US 12,138,282 B2
Treatment with an IL-2 based therapy
Victoria Lunyak, San Anselmo, CA (US); and Meenakshi Gaur, San Francisco, CA (US)
Assigned to AELAN CELL TECHNOLOGIES, INC., Greenbrae, CA (US)
Appl. No. 15/579,186
Filed by Aelan Cell Technologies, Inc., San Francisco, CA (US)
PCT Filed Jun. 2, 2016, PCT No. PCT/US2016/035472
§ 371(c)(1), (2) Date Sep. 5, 2018,
PCT Pub. No. WO2016/196765, PCT Pub. Date Dec. 8, 2016.
Claims priority of provisional application 62/175,203, filed on Jun. 12, 2015.
Claims priority of provisional application 62/170,604, filed on Jun. 3, 2015.
Claims priority of provisional application 62/170,619, filed on Jun. 3, 2015.
Prior Publication US 2018/0136209 A1, May 17, 2018
Int. Cl. A61K 35/28 (2015.01); A61K 38/20 (2006.01); A61K 38/43 (2006.01); A61P 35/00 (2006.01); C07K 16/24 (2006.01); C12N 5/00 (2006.01); C12N 5/0775 (2010.01); C12Q 1/6886 (2018.01); G01N 33/574 (2006.01)
CPC A61K 35/28 (2013.01) [A61K 38/2013 (2013.01); A61K 38/43 (2013.01); A61P 35/00 (2018.01); C07K 16/246 (2013.01); C12N 5/0018 (2013.01); C12N 5/0663 (2013.01); C12N 5/0667 (2013.01); C12Q 1/6886 (2013.01); G01N 33/574 (2013.01); C12N 2501/2302 (2013.01); C12N 2501/65 (2013.01); C12Q 2600/158 (2013.01); G01N 2333/4703 (2013.01); G01N 2333/475 (2013.01); G01N 2333/495 (2013.01); G01N 2333/55 (2013.01); G01N 2333/705 (2013.01); G01N 2333/91205 (2013.01); G01N 2333/96466 (2013.01); G01N 2333/96486 (2013.01)] 12 Claims
 
1. A method of selecting and treating an individual for cancer with an IL-2-based therapy, wherein the cancer is melanoma or renal cell carcinoma, the method comprising:
(a) measuring the expression levels of at least three biomarkers selected from a panel of biomarkers in a sample from an individual, wherein either (1) the individual has received at least one dose of an IL-2-based therapy or (2) the sample is combined with IL-2 in vitro, wherein the sample comprises mesenchymal stem cells (MSCs), wherein the biomarkers are indicative of cellular senescence of the cells in the sample, and wherein the panel of biomarkers comprises FGF1, FGF11, FGF14, IL-32, IL-6, ILIRN, IL-20RB, IL-21R, PLAU, PLEKHA6, CTSB, FERMT1, CRMP1, VEGFB, VEGFA, and PLEKHA1;
(b) comparing the levels of the biomarkers to reference levels to query the senescence status of the MSCs, wherein a decrease or no change in the levels compared to the reference levels indicates that the individual may not experience an adverse event associated with the IL-2-based therapy, wherein the adverse event is one or more of an increased risk of tumorigenesis and an increased risk of metastasis;
(c) selecting the individual for treating using the comparison of step (b), wherein the sample from the individual shows a decrease or no change in the levels compared to the reference levels indicating that the individual may not experience an adverse event associated with the IL-2-based therapy; and
(d) administering an effective amount of the IL-2-based therapy to the selected individual.