Anti-PD-1 antibodies and uses thereof
Inventors
CORNFELD, MARK • Pandya, Naimish Bharat • Wigginton, Jon Marc • La Motte-Mohs, Ross • Sumrow, Bradley James
Assignees
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Publication Number
US-12448448-B2
Publication Date
2025-10-21
Expiration Date
Abstract
Methods of treatment of cancer with antibodies and antibody fragments that bind to PD-1 are disclosed.
Core Innovation
The invention relates to a method of treating Merkel cell carcinoma in a human subject in need thereof by administering a therapeutically effective amount of an antibody that binds to human PD-1. The antibody comprises a heavy chain and a light chain, with the heavy chain amino acid sequence set forth in SEQ ID NO:2 and the light chain amino acid sequence set forth in SEQ ID NO:3. The antibody is described as a PD-1-binding humanized IgG4 antibody (ANTIBODY X).
The invention further specifies administration at a dose of 500 mg once every four weeks. The disclosed antibody and formats include pharmaceutical compositions and administration routes for treating cancers, with multiple oncologic indications listed in the document. The disclosed sequences and antibody binding to human PD-1 are positioned as the defining features for the treatment method and the associated clinical evaluation.
The document also describes related antibody formats, formulation considerations, and antibody engineering/production concepts, including variants associated with acidic/deamidation and altered glycosylation. In addition, the disclosure includes representative Phase 1/2 clinical studies in treatment settings such as SCAC, metastatic Merkel cell carcinoma, and endometrial cancer cohorts, with primary endpoints including ORR by RECIST.
Claims Coverage
The independent claim recites a treatment method for Merkel cell carcinoma using a PD-1-binding antibody with specified heavy- and light-chain sequences and a defined 500 mg every four weeks dosing regimen, for a total of 1 independent claim family (clm-00001).
PD-1-binding anti-Merkel cell carcinoma antibody with specified heavy and light chains
A method of treating Merkel cell carcinoma by administering to a human subject a therapeutically effective amount of an antibody that binds to human PD-1, wherein the antibody comprises a heavy chain comprising the amino acid sequence set forth in SEQ ID NO:2 and a light chain comprising the amino acid sequence set forth in SEQ ID NO:3.
500 mg once every four weeks dosing regimen
The antibody is administered at a dose of 500 mg once every four weeks.
Across the independent claim, the main inventive coverage is anchored in administering an anti-human PD-1 antibody with heavy- and light-chain amino acid sequences defined by SEQ ID NO:2 and SEQ ID NO:3, together with a specified dosing regimen of 500 mg once every four weeks for treating Merkel cell carcinoma.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Treating Merkel cell carcinoma in a human subject.
Treating endometrial cancer, including MSI-H, dMMR, and POLE-positive endometrial cancer cohorts.
Treating Merkel cell carcinoma and SCAC in Phase 2 settings, with metastatic MCC described in clinical studies.
Treating anal cancer.
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