US20250257136
2025-08-14
Chemistry; metallurgy
C07K16/2818
The patent application outlines a method for cancer immunotherapy that involves disrupting the PD-1/PD-L1 signaling pathway. This approach utilizes antibodies to inhibit this pathway, thereby enhancing the immune system's ability to target and destroy cancer cells. The method includes selecting patients based on the expression levels of PD-L1 in their tumor samples, ensuring that only those who are likely to benefit from the therapy receive it.
A critical aspect of this method is identifying suitable candidates for immunotherapy. Patients are selected based on whether their tumor cells express PD-L1 above a certain threshold, as determined by analyzing tissue samples. This personalized approach ensures that treatments are administered to patients who are most likely to respond positively, improving the overall effectiveness of the therapy.
The therapeutic agents used in this method are antibodies that specifically target and disrupt the PD-1/PD-L1 interaction. Notably, antibodies such as nivolumab and BMS-936559 are mentioned as preferred agents. By blocking this pathway, these antibodies help to reactivate the immune response against cancer cells, leading to potential tumor regression and improved patient outcomes.
The application also introduces diagnostic techniques for assessing PD-L1 expression in tumor samples. Formalin-fixed and paraffin-embedded (FFPE) tissue samples are analyzed using immunohistochemical (IHC) staining with specific monoclonal antibodies. These techniques allow for precise measurement of PD-L1 levels, facilitating accurate patient selection for immunotherapy.
This method has significant implications for treating various cancers, including melanoma, renal cell carcinoma, non-small cell lung cancer, and others. By tailoring treatment based on individual biomarker profiles, it represents a step forward in personalized medicine, aiming to enhance treatment efficacy while minimizing unnecessary exposure to therapies unlikely to benefit certain patients.