OSE Immunotherapeutics Leads €1.3 Million Consortium to Advance mRNA Therapeutics Using Lipid Nanoparticle Technology
• 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.
• The strategic collaboration brings together OSE Immunotherapeutics, Inside Therapeutics, and MiNT Laboratory to overcome challenges in RNA therapy selectivity, safety, target expansion, and manufacturing scalability.
• The consortium aims to develop novel RNA therapeutics for inflammatory disorders and autoimmune diseases, leveraging advantages over conventional antibody approaches while improving delivery methods.
Novel Gene Expression Signature Predicts Immunotherapy Response Across Cancer Types
• 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.
• The new biomarker could overcome limitations of current predictive markers like PD-L1 expression and tumor mutational burden, potentially improving patient stratification regardless of cancer type.
• Findings presented at the 2025 AACR Annual Meeting demonstrate the signature's ability to identify three distinct patient groups with different clinical outcomes following immunotherapy treatment.
Boehringer Ingelheim Prepares for Multiple New Product Launches in 2025 Following Strong R&D Investment
• 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 Reports Strong Financial Results and Pipeline Progress in 2024
• 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.
• The company secured three strategic pharmaceutical agreements worth up to $713 million with AbbVie and €1.1 billion with Boehringer Ingelheim, significantly strengthening its financial position.
• Clinical advances were reported across the pipeline, including positive Phase 2 results for Lusvertikimab in ulcerative colitis and the launch of a pivotal Phase 3 trial for Tedopi® in non-small cell lung cancer.
OSE2101 Cancer Vaccine Shows Promising Results in Phase 2 Pancreatic Cancer Trial
• 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 neoepitope-based therapeutic cancer vaccine showed minimal toxicity when used as maintenance therapy in HLA-A2 positive patients who had not progressed after FOLFIRINOX induction chemotherapy.
• Researchers emphasize these results provide hope in a difficult-to-treat cancer with low survival rates, though further analysis and longer follow-up are needed to fully understand the vaccine's contribution to the observed benefits.
Veloxis Pharmaceuticals' Transplant Candidate VEL-101 Receives Official Name "Pegrizeprument"
• 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.
Anti-IL23p19 Therapies Transform IBD Treatment Landscape Ahead of ECCO 2025
• The anti-IL23p19 class has emerged as a breakthrough in IBD treatment, with three major players - AbbVie's Skyrizi, Eli Lilly's Omvoh, and J&J's Tremfya - reshaping the therapeutic landscape.
• ECCO 2025 will showcase critical data for these therapies, including Omvoh's long-term efficacy in Crohn's disease, Tremfya's subcutaneous induction results, and new bowel urgency endpoints for ulcerative colitis.
• Market dynamics are evolving with the entry of Stelara biosimilars in Europe and the emergence of new therapeutic approaches, including TL1A inhibitors and IL-7R antagonists.
Lusvertikimab Shows Promise in Ulcerative Colitis Phase 2 Trial
• Lusvertikimab, an anti-IL-7R antibody, achieved statistically significant results in primary and secondary endpoints in patients with moderate to severe ulcerative colitis.
• The Phase 2 CoTikiS study demonstrated high rates of clinical and endoscopic remission after 10 weeks of treatment with lusvertikimab.
• Treatment with lusvertikimab significantly reduced fecal calprotectin (FCP), a key biomarker of mucosal inflammation, indicating a potential for mucosal healing.
• A favorable safety profile was observed, reinforcing lusvertikimab's potential as a novel therapeutic option for ulcerative colitis.
OSE Immunotherapeutics Announces Positive H1 2024 Results and Corporate Updates
• OSE Immunotherapeutics reported total H1 2024 incomes of €82.5 million, driven by new partnerships with AbbVie and Boehringer Ingelheim, strengthening its financial position.
• Positive efficacy and safety results were observed in Phase 1/2 trials for OSE-279 in solid tumors and FR104/VEL-101 in renal transplantation, showcasing advancements in the clinical pipeline.
• The company launched the Artemia Phase 3 registration study for Tedopi® in second-line non-small cell lung cancer and reported positive Phase 2 results for Lusvertikimab in ulcerative colitis.
• Strategic agreements with AbbVie and Boehringer Ingelheim, along with non-dilutive funding, provide financial visibility until 2027, supporting clinical development and R&D investments.
Tulisokibart Shows Promise in Treating Moderate to Severe Ulcerative Colitis
• A Phase 2 trial of tulisokibart, an anti-TL1A monoclonal antibody, demonstrated superior efficacy compared to placebo in inducing clinical remission in patients with moderate to severe ulcerative colitis.
• The study utilized a genetic-based diagnostic test to identify patients more likely to respond to tulisokibart, showing improved remission rates in this subgroup.
• Tulisokibart modulates inflammation and the body's anti-inflammatory mechanisms, offering a novel approach compared to existing IBD treatments that can exacerbate inflammation.
• The safety profile of tulisokibart appeared comparable to placebo, with similar rates of adverse events, supporting its potential as a valuable new treatment option.
OSE Immunotherapeutics Launches Phase 3 Trial of Tedopi® for Second-Line NSCLC
• OSE Immunotherapeutics initiates the Artemia Phase 3 trial to evaluate Tedopi® in second-line metastatic non-small cell lung cancer (NSCLC).
• The global trial will enroll 363 HLA-A2 positive patients with secondary resistance to immune checkpoint inhibitors across multiple countries.
• Tedopi® monotherapy will be compared to standard of care, with overall survival as the primary endpoint for regulatory registration.
• Trial in Progress posters were presented at the 2024 World Conference on Lung Cancer and will be presented at the European Society for Medical Oncology congress.
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