BioSenic receives a Chinese patent with broad claims, protecting the combined use of metal ions and arsenic salts to treat a wide range of serious diseases
August 24 2023 - 12:00AM
BioSenic receives a Chinese patent with broad claims, protecting
the combined use of metal ions and arsenic salts to treat a wide
range of serious diseases
INSIDE INFORMATION
- Composition-of-matter patent covers the therapeutic use
of arsenic salts and metal ions through various routes of
administration
- Enriched IP portfolio protects ATO with demonstrated
therapeutic potential for indications ranging from cancer to immune
or infectious diseases
Mont-Saint-Guibert, Belgium, 24 August,
2023, 7.00am CET – BioSenic
(Euronext Brussels and Paris: BIOS), the
clinical-stage company specializing in serious autoimmune and
inflammatory diseases and cell therapy, today announces the
issuance of a key new patent entitled ‘Use of metal ions to
potentiate the therapeutic effects of arsenic’ to its subsidiary
company Medsenic by the China National Intellectual Property
Administration (CNIPA). This patent (ZL202080040613.1) covers the
use of its ATO platform in combination with metal ions like copper,
which has the potential to improve the treatment of autoimmune
diseases. The European Patent Office (EPO) granted similar
protection (EP3972613) in April 2023.
BioSenic is exploring the therapeutic use of ATO
for a number of disease areas, and has recently published
peer-reviewed data from several preclinical studies elucidating its
mechanisms for modulating immune responses, and the ability of
certain metal ions to enhance this therapeutic potential. The
intellectual property rights recently secured in EU and China pave
the way for clinical and commercial developments by BioSenic and
interested partners, particularly in the fields of cancer and
autoimmunity.
The patent involves two main immediate areas of
application. The first is in immune and autoimmune related diseases
such as chronic Graft-versus-Host Diseases (cGvHD), systemic
sclerosis and systemic lupus erythematosus. The second is in
oncology, where ATO has already demonstrated exceptional results
for patients, including complete remission of acute promyelocytic
leukaemia. This patent issued by CNIPA is in line with the
company’s general strategy of setting a dense and meaningful
intellectual property portfolio. Indeed, these patents will support
the BioSenic’s plans for international clinical trials in
pathologies with unmet medical needs, and toward the company’s
long-term goal of seeking market access approvals for its various
formulations including the original properties of arsenic
salts.
"It is remarkable that China, the home of
medicinal arsenic, is validating BioSenic's discoveries and paving
the way for industrial development for the treatment of diseases
with clinical unmet medical needs, such as cancer, autoimmunity and
infectious diseases, in Asia and elsewhere,” said François
Rieger, PhD, Chairman and Chief Executive Officer of
BioSenic. “We are thrilled to open up new chapters in the
continuous worldwide effort in trying to control 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 formulations containing arsenic and active new
ingredients such as metal ions, minimizing secondary side
effects.
About BioSenic
BioSenic is a leading biotech company
specializing in the development of clinical assets issued from: (i)
the arsenic trioxide (ATO) platform (with key target indications
including Graft-versus-Host Disease (GvHD), systemic lupus
erythematosus (SLE) and systemic sclerosis (SSc)) and (ii), the
development of innovative products to meet unmet needs in
orthopedics.
Following a reverse merger in October 2022,
BioSenic combined a strategic positionings and strengths to use,
separately and combined, an entirely new arsenal of various
anti-inflammatory and anti-autoimmune formulations using the
immunomodulatory properties of ATO/oral ATO (OATO) with its
innovative cell therapy platform and strong IP for tissue repair
protection.
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 technology
platformsBioSenic’s technology is based on two main
platforms:
- The ATO platform, which has been successfully developed, has
immunomodulatory properties with fundamental effects on the
activated cells of the immune system. The first effect is the
increase of the cell oxidative stress in activated B, T and other
cells of the innate/adaptative immune system to the point they will
enter a cell death program (apoptosis) and be eliminated. The
second effect is potent immunomodulatory properties on several
cytokines involved in inflammatory or autoimmune cell pathways,
with return to homeostasis. 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).
cGvHD is primarily mediated by the transplanted immune cells that
can lead to severe multiorgan damage. BioSenic has been successful
in a Phase II trial with its intravenous formulation, which has
orphan drug designation status by FDA and EMA. The Company is
heading towards an international Phase III 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) in an early Phase IIa
study. Systemic sclerosis is also part of the clinical pipeline of
BioSenic. This serious chronic disease badly affects skin, lungs or
vascularization, and has no actual current effective treatment.
Preclinical studies on pertinent animal models are positive, giving
good grounds to launch a Phase II clinical protocol.
- The allogeneic cell and gene therapy platform
developed by BioSenic, with 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 stromal cells from healthy donors into
bone-forming cells on the site of injury. ALLOB has recently been
evaluated in a randomized, double-blind, placebo-controlled Phase
IIb study in patients with high-risk tibial fractures, using its
optimized production process, after a successful first safety and
efficacy study (Phase 1/2a) on fractured long bones, with
late-delayed union. However, in June 2023, BioSenic decided to
suspend its interventional trial on fracture healing using ALLOB,
following negative results obtained for the primary endpoint in
this exploratory Phase IIb clinical trial, interpreted as a failure
of a too early cell injection, just after fracture. BioSenic is now
focusing on determining the best time to optimise the efficacy of
ALLOB (choice between early or late treatment).
Note: Biosenic has reevaluated a previous
important and years-long clinical development program. In March
2023, after the clinical identification of distinct OA subtypes,
BioSenic delivered a new post-hoc analysis of its Phase III JTA-004
trial on knee OA, demonstrating positive action on the most
severely affected patient subpopulation. This new post-hoc analysis
drastically changes the therapeutic profile of the combined
components and allows for better patient targeting in future
clinical developments. This leads to a next-generation of JTA,
off-the-shelf enhanced viscosupplement to treat knee osteoarthritis
(OA), made of a unique combination of mammalian plasma proteins,
derivatives of hyaluronic acid (a natural component of synovial
fluid in the knee) and a third active component. JTA or some
derivatives are intended to provide effective lubrication and
protection to the cartilage of the arthritic joint and to alleviate
osteoarthritic (OA) pain and inflammation. The company, will
nevertheless focus its present R&D and clinical activities on a
selective, accelerated development of its autoimmune (ATO/OATO)
platform.
For further information, please
contact:
BioSenic SAFrançois Rieger, PhD,
Chief Executive OfficerTel: +33 (0)671 73 31
59investorrelations@biosenic.com
International Media Enquiries:IB
CommunicationsNeil Hunter / Michelle BoxallTel: +44 (0)20
8943 4685neil.hunter@ibcomms.agency / michelle@ibcomms.agency
For French Investor Enquiries:Seitosei
ActifinGhislaine GasparettoTel: +33 (0)1 56 88 11
22ggasparetto@actifin.fr
Certain statements, beliefs and opinions in this
press release are forward-looking, which reflect the Company or, as
appropriate, the Company directors’ current expectations and
projections about future events. By their nature, forward-looking
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that could cause actual results or events to differ materially from
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