Merck Stable PD-1 Antibody Formulations 5-250 mg/mL Pembrolizumab Cancer Treatment
Summary
Merck Sharp & Dohme LLC filed USPTO Application US20260109768A1 on April 23, 2026, covering stable formulations of anti-PD-1 antibodies (5-250 mg/mL concentration range) with buffer, stabilizer, surfactant, and antioxidant excipients, specifically identifying pembrolizumab as the target antibody. The application names William P. Forrest Jr., Chakravarthy Nachu Narasimhan, and Yogita Krishnamachari as inventors and claims methods for treating various cancers via intravenous or subcutaneous administration. Patent prosecution will determine scope and grant likelihood.
“In particular embodiments, the anti-PD-1 antibody is pembrolizumab.”
About this source
USPTO classification C07K covers peptides: short amino-acid chains that form the backbone of antibodies, hormones, vaccines, and increasingly a wider class of therapeutic modalities. Every newly published application in C07K lands in this feed, around 175 a month. Applications publish 18 months after filing, so this feed reveals what antibody engineering groups, vaccine developers, and plant biotech researchers were working on in the prior year and a half. Watch this if you compete in biologics, file freedom-to-operate analyses on antibody drug candidates, scout acquisition targets in vaccine platforms, or track protein-based agricultural biotech filings.
What changed
Merck Sharp & Dohme LLC filed a patent application (US20260109768A1) with the USPTO on April 23, 2026 covering stable pharmaceutical formulations of PD-1 antibodies at concentrations between 5-250 mg/mL. The formulations include a buffer, stabilizer, surfactant, and antioxidant, with pembrolizumab specifically named as the anti-PD-1 antibody embodiment. The application further covers methods of treating cancer using these formulations via intravenous or subcutaneous routes.
Competitors developing PD-1/PD-L1 antibody therapeutics should monitor this filing for potential overlap with their formulation strategies and patent prosecution trajectories. Freedom-to-operate analyses for oncology biologic programs should consider this application's claims once prosecution concludes.
Archived snapshot
Apr 23, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
STABLE FORMULATIONS OF PROGRAMMED DEATH RECEPTOR 1 (PD-1) ANTIBODIES AND METHODS OF USE THEREOF
Application US20260109768A1 Kind: A1 Apr 23, 2026
Assignee
Merck Sharp & Dohme LLC
Inventors
William P. Forrest, Jr., Chakravarthy Nachu Narasimhan, Yogita Krishnamachari
Abstract
The invention relates to stable formulations of antibodies against human programmed death receptor PD-1, or antigen binding fragments thereof. In some embodiments the formulations of the invention comprise between 5-250 mg/mL anti-PD-1 antibody, or antigen binding fragment thereof, a buffer, a stabilizer, a surfactant, and an antioxidant in the amounts specified herein. In particular embodiments, the anti-PD-1 antibody is pembrolizumab. The invention further provides methods for treating various cancers with stable formulations of the invention. In some embodiments of the methods of the invention, the formulations are administered to a subject by intravenous or subcutaneous administration.
CPC Classifications
C07K 16/2818 A61K 47/10 A61K 47/183 A61K 47/186 A61K 47/26 A61K 47/40 A61P 35/00
Filing Date
2025-10-30
Application No.
19374092
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