RU2017128109A - Молекулярные конструкции с нацеливающими и эффекторными элементами - Google Patents
Молекулярные конструкции с нацеливающими и эффекторными элементами Download PDFInfo
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- RU2017128109A RU2017128109A RU2017128109A RU2017128109A RU2017128109A RU 2017128109 A RU2017128109 A RU 2017128109A RU 2017128109 A RU2017128109 A RU 2017128109A RU 2017128109 A RU2017128109 A RU 2017128109A RU 2017128109 A RU2017128109 A RU 2017128109A
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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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/397—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having four-membered rings, e.g. azetidine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/445—Non condensed piperidines, e.g. piperocaine
- A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
- A61K31/4545—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a six-membered ring with nitrogen as a ring hetero atom, e.g. pipamperone, anabasine
-
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Claims (35)
1. Линкерное звено, содержащее центральную сердцевину, множество связывающих ветвей и необязательно соединяющую ветвь, где
центральная сердцевина содержит (1) первый полипептид, содержащий множество лизиновых (K) остатков, где каждый остаток K отделен от следующего за ним остатка K вставочной последовательностью, содержащей глициновые (G) и сериновые (S) остатки, и количество остатков K находится в диапазоне от 2 до 15; или (2) второй полипептид, содержащий последовательность (Хаа-K)n, где каждый Хаа представляет собой пегилированную аминокислоту, имеющую 2-12 повторяющихся этиленгликолевых (EG) звеньев, а n представляет собой целое число от 2 до 15;
множество связывающих ветвей соответственно связано с остатками K центральной сердцевины,
каждая из множества связывающих ветвей имеет малеимидную группу на своем свободном конце; и
аминокислотный остаток на N- или С-конце центральной сердцевины имеет азидную или алкиновую группу; или аминокислотный остаток на N- или С-конце центральной сердцевины представляет собой цистеиновый остаток, и тиольная группа цистеинового остатка связана с соединяющей ветвью, имеющей азидную, алкиновую, тетразиновую или напряженную алкиновую группу на свободном конце соединяющей ветви.
2. Линкерное звено по п. 1, где вставочная последовательность имеет последовательность GS, GGS, GSG или SEQ ID NO: 1-16.
3. Линкерное звено по п. 1 или 2, где каждая из связывающих ветвей представляет собой цепь PEG, имеющую 2-20 повторяющихся EG-звеньев, а соединяющая ветвь представляет собой цепь PEG, имеющую 2-12 повторяющихся EG-звеньев.
4. Линкерное звено по любому из пп. 1-3, где аминокислотный остаток, имеющий азидную группу, представляет собой L-азидогомоаланин (AHA), 4-азидо-L-фенилаланин, 4-азидо-D-фенилаланин, 3-азидо-L-аланин, 3-азидо-D-аланин, 4-азидо-L-гомоаланин, 4-азидо-D-гомоаланин, 5-азидо-L-орнитин, 5-азидо-D-орнитин, 6-азидо-L-лизин или 6-азидо-D-лизин; аминокислотный остаток, имеющий алкиновую группу, представляет собой L-гомопропаргилглицин (L-HPG), D-гомопропаргилглицин (D-HPG) или бета-гомопропаргилглицин (β-HPG), напряженная алкиновая группа представляет собой транс-циклооктеновую (ТСО), дибензоциклооктиновую (DBCO), дифторциклооктиновую (DIFO), бициклонониновую (BCN) или дибензоциклооктиновую (DICO) группу; илитетразиновая группа представляет собой 1,2,3,4-тетразиновую, 1,2,3,5-тетразиновую или 1,2,4,5-тетразиновую группы или их производные.
5. Линкерное звено по любому из пп. 1-4, дополнительно содержащее множество первых элементов, соответственно связанных со множеством связывающих ветвей посредством реакции тиольной и малеимидной групп.
6. Линкерное звено по п. 5, дополнительно содержащее второй элемент, который связан с азидной группой посредством реакции азид-алкинового циклоприсоединения, катализируемого медью (CuAAC), или химической азид-алкиновой клик-реакции, промотируемой напряжением (SPAAC);
связан с алкиновой группой посредством реакции CuAAC;
связан с напряженной алкиновой группой посредством реакции Дильса-Альдера с обратными электронными требованиями (iEDDA) или реакции SPAAC или
связан с тетразиновой группой посредством реакции iEDDA.
7. Линкерное звено по п. 6, дополнительно содержащее третий элемент, где, если второй элемент связан посредством реакции CuAAC, третий элемент связан с соединяющей ветвью посредством реакции iEDDA, в то время как, если второй элемент связан посредством реакции SPAAC, третий элемент связан с соединяющей ветвью посредством реакции iEDDA.
8. Линкерное звено по п. 7, где третий элемент представляет собой длинную цепь PEG, имеющую молекулярный вес, составляющий приблизительно 20000-50000 дальтонов.
