HRP20240213T1 - Bispecifična antitijela protiv ceacam5 i cd47 - Google Patents
Bispecifična antitijela protiv ceacam5 i cd47 Download PDFInfo
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- HRP20240213T1 HRP20240213T1 HRP20240213TT HRP20240213T HRP20240213T1 HR P20240213 T1 HRP20240213 T1 HR P20240213T1 HR P20240213T T HRP20240213T T HR P20240213TT HR P20240213 T HRP20240213 T HR P20240213T HR P20240213 T1 HRP20240213 T1 HR P20240213T1
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- Prior art keywords
- seq
- bispecific antibody
- variable region
- light chain
- binding part
- Prior art date
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- 101000914324 Homo sapiens Carcinoembryonic antigen-related cell adhesion molecule 5 Proteins 0.000 claims 8
- 101000868279 Homo sapiens Leukocyte surface antigen CD47 Proteins 0.000 claims 6
- 206010028980 Neoplasm Diseases 0.000 claims 6
- 201000011510 cancer Diseases 0.000 claims 6
- 210000004027 cell Anatomy 0.000 claims 6
- 102100025475 Carcinoembryonic antigen-related cell adhesion molecule 5 Human genes 0.000 claims 4
- 102000047627 human CEACAM5 Human genes 0.000 claims 4
- 208000002154 non-small cell lung carcinoma Diseases 0.000 claims 4
- 102000040430 polynucleotide Human genes 0.000 claims 4
- 108091033319 polynucleotide Proteins 0.000 claims 4
- 239000002157 polynucleotide Substances 0.000 claims 4
- 208000029729 tumor suppressor gene on chromosome 11 Diseases 0.000 claims 4
- 102100032913 Leukocyte surface antigen CD47 Human genes 0.000 claims 3
- 206010057249 Phagocytosis Diseases 0.000 claims 3
- 239000003814 drug Substances 0.000 claims 3
- 102000044459 human CD47 Human genes 0.000 claims 3
- 230000008782 phagocytosis Effects 0.000 claims 3
- 206010006187 Breast cancer Diseases 0.000 claims 2
- 208000026310 Breast neoplasm Diseases 0.000 claims 2
- 206010009944 Colon cancer Diseases 0.000 claims 2
- 208000001333 Colorectal Neoplasms Diseases 0.000 claims 2
- 101000863873 Homo sapiens Tyrosine-protein phosphatase non-receptor type substrate 1 Proteins 0.000 claims 2
- 206010061902 Pancreatic neoplasm Diseases 0.000 claims 2
- 208000005718 Stomach Neoplasms Diseases 0.000 claims 2
- 102100029948 Tyrosine-protein phosphatase non-receptor type substrate 1 Human genes 0.000 claims 2
- 229940070039 cibisatamab Drugs 0.000 claims 2
- 239000013604 expression vector Substances 0.000 claims 2
- 206010017758 gastric cancer Diseases 0.000 claims 2
- 230000002401 inhibitory effect Effects 0.000 claims 2
- 230000003993 interaction Effects 0.000 claims 2
- 208000015486 malignant pancreatic neoplasm Diseases 0.000 claims 2
- 238000004519 manufacturing process Methods 0.000 claims 2
- 201000002528 pancreatic cancer Diseases 0.000 claims 2
- 208000008443 pancreatic carcinoma Diseases 0.000 claims 2
- 239000008194 pharmaceutical composition Substances 0.000 claims 2
- 239000000825 pharmaceutical preparation Substances 0.000 claims 2
- 239000007787 solid Substances 0.000 claims 2
- 201000011549 stomach cancer Diseases 0.000 claims 2
- 210000004881 tumor cell Anatomy 0.000 claims 2
- 102100025466 Carcinoembryonic antigen-related cell adhesion molecule 3 Human genes 0.000 claims 1
- 101000914337 Homo sapiens Carcinoembryonic antigen-related cell adhesion molecule 3 Proteins 0.000 claims 1
- 101000946860 Homo sapiens T-cell surface glycoprotein CD3 epsilon chain Proteins 0.000 claims 1
- SHZGCJCMOBCMKK-DHVFOXMCSA-N L-fucopyranose Chemical group C[C@@H]1OC(O)[C@@H](O)[C@H](O)[C@@H]1O SHZGCJCMOBCMKK-DHVFOXMCSA-N 0.000 claims 1
- 102100035794 T-cell surface glycoprotein CD3 epsilon chain Human genes 0.000 claims 1
