OSE Immunotherapeutics Announces Positive H1 2024 Results and Corporate Updates
核心洞察
OSE Immunotherapeutics reported total H1 2024 incomes of €82.5 million, driven by new partnerships with AbbVie (搜索) 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 (搜索) 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 (搜索) and reported positive Phase 2 results for Lusvertikimab in ulcerative colitis (搜索).
OSE Immunotherapeutics SA announced its consolidated half-year financial results and provided updates on key milestones achieved during H1 2024, highlighting advancements in immunotherapies for immuno-oncology and immuno-inflammation.
The company reported total H1 2024 incomes of €82.5 million, primarily driven by new strategic partnerships with AbbVie (搜索) and Boehringer Ingelheim. These collaborations and clinical advancements are expected to support the company's growth and pipeline development through 2027.
Financial Highlights
OSE Immunotherapeutics secured three pharmaceutical agreements during H1 2024, bolstering its financial position. A new partnership with AbbVie (搜索) grants AbbVie an exclusive global license to develop, manufacture, and commercialize ABBV-230. OSE Immunotherapeutics received a $48 million upfront payment and is eligible for up to $665 million in clinical development, regulatory, and commercial milestones, plus potential tiered royalties on global net sales.
In May 2024, OSE Immunotherapeutics and Boehringer Ingelheim expanded their partnership with two new projects:
- A new preclinical program based on OSE’s cis-targeting anti-PD1/cytokine platform via an asset acquisition, resulting in €13.5 million upfront and a potential near-term milestone of €17.5 million.
- An amendment to the existing collaboration for anti-SIRPα compounds BI 765063 and BI 770371, now also targeting cardiovascular-renal-metabolic (CRM) diseases, with a €25.3 million one-time payment.
OSE Immunotherapeutics also received €8.4 million in non-dilutive funding under the “i-Démo” call for projects as part of the “France 2030” program to support the Phase 3 clinical trial of cancer vaccine Tedopi®.
As of June 30, 2024, the company’s cash position was €80.7 million, including €25.9 million in available cash and €54.9 million in financial assets, providing financial visibility until 2027.
Clinical Pipeline Advancements
Several clinical programs have shown promising results:
- Lusvertikimab (OSE-127) in Ulcerative Colitis: Positive efficacy results from the Phase 2 CoTikiS study evaluating the IL-7R antagonist Lusvertikimab in ulcerative colitis were reported. These results are considered a strong catalyst for potential future partnership opportunities.
- Tedopi® in Non-Small Cell Lung Cancer (NSCLC): The global Artemia Phase 3 registration trial for the neo-epitope-based cancer vaccine Tedopi® was launched for second-line NSCLC patients after secondary resistance to immune checkpoint inhibitors (ICI). This trial is pivotal for the registration of Tedopi®.
- OSE-279 (anti-PD1) in Advanced Solid Tumors: Updated positive results from the Phase 1/2 study of OSE-279 were presented at the ESMO Targeted Anticancer Therapy Congress, demonstrating a good pharmacokinetic/pharmacodynamic (PK/PD) profile and manageable safety, with efficacy signals across 13 different tumor types.
- FR104/VEL-101 in Kidney Transplantation: Positive Phase 1/2 data from the FIRsT study evaluating FR104/VEL-101 in renal transplant patients were presented at the American Transplant Congress (ATC). The data showed safety and initial efficacy signs, with no acute rejection episodes after one year of follow-up in the eight patients who completed the treatment.
Early-Stage Programs
OSE Immunotherapeutics continues to advance its early-stage programs, including novel data on CLEC-1, a myeloid immune checkpoint target for cancer immunotherapy, published in the Journal of Immunology. Preclinical data on a novel mRNA therapeutic platform for inflammatory and autoimmune disorders were also presented at the Federation of Clinical Immunology Societies (FOCIS) annual meeting.
Strategic Partnerships
In addition to the AbbVie (搜索) agreement, Boehringer Ingelheim will progress the first-in-class SIRPα (搜索) immuno-oncology program into the next phase of clinical development, with an improved next-generation SIRPα inhibitor antibody tested in a Phase 1b study in solid tumors. A Phase 2 study in cardiovascular-renal-metabolic (CRM) diseases is planned for late 2024.