IP Library Granted Patent US 12,410,221
Granted Patent B2
US 12,410,221 · App. 18/176,283 · Granted Sep 9, 2025

Tumor antigens for determining cancer therapy

Inventors: Ugur Sahin (Mainz, DE); Claudia Paret (Mainz, DE); Kirsten Vormbrock (Mainz, DE); Christian Bender (Mainz, DE); Petra Simon (Mainz, DE); Christoph Hartmann (Frankfurt, DE); Stefanie Hubich (Mainz, DE); Thomas Bukur (Mainz, DE); Thorsten Litzenberger (Olsbrücken, DE)
Assignees: BioNTech SE; TRON—Translationale Onkologie an der Universitätsmedizin der Johannes Gutenberg-Universität Mainz
C07K14/4748A61K39/0011A61K39/001189C12Q1/6886G01N33/57415G01N33/57484A61K2039/507A61K2039/53A61K2039/70C12Q2600/106C12Q2600/158C12Q2600/16G01N2333/47
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Quick Facts
Patent No.
US 12,410,221
App. No.
18/176,283
Granted
Sep 9, 2025
Kind
B2
Abstract

The present invention relates to the treatment of cancer, in particular breast cancer, particularly triple-negative breast cancer. More particularly, the invention concerns methods for cancer treatment involving a specific set of tumor antigens.

Claims (16)

1. A method for treating triple negative breast cancer in a patient having triple negative breast cancer, the method comprising:

(a) determining an expression pattern of a set of tumor antigens in a sample from the patient having triple negative breast cancer, wherein the set of tumor antigens comprises at least one selected from chromosome X open reading frame 61 (CXorf61), Preferentially expressed Antigen in Melanoma (PRAME), and cancer antigen 1 (CAGE1);

(b) diagnosing the patient having triple negative breast cancer as needing a cancer therapy regimen when at least one tumor antigen selected from CXorf61, PRAME, and CAGE1 is expressed; and

(c) treating the patient having triple negative breast cancer with an immunotherapeutic that targets the at least one tumor antigen expressed in the patient.

2. The method of claim 1 wherein the expression pattern is determined in a sample obtained from a triple negative breast cancer patient.

3. The method of claim 2 wherein the sample comprises cancer cells.

4. The method of claim 1 wherein determining the expression pattern comprises a quantitative and/or qualitative determination of the expression of the tumor antigens.

5. The method of claim 1 wherein determining the expression pattern comprises determining the expression of RNA and/or protein of the tumor antigens.

6. The method of claim 1 wherein the immunotherapeutic provides one or more T cell epitopes of each of the tumor antigens of the set of tumor antigens which are expressed in cancer cells of the patient.

7. The method of claim 6 wherein the immunotherapeutic is an RNA vaccine.

8. A method for preventing or treating triple negative breast cancer in a patient comprising administering to said patient an immunotherapeutic targeting each tumor antigen of a set of tumor antigens, wherein the set of tumor antigens comprises at least one selected from CXorf61, PRAME, and CAGE1.

9. The method of claim 8 which comprises inducing an immune response in the patient against each tumor antigen of the set of tumor antigens.

10. The method of claim 9 wherein the immune response comprises a cellular response.

11. The method of claim 10 wherein the immunotherapeutic is a vaccine and the cellular response is induced by administering the vaccine providing one or more T cell epitopes of each tumor antigen of the set of tumor antigens to the patient.

12. The method of claim 11 wherein the one or more T cell epitopes are comprised in the vaccine in one or more peptides or polypeptides wherein said one or more peptides or polypeptides following administration are processed to produce the one or more T cell epitopes.

