BioSenic and Pluristyx sign term sheet for market availability of
ALLOB mesenchymal cells
INSIDE INFORMATION
Potential
license agreement to produce and
commercialize original and
transformed ALLOB
cells
BioSenic to
potentially receive
royalty rates on net
sales up to 25%
Mont-Saint-Guibert,
Belgium, May
24th
2023,
7.00am
CET – BioSenic (Euronext
Brussels and Paris: BIOS), the clinical stage company
specializing in serious autoimmune and inflammatory diseases and
cell repair, today announces the signing of a term sheet with
Pluristyx, a leading provider of gene-edited iPSC and cell therapy
solutions, with a view to further negotiate the terms and
conditions of a potential license and collaboration agreement.
This term sheet will be used as basis for the
preparation of a potential wider licensing and collaboration
agreement to make BioSenic’s well characterized cells with various
original properties available to the market. These cells include
immune privilege, anti-inflammatory properties et tissue repair
established capacities, both in vitro and in vivo. BioSenic has
derived these GMP manufactured cells from Mesenchymal Stem Cells
(MSCs), bone marrow cells from healthy donors. The cells have then
been prepared for a number of preclinical and clinical studies.
These cells constitute BioSenic’s investigational medicinal
product, ALLOB, which is currently being evaluated in a randomized,
double-blind, placebo-controlled Phase IIb study in patients with
high-risk tibial fractures. Subject to the fulfillment of customary
condition precedents, BioSenic and Pluristyx aim to further
negotiate the terms and conditions with a view on completing a
final agreement and to fully execute it by Q3 2023. Depending on
the outcome of the negotiations, a final license and collaboration
agreement might, however, never be entered into.
In 2021, BioSenic (at the time Bone
Therapeutics, prior to its merger to create BioSenic) and Pluristyx
(previously Implant Therapeutics) entered into its original
research evaluation agreement. The agreement enabled BioSenic to
access, evaluate and materially transfer Implant Therapeutics’
Induced Pluripotent Stem Cell (iPSC) lines, media, differentiation
protocols and expertise. These specific single source MSCs are
highly standardized, are expandable and scalable. They are also
more flexible with regards to modification methodologies, including
gene editing and transduction, than existing autologous and
allogeneic approaches. Pluristyx has developed technologies to
conditionally transform dividing cell populations, including cells
such as ALLOB.
The potential BioSenic / Pluristyx licensing and
collaboration agreement, if entered into, would enable BioSenic to
prepare these cells for market availability for preclinical
research and possible clinical applications. Pluristyx specializes
in partnerships with companies and research institutions to create
and commercialize new therapies and offer services to clients who
need support with their own cell therapy development,
manufacturing, and/or regulatory compliance.
“BioSenic’s pre-merged Bone Therapeutics, has
spent over 10 years establishing the scientific and technical
foundations for the safe use of manufactured mesenchymal stem cells
originating from the bone marrow of healthy human donors. This has
involved pre-clinical and clinical studies demonstrating cartilage
and bone formation or repair. Phase 2 clinical studies have also
demonstrated spinal fusion and bone fractures enhanced repair,”
said Prof. François Rieger, PhD, Chairman and Chief
Executive Officer of
BioSenic. “BioSenic has therefore
extensively demonstrated that bone marrow cells that originate from
stem cells are able to differentiate in a variety of tissue types
in addition to bone. They are of a very low immunogenic type with a
so-called immune privilege, and they can be prepared as partially
differentiated cells along their cell differentiation multiple
pathways. As a result, these cells can be further transformed in
vitro with specific genes adding to their initial properties with
new anti-inflammatory properties or cell division regulatory
mechanisms able to control excessive division or abnormal migration
or misdirected organ implantation. This partnership between
BioSenic and Pluristyx will enable the wider sector to expand the
use of the ALLOB and related cells and deliver new ways to treat
numerous human pathologies still with unsatisfactory or unmet
medical needs. The availability of the ALLOB cell clones and lines
will generate a very significant income. BioSenic will be able to
utilize this income to financially support its own projects based
on its present two main technical Arsenic and ALLOB platforms,
targeting autoimmune and cancer conditions and bone and cartilage
repair.”
“Pluristyx will be able to apply using its
conditional immortalizing and transforming strategies in
partnership with BioSenic to generate transformed versions of the
ALLOB line. We believe this will generate clonal cell lines
resources that will be invaluable to a number of companies and
laboratories internationally,” said Dr
Mahendra Rao, Vice President of
Pluristyx. “Using Pluristyx’s base immortalized
line to add to our platform technologies, such as Failsafe and
Hypoimmune, will enable the development of safe cellular therapy
for use by Biosenic and its licensed partners.”
Subject to the terms and conditions of the
definitive license and collaboration agreement, BioSenic will grant
to Pluristyx conditional non-exclusive, non-transferrable,
sublicensable (on a case-by-case basis) and royalty-bearing license
on the BioSenic technology to exploit ALLOB. The main
responsibilities of Pluristyx shall include the production and sale
of immortalized ALLOB cells, the exploitation of licensed products
and the generation of a Cell Bank.
