- Global license and collaboration agreement to
focus on the development of OSE-230, a monoclonal antibody designed
to resolve chronic inflammation
- OSE Immunotherapeutics to receive an upfront
payment of $48 million and will be
eligible to receive up to an additional $665
million in milestone payments
NORTH
CHICAGO, Ill. and NANTES, France, Feb. 28,
2024 /PRNewswire/ -- AbbVie Inc. (NYSE: ABBV)
and OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), a
clinical-stage immunotherapy company, today announced a
strategic partnership to develop OSE-230, a monoclonal antibody
designed to resolve chronic and severe inflammation,
currently in the pre-clinical development stage.
OSE-230 is a first-in-class monoclonal antibody designed to
activate ChemR23, a G-Protein Coupled Receptor (GPCR) target.
Activation of ChemR23 may offer a novel mechanism for the
resolution of chronic inflammation, modulating functions of both
macrophages and neutrophils.
"This collaboration underscores our commitment to expanding our
immunology portfolio with the ultimate goal of improving the
standard of care for patients living with inflammatory diseases
globally," said Jonathon Sedgwick,
Ph.D., senior vice president and global head of discovery research,
AbbVie. "By leveraging our expertise in immunology drug
development, we look forward to advancing OSE-230, which offers a
novel mechanism-of-action to treat chronic inflammation."
"We are very pleased to collaborate with AbbVie, a global leader
in the development and commercialization of innovative medicines,
to drive our OSE-230 program forward," said Nicolas Poirier, chief executive officer, OSE
Immunotherapeutics. "This partnership represents a major milestone
in our company's progress and recognizes the value of our
innovative R&D capabilities. I would like to thank all our
employees who helped us reach this milestone through dedication and
hard work."
Under the terms of the agreement, AbbVie will receive an
exclusive global license to develop, manufacture and commercialize
OSE-230. OSE Immunotherapeutics will receive a $48 million upfront payment and will be eligible
to receive up to an additional $665
million in clinical development, regulatory and commercial
milestones. In addition, OSE Immunotherapeutics will be eligible to
receive potential tiered royalties on global net sales of
OSE-230.
The transaction is subject to the satisfaction of customary
closing conditions, including the applicable waiting period under
the Hart-Scott-Rodino Antitrust Improvements Act.
About AbbVie
AbbVie's mission is to discover and
deliver innovative medicines and solutions that solve serious
health issues today and address the medical challenges of tomorrow.
We strive to have a remarkable impact on people's lives across
several key therapeutic areas – immunology, oncology, neuroscience,
and eye care – and products and services in our Allergan Aesthetics
portfolio. For more information about AbbVie, please visit us at
www.abbvie.com. Follow @abbvie on LinkedIn, Facebook,
Instagram, X (formerly Twitter), and YouTube.
ABOUT OSE Immunotherapeutics
OSE Immunotherapeutics is
a biotech company dedicated to developing first-in-class assets in
immuno-oncology (IO) and immuno-inflammation (I&I).
The Company's current well-balanced first-in-class clinical
pipeline includes:
- Tedopi® (immunotherapy activating tumor
specific T-cells, off-the-shelf, neoepitope-based): this cancer
vaccine is the Company's most advanced product; positive results
from the Phase 3 trial (Atalante 1) in Non-Small Cell Lung Cancer
patients in secondary resistance after checkpoint inhibitor
failure. Other Phase 2 trials, sponsored by clinical oncology
groups, of Tedopi® in combination are ongoing in solid
tumors.
- OSE-279 (anti-PD1): first positive results in the
ongoing Phase 1/2 in solid tumors. OSE-279 is the backbone therapy
of the BiCKI® platform.
- OSE-127 - lusvertikimab (humanized
monoclonal antibody antagonist of IL-7 receptor); ongoing Phase 2
in Ulcerative Colitis (sponsor OSE Immunotherapeutics); ongoing
preclinical research in leukemia (OSE Immunotherapeutics).
- FR-104/VEL-101 (anti-CD28 monoclonal antibody):
developed in partnership with Veloxis Pharmaceuticals, Inc. in
transplantation; ongoing Phase 1/2 in renal transplant (sponsor
Nantes University Hospital); Phase 1 ongoing in the US (sponsor
Veloxis Pharmaceuticals, Inc.).