13. The method of claim 11 wherein the vaccine is an RNA vaccine.

Assignments (8)
CHANGE OF NAME Recorded May 14, 2025
From: BIONTECH AG
To: BIONTECH SE
Reel/Frame 071268/0825 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 8, 2025
From: PARET, CLAUDIA; VORMBROCK, KIRSTEN; BENDER, CHRISTIAN; LITZENBERGER, THORSTEN
To: TRON GGMBH
Reel/Frame 071067/0689 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 5, 2025
From: UNIVERSITÄTSMEDIZIN DER JOHANNES GUTENBERG-UNIVERSITÄT MAINZ
To: TRON GGMBH
Reel/Frame 071027/0828 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 1, 2025
From: BUKUR, THOMAS
To: UNIVERSITÄTSMEDIZIN DER JOHANNES GUTENBERG-UNIVERSITÄT MAINZ
Reel/Frame 070996/0586 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 30, 2025
From: BIONTECH CELL & GENE THERAPIES GMBH
To: BIONTECH AG
Reel/Frame 070981/0318 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 28, 2025
From: HARTMANN, CHRISTOPH; HUBICH, STEFANIE
To: TRON GGMBH; UNIVERSITÄTSMEDIZIN DER JOHANNES GUTENBERG-UNIVERSITÄT MAINZ
Reel/Frame 070964/0192 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 25, 2025
From: SIMON, PETRA
To: TRON GGMBH; BIONTECH CELL & GENE THERAPIES GMBH
Reel/Frame 070948/0551 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 23, 2025
From: SAHIN, UGUR
To: BIONTECH AG; TRON GGMBH; UNIVERSITATSMEDIZIN DER JOHANNES GUTENBERG-UNIVERSITATE MAINZ
Reel/Frame 070923/0861 →
Priority Claims (2)
WO PCT/EP2013/002271 · Jul 30, 2013 · international
WO PCT/EP2013/003173 · Oct 22, 2013 · international
Continuity (3)
Division 16229841 · Dec 21, 2018
Continuation 14908246
Related Publication 20230355732A1 · Nov 9, 2023
References Cited (33)
US 10188712B2 · Sahin · 2019 [cited by examiner]
US 11628209B2 · Sahin · 2023 [cited by examiner]
US 20100120683A1 · Kessler et al. · 2010 [cited by applicant]
JP 2007126442 · 2007 [cited by applicant]
WO WO2008080468A1 · 2008 [cited by applicant]
WO WO2012168259A1 · 2012 [cited by examiner]
Bauer, K.R. et al., Descriptive Analysis of Estrogen Receptor (ER)-Negative, Progesterone Receptor (PR)-Negative, and HER2-Negative Invasive Breast Cancer, the So-Called Triple-Negative Phenotype: a Population-Based Stu… [cited by applicant]
Database EMBL [Online] Jun. 16, 1997 (Jun. 16, 1997), “Human DNA sequence from clone RP3-452H17 on chromosome Xq22.1-23 Contains the 3' end of the SLC6A14 gene for solute carrier family 6 (neurotransmitter transporter) … [cited by applicant]
Database Geneseq [Online] Sep. 16, 2002 (Sep. 16, 2002), “Human prostate expression marker eDNA 25133”, retrieved from EBI accession No. GSN:ABV25142 (2 pages). [cited by applicant]
Fratta, E. et al., The biology of cancer testis antigens: Putative function, regulation and therapeutic potential. Mol Oncol. 2011; 5:164-82. [cited by applicant]
Fukuyama et al., Identification of a new cancer/germline gene, KK-LC-1, encoding an antigen recognized by autologous CTL induced on human lung adenocarcinoma. Cancer Res. 66(9):4922-8. [cited by applicant]
Helftenbein et al., In silica strategy for detection of target candidates for antibody therapy of solid tumors. Gene. 2008; 414(1-2):76-84. [cited by applicant]
Kessler et al., Efficient identification of novel HLA-A(*)0201-presented cytotoxic T lymphocyte epitopes in the widely expressed tumor antigen PRAME by proteasome-mediated digestion analysis. J Exp Med. 2001; 193(1):73-… [cited by applicant]
Klein et al. Whole genome microarray analysis and target validation by using qPCR. J Lab Med 2004; 28(3):215-224. [cited by applicant]
