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2015-12-16

BioInvent: BioInvent update on clinical and preclinical drug programs

Lund, Sweden - 16 December 2015 - BioInvent International (OMXS: BINV)
is today providing an update on its clinical and preclinical drug
programs. Several positive interactions with regulatory authorities
have taken place and clinical trials with three of the Company's
antibodies are expected to start in 2016. A scientific advice meeting
with the UK Medicines and Healthcare Products Regulatory Agency
(MHRA) was held in preparation for the first clinical study of
BI-1206. The study plan presented to the regulator, as well as
BioInvent's data, were well received. Cancer Research UK plans to
submit the Clinical Trial Application in April 2016.

With an increased commitment to the BI-505 program, BioInvent will
submit a clinical trial application to the US Food and Drug
Administration (FDA) in December 2015.

BioInvent and its partner Oncurios is planning to start a clinical
trial with TB-403 in medulloblastoma during early 2016.

BioInvent has established itself as a company with strong clinical
programs and a strong position in the immuno-oncology area.

BI-1206
BI-1206 is an antibody that blocks the CD32b protein which is
overexpressed in lymphoma (cancer in the lymphatic system). By
combining today's standard of care therapy rituximab
(Rituxan®/MabThera®) with BI-1206, it is possible to achieve a better
anti-tumour effect. The planned Phase l/ll clinical study will be
sponsored, managed and funded by one of the world's largest
scientific non-profit organisations, Cancer Research UK. This is done
under an agreement with BioInvent as part of the Clinical Development
Partnerships Scheme, a joint initiative between the Centre For Drug
Development and Cancer Research Technology.

· In a recent scientific advice meeting with the MHRA, the design of
the first clinical study with BI-1206 was discussed. The study will
enrol patients with non-Hodgkin lymphoma and chronic lymphatic
leukaemia.

· Cancer Research UK plans to submit a Clinical Trial Application
for the Phase I/II study to the MHRA in April 2016. The lead clinical
site at the University of Southampton and at least three other
clinical trial sites in the UK will be involved in the trial and aim
to be ready to open to recruitment as soon as all necessary
regulatory and ethical approvals are in place.

· In collaboration with leading academic institutions, BioInvent has
started preclinical evaluation of BI-1206 against different sub-types
of non-Hodgkin lymphoma using human material from biobanks. The
results will provide an important basis for designing the continuing
clinical programme.

"The meeting with the UK regulatory agency, MHRA, is an important step
forward for BI-1206. We have reached an important milestone in this
highly innovative program. We are now in a good position to advance
this program further towards market registration for carefully
selected patient cohorts with the greatest medical need," says
Michael Oredsson, CEO of BioInvent.

BI-505
BI-505 is a human antibody against ICAM-1 developed by BioInvent,
which will be clinically tested in cooperation with researchers at
Penn Medicine as an immuno-oncological therapy to prevent or delay
relapse in patients with multiple myeloma (a form of bone marrow
cancer) undergoing stem-cell transplantation. Preclinical data
indicates improved activity against myeloma when BI-505 is
administered in combination with Velcade® or Revlimid®. BI-505's
favourable safety profile has been demonstrated in a previous phase I
trial. This and the unique mechanism of action, "flagging" remaining
myeloma cells for elimination by actively recruited macrophages, as
well as the potential to inhibit ICAM-1 dependent survival signals
between myeloma cells and tumour stroma, indicate a unique
possibility of improving the therapeutic effect of stem-cell
transplantation.

· Bioinvent plans to submit an application to the FDA in the USA,
requesting to start the randomised, controlled phase II study on
multiple myeloma patients undergoing autologous stem-cell
transplantation, by December 2015 with Penn Medicine as the
coordinating site.

· The study is expected to start in the first quarter of 2016, which
is in line with previous communication.

· BioInvent has decided to assume overall responsibility for the
study as sponsor of the trial. This will improve control of data and
enable expansion of the trial to additional sites, if required.

"By taking on overall responsibility and increasing the number of
trial centres for the study with BI-505 we can generate data of the
quality required by authorities to enter into discussions regarding a
registration procedure based on successful phase II data," says Anna
Teige Wickenberg, Vice President Clinical Development, BioInvent.

TB-403
BioInvent and its partner Oncurious are planning to start a new
clinical study with the antibody TB-403 against certain rare forms of
cancer in the brain, nervous system and connective tissue in children
and adolescents. TB-403 has already been evaluated in clinical
studies in adults for other cancers and has demonstrated a good
safety profile. The project's new direction is based on new knowledge
about the antibody's mechanism of action. BioInvent has the right to
40 percent of all future revenue from the project.

· The study, which is expected to start in early 2016, will be
implemented in cooperation with a network of specialist clinics in
the USA with good access to the relevant patient cohorts.

