Methods for Treating HPV16-Associated Cancers
AssigneeCue Biopharma, Inc.
InventorsMatteo G. Levisetti, Steven Paul Margossian
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Abstract
This disclosure provides a method of treating an HPV16-associated cancer in an individual, the method comprising administering to the individual a T-cell modulatory protein (TMP) and an PD-(L)1 CPI that targets PD-1 or PD-L1, i.e., a “PD-(L)1 CPI”, where (A) the individual previously was determined to have progressive disease based on RECIST 1.1 criteria following (i) monotherapy with a PD-(L)1 CPI, or (ii) combination therapy comprising treatment with a PD-(L)1 CPI and a therapeutic agent other than the TMP, or (B) where the individual has a PD-L1 Combined Positive Score (PD-L1 CPS) of 0 or more than 0 but less than 1.
Claims97
A method of treating an HPV16-associated cancer in an individual, the method comprising administering to the individual a combination of (i) a PD-(L)1 CPI, and (ii) a T cell modulating protein (TMP), wherein the TMP comprises:
- i) an HPV16 cancer-associated peptide, wherein the HPV16 cancer-associated peptide is a peptide having a length of from 8 amino acids to 14 amino acids;
- ii) a β2-microglobulin (β2M) polypeptide;
- iii) one or more immunomodulatory polypeptides;
- iv) a class I major histocompatibility complex (MHC) heavy chain polypeptide;
- and
- v) a scaffold component, optionally wherein the scaffold component is an immunoglobulin (Ig) Fc polypeptide,
- wherein the TMP may comprise one or more independently selected peptide linkers between any two of the components, and wherein when the TMP comprises more than one immunomodulatory polypeptide, the immunomodulatory polypeptides may be connected by one or more independently selected peptide linkers,
- wherein the individual was previously determined to have progressive disease based on RECIST 1.1 criteria following (i) monotherapy with a PD-(L)1 CPI, or (ii) combination therapy comprising treatment with a PD-(L)1 CPI and one or more therapeutic agents (optionally one or more chemotherapeutic agents) other than the TMP, and
- wherein the PD-(L)1 CPI and the TMP are administered at the same time or at different times.
A method of treating an HPV16-associated cancer in an individual, the method comprising administering to the individual a combination of (i) a PD-(L)1 CPI, and (ii) a T cell modulating protein (TMP), wherein the TMP comprises:
- i) an HPV16 cancer-associated peptide, wherein the HPV16 cancer-associated peptide is a peptide having a length of from 8 amino acids to 14 amino acids;
- ii) a β2-microglobulin (β2M) polypeptide;
- iii) one or more immunomodulatory polypeptides;
- iv) a class I major histocompatibility complex (MHC) heavy chain polypeptide;
- and
- v) a scaffold component, optionally wherein the scaffold component is an immunoglobulin (Ig) Fc polypeptide,
- wherein the TMP comprises one or more independently selected peptide linkers between any two of the components, and wherein when the TMP comprises more than one immunomodulatory polypeptide, the immunomodulatory polypeptides may be connected by one or more independently selected peptide linkers,
- wherein the PD-(L)1 CPI and the protein are administered at the same time or at different times, and
- wherein the cancer is associated with a PD-L1 Combined Positive Score (PD-L1 CPS) that is either 0 or more than 0 but less than 1.
Dependencies are inferred from the claim text.