- Ipsen secures
exclusive global rights to develop, manufacture and commercialize
BMX-502, a pre-clinical novel T cell engager (TCE) with
first-in-class potential
- BMX-502 is a
bispecific antibody engaging MAIT cells, a subset of
non-conventional T cells, and targeting the clinically validated
tumor antigen GPC3 to kill cancer cells
PARIS, FRANCE; 03 December 2024
- Ipsen (Euronext: IPN; ADR: IPSEY) and Biomunex Pharmaceuticals
today announced an exclusive global licensing agreement for
BMX-502. BMX-502 is a bispecific antibody that engages and
activates a subset of cytotoxic T cells called Mucosal-Associated
Invariant T cells (MAIT cells) and targets the GPC3 tumor antigen,
to kill cancer cells. GPC3 is a clinically validated target, highly
expressed across several cancer types.1 MAIT cells are present
throughout the body, highly enriched in many specific tissues of
the body, particularly in mucosal and barrier tissues. BMX-502
offers a promising approach to treating tumors in these
tissues.2,3
Developed using Biomunex’s proprietary BiXAb
technology, BMX-502 selectively engages MAIT cells and leverages
their unique properties to maximize anti-tumor activity. MAIT
engagers should overcome some of the limitations of current pan-T
cell engager therapies, including activation of regulatory T cells
and cytokine release syndrome, side effects that are difficult to
manage for patients and represent a significant burden on the
healthcare system.4 MAIT engagers have the potential to provide a
more robust therapeutic window compared to classical pan-T cell
engagers in specific tumor types.
“As we continue to grow Ipsen’s pipeline using a
science-first approach to partnering across the ecosystem, we
believe BMX-502 is a strong addition with first-in-class potential
in solid tumors,” said Mary Jane Hinrichs, SVP and Head of Early
Development at Ipsen. “This new MAIT-engager program will
complement our existing TCE portfolio as we harness the
next-generation of T cell engagers to overcome treatment
challenges, including dose-limiting toxicity, to bring
transformational new medicines to people living with solid tumors
around the world.”
“This agreement with such an innovative oncology
company as Ipsen is proof of the relevance of MAIT-engager approach
of Biomunex, the first company worldwide to have identified the
high therapeutic potential of MAIT cells in cancer treatment. It
also represents the demonstration of the added-value of our
best-in-class BiXAb platform to rapidly generate innovative and
promising bispecific antibodies. We are convinced that our MAIT
engagers will represent a new step forward in the development of
disruptive immuno-therapies for the treatment of cancer. We look
forward to initiating and supporting the development of BMX-502
alongside Ipsen,” added Dr. Pierre-Emmanuel Gerard, founder,
President and CEO of Biomunex.
Under the terms of the agreement, Biomunex will
complete the IND-enabling package. Ipsen will assume responsibility
for Phase I preparation activities, including submission of the
Investigational New Drug (IND) application, and all subsequent
clinical-development and global commercialization activities.
Biomunex is eligible to receive up to $610 million, including
upfront, contingent upon successful development, regulatory and
commercial milestones, in addition to tiered global royalties on
sales.
ENDS
About Ipsen
We are a global biopharmaceutical company with a
focus on bringing transformative medicines to patients in three
therapeutic areas: Oncology, Rare Disease and Neuroscience.
Our pipeline is fueled by external innovation
and supported by nearly 100 years of development experience and
global hubs in the U.S., France and the U.K. Our teams in more than
40 countries and our partnerships around the world enable us to
bring medicines to patients in more than 80 countries.
Ipsen is listed in Paris (Euronext: IPN) and in
the U.S. through a Sponsored Level I American Depositary Receipt
program (ADR: IPSEY). For more information, visit ipsen.com.
About Biomunex
Pharmaceuticals
Biomunex Pharmaceuticals is a biopharmaceutical
company based in Paris (France) and Cambridge, MA, USA, led by an
international and experienced team. Biomunex specializes in the
discovery and development of breakthrough immunotherapeutic
approaches, based on solid data and proven biological and clinical
evidence, to address unmet medical needs in oncology.
Biomunex has created and developed BiXAb®, a
robust, “Plug and Play”, next-generation bi- and multi-specific
antibody technology platform, using a proprietary computational
modeling approach, with a very robust IP and patent portfolio. The
BiXAb platform allows the generation of bispecific antibodies from
any pair of monoclonal antibodies in a simple, fast and
cost-effective manner.
Biomunex is the first company worldwide
developing MAIT engagers, an immuno-oncology approach that allows,
through bispecific antibodies from its BiXAb platform, to
specifically target and engage MAIT cells, to kill cancer cells,
for the treatment of solid tumors.
