BioSenic patent granted in Canada for broader protection of ATO
therapeutic platform
PRESS RELEASE – INSIDE INFORMATION
BioSenic patent granted in Canada
for broader protection of its ATO therapeutic platform
- Composition-of-matter patent
covers the therapeutic use of arsenic salts and metal ions through
various routes of administration.
- Enriched IP portfolio protects
arsenic trioxide (ATO) use combined with copper ions delivery,
which has demonstrated increased therapeutic potential for
indications ranging from immune to cancer and infectious
diseases.
Mont-Saint-Guibert, Belgium, 30 January
2024, 7.00am CET – BioSenic
(Euronext Brussels and Paris: BIOS), the
clinical-stage company specializing in serious autoimmune and
inflammatory diseases and cell repair therapy, today announces the
granting of a key patent by the Canadian Intellectual Property
Office to expand protection of the arsenic trioxide (ATO) platform.
The patent, titled “Use of metal ions to potentiate the therapeutic
effects of arsenic,” covers the use of ATO platform in combination
with metal ions such as copper. This combination has shown the
ability to significantly improve the treatment of autoimmune
diseases and could be applied to the treatment of various forms of
cancer conditions and infectious pathologies related to cytokine
storms. Similar protection had been granted in Europe and Australia
last year, together with a first patent acceptance in China, which
opened the doors for further divisional applications in addition to
the primary decision limited to graft-versus-host disease
(GvHD).
BioSenic is exploring the therapeutic use of ATO
for a number of indications. The company has recently published
peer-reviewed data from several preclinical studies elucidating
ATO’s mechanisms for modulating immune responses, and the ability
of certain metal ions to enhance this therapeutic potential. The
actual growing portfolio of intellectual property rights is part of
a strategy to build dense and meaningful protection for its lead
product, paving the way for clinical and commercial developments by
BioSenic and interested partners, particularly in the field of
autoimmunity.
The new patent, granted to BioSenic’s subsidiary
company Medsenic, involves two main immediate areas of application.
The first one is in immune- and autoimmune-related diseases –
specifically, the BioSenic’s lead project in 2024, chronic GvHD
and, later on, systemic sclerosis and systemic lupus erythematosus.
The second is in oncology, where ATO has already demonstrated
exceptional results for patients, including complete remission in
acute promyelocytic leukaemia. These patents will support
BioSenic’s plans for international clinical trials in pathologies
with unmet medical needs, toward the company’s long-term goal of
seeking market access approvals for its various formulations,
optimizing the original properties of arsenic salts – alone or in
combination.
François Rieger, PhD, Chairman and CEO
of BioSenic said: “This newly granted patent in Canada
further structures our intellectual property rights on the
formulations and compositions of matter related to the
extraordinary properties of arsenic salts, which we find to
generally reorient organisms toward normal function and homeostasis
in various cells and organs. We are happy to open new chapters in
the continuous, worldwide effort in trying to control chronic or
lethal diseases with no real cure.”
The expected availability of an oral formulation
that combines arsenic and copper puts BioSenic in a unique position
to build on clinical successes in its fields of applications. As a
result, BioSenic will be able to continue clinical development with
proprietary original formulations containing arsenic and new active
ingredients such as metal ions, increasing the potency of its
products, and minimizing secondary side effects.
The Canadian patent, corresponding to
Application 3,138,472, was granted to Medsenic, a subsidiary of
BioSenic. The similar patents were granted by European Union
Intellectual Property Office (EP3972613) in April 2023, by China
National Intellectual Property Administration in August 2023, and
by Australia Patent Office in December 2023, respectively.
About BioSenic
BioSenic is a biotech company specializing in the clinical
development of autoimmune disease therapies. Following a reverse
merger in October 2022, BioSenic combined its strategic
positioning, key strengths and strong IP to develop products along
two tracks, separately and in combination. The first platform
leverages immunomodulatory properties of arsenic trioxide (ATO) for
an entirely new arsenal of formulations, including oral delivery
(OATO), for anti-inflammatory and anti-autoimmune indications such
as chronic graft-versus-host disease (cGvHD), systemic lupus
erythematosus (SLE) and systemic sclerosis (SSc). In parallel,
BioSenic develops innovative products through a second platform
that includes cell therapies and strong IP protection for tissue
repair technologies.
BioSenic is based in the Louvain-la-Neuve
Science Park in Mont-Saint-Guibert, Belgium. Further information is
available at http://www.biosenic.com.
About BioSenic's technology
platforms
The ATO
platform has immunomodulatory properties with
fundamental effects on the activated cells of the immune system.
One direct application is its use in autoimmunity to treat in its
chronic, established stage. Chronic GvHD is one of the most common
and clinically significant complications affecting long-term
survival of allogeneic hematopoietic stem cell transplantation
(allo-HSCT), a curative treatment for patients with serious blood
diseases, including cancers.
BioSenic’s intravenous ATO formulation,
Arscimed®, has orphan drug
designation status by FDA and EMA, and it has shown good safety and
significant clinical efficacy for skin, mucosae, and the
gastrointestinal tract in an early Phase 2a study. The company is
planning a confirmatory international Phase 3 study with its oral
ATO (OATO) formulation. OATO
will also target moderate-to-severe forms of SLE. BioSenic is also
developing a new IP-protected OATO formulation for the treatment of
SSc, a serious chronic disease that affects skin, lungs or
vascularization, and has no current effective treatment.
Preclinical studies on pertinent animal models support the launch
of a Phase 2 clinical trial.
ALLOB is an
allogeneic cell therapy platform made of differentiated, bone
marrow-sourced mesenchymal stromal cells (MSCs), which can be
stored at the point-of-use in hospitals. ALLOB represents a unique
and proprietary approach to organ repair, and specifically to bone
regeneration, by turning undifferentiated MSCs from healthy donors
into bone-forming cells at the site of injury. BioSenic is studying
the results of a Phase 2 trial to optimise the efficacy of ALLOB by
determining the best timing for therapeutic intervention and
seeking partners to continue the development of the promising
underlying therapy strategies.
The company is also exploring partnerships
at all levels for its JTA-004
viscosupplement for a severe inflammatory subtype of
osteoarthritis, following a positive post hoc analysis of Phase 3
data demonstrating safety and efficacy in support of this
licensing.
For further information, please
contact:
BioSenic SA
François Rieger, PhD, CEO
Tel: +33 (0)671 73 31 59
investorrelations@biosenic.com
International Media Enquiries:
IB Communications
Michelle Boxall
Tel: +44 (0)20 8943 4685
michelle@ibcomms.agency
For French Investor Enquiries:
Seitosei Actifin
Ghislaine Gasparetto
Tel: +33 (0)1 56 88 11 22
ghislaine.gasparetto@seitosei-actifin.com
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