US 12,455,289 B2
Monoclonal antibodies against loricrin
Penny Lovat, Newcastle Upon Tyne (GB); Marie Labus, Newcastle Upon Tyne (GB); Rob Ellis, Newcastle Upon Tyne (GB); and Ashleigh McConnell, Newcastle Upon Tyne (GB)
Assigned to AMLO Biosciences Limited, Newcastle Upon Tyne (GB)
Appl. No. 17/309,221
Filed by AMLO Biosciences Limited, Newcastle Upon Tyne (GB)
PCT Filed Nov. 4, 2019, PCT No. PCT/GB2019/053121
§ 371(c)(1), (2) Date May 7, 2021,
PCT Pub. No. WO2020/099829, PCT Pub. Date May 22, 2020.
Claims priority of application No. 1818622 (GB), filed on Nov. 15, 2018; and application No. 1911213 (GB), filed on Aug. 6, 2019.
Prior Publication US 2021/0396758 A1, Dec. 23, 2021
Int. Cl. G01N 31/00 (2006.01); A61K 45/06 (2006.01); G01N 33/53 (2006.01); G01N 33/574 (2006.01); G01N 33/68 (2006.01)
CPC G01N 33/5743 (2013.01) [A61K 45/06 (2013.01); G01N 33/6881 (2013.01); C07K 2317/34 (2013.01); G01N 2333/47 (2013.01)] 18 Claims
 
1. A method for determining whether a subject with melanoma has an increased risk of metastasis, the method comprising:
(i) determining the expression of Loricrin in a tissue sample obtained from the subject by contacting the tissue sample with a monoclonal antibody against Loricrin and visualizing the antibody in the tissue sample with a reagent that generates a detectable signal, wherein the tissue sample comprises tissue overlying a primary melanoma; and
(ii) comparing the expression obtained in (i) with a reference tissue or levels obtained therefrom,
wherein;
a decrease in the expression of Loricrin in the tissue sample compared to the reference tissues or levels, or a loss of expression of Loricrin in the tissue sample, is indicative of an increased risk of metastasis, and
the antibody against Loricrin comprises the following complementarity determining regions (CDRs):
(a) HCDR1 comprising the amino acid sequence of SEQ ID NO: 22;
(b) HCDR2 comprising the amino acid sequence of SEQ ID NO: 23;
(c) HCDR3 comprising the amino acid sequence of SEQ ID NO: 24;
(d) LCDR1 comprising the amino acid sequence of SEQ ID NO: 25;
(e) LCDR2 comprising the amino acid sequence of SEQ ID NO: 26; and
(f) LCDR3 comprising the amino acid sequence of SEQ ID NO: 27.