# US 2025/0154259 A1 · Novel methods of therapy > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2025/0154259 A1 - Document ID: US20250154259A1 - Status: Published application - Kind: A1 - Application number: 18/836,975 - Filed: 2023-02-17 - Published: 2025-05-15 - Earliest claimed: 2022-02-17 - Applicants: Bivictrix Limited - Inventors: Tiffany Thorn - Web page: https://patentgrep.com/patent/US20250154259A1 ## CPC - C07K 16/2827: {against B7 molecules, e.g. CD80, CD86} - A61K 47/68031: {the drug being an auristatin} - A61K 47/6849: {the antibody targeting a receptor, a cell surface antigen or a cell surface determinant} - A61K 47/6851: {the antibody targeting a determinant of a tumour cell} - A61K 47/6879: {the immunoglobulin having two or more different antigen-binding sites, e.g. bispecific or multispecific immunoglobulin} - A61P 35/00: Antineoplastic agents - C07K 16/2803: {against the immunoglobulin superfamily} - C07K 2317/31: multispecific - C07K 2317/52: Constant or Fc region; Isotype - C07K 2317/55: Fab or Fab' - C07K 2317/622: Single chain antibody (scFv) - C07K 2317/732: Antibody-dependent cellular cytotoxicity [ADCC] - C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00) - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract The present invention relates to compositions for use in the treatment of a malignancy, wherein the composition comprises an agent that binds CD33 and B7H4. The present invention also relates to combinations agents targeting the protein pairs. ## Claims ### Claim 1 A composition for use in the treatment of a malignancy, wherein the composition comprises an agent that binds to CD33 and B7H4. ### Claim 2 (depends on 1) The composition for use according to claim 1, wherein the composition is a non-immune suppressing treatment. ### Claim 3 (depends on 2) The composition for use according to claim 2, wherein the non-immune suppressing treatment is non-myelosuppressing treatment. ### Claim 4 The composition for use according to any preceding claim, wherein the agent is an antibody or antigen binding fragment thereof. ### Claim 5 The composition for use according to any preceding claim, wherein the agent is a bispecific antibody or antigen binding fragment thereof that binds CD33 and B7H4. ### Claim 6 The composition for use according to a preceding claim, wherein the composition further comprises a payload. ### Claim 7 (depends on 6) The composition for use according to claim 6 wherein the payload is a cell killing agent, an immune-modulating payload, a macrophage class switching agent, or a light activatable payload. ### Claim 8 (depends on 7) The composition for use according to claim 7 wherein the immune-modulating payload is a STING agonist or a toll-like receptor agonist. ### Claim 9 (depends on 7) The composition for use according to claim 7, wherein the cell killing agent comprises a cytotoxin. ### Claim 10 (depends on 9) The composition for use according to claim 9, wherein said cytotoxin is selected from: i) a peptide toxin; or ii) a chemical toxin. ### Claim 11 (depends on 9, 10) The composition for use according to claims 9 to 10, wherein the composition further comprises a linker for linking the payload to the agent that binds to CD33 and B7H4 expressed on the cell surface. ### Claim 12 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11) The composition for use according to claims 1 to 11, wherein the composition is a bispecific antibody drug conjugate. ### Claim 13 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12) The composition for use according to claims 1 to 12, wherein the malignancy comprises a malignant disease associated with an increase in myeloid derived suppressor cells. ### Claim 14 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13) The composition for use according to claims 1 to 13, wherein the malignancy is an ovarian cancer, an ovarian cancer derived cancer, Acute Myeloid Leukaemia (AML) or AML derived cancer. ### Claim 15 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13) The composition for use according to claims 1 to 13, wherein the malignancy is selected from one of the following cancers: haematological cancers including Multiple Myeloma (MM), Acute Myeloid Leukaemia (AML), T-Cell Acute Lymphoblastic Leukaemia (T-ALL), Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), Chronic Lymphocytic