About
PluristyxPluristyx with panCELLa offers an
enlarged portfolio of unique and effective non-modified and
genetically engineered iPSC-based technologies and related services
to provide end-to-end client support throughout the product
lifecycle. Pluristyx is fast becoming the leading provider of
gene-edited iPSC and cell therapy solutions, accelerating the path
to clinic and providing the best route to commercialization.
About
BioSenic
BioSenic is a leading biotech company
specializing in the development of clinical assets issued from:
(i), the allogeneic cell therapy platform ALLOB and (ii) the
Arsenic TriOxide (ATO) platform. Key target indications for the
platforms include Graft versus Host Disease (GvHD), Systemic lupus
erythematosus (SLE), Systemic Sclerosis (SSc) and high-risk tibial
fractures.Following the merger in October 2022, BioSenic combines
the strategic positionings and strengths of Medsenic and Bone
Therapeutics. The merger also enables Biosenic to add to its
innovative cell therapy platform and strong IP for tissue repair
protection with an entirely new arsenal of various
anti-inflammatory and anti-autoimmune formulations using the
immunomodulatory properties of 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 BioSenic
technology platforms
BioSenic’s technology is based on two main
platforms:
1) The allogeneic cell and gene
therapy platform, developed by BioSenic with differentiated bone
marrow sourced Mesenchymal Stromal Cells (MSCs) that can be stored
at the point of use in hospitals. Its current investigational
medicinal product, ALLOB, represents a unique, 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 after a single local
injection. These cells are produced via a BioSenic's scalable
manufacturing process. Following the CTA approval by regulatory
authorities in Europe, BioSenic has initiated patient recruitment
for the Phase IIb clinical trial with ALLOB in patients with
difficult tibial fractures, using its optimized production process.
ALLOB is currently being 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. The patient
recruitment has been halted late February 2023 with 57 patients and
the new rules permitted for statistical analysis should allow
BioSenic to get the main results of this trial much earlier than
anticipated in the original protocol, since they are expected by
mid-2023. 2) The Arsenic TriOxide (ATO) platform
developed by Medsenic. The immunomodulatory properties of ATO have
demonstrated a double basic effect on cells of the immune system.
The first effect is the increase of the cell oxidative stress in
activated B, T or 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 pro-inflammatory cytokines
involved in inflammatory or autoimmune cell pathways. One direct
application is its use in onco-immunology to treat GvHD
(Graft-versus-Host Disease) in its chronic, established stage. GvHD
is one of the most common and clinically significant complications
affecting long-term survival of allogeneic hematopoietic stem cell
transplantation (allo-SCT). GvHD is primarily mediated by the
transplanted immune system that can lead to severe multiorgan
damage. Medsenic had been successful in a Phase II trial with its
intravenous formulation, allowing arsenic trioxide to be granted an
orphan drug designation status by FDA and EMA and is heading
towards an international Phase III confirmatory study, with a new,
IP protected, oral (OATO) formulation. Moderate to Severe forms of
Systemic Lupus erythematosus (SLE) is another selected target,
using the same oral formulation. ATO has shown good safety and
significant clinical efficacy on several affected organs (skin,
mucosae and the gastro-intestinal tract) in a Phase IIa study.
Systemic Sclerosis is, in addition, part of the clinical pipeline
of BioSenic. Preclinical studies on pertinent animal models are
positive. This gives good grounds to launch a Phase II clinical
protocol for this serious disease that badly affects skin, lungs or
vascularization, and with no actual current effective
treatment.
In addition, BioSenic is developing an
off-the-shelf next-generation improved viscosupplement, JTA-004,
consisting of a unique combination of plasma proteins, hyaluronic
acid - a natural component of knee synovial fluid, and a
fast-acting analgesic. JTA-004 intends to provide added lubrication
and protection to the cartilage of the arthritic joint and to
alleviate osteoarthritic pain (OA) and inflammation. In March 2023,
after the identification of new OA subtypes, BioSenic delivered a
new post-hoc analysis of its Phase III JTA-004 trial on knee OA
with positive action on the most severely affected patient
population. This new post-hoc analysis changes the therapeutic
profile of the molecule and potentially allows for the possibility
of stratifying patients for a new, optimized Phase III clinical
study. BioSenic, which does not intend to allocate R&D
resources to support the clinical development of JTA-004 and will
continue to focus its R&D activities on the development of its
autoimmune (ATO) and cell therapy (ALLOB) platforms, is now seeking
to collaborate with existing and potential partners to explore
options for the future development of JTA-004 based on this new
post-hoc analysis.
For further information, please
contact:
BioSenic SAPr.
François Rieger, PhD, Chief Executive OfficerTel: +33 (0)671 73 31
59investorrelations@biosenic.com
For Belgian Media and Investor
Enquiries:BepublicBert BouserieTel: +32 (0)488 40
44 77bert.bouserie@bepublicgroup.be
For International Media Enquiries:IB
CommunicationsNeil Hunter / Michelle BoxallTel: +44 (0)20
8943 4685neil.hunter@ibcomms.agency / michelle@ibcomms.agency
For French Media
Enquiries:NewCap
MediaAnnie-Florence LoyerTel: +33 (0)1 44 71 00
12afloyer@newcap.fr
For French Investor
Enquiries:Seitosei
ActifinGhislaine GasparettoTel: +33 (0)1 56 88 11
22ggasparetto@actifin.fr
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