· The preparations for study start are well underway.
· The first safety evaluation part of the study includes patients
with medulloblastoma (tumour in the cerebellum), neuroblastoma
(tumour in the sympathetic nervous system), Ewings sarcoma (tumour in
the connective tissue) and alveolar rhabdomyosarcoma (tumour in the
connective tissue), whereas children with medulloblastoma will be
included in the efficacy evaluation part of the study.

"Children who suffer from these serious cancers are in great need of
more effective treatment and we have therefore prioritised designing
a study that should give us the answer as to whether TB-403 is
effective in children with medulloblastoma," says Michael Oredsson,
CEO of BioInvent.

REGULATORY T-CELLS (TREG)
Regulatory T-cells (Tregs) have a strong ability to inhibit various
immune responses. A series of clinical studies show that antibodies
targeting CTLA-4 and PD-1 can induce a very long-lasting response in
some cancer patients. BioInvent's F.I.R.S.T™ technology platform is
an excellent tool for identification of both target structures and
antibodies in the Treg area.

· BioInvent has succeeded in identifying high-affinity antibodies
with depleting activity against regulatory T-cells

· A first pool of mouse-reactive anti-Treg antibodies, which can be
screened in well- established preclinical models to identify novel
targets particularly suitable for antibody-mediated Treg depletion,
or modulation of Treg immune suppressive activity, have been
identified. Target: antibody pairs will be used to evaluate new drug
targets and antibody mechanism-of-action in preclinical
proof-of-concept tests, paving way for human cross-reactive, or
functionally equivalent human lead clinical candidate antibodies.
BioInvent recently announced that the Company has received a
non-exclusive licence for a special type of antibody format, IgG2B.
Preclinical trials with IgG2B antibodies have shown that this
antibody type has the potential to more independently activate immune
cells e.g. macrophages and T cells to promote anticancer immune
responses. When targeted to appropriate receptors, the IgG2b isotype
is expected to increase chances of developing new effective drugs in
the immune-oncology area.

OX-40
BioInvent is working in cooperation with Cancer Research Technology
(CRT) and the University of Southampton in the UK to develop new
immunotherapeutic cancer drugs based on antibodies that target OX-40
and 4-1BB, two known co-receptors that help activate T-cells and
long-lasting antitumor immune responses.

· Antibodies with high affinity, agonistic activity on effector
T-cells and the ability to eliminate regulatory T-cells in vitro have
been generated.

· Preclinical in vivo studies to document proof-of-concept for
BioInvent's antibodies in the OX-40 project will be initiated during
the first quarter of 2016.

TUMOUR ASSOCIATED MYELOID CELLS (TAM)
Myeloid cells are essential to our innate immune system, but they can
also be "hijacked" by tumours to support growth and cancer spread. In
the fourth quarter of 2015, BioInvent worked on preparations to
develop function-modulating antibodies against tumour associated
myeloid cells (TAM), a type of white blood cell that is recruited by
cancer cells to sustain growth and spread, and prevent immune attack.
Antibody-mediated "reprogramming" of immune-suppressive
tumour-associated myeloid cells into anti-tumor effector cells is
therefore a very attractive therapeutic concept and represents an
area of research in which BioInvent and its partners are at the
cutting edge.

"F.I.R.S.T is a unique platform to identify new antibody-based drugs
that more specifically destroy, or transform, cancer-driving immune
cells such as Treg and TAM. Preclinical data indicates that
antibodies against Treg and TAM can significantly improve the effects
of the immunotherapies available today and make it possible to treat
cancers where current immunotherapies aren't working due to a
strongly suppressed immune response to the cancer," says Björn
Frendéus, Chief Scientific Officer, BioInvent.

To the editors:

About BioInvent
BioInvent International AB develops immune oncology drugs. With one of
the world's largest antibody libraries, and a unique, proprietary
discovery method, BioInvent can identify the optimal cellular targets
and antibodies for the treatment of various tumor types. BioInvent
has also considerable experience in and a facility for process
development and production of antibodies for clinical studies. This
makes it possible to develop proprietary drug projects, but also to
supply leading international pharmaceutical companies with effective
tools for their drug development. BioInvent currently has three
proprietary projects in or close to clinical development and
partnership agreements with seven global pharmaceutical and biotech
companies. More information is available at www.bioinvent.com.

For further information, please contact:
Michael Oredsson
President and CEO
+46 (0)46 286 85 67
+46 (0)70716 89 30
michael.oredsson@bioinvent.com

BioInvent International AB (publ)
Co. reg. No: 556537-7263
Visiting address: Sölvegatan 41
Mailing address: 223 70 LUND
Phone: +46(0)46 286 85 50
info@bioinvent.com
www.bioinvent.com

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 way 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 Financial Instruments Trading Act. The
information was submitted for publication at 8.40 a.m. CET, on 16
December, 2015.

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