- 238000012258 culturing Methods 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- 238000011275 oncology therapy Methods 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
Classifications
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/30—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
- C07K16/3007—Carcino-embryonic Antigens
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
- C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/40—Immunoglobulins specific features characterized by post-translational modification
- C07K2317/41—Glycosylation, sialylation, or fucosylation
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
- C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
- C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Immunology (AREA)
- Organic Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Molecular Biology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oncology (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Cell Biology (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Ultra Sonic Daignosis Equipment (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Pens And Brushes (AREA)
- Conversion Of X-Rays Into Visible Images (AREA)
Claims (27)
1. Bispecifično antitijelo koje sadrži prvi vezujući dio koji se specifično veže za humani CEACAM5 i drugi vezujući dio koji se specifično veže za humani CD47 naznačen time što:
a) prvi vezujući dio kao varijabilna regija teškog lanca sadrži varijabilnu regiju teškog lanca koji sadrži CDRH1 prema SEQ ID NO:1, CDRH2 prema SEQ ID NO:2 i CDRH3 prema SEQ ID NO:3,
b) prvi vezujući dio kao varijabilna regija lakog lanca sadrži varijabilnu regiju lakog lanca koji sadrži CDRL set izabran iz grupe koja se sastoji od
CDRL1 prema SEQ ID NO:17, CDRL2 prema SEQ ID NO:18 i CDRL3 prema SEQ ID NO:19, ili
CDRL1 prema SEQ ID NO:23, CDRL2 prema SEQ ID NO:24 i CDRL3 prema SEQ ID NO:25, i
c) drugi vezujući dio kao varijabilna regija teškog lanca sadrži varijabilnu regiju teškog lanca koji sadrži CDRH1 prema SEQ ID NO:1, CDRH2 prema SEQ ID NO:2 i CDRH3 prema SEQ ID NO:3, i kao varijabilna regija lakog lanca sadrži varijabilnu regiju lakog lanca koji sadrži CDRL1 prema SEQ ID NO:7, CDRL2 prema SEQ ID NO:8 i CDRL3 prema SEQ ID NO:9.
2. Bispecifično antitijelo prema patentnom zahtjevu 1, naznačeno time što sadrži prvi vezujući dio koji se specifično veže za humani CEACAM5 i drugi vezujući dio koji se specifično veže za humani CD47, naznačen time što u prvom vezujućem dijelu kao varijabilna regija teškog lanca sadrži varijabilnu regiju teškog lanca SEQ ID NO: 4 i kao varijabilna regija lakog lanca sadrži varijabilnu regiju lakog lanca SEQ ID NO: 33 ili SEQ ID NO: 35 i koji u drugom vezujućem dijelu kao varijabilna regija teškog lanca sadrži varijabilnu regiju teškog lanca SEQ ID NO:4 i kao varijabilna regija lakog lanca sadrži varijabilnu regiju lakog lanca koji ima SEQ ID NO:10.
3. Bispecifično antitijelo koje sadrži prvi vezujući dio koji se specifično veže za humani CEACAM5 i drugi vezujući dio koji se specifično veže za humani CD47, naznačen time što u prvom vezujućem dijelu kao varijabilna regija teškog lanca sadrži varijabilnu regiju teškog lanca SEQ ID NO:4 i kao varijabilna regija lakog lanca sadrži varijabilnu regiju lakog lanca izabran iz grupe koja se sastoji od SEQ ID NO:32, SEQ ID NO:34 i SEQ ID NO:36 i u drugom vezujućem dijelu kao varijabilna regija teškog lanca sadrži varijabilnu regiju teškog lanca SEQ ID NO:4 i kao varijabilna regija lakog lanca sadrži varijabilnu regiju lakog lanca koji ima SEQ ID NO:10.
