Ose Immunotherapeutics Announces the Entry Into Force of the Global License to Develop an Innovative Monoclonal Antibody in the Treatment of Chronic Inflammation

Wednesday, April 17, 2024

OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), a clinical-stage immunotherapies company, announces the end of the waiting period provided for by the Hart-Scott law -Rodino Antitrust Improvements Act relating to the worldwide license granted to AbbVie for the development of OSE-230, a preclinical stage monoclonal antibody, for the resolution of chronic and severe inflammation.

Under the partnership agreement announced on February 28, 2024, OSE Immunotherapeutics has granted an exclusive global license to AbbVie to develop OSE-230, a monoclonal antibody designed for the resolution of chronic inflammation.

Under the terms of this agreement, OSE Immunotherapeutics will now receive the anticipated upfront payment of $48 million. Additionally, OSE Immunotherapeutics may receive up to an additional $665 million in development, regulatory and commercialization milestone payments and potential tiered royalties on global net sales of OSE-230.

About OSE Immunotherapeutics

OSE Immunotherapeutics is a biotechnology company developing first-in-class products in immuno-oncology (IO) and immuno-inflammation (I&I). Its first-in-class clinical portfolio includes:

• Tedopi® (specific T lymphocyte activation immunotherapy against cancer cells, “  off-the-shelf  ” based on neo-epitopes): the Company's most advanced product; positive results from the Phase 3 trial (Atalante 1) in non-small cell lung cancer (NSCLC) in patients with secondary resistance after failure of a checkpoint inhibitor. Other trials, promoted by clinical oncology groups, of Tedopi® in combination are underway in solid tumors.
• OSE-279 (anti-PD1): First positive results from the ongoing Phase 1/2 study in solid tumors.
• OSE-127 - Lusvertikimab (humanized monoclonal antibody antagonist of the IL-7 receptor): Phase 2 in progress in ulcerative colitis (promoter OSE Immunotherapeutics); ongoing preclinical research work in leukemia (OSE Immunotherapeutics).
• FR104/VEL-101 (anti-CD28 monoclonal antibody): developed in partnership with Veloxis Pharmaceuticals, Inc. in transplantation; Phase 1/2 underway in kidney transplantation (under the promotion of the University Hospital Center of Nantes); Phase 1 successfully completed in the United States (promoter Veloxis Pharmaceuticals, Inc.).
• BI 765063 and BI 770371 (anti-SIRPα monoclonal antibodies on the SIRPα/CD-47 axis): developed in partnership with Boehringer Ingelheim (BI) in advanced solid tumors; positive results from Phase 1 dose escalation in monotherapy and in combination, in particular with the anti-PD1 antibody ezabenlimab; BI-promoted international Phase 1b ongoing in combination with ezabenlimab alone or with other drugs in relapsed or metastatic head and neck cancer and hepatocellular carcinoma.
• OSE-230 (ChemR23 agonist monoclonal antibody) developed in partnership with AbbVie in chronic inflammation.

OSE Immunotherapeutics aims to create significant value through its three patented research platforms, central to its goal of delivering first-in-class, next-generation immunotherapy treatments :

• Pro-resolving monoclonal antibody platform that aims to improve the resolution of inflammation and optimize the therapeutic potential of targeting neutrophils and macrophages in I&I. OSE-230 (licensed to AbbVie) is the first candidate from this platform, other research programs are underway on new GPCR targets.
• Myeloid checkpoint platform that aims to optimize the therapeutic potential of myeloid cells in IO by targeting regulatory immune receptors expressed by macrophages and dendritic cells. BI 765063 and BI 770371 (licensed to Boehringer Ingelheim) are the most advanced candidates generated by this platform. Other research programs are underway, in particular the new anti-CLEC-1 monoclonal antibody which has shown positive preclinical results as a monotherapy.
• Cytokines platform dedicated to the optimization of Cis-delivery of cytokines in IO and I&I. BiCKI® is a bispecific fusion protein platform built around a central anti-PD-1 backbone fused with new immunotherapy targets to increase anti-tumor efficacy. BiCKI®-IL-7 is the most advanced BiCKI® candidate, targeting anti-PD1xIL-7. Other research programs are underway on cytokine unmasking technologies.

More information on OSE Immunotherapeutics' assets is available on the Company's website: http://ose-immun.com
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Sylvie Détry

sylvie.detry@ose-immun.com

Media: FP2COM
Florence Portejoie
fportejoie@fp2com.fr
+33 6 07 76 82 83

Nicolas Poirier

Managing Director

nicolas.poirier@ose-immun.com

U.S. Media Contact

RooneyPartners LLC
Kate Barrette
kbarrette@rooneypartners.com

+1 212 223 0561

Forward-Looking Statements
This release contains, implicitly or expressly, information and statements that may be deemed forward-looking regarding OSE Immunotherapeutics. They do not constitute historically proven facts. This information and statements include financial projections based on assumptions or assumptions made by the management of OSE Immunotherapeutics in light of their experience and their perception of historical trends, current economic and industry conditions, future developments and other factors that they consider appropriate.
These forward-looking statements can often be identified by the use of the conditional tense and by the verbs "expect", "anticipate", "believe", "plan" or "estimate" and their variations and conjugations as well as by other similar terms. Although the management of OSE Immunotherapeutics believes that these forward-looking statements are reasonable, OSE Immunotherapeutics shareholders and other investors are alerted to the fact that their achievement is inherently subject to numerous known and unknown risks and uncertainties, which are difficult to predict. and outside the control of OSE Immunotherapeutics. These risks may cause actual results and developments to differ materially from those indicated or implied in these forward-looking statements. These risks include in particular those developed or identified in public documents filed by OSE Immunotherapeutics with the AMF. Such forward-looking statements constitute no guarantee of future performance. This press release only includes summary elements and should be read in conjunction with the Universal Registration Document of OSE Immunotherapeutics, registered by the AMF on May 2, 2023, including the 2022 annual financial report, available on the OSE website. Immunotherapeutics. OSE Immunotherapeutics undertakes no obligation to update forward-looking information and statements except as required by applicable laws and regulations.

Source: globenewswire.com