US 11,873,344 B2
Protein biomarker and uses thereof
Matthias Schneider, Neufarn (DE); Sabine Blum, Munich (DE); Renee Jeanne Mendell-Harary, Skillman, NJ (US); Daniel J. Freeman, Holmdel, NJ (US); Robert Allen Beckman, Blue Bell, PA (US); Xiaoping Jin, Hillsborough, NJ (US); Kimio Yonesaka, Osakasayama (JP); and Kazuhiko Nakagawa, Osakasayama (JP)
Assigned to Daiichi Sankyo Co., Ltd., Tokyo (JP); Daiichi Sankyo Europe GmbH, Munich (DE); Kinki University, Osaka (JP); and Amgen, Inc., Thousand Oaks, CA (US)
Filed by Daiichi Sankyo Co., Ltd., Tokyo (JP); DAIICHI SANKYO EUROPE GMBH, Munich (DE); Kinki University, Osaka (JP); and Amgen, Inc., Thousand Oaks, CA (US)
Filed on Aug. 21, 2019, as Appl. No. 16/547,440.
Application 16/547,440 is a continuation of application No. 15/297,793, filed on Oct. 19, 2016, abandoned.
Application 15/297,793 is a continuation of application No. 14/502,769, filed on Sep. 30, 2014, abandoned.
Claims priority of provisional application 61/884,983, filed on Sep. 30, 2013.
Prior Publication US 2020/0115467 A1, Apr. 16, 2020
Int. Cl. C12Q 1/68 (2018.01); C07K 16/32 (2006.01); G01N 33/569 (2006.01); A61K 31/517 (2006.01); A61K 39/395 (2006.01); A61K 45/06 (2006.01); A61N 5/10 (2006.01); C07K 16/28 (2006.01); C07K 16/40 (2006.01); G01N 33/574 (2006.01); A61K 39/00 (2006.01)
CPC C07K 16/32 (2013.01) [A61K 31/517 (2013.01); A61K 39/39558 (2013.01); A61K 45/06 (2013.01); A61N 5/10 (2013.01); C07K 16/2863 (2013.01); C07K 16/40 (2013.01); G01N 33/5695 (2013.01); G01N 33/57423 (2013.01); A61K 2039/505 (2013.01); C07K 2317/21 (2013.01); C07K 2317/76 (2013.01); G01N 2333/4756 (2013.01)] 12 Claims
 
1. A method of treating a human subject harboring head and neck cancer comprising administering a treatment comprising an anti-HER3 antibody to a human subject diagnosed with head and neck cancer, wherein the head and neck cancer has progressed on at least one prior systemic therapy and a protein level of heregulin (HRG) in a sample of the head and neck cancer obtained from the subject is determined to be higher than 980 pg/mL using an FDA-approved test for detecting HRG at the protein level, and wherein HRG is the only protein for which the protein level is assessed.