4. Bispecifično antitijelo prema patentnom zahtjevu 2, naznačeno time što u prvom vezujućem dijelu sadrži teški lanac koji sadrži SEQ ID NO: 5 i laki lanac izabran iz grupe koja se sastoji od SEQ ID NO: 38 ili SEQ ID NO: 40 i u drugom vezujućem dijelu sadrži regiju teškog lanca SEQ ID NO:5 i laki lanac koji ima SEQ ID NO:11.
5. Bispecifično antitijelo prema patentnom zahtjevu 3, naznačeno time što u prvom vezujućem dijelu sadrži teški lanac koji sadrži SEQ ID NO: 5 i laki lanac izabran iz grupe koja se sastoji od SEQ ID NO: 37, SEQ ID NO: 39 i SEQ ID NO: 41 i u drugom vezujućem dijelu sadrži regiju teškog lanca SEQ ID NO:5 i laki lanac koji ima SEQ ID NO:11.
6. Bispecifično antitijelo prema bilo kojem od patentnih zahtjeva 1 do 5, naznačeno time što je navedeno antitijelo monovalentno za prvi vezujući dio i monovalentno za drugi vezujući dio.
7. Bispecifično antitijelo prema bilo kojem od patentnih zahtjeva 1 do 6, naznačeno time što navedeno antitijelo sadrži Fc regiju koja je konstruiran glikoinženjeringom tako da ima smanjen broj ostataka fukoze u usporedbi sa istim bispecifičnim antitijelom koje nije konstruirano glikoinženjeringom.
8. Bispecifično antitijelo prema patentnom zahtjevu 1, naznačeno odnosom KD vrijednosti za vezivanje za rekombinantni CEACAM3 i rekombinantni CEACAM5 faktora od 100 ili više.
9. Bispecifično antitijelo prema patentnom zahtjevu 1, naznačeno povećanjem od najmanje 8% maksimalnog indeksa fagocitoze LoVo tumorskih stanica u usporedbi sa indeksom fagocitoze bispecifičnog antitijela K2AC22, koje sadrži uobičajeni teški lanac SEQ ID NO:6, vezujući dio lakog lanca koji se veže za CD47 SEQ ID NO: 42, i laki lanac koji se veže za CEACAM5 prema SEQ ID NO:11.
10. Bispecifično antitijelo prema patentnom zahtjevu 9, naznačeno povećanjem maksimalnog indeksa fagocitoze između 8% i 20% za LoVo tumorske stanice.
11. Bispecifično antitijelo prema patentnom zahtjevu 1, naznačeno inhibiranjem interakcije između CD47 i SIRPα na MKN-45 stanicama sa IC50 od 0.1 nM ili niže.
12. Bispecifično antitijelo prema patentnom zahtjevu 11, naznačeno inhibiranjem interakcije između CD47 i SIRPα na MKN-45 stanicama sa IC50 od 0.1 nM do 0.04 nM.
13. Bispecifično antitijelo prema patentnom zahtjevu 1, pri čemu je navedeno bispecifično antitijelo naznačeno time što cibisatamab u koncentraciji od 300 nM, ne pomiče EC50 krive vezivanja navedenog bispecifičnog antitijela za stanice MKN-45 ili za LS174T stanice za više od faktora 3 ka višim koncentracijama.
14. Izolirani polinukleotid ili set polinukleotida koji kodira bispecifično antitijelo prema bilo kojem od patentnih zahtjeva 1 do 13.
15. Ekspresijski vektor koji sadrži polinukleotid ili polinukleotide prema patentnom zahtjevu 14.
16. Stanica domaćin koja sadrži ekspresijski vektor prema patentnom zahtjevu 15.
17. Postupak za proizvodnju bispecifičnog antitijela prema bilo kojem od patentnih zahtjeva 1-13, koji sadrži a) kultiviranje stanice domaćina prema patentnom zahtjevu 16 pod uvjetima koji dozvoljavaju proizvodnju navedenog bispecifičnog antitijela, i b) izoliranje navedenog antitijela.
18. Bispecifično antitijelo prema bilo kojem od patentnih zahtjeva 1-13, za uporabu u terapiji humanog raka.
19. Bispecifično antitijelo za uporabu prema patentnom zahtjevu 18, naznačeno time što rak je solidni rak.
20. Bispecifično antitijelo za uporabu prema patentnom zahtjevu 19, naznačeno time što rak je kolorektalni rak, NSCLC (nesitnostanični rak pluća), rak želuca, rak gušterače, rak dojke ili drugi rak koji eksprimira CEACAM5.