Ipsen contacts
Email:
corporate.communications@ipsen.com
Investors
Nicolas Bogler | +33 (0) 6 52
19 98 92
Media (Global)
Jennifer Smith-Parker | +44(0)
7843 137764
Media (France)
Anne Liontas | +33 (0) 7 67 34
72 96
Biomunex Pharmaceuticals
contacts
Media - NewCap
Arthur Rouillé | +33 (0)1 44 71
00 15 – arouille@newcap.fr
Disclaimers and/or Forward-Looking
Statements The forward-looking statements, objectives and
targets contained herein are based on Ipsen’s management strategy,
current views and assumptions. Such statements involve known and
unknown risks and uncertainties that may cause actual results,
performance or events to differ materially from those anticipated
herein. All of the above risks could affect Ipsen’s future ability
to achieve its financial targets, which were set assuming
reasonable macroeconomic conditions based on the information
available today. Use of the words ‘believes’, ‘anticipates’ and
‘expects’ and similar expressions are intended to identify
forward-looking statements, including Ipsen’s expectations
regarding future events, including regulatory filings and
determinations. Moreover, the targets described in this document
were prepared without taking into account external-growth
assumptions and potential future acquisitions, which may alter
these parameters. These objectives are based on data and
assumptions regarded as reasonable by Ipsen. These targets depend
on conditions or facts likely to happen in the future, and not
exclusively on historical data. Actual results may depart
significantly from these targets given the occurrence of certain
risks and uncertainties, notably the fact that a promising medicine
in early development phase or clinical trial may end up never being
launched on the market or reaching its commercial targets, notably
for regulatory or competition reasons. Ipsen must face or might
face competition from generic medicine that might translate into a
loss of market share. Furthermore, the research and development
process involves several stages each of which involves the
substantial risk that Ipsen may fail to achieve its objectives and
be forced to abandon its efforts with regards to a medicine in
which it has invested significant sums. Therefore, Ipsen cannot be
certain that favorable results obtained during preclinical trials
will be confirmed subsequently during clinical trials, or that the
results of clinical trials will be sufficient to demonstrate the
safe and effective nature of the medicine concerned. There can be
no guarantees a medicine will receive the necessary regulatory
approvals or that the medicine will prove to be commercially
successful. If underlying assumptions prove inaccurate or risks or
uncertainties materialize, actual results may differ materially
from those set forth in the forward-looking statements. Other risks
and uncertainties include but are not limited to, general industry
conditions and competition; general economic factors, including
interest rate and currency exchange rate fluctuations; the impact
of pharmaceutical industry regulation and healthcare legislation;
global trends toward healthcare cost containment; technological
advances, new medicine and patents attained by competitors;
challenges inherent in new-medicine development, including
obtaining regulatory approval; Ipsen’s ability to accurately
predict future market conditions; manufacturing difficulties or
delays; financial instability of international economies and
sovereign risk; dependence on the effectiveness of Ipsen’s patents
and other protections for innovative medicines; and the exposure to
litigation, including patent litigation, and/or regulatory actions.
Ipsen also depends on third parties to develop and market some of
its medicines which could potentially generate substantial
royalties; these partners could behave in such ways which could
cause damage to Ipsen’s activities and financial results. Ipsen
cannot be certain that its partners will fulfil their obligations.
It might be unable to obtain any benefit from those agreements. A
default by any of Ipsen’s partners could generate lower revenues
than expected. Such situations could have a negative impact on
Ipsen’s business, financial position or performance. Ipsen
expressly disclaims any obligation or undertaking to update or
revise any forward-looking statements, targets or estimates
contained in this press release to reflect any change in events,
conditions, assumptions or circumstances on which any such
statements are based, unless so required by applicable law. Ipsen’s
business is subject to the risk factors outlined in its
registration documents filed with the French Autorité des
Marchés Financiers. The risks and uncertainties set out are not
exhaustive and the reader is advised to refer to Ipsen’s latest
Universal Registration Document, available on ipsen.com.
References
1 Guo et al. Glypican-3: A New Target for Diagnosis
and Treatment of Hepatocellular Carcinoma. Journal of Cancer 2020.
11(8): 2008-2021. Last accessed: November 2024 2 Godfrey et al. The
biology and functional importance of MAIT cells. Nature Immunology.
2019. 20:110-1128 Last accessed: November 2024 3 Petley et al. MAIT
cells regulate NK cell-mediated tumor activity. 2021 Nature
Communications 12:4746 last accessed November 20244 Biomunex
Presentation, AACR 2024. Available here:
https://www.biomunex.com/wp-content/uploads/2024/05/Poster-AACR-2024-FINALIZED.pdf
. Last accessed November 2024
- Ipsen PR_Biomunex_03122024
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