions and forecasts for future scenarios. Predictions for the
future only apply as the date they are made and are, by their very nature, in
the same was as research and development work in the

biotech segment, associated with risk and uncertainty. With this in mind, the
actual outcome may deviate significantly from the scenarios described in this
press release.

Information disclosed in this press release is provided herein pursuant to the
Swedish Securities Markets Act and/or the Swedish Financial Instruments
Trading Act. The information was submitted for publication at 8.30 a.m. CET,
on 24 January, 2013.


BioInvent International AB
Cristina Glad
President & CEO
Phone:+46 (0)46286 85 51
Mobile: +46 (0)708 16 85 70
The Trout Group
Christine Yang
Vice President
Phone: +1646378 2929
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