9. Линкерное звено по п. 6, где
первый элемент представляет собой первый одноцепочечный вариабельный фрагмент (scFv), специфичный к цитокину или рецептору цитокина; или растворимый рецептор цитокина; а
второй элемент представляет собой второй scFv, специфичный к тканевому белку внеклеточного матрикса.
10. Линкерное звено по п. 9, где тканевой белок внеклеточного матрикса выбран из группы, состоящей из α-аггрекана, коллагена I типа, коллагена II типа, коллагена III типа, коллагена V типа, коллагена VII типа, коллагена IX типа и коллагена XI типа; цитокин выбран из группы, состоящей из фактора некроза опухоли-α (TNF-α), интерлейки на-17 (IL-17), IL-1, IL-6, IL-12/IL-23 и фактора активации В-клеток (BAFF); рецептор цитокина представляет собой рецептор, специфичный к IL-6 (IL-6R), или рецептор, специфичный к IL-17 (IL-17R); или растворимый рецептор цитокина является специфичным к TNF-α или IL-1.
11. Линкерное звено по п. 6, где
первый элемент представляет собой первый scFv, специфичный к первому антигену клеточной поверхности; а
второй элемент представляет собой второй scFv, специфичный ко второму антигену клеточной поверхности.
12. Линкерное звено по п. 11, где первый антиген клеточной поверхности выбран из группы, состоящей из CD5, CD19, CD20, CD22, CD23, CD27, CD30, CD33, CD34, CD37, CD38, CD43, CD72a, CD78, CD79a, CD79b, CD86, CD134, CD137, CD138 и CD319; а второй антиген клеточной поверхности представляет собой CD3 или CD16a.
13. Линкерное звено по п. 6, где
первый элемент представляет собой пептидный гормон, фактор роста или первый scFv, специфичный к опухолеассоциированному антигену; а
второй элемент представляет собой второй scFv, специфичный к антигену клеточной поверхности.
14. Линкерное звено по п. 13, где пептидный гормон представляет собой секретин, холецистокинин (CCK), соматостатин или тиреостимулирующий гормон (TSH);фактop роста выбран из группы, состоящей из эпидермального фактора роста (EGF), мутантного EGF, эпирегулина, гепарин-связывающего эпидермального фактора роста (HB-EGF), фактора роста эндотелия сосудов A (VEGF-A), основного фактора роста фибробластов (bFGF) и фактора роста гепатоцитов (HGF); опухолеассоциированный антиген выбран из группы, состоящей из рецептора человеческого эпидермального фактора роста (HER1), HER2, HER3, HER4, углеводного антигена 19-9 (СА 19-9), углеводного антигена 125 (СА 125), раково-эмбрионального антигена (СЕА), муцина 1 (MUC 1), ганглиозида GD2, антигена, ассоциированного с меланомой (MAGE), простатического специфического мембранного антигена (PSMA), антигена стволовых клеток предстательной железы (PSCA), мезотелина, Tn, родственного муцину, сиалированного Tn, глобо-Н, стадиеспецифического эмбрионального антигена 4 (SSEA-4) и молекулы адгезии эпителиальных клеток (ЕрСАМ); или антиген клеточной поверхности представляет собой CD3 или CD16a.
15. Линкерное звено по п. 6, где,
если первый элемент представляет собой первый scFv, специфичный к лиганду рецептора-активатора ядерного фактора кВ (RANKL), второй элемент представляет собой второй scFv, специфичный к коллагену I типа или остеонектину; или,
если первый элемент представляет собой scFv, специфичный к VEGF-A, второй элемент представляет собой длинную цепь PEG, имеющую молекулярный вес, составляющий приблизительно 20000-50000 дальтонов.
16. Способ лечения субъекта, имеющего или предположительно имеющего иммунологическое нарушение, включающий введение субъекту, нуждающемуся в этом, терапевтически эффективного количества линкерного звена по п. 9.
17. Способ лечения субъекта, имеющего или предположительно имеющего диффузную опухоль, включающий введение субъекту, нуждающемуся в этом, терапевтически эффективного количества линкерного звена по п. 11.
18. Способ лечения субъекта, имеющего или предположительно имеющего солидную опухоль, включающий введение субъекту, нуждающемуся в этом, терапевтически эффективного количества линкерного звена по п. 13.
19. Способ лечения субъекта, имеющего или предположительно имеющего остеопорозное заболевание, включающий введение субъекту, нуждающемуся в этом, терапевтически эффективного количества линкерного звена по п. 15, где первый элемент представляет собой первый scFv, специфичный к лиганду рецептора-активатора ядерного фактора кВ (RANKL); а второй элемент представляет собой второй scFv, специфичный к коллагену I типа или остеонектину.
20. Способ лечения субъекта, страдающего от возрастной макулярной дегенерации (AMD), включающий введение субъекту, нуждающемуся в этом, терапевтически эффективного количества линкерного звена по п. 15, где первый элемент представляет собой scFv, специфичный к VEGF-A, второй элемент представляет собой длинную цепь PEG, имеющую молекулярный вес, составляющий приблизительно 20000-50000 дальтонов.
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