- BI 765063 and BI 770371 (anti-SIRPα
monoclonal antibody on CD47/SIRPα pathway) developed in partnership
with Boehringer Ingelheim in advanced solid tumors; positive Phase
1 dose escalation results in monotherapy and in combination, in
particular with anti-PD-1 antibody ezabenlimab; international Phase
1b ongoing clinical trial in
combination with ezabenlimab alone or with other drugs in patients
with recurrent/metastatic head and neck squamous cell carcinoma
(HNSCC) and hepatocellular carcinoma (HCC).
- OSE-230 (ChemR23 agonist mAb) developed in
partnership with AbbVie in chronic inflammation.
OSE Immunotherapeutics expects to generate further significant
value from its three proprietary drug discovery platforms, which
are central to its ambitious goal to deliver next-generation
first-in-class immunotherapies:
- Pro-resolutive mAb platform focused on targeting
and advancing inflammation resolution and optimizing the
therapeutic potential of targeting Neutrophils and Macrophages
in I&I. OSE-230 (licensed to AbbVie) is the
first candidate generated by the platform, additional discovery
programs ongoing on new pro-resolutive GPCRs.
- Myeloid Checkpoint platform focused on optimizing the
therapeutic potential of myeloid cells in IO by targeting immune
regulatory receptors expressed by Macrophages and Dendritic
cells. BI 765063 and BI 770371 (licensed to
Boehringer Ingelheim) are the most advanced candidates generated by
the platform. Ongoing additional discovery programs, in particular
with positive preclinical results obtained in monotherapy with new
anti-CLEC-1 mAbs.
- Cytokine platform focused on leveraging the
Cis-Delivery of cytokine in IO and I&I. BiCKI® is a
bispecific fusion protein platform built on the key backbone
component of anti-PD1 combined with a new immunotherapy target to
increase anti-tumor efficacy. BiCKI®-IL-7v
is the most advanced BiCKI® candidate targeting
anti-PD1xIL-7. Ongoing additional discovery programs on
Cis-Demasking technologies.
AbbVie Forward-Looking Statements
Some statements in
this news release are, or may be considered, forward-looking
statements for purposes of the Private Securities Litigation Reform
Act of 1995. The words "believe," "expect," "anticipate," "project"
and similar expressions and uses of future or conditional verbs,
generally identify forward-looking statements. AbbVie cautions that
these forward-looking statements are subject to risks and
uncertainties that may cause actual results to differ materially
from those expressed or implied in the forward-looking statements.
Such risks and uncertainties include, but are not limited to,
challenges to intellectual property, competition from other
products, difficulties inherent in the research and development
process, adverse litigation or government action, and changes to
laws and regulations applicable to our industry. Additional
information about the economic, competitive, governmental,
technological and other factors that may affect AbbVie's operations
is set forth in Item 1A, "Risk Factors," of AbbVie's 2023 Annual
Report on Form 10-K, which has been filed with the Securities and
Exchange Commission, as updated by its subsequent Quarterly Reports
on Form 10-Q. AbbVie undertakes no obligation, and specifically
declines, to release publicly any revisions to forward-looking
statements as a result of subsequent events or developments, except
as required by law.
OSE Forward-looking statements
This press
release contains express or implied information and statements that
might be deemed forward-looking information and statements in
respect of OSE Immunotherapeutics. They do not constitute
historical facts. These information and statements include
financial projections that are based upon certain assumptions and
assessments made by OSE Immunotherapeutics' management in light of
its experience and its perception of historical trends, current
economic and industry conditions, expected future developments and
other factors they believe to be appropriate.
These forward-looking statements include statements
typically using conditional and containing verbs such as "expect",
"anticipate", "believe", "target", "plan", or "estimate", their
declensions and conjugations and words of similar import. Although
the OSE Immunotherapeutics management believes that the
forward-looking statements and information are reasonable, the OSE
Immunotherapeutics' shareholders and other investors are cautioned
that the completion of such expectations is by nature subject to
various risks, known or not, and uncertainties which are difficult
to predict and generally beyond the control of OSE
Immunotherapeutics. These risks could cause actual results and
developments to differ materially from those expressed in or
implied or projected by the forward-looking statements. These risks
include those discussed or identified in the public filings made by
OSE Immunotherapeutics with the AMF. Such forward-looking
statements are not guarantees of future performance. This press
release includes only summary information and should be read with
the OSE Immunotherapeutics Universal Registration Document filed
with the AMF on May 2, 2023,
including the annual financial report for the fiscal year 2022,
available on the OSE Immunotherapeutics' website. Other than as
required by applicable law, OSE Immunotherapeutics issues this
press release at the date hereof and does not undertake any
obligation to update or revise the forward-looking information or
statements.
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SOURCE AbbVie