* 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 malignancies(1)
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 (FolR?)-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 (http://www.sutrobio.com).
Ipsen contacts
Email: corporate.communications@ipsen.com
(mailto: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 | 1-650-823-7681
Email: ewhite@sutrobio.com (mailto:ewhite@sutrobio.com)
Ipsen 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
(https://www.globenewswire.com/Tracker?data=cRbeTYiLm_i554EQ7ITgGkjFSkEO7CuADsdG
INJYRhuLZP1b2RRGQKaNMQhqDBefwdyOcUcRf2VYKHI9RWUEWA==).
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
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(1) Preclinical development of STRO-003, a ROR1 targeted antibody-drug
conjugate. 14(th) Annual WADS ADC. San Diego 2023. Available here:
https://www.sutrobio.com/wp-content/uploads/2023/10/WADC_SD_2023_HKiefel.pdf
(2) 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
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