Leukaemia (CLL), Myelodysplastic Syndrome (MDS), and Diffuse Large B cell Lymphoma (DLBCL); or Hepatocellular Carcinoma; or Gynaecological Cancers including Ovarian Cancer, Cervical Cancer, and Endometrial Cancer; lung cancer, bladder cancer breast cancer, renal cell carcinoma, melanoma, colorectal cancer, gastric cancer, pancreatic cancer, thyroid cancer, liver cancer and glioblastoma. ### Claim 16 A bispecific antibody or antibody fragment capable of binding CD33 and B7H4 for use in the treatment of cancer. ### Claim 17 (depends on 16) The bispecific antibody according to claim 16 wherein the cancer is a haematological cancer or Multiple Myeloma. ### Claim 18 (depends on 16, 17) The bispecific antibody according to claim 16 or 17 wherein said use comprises contacting cells that express both CD33 and B7H4. ### Claim 19 A method for treating a malignancy comprising administering to a subject in need thereof an agent that binds to CD33 and B7H4. ### Claim 20 (depends on 19) The method according to claim 19, wherein the treatment is a non-immune suppressing treatment. ### Claim 21 (depends on 20) The method according to claim 20, wherein the treatment is a non-myelosuppressing treatment. ### Claim 22 (depends on 19, 20, 21) The method according to any of claims 19 to 21, wherein the agent is an antibody or antigen binding fragment thereof. ### Claim 23 (depends on 22) The method according to claim 22, wherein the agent is a bispecific antibody or antigen binding fragment thereof that binds CD33 and B7H4. ### Claim 24 (depends on 19, 20, 21, 22) The method according to any of claims 19 to 22, wherein the composition further comprises a payload. ### Claim 25 (depends on 24) The composition for use according to claim 24 wherein the payload is a cell killing agent, an immune-modulating payload, a macrophage class switching agent, or a light activatable payload. ### Claim 26 (depends on 25) The composition for use according to claim 25 wherein the immune-modulating payload is a STING agonist or a toll-like receptor agonist. ### Claim 27 (depends on 25) The method according to claim 25, wherein the cell killing agent comprises a cytotoxin. ### Claim 28 (depends on 27) The method according to claim 27, wherein said cytotoxin is selected from: i) a peptide toxin; or ii) a chemical toxin. ### Claim 29 (depends on 26, 27, 28) The method according to any of claims 26 to 28, wherein the composition further comprises a linker for linking the payload to the agent that binds to CD33 and B7H4. ### Claim 30 (depends on 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29) The method according to any of claims 19 to 29, wherein the composition is a bispecific antibody drug conjugate. ### Claim 31 (depends on 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30) The method according to claims 19 to 30, wherein the malignancy is selected from one of the following cancers: haematological cancers or Multiple Myeloma. ### Claim 32 (depends on 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30) The method according to any of claims 19 to 30, wherein the malignancy is an AML or AML derived cancer. ### Claim 33 (depends on 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30) The method according to any of claims 19 to 30, wherein the malignancy is selected from one of the following cancers: haematological cancers including Multiple Myeloma (MM), Acute Myeloid Leukaemia (AML), T-Cell Acute Lymphoblastic Leukaemia (T-ALL), Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), Chronic Lymphocytic Leukaemia (CLL), Myelodysplastic Syndrome (MDS), and Diffuse Large B cell Lymphoma (DLBCL); or Hepatocellular Carcinoma; or Gynaecological Cancers including Ovarian Cancer, Cervical Cancer, and Endometrial Cancer; lung cancer, bladder cancer, breast cancer, renal cell carcinoma, melanoma, colorectal cancer, gastric cancer, pancreatic cancer, thyroid cancer, liver cancer and glioblastoma. ### Claim 34 A method of targeting cells that express both CD33 and B7H4 comprising administering to a subject an agent that binds to CD33 and B7H4. ### Claim 35 (depends on 34) The method of claim 34 wherein the agent is a bispecific antibody or antigen binding fragment thereof that binds CD33 and B7H4 linked to a cell killing portion. ### Claim 36 A combination of agents for use in the treatment of a malignancy, wherein the cell inhibiting