US 12,009,079 B2
Type I interferon signatures and methods of use
Matteo Cesaroni, Philadelphia, PA (US); Marc Chevrier, Collegeville, PA (US); Jarrat Jordan, Norristown, PA (US); and Jessica Schreiter, Macungie, PA (US)
Assigned to Janssen Biotech, Inc., Horsham, PA (US)
Filed by Janssen Biotech, Inc., Horsham, PA (US)
Filed on Oct. 25, 2019, as Appl. No. 16/663,527.
Claims priority of provisional application 62/751,019, filed on Oct. 26, 2018.
Prior Publication US 2020/0131241 A1, Apr. 30, 2020
Int. Cl. C07K 14/56 (2006.01); C12Q 1/6809 (2018.01); G16H 20/10 (2018.01); G16H 50/30 (2018.01)
CPC G16H 20/10 (2018.01) [C07K 14/56 (2013.01); C12Q 1/6809 (2013.01); G16H 50/30 (2018.01); C07K 2317/565 (2013.01); C12Q 2539/00 (2013.01); C12Q 2545/114 (2013.01)] 20 Claims
 
1. A method of treating a subject having a type I interferon (IFN-I) mediated disease that is responsive to treatment with an IFN-I inhibitor, comprising:
a) providing a biological sample from the subject;
b) assaying gene expression of genes DHX58, EIF2AK2, HERC5, IFI44, IFI44L, IFI6, IRF7, PARP9, PLSCR1 and SAMD9L in the biological sample;
c) determining a combined expression value of the genes DHX58, EIF2AK2, HERC5, IFI44, IFI44L, IFI6, IRF7, PARP9, PLSCR1 and SAMD9L in the biological sample; and
d) treating the subject with the IFN-I inhibitor when the combined expression value is equal to or higher than a threshold value, wherein the combined expression value is a sum of (i) normalized threshold cycle (CT) values (SUMΔCT) of genes DHX58, EIF2AK2, HERC5, IFI44, IFI44L, IFI6, IRF7, PARP9, PLSCR1 and SAMD9 and the threshold value is SUMΔCT of 57.474 or (ii) log 2 fold changes of normalized differential expression between the biological sample and a biological sample obtained from one or more healthy controls (SUMlog2(2 −ddCT)) of genes DHX58, EIF2AK2, HERC5, IFI44, IFI44L, IFI6, IRF7, PARP9, PLSCR1 and SAMD9L and the threshold value is SUMlog2(2 −ddCT) of 8.725.