AbbVie and OSE Immunotherapeutics, a clinical-stage immunotherapy company, announced on Feb. 28, 2024 that they have entered into a strategic partnership to develop OSE-230, a monoclonal antibody (mAb) in development to treat chronic and severe inflammation. The mAb is currently in pre-clinical development.
Under the agreement, OSE Immunotherapeutics will receive a $48 million upfront payment and is eligible to receive up to an additional $665 million in clinical development, regulatory, and commercial milestones. OSE Immunotherapeutics will also be eligible to receive potential tiered royalties on global net sales of OSE-230. AbbVie will have an exclusive global license to develop, manufacture, and commercialize OSE-230.
OSE-230 is designed to activate ChemR23, a G-protein coupled receptor (GPCR) target, which may offer a new mechanism by which chronic inflammation can be resolved. Activating ChemR23 may modulate the functions of both macrophages and neutrophils, according to a company press release.
"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, senior vice-president and global head of discovery research, AbbVie, in the press release. "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 … to drive our OSE-230 program forward," said Nicolas Poirier, chief executive officer, OSE Immunotherapeutics, in the release. "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."
OSE Immunotherapeutics' pipeline also includes the following candidates:
- Tedopi (immunotherapy-activating tumor-specific T-cells, off-the-shelf, neoepitope-based). This candidate is a cancer vaccine and is the company's most advanced product. It has generated positive results in a Phase III trial (Atalante 1) in patients with non-small cell lung cancer who are experiencing secondary resistance after checkpoint inhibitor failure. Tedopi is also in other ongoing Phase II trials, sponsored by clinical oncology groups, in combination treatment scenarios for solid tumors.
- OSE-279 (anti-programmed cell death protein 1 [PD-1]). This candidate has generated its first set of positive results in an ongoing Phase I/II study in solid tumors. OSE-279 is the primary therapy derived from the company’s bispecific fusion protein platform, BiCKI.
- OSE-127 - lusvertikimab (humanized mAb antagonist of interleukin 7 [IL-7] receptor). This candidate is in an ongoing Phase II study in ulcerative colitis and in ongoing preclinical research in leukemia.
- FR-104/VEL-101 (anti-CD28 mAb). This mAb was developed in partnership with Veloxis Pharmaceuticals, an Asahi Kasei company, for use in transplantation treatment. It is in ongoing Phase I/II studies in renal transplant and an ongoing Phase I study in the United States.
- BI 765063 and BI 770371 (anti-signal-regulating protein alpha [SIRPα] mAb on CD47/SIRPα pathway). These candidates were developed in partnership with Boehringer Ingelheim for treatment of advanced solid tumors. They have demonstrated positive Phase I dose-escalation results in monotherapy and in combination, particularly with the anti-PD-1 antibody, ezabenlimab. They are also in an ongoing international Phase Ib clinical trial in combination with ezabenlimab alone or with other drugs for treating patients with recurrent/metastatic head and neck squamous cell carcinoma and hepatocellular carcinoma.
In addition to these pipeline candidates, OSE Immunotherapeutics also expects to generate further potential candidates based on its three proprietary drug discovery platforms:
- Pro-resolutive mAb platform, which focuses on targeting and advancing the resolution of inflammatory conditions and optimizing the therapeutic potential of targeting neutrophils and macrophages in immunology and inflammation (I&I). OSE-230 is the first candidate generated by this platform. Additional discovery programs are ongoing on new pro-resolutive G protein-coupled receptors.
- Myeloid Checkpoint platform, which aims to optimize the therapeutic potential of myeloid cells in immuno-oncology (IO) by targeting immune regulatory receptors that are expressed by macrophages and dendritic cells. BI 765063 and BI 770371 are the most advanced candidates generated by this platform. There are also additional ongoing discovery programs, with positive preclinical results obtained in monotherapy studies with new anti-C-type lectin-like receptor-1 mAbs.
- Cytokine platform, which focuses on leveraging the Cis-delivery of cytokine in IO and I&I. BiCKI is a bispecific fusion protein platform. It is built on the key backbone component of anti-PD-1 combined with a new immunotherapy target. This combination aims to increase anti-tumor efficacy. BiCKI-IL-7v is the most advanced candidate generate by the BiCKI platform, which targets anti-PD-1xIL-7. There are ongoing additional discovery programs on Cis-demasking technologies.
Source: AbbVie