agents bind to CD33 and B7H4. ### Claim 37 (depends on 36) The combination for use according to claim 36, wherein the combination is non-immune suppressing. ### Claim 38 (depends on 37) The combination for use according to claim 37, wherein the non-immune suppressing treatment is non-myelosuppressing. ### Claim 39 (depends on 36, 37, 38) The combination for use according to any of claims 36 to 38, wherein the agents comprise antibodies or antigen binding fragment thereof. ### Claim 40 (depends on 36, 37, 38, 39) The combination for use according to any of claims 36 to 39, wherein the agents further comprises a payload. ### Claim 41 (depends on 40) The combination for use according to claim 40 wherein the payload is a cell killing agent, an immune-modulating payload, a macrophage class switching agent or a light activatable payload. ### Claim 42 (depends on 41) The combination for use according to claim 41 wherein the immune-modulating payload is a STING agonist or a toll-like receptor agonist. ### Claim 43 (depends on 42) The combination for use according to claim 42, wherein the cell killing agent comprises a cytotoxin. ### Claim 44 (depends on 43) The combination for use according to claim 43, wherein said cytotoxin is selected from: i) a peptide toxin; or ii) a chemical toxin. ### Claim 45 (depends on 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46) The combination for use according to claims 36 to 46, wherein the agents further comprises a linker for linking the payload to the agent that binds to CD33 and B7H4 expressed on the cell surface. ### Claim 46 (depends on 36, 37, 38, 39) The combination for use according to claims 36 to 39, wherein the agent is an antibody drug conjugate. ### Claim 47 (depends on 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46) The combination for use according to claims 32 to 46, wherein the malignancy comprises a malignant disease associated with an increase in myeloid derived suppressor cells. ### Claim 48 (depends on 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47) The combination for use according to claims 36 to 47, wherein the malignancy is an ovarian cancer, ovarian cancer derived cancer, AML or AML derived cancer. ### Claim 49 (depends on 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48) The combination for use according to claims 36 to 48, wherein the malignancy is selected from one of the following cancers: haematological cancers including Multiple Myeloma (MM), Acute Myeloid Leukaemia (AML), T-Cell Acute Lymphoblastic Leukaemia (T-ALL), Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), Chronic Lymphocytic Leukaemia (CLL), Myelodysplastic Syndrome (MDS) and Diffuse Large B cell Lymphoma (DLBCL); or Hepatocellular Carcinoma; or Gynaecological Cancers including Ovarian Cancer, Cervical Cancer and Endometrial Cancer; lung cancer, bladder cancer breast cancer, renal cell carcinoma, melanoma, colorectal cancer, gastric cancer, pancreatic cancer, thyroid cancer, liver cancer and glioblastoma. ### Claim 50 A bispecific antibody or antigen binding fragment thereof capable of binding CD33 and B7H4. ### Claim 51 (depends on 50) The bispecific antibody or antigen binding fragment thereof according to claim 50 linked to a payload. ### Claim 52 (depends on 51) The composition for use according to claim 51 wherein the payload is a cell killing agent, an immune-modulating payload, a macrophage class switching agent, or a light activatable payload. ### Claim 53 (depends on 52) The composition for use according to claim 52 wherein the immune-modulating payload is a STING agonist or a toll-like receptor agonist. ### Claim 54 (depends on 52) The bispecific antibody or antigen binding fragment thereof according to claim 52, wherein the payload comprises a cytotoxin. ### Claim 55 (depends on 54) The bispecific antibody or antigen binding fragment thereof according to claim 54, wherein said cytotoxin is selected from: i) a peptide toxin; or ii) a chemical toxin. ### Claim 56 (depends on 50, 51, 52, 53, 54, 55) A pharmaceutical composition comprising an antibody or antigen binding fragment thereof according to any of claims 50 to 55. ### Claim 57 (depends on 50, 51, 52, 53, 54, 55, 56) A kit comprising an antibody or antigen binding fragment thereof according to any of claims 50 to 55 or a pharmaceutical composition according to claim 56.