21. Bispecifično antitijelo prema bilo kojem od patentnih zahtjeva 1-13 za uporabu u istovremenoj, odvojenoj ili uzastopnoj kombinaciji sa drugim bispecifičnim antitijelom koje sadrži treći vezujući dio koji se specifično veže za humani CEACAM5, i četvrti vezujući dio koji se specifično veže za humani CD3ε u liječenju subjekta koji ima rak koji eksprimira CEACAM5.
22. Bispecifično antitijelo prema patentnom zahtjevu 21, naznačeno time što drugo bispecifično antitijelo je cibisatamab.
23. Bispecifično antitijelo za uporabu prema patentnom zahtjevu 21 ili 22 naznačeno time što bispecifično antitijelo prema pronalasku i drugo bispecifično antitijelo se primjenjuju na navedenog subjekta istovremeno u intervalima od 6 do 15 dana.
24. Farmaceutska kompozicija koja sadrži bispecifično antitijelo prema bilo kojem od patentnih zahtjeva 1 do 13 i farmaceutski prihvatljiv ekscipijens ili nosač.
25. Farmaceutski pripravak prema patentnom zahtjevu 24, za uporabu kao lijek.
26. Farmaceutski pripravak prema zahtjevu 24, za uporabu kao lijek u liječenju solidnog raka.
27. Farmaceutski pripravak prema patentnom zahtjevu 24, za uporabu kao lijek u liječenju kolorektalnog raka, NSCLC (nesitnostaničnog raka pluća), raka želuca, raka gušterače ili raka dojke.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP20215766 | 2020-12-18 | ||
| US202163135996P | 2021-01-11 | 2021-01-11 | |
| EP21834934.8A EP4055055B1 (en) | 2020-12-18 | 2021-12-17 | Bispecific antibodies against ceacam5 and cd47 |
| PCT/IB2021/061983 WO2022130348A1 (en) | 2020-12-18 | 2021-12-17 | Bispecific antibodies against ceacam5 and cd47 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20240213T1 true HRP20240213T1 (hr) | 2024-04-26 |
Family
ID=79164846
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20240213TT HRP20240213T1 (hr) | 2020-12-18 | 2021-12-17 | Bispecifična antitijela protiv ceacam5 i cd47 |
Country Status (16)
| Country | Link |
|---|---|
| US (2) | US11753481B2 (hr) |
| EP (1) | EP4055055B1 (hr) |
| JP (1) | JP2024501809A (hr) |
| KR (1) | KR20230121772A (hr) |
| AU (1) | AU2021400227A1 (hr) |
| CA (1) | CA3193210A1 (hr) |
| CL (1) | CL2023001797A1 (hr) |
| CO (1) | CO2023009100A2 (hr) |
| ES (1) | ES2967381T3 (hr) |
| HR (1) | HRP20240213T1 (hr) |
| IL (1) | IL301701A (hr) |
| MX (1) | MX2023007220A (hr) |
| PE (1) | PE20231386A1 (hr) |
| PL (1) | PL4055055T3 (hr) |
| RS (1) | RS65211B1 (hr) |
| WO (1) | WO2022130348A1 (hr) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112566938A (zh) * | 2018-06-03 | 2021-03-26 | 拉姆卡普生物测试有限公司 | 针对ceacam5和cd47的双特异性抗体 |
| AU2021400227A1 (en) | 2020-12-18 | 2023-04-27 | Lamkap Bio Beta Ltd | Bispecific antibodies against ceacam5 and cd47 |
| WO2023170474A1 (en) * | 2022-03-07 | 2023-09-14 | Novimmune Sa | Cd28 bispecific antibodies for targeted t cell activation |
| WO2023242351A1 (en) | 2022-06-16 | 2023-12-21 | Lamkap Bio Beta Ag | Combination therapy of bispecific antibodies against ceacam5 and cd47 and bispecific antibodies against ceacam5 and cd3 |
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| CA3193210A1 (en) | 2022-06-23 |
| IL301701A (en) | 2023-05-01 |
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| US20240101705A1 (en) | 2024-03-28 |
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