Ipsen and Sutro Biopharma announce exclusive global licensing
agreement for an ADC targeting solid tumors
- Ipsen secures
exclusive global rights for development and commercialization of
STRO-003, an antibody-drug conjugate, completing the final stages
of pre-clinical development
- STRO-003 targets
ROR1, a clinically validated antibody drug conjugate (ADC)
target
- STRO-003 has
shown robust monotherapy efficacy and potential for a
differentiated safety profile in preclinical development in solid
tumors and hematological malignancies1
PARIS, FRANCE; SAN FRANCISCO, U.S., 02
April 2024 - Ipsen (Euronext: IPN; ADR: IPSEY) and Sutro
Biopharma (NASDAQ: STRO, “Sutro”, “the Company”) today announced an
exclusive global licensing agreement for STRO-003. STRO-003, an
antibody-drug conjugate (ADC) in the final stages of pre-clinical
development, targets the ROR1 tumor antigen which is known to be
overexpressed in many different cancer types including solid tumors
and hematological malignancies.1 The agreement gives Ipsen
exclusive worldwide rights to develop and commercialize STRO-003
and will be the first ADC candidate joining Ipsen’s expanding
portfolio.
“The potential for ADCs in oncology is
well-documented and we are excited by the addition of STRO-003,
Ipsen’s first ADC candidate with best-in-class potential.” said
Mary Jane Hinrichs, SVP and Head of Early Development at Ipsen.
“STRO-003 is a next-generation ROR1 ADC, leveraging Sutro’s
site-specific technology to generate a highly stable conjugate,
coupled with exatecan payloads, that have shown significant
potential in solid tumors. This is our focus as we prepare to enter
Phase I, harnessing Ipsen’s global expertise in oncology
development, while also reinforcing our commitment to bringing new
medicines to patients with few treatment options.”
“We are excited to partner STRO-003 with Ipsen
to help us reach more patients faster while retaining significant
downstream participation in a medicine in which we believe,” said
Jane Chung, President and Chief Operating Officer at Sutro.
“Sutro’s research innovation represented in STRO-003 illustrates
our leadership in ADC design. We look forward to collaborating with
Ipsen’s impressive oncology development team to bring a
differentiated ROR1-targeted ADC to patients.”
ADCs are comprised of three main components: the
antibody, payload and linker. The antibody selectively targets an
identified tumor antigen, such as ROR1. Payloads are the
pharmaceutically active component to treat the cancer, attached to
the antibody via a chemical linker. The linker connects the
antibody and the payload and reduces the amount of payload that
reaches non-tumor tissue.2
Under the terms of the agreement, Ipsen will
assume responsibility for Phase I preparation activities, including
submission of the Investigational New Drug (IND) application, and
all subsequent clinical-development activities and global
commercialization activities. Sutro Biopharma is eligible
to receive up to $900m in potential upfront, development,
regulatory and commercial milestone payments including
approximately $90m in near-term payments, including an equity
investment, and tiered royalties on global sales,
contingent upon successful development and commercialization.
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 Sutro Biopharma
Sutro Biopharma, Inc., is a clinical-stage
company relentlessly focused on the discovery and development of
precisely designed cancer therapeutics, transforming what science
can do for patients. Sutro’s fit-for-purpose technology, including
cell-free XpressCF®, provides the opportunity for broader patient
benefit and an improved patient experience. Sutro has multiple
clinical stage candidates, including luveltamab tazevibulin, or
luvelta, a registrational-stage folate receptor alpha
(FolRα)-targeting ADC in clinical studies. A robust pipeline,
coupled with high-value collaborations and industry partnerships,
validates our continuous product innovation. Sutro is headquartered
in South San Francisco. For more information, follow Sutro on
social media @Sutrobio, or visit www.sutrobio.com.
Ipsen contacts
Email:
corporate.communications@ipsen.com
Investors
Craig Marks | + 44 7584 349
193
Nicolas Bogler | +33 (0) 6 52
19 98 92
Media
Amy Wolf | +41 7 95 76 07
23
Jess Smith | + 44 7557 267
634
Sutro Biopharma contacts
Emily White |
1-650-823-7681Email: ewhite@sutrobio.com
Ipsen Disclaimers and/or Forward-Looking
StatementsThe 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.
Sutro Forward-Looking
Statements
This press release contains forward-looking
statements within the meaning of the “safe harbor” provisions of
the Private Securities Litigation Reform Act of 1995, including,
but not limited to, the Company’s entry into the exclusive global
licensing agreement with Ipsen and potential benefits of such
agreement, including potential future payments thereunder,
anticipated preclinical and clinical development activities,
potential benefits of luvelta and the Company’s other product
candidates and platform; potential expansion into other indications
and combinations, including the timing and development activities
related to such expansion; and potential market opportunities for
luvelta and the Company’s other product candidates. All statements
other than statements of historical fact are statements that could
be deemed forward-looking statements. Although the Company believes
that the expectations reflected in such forward-looking statements
are reasonable, the Company cannot guarantee future events,
results, actions, levels of activity, performance or achievements,
and the timing and results of biotechnology development and
potential regulatory approval is inherently uncertain.
Forward-looking statements are subject to risks and uncertainties
that may cause the Company’s actual activities or results to differ
significantly from those expressed in any forward-looking
statement, including risks and uncertainties related to the
Company’s ability to advance its product candidates, the receipt
and timing of potential regulatory designations, approvals and
commercialization of product candidates and the Company’s ability
to successfully leverage Fast Track designation, the market size
for the Company’s product candidates to be smaller than
anticipated, clinical trial sites, supply chain and manufacturing
facilities, the Company’s ability to maintain and recognize the
benefits of certain designations received by product candidates,
the timing and results of preclinical and clinical trials, the
Company’s ability to fund development activities and achieve
development goals, the Company’s ability to protect intellectual
property, the value of the Company’s holdings of Vaxcyte common
stock, and the Company’s commercial collaborations with third
parties and other risks and uncertainties described under the
heading “Risk Factors” in documents the Company files from time to
time with the Securities and Exchange Commission. These
forward-looking statements speak only as of the date of this press
release, and the Company undertakes no obligation to revise or
update any forward-looking statements to reflect events or
circumstances after the date hereof.
References
1 Preclinical development of STRO-003, a ROR1
targeted antibody-drug conjugate. 14th Annual WADS ADC. San Diego
2023. Available here:
https://www.sutrobio.com/wp-content/uploads/2023/10/WADC_SD_2023_HKiefel.pdf2
E. Jabbour, S. Paul, H. Kantarjian. The clinical development of
antibody-drug conjugates – lessons from leukemia. Nature Reviews
Clinical Onoclogy. 2021. 18: 418-433. Available here:
https://www.nature.com/articles/s41571-021-00484-2
- Ipsen PR_ Sutro Biopharma licensing agreement_02042024
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