Kreiter et al., Tumor vaccination using messenger RNA: prospects of a future therapy. Curr Opin Immunol. 2011; 23(3):399-406. [cited by applicant]
Paret, C. et al., CXorf61 is a Target for T Cell Based Immunotherapy of Triple-Negative Brast Cancer. Oncotarget. 2015; 6(28):25356-67. [cited by applicant]
Park et al., Identification and characterization of a novel cancer/testis antigen gene CAGE-1. Biochim Biophys Acta, Gene Struct Exp. 2003; 1625(2):173-82. [cited by applicant]
Sahin et al., Serological analysis of human tumor antigens: molecular definition and implications. Mol Med Today. 1997; 3(8):342-9. [cited by applicant]
Sahin et al., Serological identification of human tumor antigens. Curr Opin Immunol. 1997; 9(5):709-16. [cited by applicant]
Stagg, J. and Allard, B., Immunotherapeutic Approaches n Triple-Negative Breast Cancer: Latest Research and Clinical Prospects. Ther Adv Med Oncol. 2013; 5(3):169-81. [cited by applicant]
Tureci et al. Seriological analysis of human tumor antigens: molecular definition and implications. Molecular Medicine Today, Aug. 1997; 342-349. [cited by applicant]
Yasumoto, K. et al., Lung Cancer-Associated Tumor Antigens and the Present Status of Immunotherapy Against Non-Small-Cell Lung Cancer. Gen Thorac Cardiovasc Surg. 2009; 57(9):449-57. [cited by applicant]
International Search Report and Written Opinion issued on Nov. 20, 2014 for application PCT/EP2014/066328, filed on Jul. 30, 2014 and published as WO2015014869 on Feb. 5, 2015 (Applicant—Biontech AG // Inventor—Sahin, e… [cited by applicant]
International Preliminary Report on Patentability issued on Feb. 2, 2016 for application PCT/EP2014/066328, filed on Jul. 30, 2014 and published as WO2015014869 on Feb. 5, 2015 (Applicant—Biontech AG // Inventor—Sahin, … [cited by applicant]
Preliminary Amendment filed on Jan. 28, 2016 with the U.S. Patent and Trademark Office for U.S. Appl. No. 14/908,246, which was filed on Jan. 28, 2016 and issued as U.S. Pat. No. 10,188,712 on Jan. 29, 2019 (Inventor—Sa… [cited by applicant]
Restriction Requirement issued Jun. 23, 2017 by the U.S. Patent and Trademark Office for U.S. Appl. No. 14/908,246, which was filed on Jan. 28, 2016 and issued as U.S. Pat. No. 10,188,712 on Jan. 29, 2019 (Inventor—Sahi… [cited by applicant]
Non-Final Office Action issued on Nov. 30, 2017 by the U.S. Patent and Trademark Office for U.S. Appl. No. 14/908,246, which was filed on Jan. 28, 2016 and issued as U.S. Pat. No. 10,188,712 on Jan. 29, 2019 (Inventor—S… [cited by applicant]
Final Office Action issued on Jun. 5, 2018 by the U.S. Patent and Trademark Office for U.S. Appl. No. 14/908,246, which was filed on Jan. 28, 2016 and issued as U.S. Pat. No. 10,188,712 on Jan. 29, 2019 (Inventor—Sahin … [cited by applicant]
Notice of Allowance issued on Sep. 24, 2018 by the U.S. Patent and Trademark Office for U.S. Appl. No. 14/908,246, which was filed on Jan. 28, 2016 and issued as U.S. Pat. No. 10,188,712 on Jan. 29, 2019 (Inventor—Sahin… [cited by applicant]
Notice of Allowance issued on Oct. 10, 2018 by the U.S. Patent and Trademark Office for U.S. Appl. No. 14/908,246, which was filed on Jan. 28, 2016 and issued as U.S. Pat. No. 10,188,712 on Jan. 29, 2019 (Inventor—Sahin… [cited by applicant]
U.S. Appl. No. 14/908,246 (U.S. Pat. No. 10,188,712), filed Jan. 28, 2016 (Jan. 29, 2019), Ugur sahin (Biontech AG). [cited by applicant]
U.S. Appl. No. 16/229,841, filed Dec. 21, 2018, Ugur sahin (Biontech AG). [cited by applicant]
PCT, PCT/EP2014/066328 (WO 2015/014869), filed Jul. 30, 2014 (Feb. 5, 2015), Ugur sahin (Biontech AG). [cited by applicant]