OSE Immunotherapeutics Announces Completion of Enrollment in Phase 2 Clinical Trial Evaluating Lusvertikimab in Patients with Ulcerative Colitis - Seite 2

⁽¹⁾ EvaluatePharma
⁽²⁾ Updated Incidence and Prevalence of Crohn’s Disease and Ulcerative Colitis in Olmsted County, Minnesota (1970-2011). Loftus EV et al. October 2014.
⁽³⁾ Drugs Context. 2019; 8: 212572 –doi: 10.7573/dic.212572
⁽⁴⁾ Belarif et al.; Journal of Clinical Investigation 2019

ABOUT LUSVERTIKIMAB (OSE-127)

Lusvertikimab* is a monoclonal immunomodulatory antibody targeting the CD127 receptor, the alpha chain of the interleukin-7 receptor (IL-7R) that induces a powerful antagonist effect on effector T lymphocytes. Interleukin-7 is a cytokine that specifically regulates the tissue migration of human effector T lymphocytes. The blockage of IL-7R prevents the migration of pathogenic T lymphocytes while preserving regulator T lymphocytes which have a positive impact on autoimmune diseases. This is a novel and differentiated mechanism of action of the only full-antagonist of IL-7R for the treatment of chronic autoimmune diseases. Lusvertikimab is the only compound targeting IL-7R under clinical development in UC.

* IL-7 receptor blockade blunts antigen-specific memory T cell responses and chronic inflammation in primates; Belarif L et al. ; Nature Communications 2018
IL-7 receptor influences anti-TNF responsiveness and T cell gut homing in inflammatory bowel disease; Belarif L et al.; J Clin Invest. 2019
First-in-Human Study in Healthy Subjects with the Noncytotoxic Monoclonal Antibody OSE-127, a Strict Antagonist of IL-7Rα
Poirier N. et al.; The Journal of Immunology 2023

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-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); successful Phase 1 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: