BioSenic provides support to forthcoming European conference on
graft-versus-host disease
Mont-Saint-Guibert, Belgium, January 31,
2024, 7.00 am CEST – BioSenic
(Euronext Brussels and Paris: BIOS), the
clinical-stage company specializing in serious autoimmune and
inflammatory diseases and cell therapy, today announces that it
will attend and support the upcoming GvHGvL Meeting on 13-15 March,
2024 at University Hospital Regensburg, a biannual conference to
lead scientific exchange around graft-versus-host disease
(GvHD).
GvHD can result from transplanting bone marrow
or stem cells from a donor to a patient. BioSenic is planning a
Phase 3 study of its first-in-class oral arsenic trioxide (OATO)
therapy in patients with chronic GvHD (cGvHD), a focus area for the
company. The trial will test OATO as a first-line therapy for cGvHD
and will begin enrolling the first of about 150 patients over three
continents this year. After consulting several clinicians with
extensive cGvHD experience in order to develop the protocol for its
pivotal Phase 3 study in cGvHD, BioSenic decided to provide support
for the biannual meeting, which is organized and hosted by the
University Hospital Regensburg in Regensburg, Germany.
BioSenic’s Chief Operating Officer and Chief
Scientific Officer Carole Nicco, PhD, HDR and Chief Medical Officer
Lieven Huysse, MD will attend the congress, focusing respectively
on the biomarkers in cGvHD and fine-tuning of the outcome criteria
for the upcoming cGvHD Phase 3 study. In addition, the pair will
hold further discussions with international key opinion leaders in
attendance.
Lieven Huysse, said: “This is
an excellent opportunity for us to meet important key opinion
leaders in the GvHD field, as we finalize the protocol of our
state-of-the-art clinical study. We understand how crucial it is to
select the most appropriate criteria if we are to move toward a
confirmatory outcome for the use of OATO as a first-line therapy,
in addition to the standard of care. We are looking forward to
learning from leaders in the GvHD field as we concentrate all our
efforts on getting the Phase 3 trial up and running.”
Carole Nicco adds: " We have
learned from ATO’s mechanisms of action that it could be a very
specific and novel type of immunomodulator. We now have a patent
pending on biomarkers that allow us to follow the efficacy of
treatment in cGvHD. We will focus on this aspect in the Phase 3
trial and ensure that we follow the effect of our treatment using
the best possible biomarkers, which happens to be one of the very
interesting sessions planned for GvH-GvL Meeting. I can't wait for
detailed discussions with other experts in order to reach a
consensus for the best-suited set of biomarkers we can add to the
companion diagnostics we have already identified."
François Rieger, President of the Board
and CEO of BioSenic Group, concludes: " Our Phase 2 study
had promising results, including a 75% overall response rate in the
full analysis set population and 82% in the per-protocol set
patient population. At BioSenic, we believe that the international
pivotal Phase 3 trial of our OATO treatment for cGvHD should
provide a definitive indication of this new therapy’s value, and
clearly define the duration and dosage of the treatment. ATO has
the distinct advantage of being safe and effective over short
cycles of administration, reducing the occurrence of potential side
effects, all of which were reversible. We expect the risk/benefit
balance to be quite favorable."
About BioSenicBioSenic 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 SAFrançois Rieger, PhD,
CEOTel: +33 (0)671 73 31 59investorrelations@biosenic.com
International Media Enquiries:IB
CommunicationsMichelle BoxallTel: +44 (0)20 8943
4685michelle@ibcomms.agency
For French Investor Enquiries:Seitosei
ActifinGhislaine GasparettoTel: +33 (0)1 56 88 11 22
ghislaine.gasparetto@seitosei-actifin.com
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