US 9,809,815 B2
Methods and compositions for diagnosis and treatment of cancer
Ugur Sahin, Mainz (DE); Özlem Türeci, Mainz (DE); Michael Koslowski, Frankfurt (DE); Gerd Helftenbein, Gemünden (DE); Korden Walter, Wiesbaden (DE); Stefan Wöll, Nackenheim (DE); and Gabriela-Elena Oprea, Mainz (DE)
Assigned to GANYMED PHARMACEUTICALS AG, Mainz (DE); and JOHANNES GUTENBERG-UNIVERSITAT MAINZ, Mainz (DE)
Appl. No. 13/201,702
Filed by Ugur Sahin, Mainz (DE); Özlem Türeci, Mainz (DE); Michael Koslowski, Frankfurt (DE); Gerd Helftenbein, Gemünden (DE); Korden Walter, Wiesbaden (DE); Stefan Wöll, Nackenheim (DE); and Gabriela-Elena Oprea, Mainz (DE)
PCT Filed Feb. 19, 2010, PCT No. PCT/EP2010/001062
§ 371(c)(1), (2), (4) Date Aug. 29, 2011,
PCT Pub. No. WO2010/094499, PCT Pub. Date Aug. 26, 2010.
Claims priority of provisional application 61/154,167, filed on Feb. 20, 2009.
Claims priority of provisional application 61/231,843, filed on Aug. 6, 2009.
Claims priority of provisional application 61/260,135, filed on Nov. 11, 2009.
Claims priority of application No. 09002452 (EP), filed on Feb. 20, 2009; application No. 09010164 (EP), filed on Aug. 6, 2009; and application No. 09014135 (EP), filed on Nov. 11, 2009.
Prior Publication US 2011/0300144 A1, Dec. 8, 2011
Int. Cl. G01N 1/00 (2006.01); G01N 33/574 (2006.01); C12N 15/113 (2010.01); A61K 31/7088 (2006.01)
CPC C12N 15/113 (2013.01) [A61K 31/7088 (2013.01)] 13 Claims
 
1. A method for diagnosis, detecting or monitoring, and treating of a tumor disease comprising the steps of:
detecting the presence of or determining the quantity of a nucleic acid which codes for a peptide comprising the amino acid sequence of a tumor antigen, in a biological sample isolated from a patient,
wherein said tumor antigen comprises an amino acid sequence encoded by a nucleic acid sequence which comprises SEQ ID NO: 1, and
diagnosing, detecting, or monitoring the tumor disease based on the presence or quantity of the nucleic acid comprising the nucleic acid sequence of SEQ ID NO: 1 in the biological sample, wherein
the detecting or determining comprises
(i) contacting the biological sample with an agent that binds specifically to the nucleic acid within the nucleic acid sequence of SEQ ID NO:1 or to a nucleic acid sequence which is complementary to said nucleic acid sequence, so as to form a complex comprising said agent; and
(ii) detecting the formation of, or determining the quantity of, the complex formed, wherein said agent is an oligonucleotide or polynucleotide that hybridizes specifically to the nucleic acid or to the complementary nucleic acid sequence, and has a nucleic acid sequence selected from the group consisting of SEQ ID NO:6 and SEQ ID NO:7;
wherein an increased amount of the complex in the biological sample of the patient as compared to a normal sample of an individual without a tumor disease indicates the patient has the tumor disease;
wherein the tumor disease is selected from the group consisting of ovarian cancer, ovarian adenocarcinoma, ovarian teratocarcinoma, lung cancer, small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC), lung carcinoma, lung adenocarcinoma, gastric cancer, breast cancer, hepatic cancer, pancreatic cancer, skin cancer, basal cell carcinoma, squamous cell carcinoma, malignant melanoma, head and neck cancer, malignant pleomorphic adenoma, sarcoma, synovial sarcoma, synovial carcinosarcoma, bile duct cancer, renal cell carcinoma, renal clear cell carcinoma, renal papillary cell carcinoma, uterine cancer, cancer of the urinary bladder, papillary carcinoma, colon cancer, transitional cell carcinoma small bowel cancer, cancer of the ileum, small bowel adenocarcinoma, adenocarcinoma of the ileum, testicular embryonal carcinoma, placental choriocarcinoma, cervical cancer, testicular cancer testicular seminoma, testicular teratoma, embryonic testicular cancer, and the metastatic forms thereof; and
administering a pharmaceutical composition to the patient if the increased amount of the complex in the biological sample of the patient is detected, wherein the pharmaceutical composition comprises an antibody binding to the tumor antigen.