Medsenic/BioSenic patent granted in Japan for more protection of
its therapeutic platform
PRIVILEGED INFORMATION
- 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, 13 août 2024,
6.00pm CET – BioSenic (Euronext
Brussels and Paris: BIOS), the clinical-stage company
specializing in serious autoimmune and inflammatory diseases, today
announces the granting of a key patent by the Japan Patent 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 several 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, 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 regional patent
for Japan further consolidates our intellectual property rights on
the formulations and compositions of matter related to the
first-in-class 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 Japanese patent, corresponding to
Application 2021-569115 filed on May 20, 2020, is now granted to
Medsenic, a subsidiary of BioSenic. Similar regional patents on the
same subject were granted by European Union Intellectual Property
Office (EP3972613) in April 2023, by China National Intellectual
Property Administration in August 2023, and by the Australian and
Canadian Patent Offices in December 2023.
About BioSenic
BioSenic is a leading biotech company
specializing in the development of clinical assets issued
from its Medsenic’s arsenic trioxide (ATO) platform. Key target
indications for the autoimmune platform include
graft-versus-host-disease (GvHD), systemic lupus erythematosus
(SLE), and now systemic sclerosis (SSc).
Following the merger in October 2022, BioSenic combined the
strategic positionings and strengths of Medsenic and Bone
Therapeutics. The merger specifically enables
Medsenic/Biosenic to develop an entirely new arsenal of various
anti-inflammatory and anti-autoimmune formulations using the
immunomodulatory properties of ATO/oral ATO (OATO).
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 the main Medsenic/BioSenic
technology platform
The ATO
platform provides derived active products with
immunomodulatory properties and fundamental effects on the
activated cells of the immune system. One direct application is its
use in onco-immunology to treat GvHD (Graft-versus-Host Disease) in
its chronic, established stage. cGvHD is one of the most common and
clinically significant complications affecting long-term survival
of allogeneic hematopoietic stem cell transplantation
(allo-HSCT).
Medsenic has been successful in a phase 2
trial with its intravenous formulation,
Arscimed®, which has orphan
drug designation status by FDA and EMA. The company is heading
towards an international phase 3 confirmatory study, with its new,
IP-protected, OATO formulation. Another selected target is
moderate-to-severe forms of systemic lupus erythematosus (SLE),
using the same oral formulation. ATO has shown good safety and
significant clinical efficacy on several affected organs (skin,
mucosae, and the gastrointestinal tract). Systemic sclerosis is now
full part of the clinical pipeline of Medsenic/BioSenic. This
serious chronic disease badly affects skin, lungs, or
vascularization, and has no current effective treatment.
Preclinical studies on pertinent animal models are positive, giving
good grounds to launch a phase 2 clinical protocol, using new
immunomodulatory formulations of APIs recognized to be active on
the immune system.
The company is currently focusing its
present R&D and clinical activities on a selective, accelerated
development of its autoimmune platform.
Note: The allogeneic cell therapy
platform-originating from the previous listed company Bone
Therapeutics company, may be of renewed interest by using isolated
and purified differentiated bone marrow Mesenchymal Stromal Cells
(MSCs) as a starting material for further isolation of passive or
active biological subcellular elements. Indeed, these cells may
provide new subcellular vesicles potentially able to deliver a
unique and proprietary approach to organ repair. BioSenic is now
involved in determining new patentable approaches in this complex
area of cell therapy.
For further information, please
contact:
BioSenic SA
François Rieger, PhD, CEO
Tel: +33 (0)671 73 31 59
investorrelations@biosenic.com
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