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AbbVie and OSE Immunotherapeutics Announce Partnership to Develop a Novel Monoclonal Antibody for the Treatment of Chronic Inflammation

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AbbVie Inc. and OSE Immunotherapeutics collaborate to develop OSE-230, a monoclonal antibody targeting chronic inflammation. OSE to receive $48 million upfront and up to $665 million in milestone payments. AbbVie gains exclusive global license for OSE-230.
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The agreement between AbbVie and OSE Immunotherapeutics for the development of OSE-230, a monoclonal antibody, represents a significant strategic move within the biotechnology industry, especially in the field of immunotherapy. Monoclonal antibodies are laboratory-produced molecules engineered to serve as substitute antibodies that can restore, enhance, or mimic the immune system's attack on cells. The upfront payment of $48 million, coupled with the potential for $665 million in milestone payments, reflects the high expectations and potential revenue associated with OSE-230.

OSE-230's mechanism, targeting ChemR23 to resolve chronic inflammation, is particularly notable as it suggests a novel approach beyond the current anti-inflammatory treatments. Chronic inflammation is implicated in a range of diseases, including autoimmune disorders and some cancers, which makes the successful development of OSE-230 potentially transformative. If successful, it could not only diversify AbbVie's portfolio but also offer a new therapeutic option to patients with limited treatment choices.

From a financial perspective, the collaboration is poised to enhance AbbVie's long-term revenue potential, assuming OSE-230 progresses favorably through clinical development and regulatory approval. The deal structure, with tiered royalties on global net sales, aligns OSE Immunotherapeutics' ongoing interest with the success of the product, incentivizing sustained cooperation. Investors should note the risk inherent in drug development, particularly at the pre-clinical stage, as many candidates do not reach commercialization. However, the size of the deal indicates confidence in the drug's prospects and the market's demand for innovative anti-inflammatory therapies.

The transaction's dependency on the Hart-Scott-Rodino Antitrust Improvements Act also highlights the importance of regulatory approval processes in such deals, which can affect the timeline and certainty of the collaboration's financial benefits to both companies.

Examining the potential market impact, the development of OSE-230 could disrupt the current immunotherapy landscape. The global market for such treatments is growing, driven by the high prevalence of inflammatory diseases and the need for more effective therapies. The collaboration taps into AbbVie's robust immunology drug development expertise, which could accelerate OSE-230's market entry. Given AbbVie's established global commercialization network, the partnership could significantly enhance the market reach of OSE-230 upon approval, potentially reshaping competitive dynamics.

It's important to monitor the ongoing research outcomes and regulatory developments related to OSE-230, as these will provide more concrete indicators of the drug's market potential and impact on both AbbVie's and OSE Immunotherapeutics' valuations.

-   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

FAQ

What is the focus of the collaboration between AbbVie and OSE Immunotherapeutics?

The collaboration aims to develop OSE-230, a monoclonal antibody designed to resolve chronic inflammation.

What upfront payment will OSE Immunotherapeutics receive?

OSE Immunotherapeutics will receive an upfront payment of $48 million.

How much can OSE Immunotherapeutics receive in milestone payments?

OSE Immunotherapeutics can receive up to an additional $665 million in milestone payments.

What does AbbVie gain from the agreement?

AbbVie gains an exclusive global license to develop, manufacture, and commercialize OSE-230.

What is the potential royalty structure for OSE Immunotherapeutics?

OSE Immunotherapeutics will be eligible to receive potential tiered royalties on global net sales of OSE-230.

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About ABBV

AbbVie Inc. is a pharmaceutical company headquartered in North Chicago, Illinois. It is ranked 6th on the list of largest biomedical companies by revenue. Their primary product is Humira (adalimumab) ($21 billion in 2022 revenues, 37% of total), administered via injection. It is approved to treat autoimmune diseases including rheumatoid arthritis, Crohns disease, plaque psoriasis, and ulcerative colitis.