US 12,257,245 B2
Methods and compositions for inhibition of EGF/EGFR pathway in combination with anaplastic lymphoma kinase inhibitors
Erik D'Hondt, Bazel (BE); and Miguel Ángel Molina-Vila, Badalona (ES)
Assigned to In3Bio Ltd., Hamilton (BM)
Filed by In3Bio Ltd., Hamilton (BM)
Filed on Aug. 7, 2019, as Appl. No. 16/534,230.
Claims priority of provisional application 62/822,290, filed on Mar. 22, 2019.
Claims priority of provisional application 62/760,529, filed on Nov. 13, 2018.
Claims priority of provisional application 62/748,772, filed on Oct. 22, 2018.
Claims priority of provisional application 62/727,056, filed on Sep. 5, 2018.
Claims priority of provisional application 62/715,351, filed on Aug. 7, 2018.
Prior Publication US 2020/0046690 A1, Feb. 13, 2020
Int. Cl. A61K 31/4545 (2006.01); A61K 31/519 (2006.01); A61K 31/5377 (2006.01); A61K 31/675 (2006.01); A61K 39/00 (2006.01); A61K 39/395 (2006.01); A61P 35/00 (2006.01)
CPC A61K 31/4545 (2013.01) [A61K 31/519 (2013.01); A61K 31/5377 (2013.01); A61K 31/675 (2013.01); A61K 39/001131 (2018.08); A61K 39/3955 (2013.01); A61P 35/00 (2018.01); A61K 2039/545 (2013.01)] 3 Claims
 
1. A method of treating a patient suffering from a non-small cell lung cancer (NSCLC), or metastatic forms thereof, responsive to an Anaplastic Lymphoma Kinase (ALK) Inhibitor and expressing the ELM4-ALK fusion gene and a mutated form of an Epidermal Growth Factor Receptor (EGFR), comprising:
administering to the patient the ALK Inhibitor and an immunogenic polypeptide comprising amino acids cysteine 6 to cysteine 42 of an Epidermal Growth Factor (EGF) at an amount effective to generate an immune response against the EGF, wherein the cysteine residues are numbered relative to amino acids 1 to 52 of SEQ ID NO: 2, or an immunogenic polypeptide comprising SEQ ID NO: 2;
wherein the ALK Inhibitor is selected from the group consisting of Crizotinib, Ceritinib, Alectinib, Brigatinib, Lorlatinib, and pharmaceutically acceptable salts thereof;
wherein the ALK Inhibitor is administered in a therapeutically effective daily dose in a range of about 10 mg to about 250 mg and the immunogenic polypeptide is administered according to a therapeutically effective repeated thrice, twice or once a week, once in two weeks, once in three weeks or at least once monthly to generate polyclonal antibodies targeting EGF.