Bicycle conjugates specific for nectin-4 and uses thereof
AssigneeBicycleTx Limited
InventorsStephen J. BLAKEMORE, Tara GELB, Sean M. SANTOS, Heather B. COHEN
Life of this patent
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Abstract
The present invention relates to a Bicycle toxin conjugate or a Bicycle tumor targeted immune agonist specific for Nectin-4, or pharmaceutically acceptable salts thereof, or pharmaceutical compositions thereof, and uses thereof.
Claims37
A method of identifying or selecting a patient having an elevated Nectin-4 protein and/or RNA expression level in tumor tissue, comprising measuring the Nectin-4, SDHC and/or DDR2 DNA copy number in tumor tissue or in circulating tumor DNA (ctDNA) of a patient, and/or measuring Nectin-4 protein level in a tumor tissue of a patient, and selecting a patient having an elevated Nectin-4, SDHC and/or DDR2 DNA copy number in the tumor tissue, and/or an elevated Nectin-4 protein level in the tumor tissue.
A method of identifying or selecting a patient having an elevated Nectin-4 protein and/or RNA expression level in a tumor tissue, comprising measuring the Nectin-4, SDHC and/or DDR2 DNA copy number of a patient using Next-generation sequencing (NGS) technologies or an array-based sequence capture, and selecting a patient who has an elevated Nectin-4, SDHC and/or DDR2 DNA copy number.
4-9. (canceled)
12-13. (canceled)
A method of treating a cancer in a patient having an elevated Nectin-4 protein and/or RNA expression level in tumor tissue, comprising administering to the patient a Bicycle toxin conjugate or Bicycle TICA specific for Nectin-4, or a pharmaceutically acceptable salt thereof, or a pharmaceutical composition thereof.
16-17. (canceled)
A method of treating a cancer in a patient, comprising selecting a patient having a Nectin-4, SDHC and/or DDR2 Log 2(CN ratio) of about 0.1 or more, about 0.2 or more, about 0.3 or more, about 0.4 or more, about 0.5 or more, about 0.6 or more, about 0.7 or more, about 0.8 or more, about 0.9 or more, or about 1.0 or more in tumor tissue or in circulating tumor DNA (ctDNA) as determined by Next-generation sequencing (NGS) technologies or an array-based sequence capture, and/or a patient having an H-score of about 15 or more, about 20 or more, about 30 or more, about 40 or more, about 50 or more, about 75 or more, about 100 or more, about 125 or more, or about 150 or more in a tumor tissue section in an Nectin-4 mIF assay, optionally wherein the H-score refers to an H-score for tumor cell membrane or an H-score for tumor cell cytoplasm, and administering to the patient a Bicycle toxin conjugate or Bicycle TICA specific for Nectin-4, or a pharmaceutically acceptable salt thereof, or a pharmaceutical composition thereof.
19-20. (canceled)
23-25. (canceled)
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34-36. (canceled)
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41-42. (canceled)
A method of treating a cancer in a patient, comprising selecting a patient having an H-score for tumor cell membrane of about 15 or more, about 20 or more, about 30 or more, about 40 or more, about 50 or more, about 75 or more, about 100 or more, about 125 or more, or about 150 or more in a tumor tissue section in a Nectin-4 mIF assay, and administering to the patient BT8009 or BT7480, or a pharmaceutically acceptable salt thereof, or a pharmaceutical composition thereof.
(canceled)
Dependencies are inferred from the claim text.