OSE IMMUNOTHERAPEUTICS

Boehringer Ingelheim's SIRP inhibitor BI 765063, when combined with PD-1 inhibitor ezabenlimab and cetuximab, showed manageable safety and promising antitumor activity in patients with recurrent/metastatic head and neck cancer.

OSE Immunotherapeutics has secured €1.3 million in non-dilutive funding to lead the 36-month "HexARN" program focused on advancing mRNA therapeutics delivered via lipid nanoparticles.

Researchers from OSE Immunotherapeutics and Léon Bérard Cancer Center have developed a tumor-agnostic composite gene expression signature that predicts survival in patients treated with immune checkpoint inhibitors.

• Boehringer Ingelheim reached 66 million patients in 2024, an 8% increase from the previous year, while investing €6.2 billion (23.2% of net sales) in research and development. • The company is preparing to launch zongertinib, potentially the first oral targeted therapy for HER2-mutated lung cancer, and nerandomilast for pulmonary fibrosis, with both anticipated for US release in late 2025. • Human Pharma sales rose 7% to €21.9 billion, led by JARDIANCE® and OFEV®, with over ten new Phase II and III trials planned in the next 12-18 months.

OSE Immunotherapeutics reported total income of €83.4 million for 2024, with a cash position of €64.2 million ensuring financial visibility until Q1 2027.

• OSE Immunotherapeutics' therapeutic cancer vaccine demonstrated promising overall survival outcomes in a Phase II trial for pancreatic ductal adenocarcinoma (PDAC), a notoriously difficult-to-treat cancer. • The vaccine trial represents a potential breakthrough in PDAC treatment, where current therapeutic options are limited and five-year survival rates remain dismally low. • This development adds to recent advances in pancreatic cancer research, including BullFrog AI's partnership with Eleison Pharmaceuticals and Candel Therapeutics' immunotherapy showing 31.4-month median overall survival.

The TEDOPaM Phase 2 trial met its primary endpoint, demonstrating that OSE2101 (Tedopi) combined with FOLFIRI chemotherapy achieved a statistically significant improvement in one-year overall survival rate for advanced pancreatic cancer patients.

• The USAN Council has approved "pegrizeprument" as the nonproprietary name for Veloxis Pharmaceuticals' lead transplant candidate VEL-101, marking a significant milestone in the drug's development pathway. • Pegrizeprument features a novel dual mechanism of action that blocks CD28-mediated T cell activation while preserving CTLA-4 immunosuppressive functions, potentially offering advantages in transplant immunosuppression. • The investigational maintenance immunosuppressive agent is being developed primarily for preventing acute rejection in kidney transplant recipients, with potential applications for other solid organ transplants.

Lusvertikimab, an anti-IL-7R antibody, achieved statistically significant results in primary and secondary endpoints in patients with moderate to severe ulcerative colitis.

OSE Immunotherapeutics reported total H1 2024 incomes of €82.5 million, driven by new partnerships with AbbVie and Boehringer Ingelheim, strengthening its financial position.